August 27, 2015

Unhygienic Scopes Continue to Spread Infection

In the same week in which the FDA issued warnings to companies whose invasive medical scopes are difficult to disinfect and that have spread deadly infections, another hospital’s infectious outbreak is being investigated for the same type of problem.

As the Los Angeles Times reported last week, Huntington Memorial Hospital in Pasadena, Calif., informed health authorities about the possible link between a small wave of infections and bacteria-trapping Olympus duodenoscopes. That company makes more than 8 in 10 of such devices used in the U.S.

As our blog explained when the first outbreaks were reported earlier this year, duodenoscopes are inserted into and down patients’ throats to view and treat a variety of serious, often life-threatening gastrointestinal problems. Although the FDA cited manufacturers for not reporting infections they knew were occurring because their equipment couldn’t be fully disinfected, the feds continue to allow their use because there are no options for the critically ill people who might benefit from them.

But as The Times story made clear, many medical experts say incidents of infection remain unreported, and their number might be quite higher than what we know.

More than 650,000 of these procedures (endoscopic retrograde cholangiopancreatography, or ERCP) are done annually in the U.S. If your doctor recommends you undergo one, make sure you understand why he or she thinks it’s worth the risk.

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August 16, 2015

FDA to Revisit Safety of Essure

Essure is the only nonsurgical permanent birth control option approved by the FDA. And thousands of women are wondering why it’s still on the market.

Many women who have undergone the procedure to implant Essure have had it removed after experiencing a range of side effects, including chronic fatigue, migraines, joint pain, digestive issues, back pain, heavy periods full of clots, difficulty concentrating, abdominal pain, hair loss, tooth deterioration, depression and severe bloating.

Amanda Dykeman, 33, was one of those women. In a story by NPR, she said, “Physically, it has permanently ruined my body inside and out."

Approved by the FDA in 2002 for women ages 21 to 45, Essure is a soft, flexible metal spring made from a nickel-titanium alloy. An obstetrician/gynecologist inserts one coil into each of a woman’s fallopian tubes. As scar tissue grows around the foreign body, it blocks the tubes and prevents eggs from entering the uterus and becoming fertilized. The principle is the same as an IUD, but it’s placed higher up the reproductive organs.

Women who have had Essure implanted must return three months later for a follow-up X-ray using dye to confirm that the tubes are fully blocked, at which point it’s considered 99.83% effective against conception.

Dykeman participated in a Facebook group of more than 18,000 women who have experienced problems with Essure. Although it’s supposed to be permanent, many of the women, like Dykeman, have had it removed and don’t understand why their doctors, the FDA and Bayer, the manufacturer of the device, for years have dismissed their concerns.

Bayer noted the product passed a detailed analysis by the FDA before it was put on the market. "Essure was reviewed through the premarket approval process for Class III medical devices, the most stringent type of device marketing application, according to the FDA," a spokeswoman for Bayer told NPR.

Bayer said approximately 750,000 women have been implanted with the device.

But as of this summer, the FDA finally seems to be hearing the complaints. It updated the short- and long-term risks listed on its website as affiliated with Essure, as well as adverse events reported through May.

Patients and doctors can report problems that occur after implantation of a medical device to the FDA's Manufacturer and User Facility Device Experience database (MAUDE), but the device surveillance system is passive, NPR explained. That means anyone can report anything that happens, whether it’s related to the device or not. Some problems might be reported several times, and others not at all.

Since Essure's approval, the FDA has received more than 5,000 reports of medical problems linked to it, primarily abdominal pain, headaches, fatigue and weight fluctuations. More than 400 accounts by patients or doctors have reported that Essure coils migrated from the fallopian tubes to other parts of the reproductive system, and five reported fetal deaths after Essure failed to prevent pregnancy. But it’s unknown how many of those 5,000 reports are duplicates, and how many are problems caused by Essure.

The FDA has scheduled a public advisory meeting of its Obstetrics and Gynecology Devices Panel for September that will include experts, physicians and patient and industry advocates to review the data and hear public comments from women.

Among measures it might consider are whether Bayer must amend labeling, whether Essure should be removed from the market and whether additional studies are required about its risks and benefits.

For a clear risk/benefit picture of Essure, any problems associated with the device would have to be compared against the risks of laparoscopy, pregnancy and other forms of birth control. (Laparoscopy is minimally invasive surgery in which a fiber-optic instrument is inserted through the abdominal wall to view the organs in the abdomen or to permit a surgical procedure.)

It’s unclear now if Essure actually causes many of the problems women report, and how common they are.

Dr. Elizabeth Micks, an Ob-Gyn and contraception specialist at the University of Washington Medical Center in Seattle, said women often voice complaints they attribute to their method of birth control, even if that method cannot feasibly cause some of them.

"Some are valid, and some may not be valid, and it's hard to really know in some cases whether the method is causing the patient's complaints," Micks said. "I think it is very clear that some women have been harmed by the Essure device. Whether that means it should not be an approved method isn't clear."

Based on the data from the clinical trials conducted before Essure was available to consumers, about 9 in 100 women experience mild to moderate pain during the procedure, and 13 in 100 experience it immediately afterward. Other known effects immediately after the procedure include cramping, vaginal bleeding, nausea, vomiting, fainting and pelvic or back pain for several days. Rarely, the body can expel a coil.

Long-term risks, according to the data, include rare cases of chronic pelvic pain; allergic reactions to the nickel; a coil that perforates the fallopian tube or uterus; or cases in which the coil migrates through the tubes, requiring surgery. Women with Essure also have a higher risk of ectopic pregnancies (conception occurs not in the uterus, but outside, usually in the fallopian tube).

Bayer reported that five years after the device went on the market there were no significant new safety concerns, such as extreme fatigue, depression or weight gain, or an increase in known ones.

But that’s insufficient, Dykeman and her fellows on social media say, because most research to date has been funded by Bayer or by Conceptus Inc., the company that developed the device and was then acquired by Bayer.

Micks wants more data on long-term complications. The longest study currently available is a 10-year retrospective study, which mostly analyzed pregnancies and contraceptive effectiveness.

"Most of the data we have are from the clinical trials, and you can't necessarily go by the clinical trial data in looking at complications because obviously some women in real life practice aren't following up,” Micks said, “so we don't really know if they have a malposition of their coils. … I feel like the terrible cases I've seen are really people who were not properly informed about the risks and benefits ahead of time. I think the bigger problem is what physicians are communicating with patients."

Dykeman probably would find that … disingenuous. Her pain and symptoms prompted her to request a hysterectomy nearly three years after she got Essure. Her surgical report noted chronic inflammation of the cervix, several attached blood clots and a photo showing a coil outside her left fallopian tube.

Her symptoms improved after the surgery, but they’re not gone. "I was recently told my entire abdomen is full of adhesions that attach my organs together with bands of scar tissue, making it hard for my food to digest," she said.

Micks has observed complications from Essure she attributed to physicians not following standard clinical practice for its use. For example, one woman's follow-up X-ray showed improper placement of the coils and the patient did not receive the proper procedure to remedy it — laparoscopic surgery. Instead, she became pregnant, underwent the Essure procedure a second time and later was found to have three coils perforating the uterus on one side.

What in the world was that practitioner thinking?

"Essure is not perfect, but no method is," Dr. Jeffrey Jensen told NPR. He’s director of the Women's Health Research Unit of the Center for Women's Health at Oregon Health and Science University in Portland. "It is an important option that should be available to women as an alternative to general anesthesia and laparoscopy."

He hopes the FDA will allow Essure to remain on the market, but whatever the agency decides, it should be based on data, not case reports, he said.

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July 28, 2015

Medical Device Bill Needs Greater Scrutiny and Patient Protections

Earlier this month, the U.S. House of Representatives passed legislation that was promoted as a way to streamline the FDA’s process for approving medical devices in order to deliver new treatments to patients sooner.

But some voices have been raised in opposition to the measure because they believe it feeds the worst of commercial instincts while compromising patient safety. Writing in the New York Times, Drs. Rita F. Redberg and Sanket S. Dhruva, both cardiologists, are among those hoping the U.S. Senate takes a more critical view of the 21st Century Cures Act, commonly referred to as Cures.

Although the FDA has regulated approval of medical devices since 1976, the writers noted that the agency has not kept up with technology. “Many high-risk medical devices today are approved on the basis of just one clinical trial (as opposed to new medications, which usually require two trials),” they pointed out. “And only a small minority of clinical studies of medical devices are randomized, controlled and blinded — the gold standard for reliable evidence (and the benchmark to which studies of drugs are held).”

That accounts, they said, for the disturbing frequency of the FDA issuing warnings and recalls after products entered the consumer market and were found to be dangerous. We often write about such events.

Redberg and Dhruva alluded to the 2009 recall of Sprint Fidelis defibrillators, which had been implanted in hundreds of thousands of heart patients and had malfunctioned frequently, causing not only harm but numerous deaths. They wondered, in light of the FDA’s weak record, how many other products of lurking danger remain undetected.

Cures, the authors contended, invites medical device manufacturers to submit evidence of safety and efficacy based on sources other than clinical trials, such as case histories. Those aren’t science, but anecdotes that relate the experiences of individual patients.

Is that really how we should be stamping approval on medical treatments? By relying on the experience of people who might not reflect reality, much less majority?

Cures also would promote faster approval for what it refers to as “breakthrough technologies” “that are believed,” the authors wrote, “but not necessarily proved to offer significant advantages over existing alternatives. This would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk.”

Earlier this year, we wrote about an FDA proposal to grant gravely ill people faster access to experimental drugs, but that’s different from the Cures definition of “breakthrough.” Those people have no other options and limited time for any treatment. In contrast, Redberg and Dhruva believe that this legislative interpretation creates “a perverse incentive for manufacturers to use this term both to take advantage of the faster approval process and as a marketing gimmick.”

No one familiar with Big Pharma’s and device manufacturers’ habits of hiding bad trial results and working to shape reports to their benefit would doubt that claim.

Basically, the op-ed writers said, Cures would shift the burden of evidence to clinical studies that are conducted only after the new devices have been put on the market. That means delays of months and maybe years, because the lag time of such studies is that long. Many are never completed, the writers commented, and when they are, the results often are not made public.

Cures mentions “timely postmarket data collection,” but in the medical realm, where precision should rule, that’s too vague. You can’t enforce something that’s vague, as history informs. “[A]ccording to a 2014 journal article co-written by one of us,” the writers recalled, “the FDA has never issued a warning letter or penalty for a postmarket study delay.”

Let’s say a postmarket clinical study does conclude that a medical device is dangerous; it’s still difficult to yank it off the consumer shelves. “In 2005, … an intracranial stent called the Wingspan was approved on an expedited basis to prevent recurrent strokes. When a high-quality clinical trial was finally completed, in 2011, it found that patients who had the device implanted were more likely to have another stroke and to die than those just receiving medical management. Despite this evidence,” Redberg and Dhruva wrote, “the FDA did not withdraw the device (though it did narrow its recommended uses). The Wingspan continues to be marketed and implanted today, putting patients at unnecessary risk.”

After a medical device is approved by the FDA, its manufacturer still can alter it. For example, it might change to a different gauge wire, or a new material. The FDA is supposed to monitor and approve such changes to ensure the device remains safe and effective. Cures, the writers pointed out, essentially gives this oversight the heave-ho.

“[A]larmingly,” they wrote, “[Cures] would establish a third-party program of nongovernment authorities to assess whether a company is permitted to make such changes. The act would enable the device manufacturer itself to select — and pay [our emphasis] — the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices.”

It’s one thing, an appropriate and righteous thing, for the government to acknowledge and address the need to expedite medical treatments people need to heal, or to retard their decline. But’s it’s another to take action that appears to do so while actually inviting greater harm and ethical sleaze. Cures, according to Redberg, Dhruva and a whole lot of thinking people who are paying attention, “would subject millions of Americans to unsafe or untested medical devices.”

We and they hope that when the Senate considers the bill that it eliminates the dangerous provisions. “Unlike medical drugs,” they pointed out, “which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the FDA are needed to ensure that innovative medical devices lead to better health.”

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July 8, 2015

Feds Go After Websites Selling Suspect Medicine and Devices

Partnering with international regulatory and law enforcement agencies, the FDA last month put the screws to more than 1,000 websites that illegally sell potentially dangerous drugs and medical devices directly to consumers.

Operation Pangea VIII, as described in a news release, was a global cooperative effort led by INTERPOL in which 115 countries participated. For its part, the FDA sent warning letters to the operators of nearly 400 websites offering unapproved or misbranded prescription medicines to U.S. patients and to nine firms distributing unapproved or uncleared medical devices online.

Some of the unapproved prescription drugs the operation targeted purported to be FDA-approved generic versions of brand name drugs. Sold illegally by the websites, they include: “Generic Nolvadex,” “Generic Meridia,” “Generic Valium,” “Generic Truvada” and “Generic Advair Diskus.”

Some of the devices sold illegally online include: “The Ondamed System” and “Colon Care Products of PA Open System Colon Hydrotherapy Device (Grace),” as well as illegal dermal fillers such as “Interfall Hydrogel polyacrylamide dermal filler,” “Dermafil hyaluronic acid dermal filler” and “Teosyal hyaluronic acid dermal filler.”

Preliminary findings from screening foreign products show that some, such as antidepressants, hormone replacement therapies, sleep aids and those to treat erectile dysfunction, high cholesterol and seizures, were intended for sale in the U.S.

In addition to health risks, illegal online pharmacies and illegal online medical device retailers can harm consumers by credit card fraud, identity theft and computer viruses. If you think you’ve been a victim of these dangerous thieves, report the suspected criminal activity to the FDA here.

Learn more about how to identify an illegal pharmacy website and how to find a safe one on the FDA’s page, BeSafeRx: Know Your Online Pharmacy.

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July 6, 2015

MRI Contrast Drugs Might Harm Your Brain

Magnetic resonance imaging (MRI) is a body scan that provides detailed images particularly good for viewing soft tissue (versus a traditional X-ray that’s better for seeing bone). Sometimes, drugs are injected before you have an MRI to add contrast, making the images sharper. But some of the drugs in those agents might be toxic.

We recently wrote about another risk of certain diagnostic scans including MRIs, when people are not told about the risks of radiation. Now, according to, it seems as though the brain can be damaged by a heavy metal the contrast drugs contain called gadolinium.

Marcie Jacobs, a woman profiled in the story, had a family history of breast cancer. In 2001, she decided to have an MRI for preventive care. She was injected with a contrast agent, and later began experiencing strange cognitive effects. At first they were fairly minor, like forgetting about work meetings.

As she continued to have MRIs over several years, the problems got worse. She was a finance manager, and her math skills deteriorated so much that she had to stop working and go on disability.

“She stopped worrying about cancer,” said ProPublica, “and started worrying about imaging drugs.”

A few weeks ago, two prominent radiologic researchers, Dr. Emanuel Kanal and Michael Tweedle wrote an editorial in the journal Radiology, calling for more scientific scrutiny of the use of gadolinium for its potential toxicity in brain tissue.

Of the nine gadolinium-based contrast agents sold in the U.S., the two are of serious concern — Omniscan, made by GE Healthcare, and Magnevist, by Bayer HealthCare. ProPublica reported that both companies said they are monitoring the issue, but that the new studies had not found any clinical impact, including brain injury.

This isn’t the first time safety questions have been raised about contrast agents. In 2007, the FDA slapped a black box warning on them (the most severe of that agency’s cautionary notifications) after they were linked to a sometimes fatal condition called nephrogenic systemic fibrosis (NSF). It’s an impairment of the kidneys, which can have trouble excreting gadolinium.

In 2009, ProPublica reported that the FDA had ignored two of its own medical reviewers who wanted to ban Omniscan for patients with severe kidney disease. By 2010, the feds finally recommended that the GE drug and two other drugs, Magnevist and Optimark, sold by Mallinckrodt Pharmaceuticals, shouldn’t be given to patients with compromised kidneys.

But the recent research cited by Kanal and Tweedle show that even patients with healthy kidneys are retaining gadolinium from Omniscan and Magnevist. It’s estimated, said ProPublica, that 1 in 3 of the 20 million annual MRIs in the U.S. rely on one of the nine contrast agents.

People scheduled for MRIs using contrast agents now are screened for kidney problems, and the incidence of NSF, according to ProPublica, “has essentially disappeared.” And even though the new studies don’t address potential clinical effects of gadolinium in the brain, Kanal told the reporters that their results should make radiologists seriously ponder which agents to prescribe.

“We can use an agent today that does not retain gadolinium in the brain to the degree that [Omniscan and Magnevist] do,” he said. And because the alternatives are at least as good as those two, he asked, “Why are some still prescribing the agents that do accumulate in the brain over the other options?”

That degree of consideration came too late for Marcie Jacobs, even though she can’t prove that those drugs were responsible for her disability.

Her records showed that she had received Omniscan for her first 11 MRIs and Magnevist before the last one, in 2007. Eventually, tests showed that traces of gadolinium had accumulated in her breast, thigh, liver and brain, even though she had no history of kidney disease and did not present a risk for kidney impairment.

Kanal, who advises the FDA and chairs the American Board of MR Safety, said the new studies have “the entire international radiological community – and the FDA – on edge, as this is an entirely unanticipated finding.”

And what does the FDA have to say? That it’s “carefully reviewing” the new studies to “better understand the potential consequences to determine what further action is needed, which may include taking steps to ensure the public is aware of these preliminary findings.”

GE found “no signs or symptoms of potential injury to the brain” associated with Omniscan and “no evidence of cytotoxicity (cell toxicity) in published autopsy studies.” It believes that “continued use of Omniscan according to approved product labeling” is appropriate.

Bayer told ProPublica patient safety is its “primary concern” and wants the authors of the original research studies “to clarify their findings,” even though “none of these studies indicate any clinical implications.”

ProPublica noted that both GE and Bayer have settled hundreds of lawsuits – many involving deaths – while denying liability for their contrast agents, so might we suggest they monitor less and do more to make their products safer?

As we always advise, don’t undergo diagnostic screenings unless there’s a very good reason. Your doctor should make very clear what those reasons are, what the risks of the procedure are, what is expected to be learned from the results and what options are there to having the scan.

To read more about the potential harms of overscreening, see our blogs on the topic.

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June 10, 2015

FBI Investigates Power Morcellator Manufacturer

Last year, after a surgical device was determined to raise the risk of spreading aggressive forms of uterine cancer, one manufacturer recalled all of its power morcellators used to remove uterine fibroids. Now, it’s reported that the FBI has been investigating the company, Johnson & Johnson and its Ethicon subsidiary, over the timing of when it knew about the dangers of its product.

Power morcellation surgery had been popular because it was a less invasive way to remove fibroids in the uterus than traditional surgery. Performed laparoscopically (a small incision is made into which the device is inserted), morcellation surgery broke up fibroids into tiny bits that were removed through the incision.

But after it was learned that many women had contracted advanced cancer after undergoing the procedure, the FDA issued morcellation warnings.

Last month, summarized a story that originally appeared in the Wall Street Journal. Reportedly, “a number of sources close to the company and familiar with uterine fibroid surgical device cancer risks say they have been interviewed by the FBI in recent months.”

When Ethicon recalled its power morcellators and stopped making and selling them, it was commanding about three-quarters of that medical device market. The decision to exit the market was made because the company and an FDA panel believed that there was no way to make the devices safe.

But “[r]eports suggest that Johnson & Johnson may have been warned nearly a decade ago about the risks of upstaging undiagnosed cancer with morcellation during uterine fibroid removal surgery,” according to (“Upstaging” means to deem a cancer at a higher, or more invasive, critical level than before.)

That was the opinion of Dr. Robert Lamparter, a pathologist interviewed by the FBI in May, according to the Journal. Lamparter had warned Ethicon in 2006, eight years before the recall, that power morcellators could be life-threatening because they could spread cancer cells that had been unknown to doctors or patients previous to the laparoscopy. “The manufacturer acknowledges he warned them,” said, “and say they responded by trying to change the instructions on the devices to make them safer.”

In November, the FDA announced that it would allow hysterectomy morcellators to remain on the market, but would require substantially stronger warnings about the risk of cancer and indicate that they would be appropriate treatment for fewer patients than had composed the market before the cancer risk was known. As we blogged, it wasn’t a very popular move by the feds.

Since last year, many hospitals have refused to perform procedures using power morcellators, and several insurance companies now decline to cover such operations.

As you might expect, the number of lawsuits over cancer diagnoses after morecellation procedures has grown. They claim that inadequate warnings were provided for consumers and the medical community.

And now, it seems, the FBI is lending credibility to those allegations.

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May 29, 2015

Panel Warns About Endoscopes, But Advises Their Continued Use

The February outbreak of carbapenem-resistant Enterobacteriacaea (CRE) at a Los Angeles hospital prompted the FDA to assemble a panel of experts to determine the fate of the device responsible for spreading the infection.

A couple of weeks ago, the Gastroenterology and Urology Devices advisory committee unanimously agreed that the device, a specialized endoscope inserted into a patient’s throat, does not offer "reasonable assurance of safety and efficacy," according to a report on

That conclusion was no surprise, because several other hospitals had documented outbreaks related to its use, and the FDA had known about for a couple of years.

The panel decided that although the equipment was difficult if not impossible to disinfect thoroughly between patients, it should not be banned from use because it was needed to treat people with certain life-threatening conditions. It advised the FDA to reclassify duodenoscopes from semi-critical medical devices to critical medical devices.

The advisors called for new protocols to ensure that the scopes can be made reliably sterile, and in deciding to allow them, came down on the “benefit” side of the risk/benefit analysis because the devices provide a unique method of visualizing internal body parts that can’t be duplicated via other means.

Their intricate design affords them superior viewing, but the complex, tiny parts are also what make more difficult to sterilize.

The committee laid out several criteria by which to determine if a patient’s condition demands the endoscopes’ use and, if so, measures that should be followed strictly to enhance the chances of complete sterilization.

The advisors’ recommendations aren’t binding, but the FDA usually relies on them heavily when devising final rules and guidance.

The FDA lacks authority to require device manufacturers to alter their designs, but it can withdraw those deemed too unsafe to justify continued use, and to require changes to device labeling. But it can't require hospitals to follow label directions.

If you or a loved one are scheduled for an endoscopic procedure, ask your doctor what all of the risks are and what outcome is expected. Find out as much as you can about the device and the protocols used to sterilize it. If it is manufactured by Olympus, whose device caused the recent outbreaks, make sure there is no alternative treatment.

If you are unsatisfied with the answers or the measures taken to protect you from contamination, go elsewhere. You can read the advisory committee’s report here.

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May 27, 2015

The Error Rate Rises When Machines Override Human Judgment

If Google maps has made you less able to find your way around a printed version, consider that some people believe that advanced medical technology has led to some epically stupid human medical errors.

Megan McArdle, a columnist for Bloomberg, has looked into the advanced technology = retarded thinking scenario in health care. She recalled the story of a 16-year-old who was hospitalized in 2013 for a routine colonoscopy to check on his congenital gastrointestinal condition.

First he experienced numbness and tingling all over his body, and soon he was having seizures. Why? Because he had been given 39 times too much antibiotic. The teenager’s tale was told on the website Medium in its story “How Medical Tech Gave a Patient a Massive Overdose.”

“[I]f I had to condense its five parts' worth of fascinating insights into one sentence,” McArdle wrote, “here's how it would read: ‘Machines make us stupid.’"

McArdle noted that after having spent three months traveling recently, with only a cellphone, she had forgotten the telephone number of her landline. “To be sure, we don't use it very often,” she wrote. “Still. We've had that number for five years. I forgot it in less than one football season.”

And just as cellphones keep wonderful records of the phone numbers we use, our computers are swift researchers with an excellent memory. Although that capability provides us with more knowledge faster, McArdle accepted that “[I]f I'm cut off from these tools, I am suddenly a moron. And if something gets entered into the computer wrong, I'm totally helpless. A few months back, people gently emailed to inquire where I was, as the panel I was on was about to begin. Turned out I'd put it into the calendar on the wrong day, …”

But that’s a common, human mistake with few real consequences. McArdle’s point was that techno errors can have serious consequences in health care, such as when software that was supposed to prevent a medical error instead contributed to a teenager receiving nearly 40 times the desired dose of his medication.

That horrific occurrence brought to light two contributing human factors: alert blindness and excessive trust in the automated system. In fact, the software did issue a warning to both the doctor and the pharmacist that something was wrong with the prescription. But it also had tried to warn them that something was wrong with a whole lot of the drug orders that were entered into the computer. Most of them were minor, so hospital staffers felt less alerted than annoyed by the serious mistake — they’d glance at the alerts and dismiss them.

If they hadn’t, McArdle wrote, “the hospital would have ground to a halt as everyone devoted their days to reading software alerts. So when a message came along that wasn't trivial, they didn't read it. Or didn't even truly see it.”

The second human failure was creepier. When the system delivered the huge number of pills to the nurse on the floor where the teenager was to receive his procedure, she thought something was wrong. But she administered them anyway, because the system’s bar code system confirmed that they were what the doctor prescribed.

McArdle said that although what the nurse did was idiotic, we’re all prone to that kind of idiocy. “There's an eerie authority to an automated system,” she wrote. …After all, computers are smarter than we are … It's easy to turn off our judgment and hand the decision over to the machine.”

But computers are machines, and machines aren’t perfect either. They’re superior performers for certain tasks they've been programmed to handle, but humans are more successful performers within an unfamiliar environment because we have the capability to judge; we have common sense.

“So when a computer tells us to do something obviously wacky, where is our common sense?” McArdle wondered.

What happened to the part of our brain that used to “get it” when our mother demonstrated the idiocy of peer group pressure by asking “If Johnny also told you to jump off a bridge, would you do it?”

When medical records were keep strictly on paper, errors were also fairly common. But we knew that, so we were more vigilant, McArdle suggested. Automated systems make fewer mistakes, so we're less likely to be watching out for them. Which means that when one occurs, it’s more likely to be a whopper. “The old system gave a lot of people the wrong medication, in the wrong dose, but it probably never gave anyone a 39-fold overdose of antibiotics,” McArdle said. “Unfortunately judgment atrophies just like a muscle.”

Use it or lose it.

The author of the Medium article and a related book, Dr. Robert Wachter, a patient safety advocate whose name is familiar to regular readers of this blog, noted how the aviation industry has refined how pilots get the alerts they need without overwhelming them with insignificant information. So why not the medical industry?

But Wachter also observed that pilot training experts are worried about a higher accident incidence when automated systems fail, and that pilots who spend a lot less time actually flying the plane than they used to might lack the judgment to assume control.

“This is a problem that is also bound to afflict driverless cars,” McArdle noted, “… so let's hope that the experts crack it [before they become commonplace].”

If we don't have a solution to the machines-make-us-dumb proposition, we do have the ability to design better machines that make fewer of these big errors. But, McArdle concluded, we also need never to forget that “human brains are better than computers at a lot of things — so when the computer's instructions seem crazy, you should trust your judgment, not the monomaniacal machine.”

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April 22, 2015

Feds Try Another Way to Fast-Track Approval for Needed Medical Devices

As we wrote a couple of months ago, the FDA has proposed that some gravely ill people get experimental drugs faster than the normal approval process allows. Now, the feds have issued guidelines for device makers to get their wares approved quickly, if they fill the unmet needs of people with life-threatening conditions.

The idea isn’t exactly new. Since the 1980s, the FDA has had a fast-track program for medical devices that it deems “substantially equivalent” to existing devices. The reasoning behind what’s known as the 510(k) process is to dispense with all or most of the clinical testing required by completely new products in order to get worthy new devices to market more quickly.

The guidelines provided earlier this month for the FDA’s Expedited Access Pathway Program (EAP) promise to fast-track medical devices to market without bypassing the pre-market approval (PMA) application process.

As explained by, the EAP is an effort to address a critical medical need without subjecting manufacturers to the “highly criticized” 510(k) process.

On the agency’s blog, FDA Voice, Dr. Jeffry Shuren, director of the FDA’s Center for Devices and Radiological Health, explained how the EAP, a voluntary program, is supposed to work. The FDA would work with a device’s developers during the approval process, and would require a Data Development Plan that shifts some data now collected during pre-market approval to post-market use. That means the manufactures wouldn’t have to provide some of their data about safety and effectiveness until the devices are already on the market.

If that sounds like a really bad idea, the feds justify the potential risk by saying they would limit the program to products “likely to predict clinical benefit,” according to Shuren. “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.”

The program went into effect last week, and eligibility is limited to medical devices intended to treat or diagnose a life-threatening or irreversible and debilitating disease or condition. A device sponsor must submit an acceptable draft Data Development Plan and the device must meet at least one of these criteria:

  • There is no other appropriate alternative treatment or means of diagnosis.

  • It uses breakthrough technology that gives it a clinically meaningful advantage that existing technology lacks.

  • It offers significant, clinically meaningful advantages not achievable by existing technology.

  • Its availability is in the best interest of patients.

Skeptics question the value of the EAP because the FDA routine is criticized for its lousy track record of collecting high-quality, useful post-marketing data. AboutLawsuits referred to a study by the Pew Charitable Trust last year that showed how most FDA-approved medical devices classified as high-to-moderate risk lack publicly available scientific data proving their safety or effectiveness.

The feds have been accused of approving products before requiring their manufacturers to conduct post-marketing studies (post-approval studies, or PAS), so companies often begin selling devices after getting approval and blowing off the follow-up studies.

Most of the time, the Pew research suggested, the FDA doesn’t bother to ask for the post-approval studies and exercises little oversight of them. AboutLawsuits said, “The report found that from 2005 through 2011, the FDA ordered 223 studies for 158 medical devices. Only 48% of those devices deemed high risk were subject to such a study.”

Tellingly, when there is adequate PAS data, the FDA requires the company to change the product label more than half the time.

The “substantially equivalent” requirements of the 510(k) process have been expanded to include products that advertise using new technologies and techniques, and they can be radically different from their predecessors, say FDA critics. They say the term “substantially equivalent” has become meaningless. If the feds couldn’t keep the old fast-track process safe for patients, why are we supposed to believe this one is any better?

Lots of previously fast-tracked products have been recalled because they were found to be dangerous only after they were implanted in patients.

Many metal-on-metal hip replacements and transvaginal surgical mesh products, AboutLawsuits pointed out, found their way onto the market under the “substantial equivalent” test. There was little pre-market testing to ensure their safety.
Their manufacturers, of course, promoted them as “revolutionary” and vastly improved over older devices.

The 510(k) process originally was intended to speed noncritical devices to market; things like bandages and tongue suppressors, not the more invasive, more complicated devices that are implanted permanently into a human body.

The FDA knows it has a problem with fast-track approval. Last summer On July 28, it issued guidance about the definition of “substantially equivalent” to older devices. Shuren’s blog post said the agency is trying to address these concerns in various ways, and promised that the EAP’s priority review process and other aspects of the program should reduce the development cycle for critically necessary medical devices without a lowering of the FDA’s safety and efficacy standards.

We hope so.

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March 31, 2015

Medical Technology Still Requires Nurses to Translate Their Talk

With all their high-tech equipment these days, hospital rooms look more like Mission Control than a healing haven. But for all the help medical machines offer, sometimes they don’t play well with each other, and that requires nurses to run communication interference.

As reported by NPR earlier this month, the ideal techno situation is what engineers call “interoperability.” That means the buzzing, blinking ventilators, IV pumps, heart monitors and computers containing patient records communicate with and update each other as part of business as usual.

But a Harris Poll commissioned by the nonprofit Gary & Mary West Health Institute found that half of more than 500 nurses said they had witnessed a medical error caused by a lack of coordination among devices.

And they should know. Sometimes, they spend more time with machines than people. More than 2 in 3 said they spend at least an hour every shift dealing with devices. A majority reported spending significant time troubleshooting problems, recording data that wasn’t shared electronically and answering alarms.

“The electronic Babel at the patient's bedside,” said the NPR story, “places a heavy burden on nurses and exacts a toll on patients.”

"The nurse ends up having to have a toolbelt on just to deliver care," Linda Burnes Bolton, chief nursing officer at Cedars-Sinai Medical Center in Los Angeles, told NPR.

The burden on nurses can be lightened, said Nicholas Valeriani, CEO of West Health, with … better technology!

That requires medical device manufacturers to reach consensus on communication standards. Their products must be able to communicate not only with each other, but with electronic health record (EHR) systems.

What’s the likelihood of that happening any time soon, when so many providers are frustrated by different EHRs that aren’t compatible, threatening not only efficient office management, but patient safety when a person’s information slips between the cracks, or gets recorded different from what the provider intended?

What’s the likelihood of that happening when, as we reported recently, certain implant device manufacturers are resisting legislative demands to ID their wares, and feuding fed agencies let them?

Valeriani told NPR that carrots, not sticks, could entice manufacturers to establish communication standards. The FDA, for example, could accelerate review of compliant products so their manufacturers could get them to market faster.

Cedars-Sinai has been working with some suppliers to address the “I-can’t-talk-to-you” problem. The hospital was successful in getting its EHRs to connect to infusion pumps so that when a doctor prescribes medication it can be transmitted electronically to the pump. A nurse still is required to verify the meds before the infusion begins.

Good idea, but not an easy fix: vendors still must write special code to make the connections work.

Shouldn’t that be part of the deal, and not an option, like a moon roof and premium sound system on a car?

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March 23, 2015

Disagreement Between Fed Agencies Thwarts Medical Device Safety

Eight years ago, Congress passed legislation to include identification numbers on individual medical devices so that if one caused a problem, its origin could be determined and whether the malfunction was rare or of a broader concern of which the public should be aware. The program still isn’t operational.

As reported in the Wall Street Journal, (WSJ) the FDA had intended to use billing claim data bearing the “unique device identifier” (UDI) by 2012 to monitor the safety of devices such as implanted heart defibrillators and artificial joints. Not until last year did manufacturers start embedding the numbers on their products. (The UDI is different from model numbers and serial numbers, which have been on medical devices for a long time.)

But in what the WSJ calls a “behind-the-scenes bureaucratic conflict,” The Centers for Medicare & Medicaid Services (Medicare, or CMS) steadfastly has opposed the FDA’s plan to monitor safety via claims data and UDIs. CMS, the paper reported, contends that including the UDI on the medical claim forms it receives from hospitals is technically difficult and too expensive.

In February, former Medicare Administrator Marilyn Tavenner voiced support for some other way than claims reporting for collecting UDIs, and although she has left the agency, the WSJ said other Medicare officials toe the same line.

That’s in opposition to Sylvia Mathews Burwell, the secretary of Health and Human Services (HHS), which oversees CMS and the FDA. During her Senate confirmation last year, Burwell indicated that the Sentinel Initiative — the FDA’s national electronic system to track the safety of drugs, biologics and medical devices once they reach the market — would benefit by incorporating UDIs into its claims data sources.

Mark McClellan, a former Medicare administrator, told the WSJ that “what you’re hearing now is CMS channeling the concerns of hospitals” that billing changes could be expensive for them, too.

So are patient safety and transparency once again taking a back seat to special interest pressure?

As readers of this blog know, deficient medical devices are huge contributors to adverse medical outcomes. For example, endoscopes; one type is responsible for the recent outbreak of the superbug CRE (carbapenem-resistant Enterobacteriaceae) that has killed some people and harmed others undergoing diagnoses for gastroenterological problems.

Other common devices with notable records of failure in recent years include defibrillator wires, and metal hip joints. As the WSJ noted, such devices have “killed or injured thousands of people before the FDA — or the companies themselves — realized the scale of the malfunctions.”

Medicare has opposed committees of experts who have worked on how the UDI might appear in billing data. One such panel, the Accredited Standards Committee X12, sets the details of electronic medical bills.

A cardiologist who has served on it and another UDI-related committee told the WSJ that Medicare and insurers could do well financially from the UDI by identifying unsafe devices before they became widespread.

An executive with insurer Aetna told the paper that it’s “critically important” for Medicare to proceed with the program, partly because private insurers generally follow Medicare’s lead in formatting their bills, and that the UDI system not only would improve quality and lower cost, but that its data, with the model and the brand, would provide the ability to do comparative studies with other devices.

“Yet in recent emails within the X12 standards committee,” the paper reported, “Medicare staffers wrote that Medicare ‘does not support any scenario wherein the UDI is integrated into a claim transaction, stored in claims history, or utilized anywhere in the claims adjudication and payment process.’”

Tavenner had suggested that including device-specific numbers into electronic medical records or device registries kept by companies could be enough to promote safety, but what if a patient gets a heart device in one state, then travels to another and has a fatal complication of it? UDI supporters say insurance databases are the best way to capture these data.

Three years ago, the FDA’s medical-device chief scientist told the WSJ that “the unique identifier is the real game-changer” when it’s part of an insurance claim. FDA officials declined to be interviewed for the paper’s recent article, but said the device identifier “can provide important benefits.”

Other consumer and medical interest groups are joining the call for UDI, including AARP, Pew Charitable Trusts, the American College of Cardiology and the Leapfrog Group.

It’s time for the competing agencies within the federal government to get it together, and adopt a plan that Congress intended and that patients deserve.

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March 15, 2015

Better Late Than Never: Gynecology Guidelines Are Issued for Robotic Surgery

Although increasingly popular, robotic surgery has been shown to be risky and expensive, so guidelines for its use issued recently by the American Congress of Obstetricians and Gynecologists (ACOG) and the Society of Gynecologic Surgeons (SGS) should be required reading for anyone considering the procedure.

Promoted as a minimally invasive procedure for a wide range of problems involving many different body parts, robotic surgery is performed by a surgeon directing remote-controlled instruments from a console, often working in spaces smaller than human fingers can access. But in addition to causing problems such as burning and bleeding that are complicated by surgeons’ lack of training and conflicts of interest, robotic surgery is more expensive than more traditional surgical procedures, and the outcomes are equivalent.

As the ACOG report said, “Initially developed for battlefield medicine, robot-assisted surgery was approved by the [FDA] 1999 for urologic and cardiac procedures and in 2005 for gynecologic surgery. Today, robot technology is applied widely in gynecology for hysterectomy, sacrocolpopexy [repair of prolapsed, or slipping, pelvic organs], myomectomy [removal of uterine fibroids], adnexal surgery [appendages of the uterus] and malignancy staging [determining how far cancer has progressed].”

Robot-assisted surgery, said ACOG, is performed at more than 2,000 academic and community hospital sites in the U.S., and its use is growing annually by more than 25% annually. It’s no coincidence, as we’ve written, that use of surgical robotic equipment has grown in tandem with hospitals’ purchase of it — it’s a profit center, and it’s heavily marketed by the hospitals that own it and the industry that sells it.

Too often, we’ve noted, patient safety has fallen through these growth cracks, and now at least some professional medical organizations are addressing it. As the ACOG report stated, “Hospitals and physicians actively advertise and promote robotic surgery programs, often with unsubstantiated claims of improved outcomes and patient safety. The purpose of this Committee Opinion, developed by the [Congress] and SGS, is to provide background information on robot-assisted surgery for gynecologic conditions, review the literature on this topic and offer practice recommendations.”

Solid scientific data about robot-assisted surgery is sorely missing, and ACOG/SGS wants to improve that situation, too — after all, you can’t (or shouldn’t) set policy if you don’t have an evidence-based foundation for it. Although the recommendations are an example of how fact chases desire, at least they’re better late than never.

Specifically, ACOG/SGS recommend:

  • Well-designed randomized controlled trials (RCTs) or comparably rigorous nonrandomized prospective trials to determine which patients are likely to benefit from robot-assisted surgery and to establish the potential risks.

  • Robot-assisted cases should be selected based on the available data and expert opinion. As with any surgical procedure, repetition drives competency. In addition to the training necessary for any new technology, ongoing quality assurance is essential to ensure appropriate use of the technology and patient safety.

  • Adoption of new surgical techniques should be driven by what is best for the patient, as determined by evidence-based medicine rather than external pressures.

  • Adequate informed consent should be obtained from patients before surgery. For robotic procedures, this includes a discussion of the indications for surgery and risks and benefits associated with the robotic technique compared with alternative approaches and other therapeutic options.

  • Surgeons should describe their experience with robotic-assisted surgery or any new technology when counseling patients regarding these procedures.

  • Surgeons should be skilled at abdominal and laparoscopic approaches for a specific procedure before undertaking robotic approaches.

  • Surgeon training, competency guidelines and standards to measure them should be developed at the institutional level.

For more information about surgical errors and gynecologic issues, see our respective backgrounders here and here.

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February 24, 2015

Outbreak Renews Concern about Contaminated Endoscopes

Last week, an outbreak of a superbug known as CRE at UCLA’s Ronald Reagan Medical Center in Los Angeles prompted the FDA to alert hospitals and medical providers to the possibility that a medical device used for gastroenterological problems might be the culprit.

At this writing, two people have died and nearly 200 have been contacted if they recently had a specialized endoscope inserted into their throats to treat cancers, gallstones and other ailments of the digestive system.

CRE (carbapenem-resistant Enterobacteriaceae), as explained in the Los Angeles Times, are difficult to treat bacteria because they are resistant to most antibiotics. As many as half of all patients with CRE bloodstream infections die, according to the Centers for Disease Control and Prevention.

The FDA said that the design of the devices might make them more difficult to clean fully, and that even meticulous cleaning of the duodenoscopes might not eliminate the bug. The feds first warned about the problem of multidrug-resistant bacteria and duodenoscopes in 2013.

One hospital safety consultant interviewed by The Times said regulators and industry officials have been too slow to respond. “Hospitals and manufacturers often take months to assess what to do, with the infected patients being the last to know,” Lawrence Muscarella said.

“These outbreaks are raising questions about whether hospitals, medical-device companies and regulators are doing enough to protect patient safety,” according to The Times. “Some consumer advocates are also calling for greater disclosure to patients of the increased risks for infection before undergoing these procedures.”

Some hospitals using the duodenoscopes quarantine them for 48 hours after the initial cleaning to check for bacterial growth before reusing them on patients. If you are scheduled for such a procedure with an endoscope, make sure that it’s essential to your care, and that you clearly understand the risks as well as the benefits. Make sure that the facility has followed the cleaning and quarantine protocol.

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February 15, 2015

Devices Used in Knee Surgery Had No Safety Proof

OtisMed Corporation didn’t have approval from the FDA for its OtisKnee guides before it started selling them. The FDA ultimately rejected the company’s application, saying that OtisMed failed to show that the product was safe and effective.

So why was the device used in the knee replacement surgery on Carla Muss-Jacobs, who suffered a terrible outcome?

A story reported by and the New York Times explained that the tool was supposed to speed both the surgery and the patient’s recovery, but Muss-Jacobs suffered terrible pain, and had to undergo a second knee replacement.

According to the story, about 700,000 knee replacements are performed every year. It’s the most common elective surgery in the U.S., and the demand will only increase as the population ages, leaving an attractive market for companies that serve the surgical community.

OtisMed’s device was a system of guides directing the angle of the surgeon's cuts to enhance the alignment of the artificial knee. It was supposed to help surgeons tailor bone cuts to a patient's anatomy.

The FDA allows manufacturers to classify their devices, which basically lets them determine whether safety studies are required before they are sold. “That can allow some products that should receive closer scrutiny to slip by,” the reporters said.

The FDA has three classes of medical devices:

  • Class III devices, like pacemakers, require extensive testing because they are implanted or sustain or support life and could put patients at serious risk.

  • Class II devices, like powered wheelchairs or pregnancy tests, are approved if companies assure that they are similar to other devices on the market.

  • Class I devices — bandages, dental floss, forceps, etc. — must be registered but don't require premarket review because they present a low risk. They may be sold without any other FDA involvement.

For OtisKnee, OtisMed told providers that its cutting guides were a Class I device and didn't need FDA approval or clearance.

In 2008, despite an earlier surgery, Muss-Jacobs had a terribly painful left knee. Orthopedic surgeon Ronald Teed told her many doctors were using the OtisKnee device, and their patients recovered faster with less pain, she told ProPublica/Times.

She woke up from her procedure with so much pain that she couldn't stop crying. She hobbled around with a walker and couldn’t work. After six months later, she consulted another surgeon, Dr. Ira Weintraub, who said the new knee had failed and was misaligned. He performed a complex revision surgery. Muss-Jacobs walked the next day, but still had a long, painful recovery.

But the damage was done. Without an income, in 2009 she declared bankruptcy and sued Teed. The case was dismissed. (Teed told the reporters that Muss-Jacobs had refused to comply with her rehabilitation plan. "She didn't do what she was told," Teed said, "and she ends up with a bad outcome.")

Despite her legal loss, Muss-Jacobs learned of other complaints about the OtisKnee, that some surgeons questioned whether the device was safe and that it had not been approved by the FDA.

OtisMed marketed OtisKnee to providers at fancy events of the American Academy of Orthopedic Surgeons promising that it would simplify surgery and boost fees due to additional MRI scans, according to Justice Department case filings. It promised that more of a patient's bone and ligaments would be preserved, improving fit and longevity. But according to the Justice Department, none of the promotional claims had been evaluated by the FDA.

Still, number of surgeons adopting the OtisKnee doubled each month in 2007.

Teed endorsed the OtisKnee, calling the surgery in an informational video a "piece of cake,” that it would reduce the risk of infections and other complications. “Eventually, though,” wrote ProPublica/Times, Teed found problems. “He said he had taken part in an OtisMed study and was one of the first surgeons to discover that the procedures were not always working as hoped. ‘Some did. Some didn't …They weren't perfect.’"

He brought the problems to the company's attention, but said "they seemed like they couldn't figure it out." Later, he heard that OtisMed had revised the materials in the cutting guides, which might have led to them warping when they were sterilized before surgery.

“The FDA should have been sterilizing ‘the crud’ out of those things to test them,” Teed said. But he denied that faulty cutting guides were the problem in Muss-Jacobs' case. Still, he said OtisKnee had taught him a lesson: "Don't jump on the bandwagon too early."

In December, OtisMed and its former chief executive pleaded guilty in federal court to criminal charges of distributing adulterated medical devices. The Justice Department said the company sold and distributed 18,000 OtisKnee devices from 2006 to 2009 without FDA approval.

In September 2009, the FDA notified OtisMed that it had not demonstrated that the guides were safe, and called the device a Class III device and told the company not to distribute it.

The OtisMed board voted to halt shipments, according to the Justice Department, but the company's chief executive directed employees to ship some that had been held up since the FDA denial, and 218 were sent to surgeons, the Justice Department filings state.

Did OtisKnee cause Muss-Jacobs' problems? That’s unknown, but U.S. Attorney Paul J. Fishman announced an $80 million settlement of criminal and civil charges against OtisMed, and said patients "should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved."

It’s not known how many people were harmed by OtisKnee. Finding a number wasn’t part of the Justice Department's case.

An FDA spokeswoman told ProPublica/Times that there are so many Class I medical devices that the agency usually doesn’t check to see if they are properly classified. "It's based on voluntary compliance," she said. "We presume companies know the rules and regulations."

The Muss-Jacobs case illustrates why all surgical patients must carefully investigate the tools their doctors intend to use. They must find out how long the surgeon has been using the procedure or technology, and what was the extent of his or her training. They must confirm that any device has been approved by the FDA. See our backgrounder on surgical errors and our blogs about knee replacement

As ProPublica/Times said, “An examination of the OtisKnee case shows how easily that trust can be violated in the rapidly evolving world of medical devices, a thriving $110 billion-a-year industry. If not for a whistle-blower, the public might never have learned about the widespread use of a potentially dangerous device that sidestepped regulation.”

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December 2, 2014

Warning Against Uterine Fibroid Treatment Is Strengthened

Last week, the FDA updated its warning from earlier this year about the cancer-spreading danger of a surgical procedure to treat uterine fibroids. For most women, the feds now say, power morcellation should not be performed.

Our blog, “FDA Warns of Cancer Risk with Uterine Procedure,” described morcellation, which involves a tool that cuts or grinds tissue into tiny pieces so they can be extracted through a small incision. It can spray bits of uterine tissue or fibroids around the surgical cavity.

The main concern now is that morcellation can spread cancer cells, turning a small hidden cancer from totally treatable and survivable into a killer spread throughout the lower abdomen.

The FDA’s order expanded the contraindications for power morcellation to gynecologic surgery patients with known or suspected malignancy, and to peri- and postmenopausal women seeking treatment for fibroids. It also imposed a so-called “black box” warning on the devices' labels.

The warning, the most extreme type the FDA issues, states that "uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices."

It’s stronger than the earlier advisory that the FDA "discourages the use of the devices during treatment for uterine fibroids.” Since April, when it was issued, many hospitals have stopped doing morcellation procedures, and many insurers won’t cover it.

Although it still might be appropriate for some women, the FDA recommends that women requiring a uterine procedure:

  • Discuss with your health-care provider all the options available to treat your condition. There are risks and benefits associated with all medical devices and procedures and you should be aware of them.

  • If your doctor recommends laparoscopic hysterectomy or myomectomy, ask him or her if power morcellation will be performed during your procedure, and to explain why he or she believes it is an appropriate treatment option for you.

  • If you have undergone a hysterectomy or myomectomy for fibroids, the tissue removed generally is tested for the presence of cancer. If your tests were normal and you have no symptoms, routine follow-up with your physician is recommended. Patients with persistent or recurrent symptoms or questions should consult their health-care provider.

  • Consider other surgical options, including traditional surgical hysterectomy (performed either vaginally or abdominally) and myomectomy, laparoscopic hysterectomy (smaller incision than open surgery) and myomectomy without morcellation. All treatments carry risk, and you should discuss them thoroughly with your health care provider.

To read the whole alert, link here. To report an adverse event with morcellation (or any other medical procedure), link to the FDA’s MedWatch program here.

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November 27, 2014

Suggested Reading: How Counterfeit Surgical Screws Found Their Way to Market and Cost People Their Health

Over the summer, the Center for Investigative Reporting (CIR) broke the story of surgeons who used counterfeit screws and rods in spine surgery, causing crippling outcomes and mounting lawsuits. Now, the CIR has published the back story in a chilling tale of greed and regulatory sloth.

Ortho Sol makes precision screws for spinal fusion surgery. In 2009, it repossessed some of its screws after Spinal Solutions LLC failed to pay for them. An Ortho Sol executive noticed that some of the screws it got back were counterfeit, that Spinal Solutions had replaced high-quality, safe equipment, with cheap knockoffs that had been implanted in the necks and backs of who knows how many people in the U.S.

Two years later, a whistle-blower from Spinal Solutions tipped off the FDA about the counterfeiting, and even then, the feds didn’t shut down the company. “By the time Spinal Solutions went broke in 2013,” CIR reports, “the company had sold millions of dollars in implants to a nationwide network of surgeons.”

Some surgical patients have suffered debilitating pain and infections from the counterfeit screws, but others whose doctors were among the recipients of Spinal Solutions shipments that mixed legitimate and counterfeit screws are left wondering about their future.

“What do they do if they find out there are these bogus parts that can come unscrewed?” Susan Reynolds told CIR. Her doctor used Spinal Solutions screws in her surgery in 2009. “I’m a walking time bomb.”

Many doctors received lucrative consulting deals from Spinal Solutions, and in return, used the company’s implants for their surgeries at hospitals in California, Nevada, Texas, Wisconsin and Maryland. CIR has no evidence they knew the screws were counterfeit, but some doctors have been accused of with taking kickbacks for using them.

Read the whole story from the Center for Investigative Reporting here, And see our original blog about the defective equipment, “Counterfeit Equipment for Spine Surgery Spurs Lawsuits,” here.

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November 17, 2014

Robotic Technology Costs More and Has More Complications for Ovary and Cyst Removal

The use of robots in the surgical suite has a checkered history and a fat file of lawsuits by patients who suffered burns, bleeding and other serious harms. Another study has added to the record of woe: robot-assisted surgery to remove ovaries or ovarian cysts had more complications than more traditional and less invasive procedures, such as laparoscopy, and also was more expensive.

For these procedures, laparoscopy involves making a small incision into which surgical tools are inserted; robotic surgery involves the vaginal insertion of instruments controlled by the surgeon using a joystick. Screen-generated images guide both procedures.

As reported by (KHN), research by Dr. Jason Wright, chief of gynecologic oncology at Columbia University, suggests that removing ovaries with the help of a robot cost about $2,500 more than laparoscopic removal, and removing cysts cost $3,300 more.

Even more worrisome for most people than the additional cost, however, is that the women whose surgeries had been performed with the assistance of a robot were slightly more likely to have complications, including bladder injury, bowel obstruction or excessive bleeding.

We’ve called into question the widespread use of robotic surgery many times (here and here). Many people believe that although some disorders are appropriate for robotic technology, it’s overused because surgeons and hospitals make huge investments in the equipment, which encourages their maximum use, even if it isn’t the best option for certain procedures.

The Wright study reviewed the operations of nearly 90,000 women who had ovaries or cysts removed between 2009 and 2012, comparing the cost and safety of robotic surgeries with laparoscopy.

The study “really questions the utility of using robotic-assisted surgery,” Wright told KHN. “More studies need to be done before it’s accepted as the standard of care.”

The data didn’t show why there were complications. But recent reports of software glitches, battery malfunctions and difficulties in seeing through the robotic system’s lens were noted on the FDA’s Manufacturer and User Facility Device Experience database. We’ve blogged about poor surgeon training, as well.

Despite the extra cost and complications, Wright’s team said that the use of robots for these kinds of procedures is on the rise, from about 3.5 in 100 ovary removals in 2009 to 15 in 100 in 2012. Cyst removals showed a similar trend.

For now, according to Wright, “Patients need to understand the risks and benefits of different procedures… The newest, most high-tech thing that’s available isn’t necessarily the best.”

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October 29, 2014

Expensive Proton Beam Technology Booms as Its Potential Remains Unclear

For years we’ve been writing about the overuse of proton beam therapy for cancer patients. But manufacturers and the doctors who use the massive, expensive equipment it requires remain head-scratchingly gung-ho.

Proton therapy is radiation that uses high-energy beams to shrink tumors. According to the Mayo Clinic, “Proton therapy has shown promise in treating several kinds of cancer. Research of proton therapy continues, as doctors try to determine who may benefit from proton therapy treatment.”

Clearly, it’s in the development stage, so why are so many providers so keen to grow the market for this incredibly expensive procedure when its potential remains unknown? A recent report by Kaiser Health News (KHN) and NPR noted that there are 14 U.S. centers in operation, with a dozen under construction. The cost for each is about $200 million.

So some industry professionals were surprised when Indiana University announced in September that it would shutter its proton therapy facility in Bloomington. Their reaction is confusing to anyone who’s paying attention — there’s little evidence, the KHN/NPR story pointed out, that proton therapy is superior to more traditional forms of radiation for almost all types of cancer. (See our blog, “Better Care with the Tried and True, or the Seduction of the New?”)

Amitabh Chandra is a professor at Harvard’s Kennedy School of Government who studies U.S. medical care. He was among those surprised at Indiana’s announcement, even though, as he told KHN/NPR, “we do know it is substantially more expensive and substantially more lucrative for physicians and providers to use this technology.”

In the Washington, D.C. area alone, three proton therapy centers are being built — one at Johns Hopkins, one at MedStar Georgetown University Hospital and one at the Maryland Proton Treatment Center. All three D.C.-area facilities are full-speed-ahead with their plans, two of which told KHN/NPR that the D.C.-Baltimore region was sufficiently larger than Bloomington and could support the huge projects. The third told the reporters that theirs is smaller and will be more cost-effective than the others.

But Indiana’s decision wasn’t made in a vacuum. Its review committee decided that it just wasn’t worth spending the money necessary to update its facility. And even more telling, its insurers have declined to subsidize proton therapy for common diseases including prostate and breast cancers. One of its insurers, Cigna, concluded that proton therapy for all tumors except a rare eye cancer was not shown to be more effective than other forms of radiation therapy.

Given the cost of the equipment, it’s no surprise that proton beam therapy costs as much as six times what standard radiation therapy costs for prostate cancer, according to Cigna. And it’s hardly a lone voice: Other major insurers including Aetna and Blue Shield of California also limit what they’ll cover with proton therapy.

When insurance does cover expensive care that isn’t superior to less expensive options, guess what? The cost of everyone’s health care rises.

Facilities that pay for fancy equipment, and doctors who train to use it, aren’t going to sit around waiting for patients to present with rare forms of cancer — they’re going to use the equipment for which the payments are due, and they’re going to charge as much as they can for it.

Of course, the providers and researchers involved with building new proton beam facilities believe wholeheartedly in its value. They note the potential of proton therapy to kill cancer with pinpoint accuracy, sparing surrounding tissue from damage. They say that it’s just a matter of time before clinical trials prove that proton therapy is worth the extra money.

Indiana University doesn’t think so. Neither do we.

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October 6, 2014

Feds’ Website for Tracking Industry Payments to Docs Is Weak

Last week the federal government launched its long-awaited website tracking the money drug and medical device companies pay to doctors for various kinds of product and research support. But it’s less a new initiative for transparency than a disappointment.

Readers of this blog will recall that the Physician Payment Sunshine Act spawned Open Payments, the first public release of industry payment data, and was part of the Affordable Care Act (“Obamacare”). It was supposed to go live 18 months ago, but was delayed until now, and even with the extra time, tracks payments only from August to December 2013.

According to Open Payments, its database “creates greater transparency around the financial relationships of manufacturers, physicians and teaching hospitals.” The information comes from annual reports made to the Centers for Medicare & Medicaid Services (CMS).

But as reported by and NPR, the site is “a very limited window into the billions in industry spending.”

When the site launched, the New York Times reported that pharmaceutical and device makers shelled out approximately $380 million to doctors in speaking and consulting fees. Some individuals received more than half a million dollars, and remember — that’s only for the initial five-month reporting period from last year.

Some doctors, according to The Times, earned millions in royalties from products they helped develop.

The Times reported that during those five months, drug and device companies made 4.4 million payments to more than half a million health-care professionals and teaching hospitals for a total tab of about $3.5 billion.

The Times called into question the value of Open Payments, at least for its debut: “[A]bout 40% of the records do not tie back to a specific professional or teaching hospital, accounting for 64% of the overall payments,” the paper said.

Consumers are invited to search the site to find out if their doctors received industry money (and possibly compromised their independent medical judgment) and if so, how much was paid by whom. But before you conduct a search, ProPublica/NPR advises you to keep five things in mind.

1. The data covers only a fraction of payments, from August to December 2013.

If you search for your doctor and can’t find him or her, that doesn't necessarily indicate he or she didn't receive a payment.

Also, those five months’ of data might not represent a company's spending over a whole year. Some companies might concentrate promotional talks, which can reward doctor/speakers handsomely, in the first part of a year, which wouldn't be represented in this data.

Some of these concerns will be resolved by the time the government releases data on payments for the full calendar year 2014, which is expected next summer.

2. Some data on research payments won't be released until the product in question is approved by the FDA, or four calendar years after the payment was made, whichever comes first.

The Sunshine Act permits drug and device companies to delay the publication of data related to research of new products or, in some cases, new uses for existing products. It’s not clear how much money is involved. And, again, just because a doctor’s name isn’t on the list as receiving a research payment doesn't mean he or she hasn't received one.

And the breadth of health-care providers is not represented in the database. Physicians (medical doctors and osteopaths), dentists, chiropractors, podiatrists and optometrists are included. But companies are not required to report payments to nurse practitioners or physician assistants.

3. Some data is being withheld because of company errors that led to cases of mistaken identity.

CMS acknowledged that 1 in 3 payment records submitted by companies for last year had data problems that could lead to cases of mistaken identity. The names associated with those payments were not released last week. Federal officials have asked companies to verify their data, which should be released publicly next year. (See our recent blog, “Feds Withhold Some Information From Doctor Dollars Database.”)

CMS officials discovered the problem while investigating a physician's complaint that payments were being attributed to him even though they were made to another physician with the same name, as we wrote in our blog. Looking into the matter, the feds discovered "intermingled data," meaning that some physicians were linked to medical license numbers or national provider identification numbers that weren’t theirs.

It serves no one’s interests to post inaccurate or misleading information; better to withhold and correct it than present an erroneous database.

4. Not all payments have the same significance.

The listed categories indicate varying levels of involvement with a company, from consulting and speaking fees to research payments, entertainment, travel and lodging and educational items.

Consumers on Open Payments see fees divided into different categories: consulting fees, speaking fees (called "services other than consulting"), research payments, honoraria, gifts, entertainment, food and beverage, travel and lodging, educational items, charitable contributions, royalties, ownership interests and grants.

Those different types of payments indicate different levels of involvement with a company.

Educational items, for instance, include medical textbooks and reprints of journal studies given to doctors. Research payments might include more than the pay somebody got to lead a study. Payments for clinical studies might include costs associated with patient care, supplies, as well as the time spent by health-care professionals treating patients and managing the study.

Educational items that directly benefit patients (such as informational posters) and medication samples do not have to be reported and you won't see their value reflected in the data.

5. This is the first federal release of this data: There will be mistakes.

Although the rollout of Open Payments isn’t as fraught as that of, the Obamacare insurance exchange, because it’s not nearly as complex, it's reasonable to expect some glitches. The same company that was responsible for launching also is responsible for the release of the payment data.

And drug and device manufacturers make mistakes. For example, doctors with similar names might be confused, so a payment made to one might be attributed to someone else.

The government gave doctors 45 days to review and dispute payments attributed to them before the information becomes public, but it's unclear how many did. Professional and trade groups say that process has been confusing.

The New York Times story illustrated how understanding the database requires more than just a quick look at a numbers tally. “When you look at why do drug companies and device companies make gifts and offer consulting payments and honoraria to physicians, the main goal is to influence prescribing practices,” Dr. Michael Carome told the paper. He’s director of Public Citizen’s Health Research Group. “The interest of those companies is to improve their financial bottom line, and not necessarily represent the best interest of patients.”

But, notes The Times, if some relationships might leave doctors open to scrutiny, other ties promote innovation. “Drug and device makers say they regularly consult with doctors to help them decide where the need is the greatest, and doctors conduct clinical trials that help get products approved,” the paper reported.

“Research, for example, accounted for nearly $1.5 billion of payments during the reporting period. Companies spent an additional $302 million on royalties and licenses, money that is paid to doctors and teaching hospitals for their role in developing companies’ products.

So if you have a question about what your doctor received, if you want to know if he or she has any kind of financial relationship with a medical company, ask him or her.

ProPublica’s Dollars for Docs site has been tracking payments by certain large drug and device companies for four years. It has information from 17 drug companies, which represent about half of U.S. drug sales from last year.

So Dollars for Docs probably has information you can't find on Open Payments. It enables you to search by name, state, company or payment category.

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September 4, 2014

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a medical device.

Although a recall was issued in mid-April for a faulty jaw implant, it wasn’t until the end of August that the public learned about it on MedWatch.

The surgical device, known as a Craniomaxillofacial (CMF) Distraction System, is used to correct jaw defects. It’s made by DePuy Synthes, which sent its customers an “urgent notice” April 16.

Used in pediatric and adult patients to correct birth defects, or those that occur as a result of trauma, apparently CMF can become unstable, and reverse direction after surgery.

It was a Class I recall, which is the most serious level, defined by the FDA as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

And it took more than four months for us to learn about it?

The FDA said infants are at the highest risk for injury if the device fails, but all patients are at risk, and could need additional surgery to replace a failed implant. So far, 15 reports of injury have been associated with the use of the device.

If you have questions or concerns about the device, call DePuy at (800) 479-6329. You can also file a report with MedWatch … for what that’s worth.

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August 7, 2014

Manufacturer Yanks Cancer-Spreading Device from the Market

As lawsuits mount over the incidence of cancer associated with the use of a medical device in the surgical removal of uterine fibroids, Johnson & Johnson announced last week that it’s recalling all of the power morcellators it has manufactured in recent years.

And early this week, a major East Coast health insurer said it no longer would cover the gynecological procedure involving power morcellation.

Power morcellation surgery has become quite popular because it’s performed laparoscopically. That’s a minimally invasive procedure whose small incision prompts faster recovery, less pain, less bleeding and less opportunity for site infection. The morcellator, whose market is dominated by J&J, cuts up the fibroids into tiny bits that can be removed through the incision.

But the machine has been associated with the risk of spreading aggressive forms of uterine cancer in patients in whom cancer was never even suspected. Earlier this year, we wrote about the shock of women finding out they had advanced cancer only after undergoing what is generally a fairly benign procedure. We followed up a couple months later with a report about the FDA issuing morcellation warnings.

Now, as reported on, J&J contacted doctors known to use the devices with the admission that the risk of spreading cancer is too high with morcellators, and that it has no future plans to manufacture or sell them. With about 72% of the market, J&J has asked hospitals to voluntarily return all of the laparoscopic surgery power morcellators.

According to Reuters, health insurer Highmark Inc., with 5.2 million customers in Pennsylvania, Delaware and West Virginia, will stop covering the procedure as of Sept. 1.

At an FDA meeting, it was determined that as many as 1 in 350 women who undergo laparoscopic surgery for uterine fibroid removal might have unsuspected sarcoma, and cancer cells within the uterus that could be spread throughout the body by power morcellation.

Although in April the FDA urged doctors to stop using the procedure, last month an FDA advisory committee split on whether to recommend severe safety warnings on power morcellator or a total power morcellator recall. We wonder why there was any doubt, given that the panel acknowledged that there was no known way to make morcellation for uterine fibroid removal safe.

It’s unknown when the FDA will make a final recall decision, but J&J didn’t wait for it to pull their devices. In the face of the lawsuits, everyone’s wondering why adequate warnings weren’t issued long ago, and whether manufacturers made devices as safe as they could have.

Luckily, for women in need of uterine fibroid removal, there are options beyond power morcellation — traditional surgical hysterectomy performed vaginally or abdominally; catheter-based blocking of the uterine artery; high-intensity focused ultrasound; drug therapy and laparoscopic hysterectomy or fibroidectomy without use of morcellation.

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July 23, 2014

Texas Might Decide Radiologic Techs Don’t Need a License

Texas has about 28,000 licensed X-ray technicians, but if the state follows the recommendation of an advisory commission, the piece of paper that certifies that they’re qualified to dose you with radiation won’t be necessary.

The state, according to the Texas Tribune, might decide that radiologic technologists, as well as several other categories of health professionals, no longer need a license to do their jobs. What the members of the Department of State Health Services’ Sunset Advisory Commission don’t seem to understand is that licensing the people with the potential to cause serious harm is a measure of protection against lack of training and ability. (See our backgrounder on radiation overdose injuries.)

The commission, which is charged with identifying inefficiencies in state government, believes licensing is regulatory redundancy because people receive X-rays, MRIs and CT scans in health-care facilities that themselves are highly regulated. By that logic, no hospital that surpasses all oversight measures ever grants practice privileges to a surgeon who — oops! — leaves a sponge inside a patient.

Such medical errors happen, but they’re less likely to occur if practitioners regularly prove they’re worthy of the trust placed in them.

Besides Texas, 10 other states do not require imaging technicians to be licensed, and you have to wonder why. As the vice president of government relations and public policy for the American Society of Radiologic Technologists told The Tribune, “Everyone knows that radiation is a carcinogen. If performed incorrectly, it’s a direct risk to public health and safety,” said Christine Lung.

In addition to administering X-rays, CT scans, MRIs and other kinds of imaging, radiologic technologists also perform interventional procedures, such as injections and IV placement. The procedures measures can deliver high doses of radiation that must be within millimeters of accuracy, and can pose a risk of infection.

“It’s not just point and shoot X-ray,” Lung said.

Along with imaging techs, the commission suggests there’s also no need to license respiratory care practitioners, perfusionists (people who monitor the heart-lung machine during open heart surgeries), dietitians and opticians.

We’re relieved that the commission’s report was met with skepticism by at least some legislators. "Your charge was to make sure that each profession is administered and licensed in a way that is the least burdensome possible," said one state senator, according to The Tribune. "But we've all gotten a lot of phone calls."

But, this is Texas, which often leads the nation in worker fatalities but is the only state that does not require private employers to carry workers’ compensation insurance or a private equivalent. This is Texas, where the political hunger to cut, cut, cut government, even government that protects people from harm, is insatiable. So of course the senator is appointing a subcommittee to devise a modified proposal that "has a realistic chance of passing the Legislature."

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July 22, 2014

Counterfeit Equipment for Spine Surgery Spurs Lawsuits

Some sleazy California surgeons and their enablers, it seems, have pulled a General Motors: They used substandard equipment that caused, if not fatalities, at least several thousand injuries to patients undergoing spinal operations.

The Center for Investigative Reporting (CIR) discovered that the doctors implanted counterfeit screws and rods manufactured in a small machine shop, into injured workers undergoing back surgery. Many have filed lawsuits after suffering adverse outcomes.

The surgeons’ motive, of course, was money: Some who used the fake hardware took kickbacks including cash and private plane rides. Middlemen and hospitals also got a slice of the poison pie by wildly inflating the cost of the screws, according to one of the suits. Some of the screws cost $300 to make but were billed at as much as $12,500 each.

One lawsuit filed last month claims that the bogus spinal implants could cause harm by causing infection or because patients could have an adverse reaction to metal that is not surgical grade. The screws also might loosen or fail.

“It’s probably the worst example where fraud has progressed from being a financial crime to hurting people for profit,” Thomas Fraysse, an attorney on the case told the CIR. “It’s beyond unethical.”

The cases involve spinal fusion surgeries, about which we’ve raised concerns. The procedure implants rods and screws in the patient’s back to relieve pain. In this case, the patients were people who had filed back injury claims for workers’ compensation, a state system that, according to the CIR, used to pay a premium for hardware used in the surgeries until a loophole was closed by recent legislation.

One of the lawsuits says the defendants committed fraud and battery, and that the deficient hardware risked the life of Arthur Golia, who got seven of the counterfeit devices implanted in his spine.

A similar case alleges that David Solomon had medical implants from the mom-and-pop machine shop implanted in 2011. One of the screws broke, requiring Solomon to undergo a second surgery in 2013. He has ongoing pain and loss of movement.

“If you break this down to the core of right and wrong, it really is using people as pieces of meat to make money,” attorney Chris Purcell told the CIR.

A whistle-blower lawsuit charges that many of the patients with fake implants might not have needed surgery in the first place. It alleges they were damaged victims of a massive scheme to defraud insurers that involved the former owner of Pacific Hospital in Long Beach.

Michael Drobot, the owner, admitted to paying doctors kickbacks of as much as $15,000 to use his hospital for the surgeries. He also admitted to paying bribes to former state Sen. Ronald Calderon for supporting a law allowing hospitals to bill insurance providers for the full cost of spinal implants. Calderon has been charged with corruption charges, and Drobot is to be sentenced in December.

Spinal Solutions LLC, is the outfit accused of distributing and inflating the cost of the hardware in some of the lawsuits. Its owner, Roger K. Williams, is accused of passing off the counterfeit rods and screws as FDA-approved even though they were made at a local tool shop. The federal agency sent him a warning letter a couple of years ago, and recalled its products last year.

The lawsuits point up how widespread illegal palm-greasing is when it comes to lucrative spine surgeries.

To understand the risks of back surgeries, and to better assess your treatment options for back trouble, see our newsletter, “Better Care for Your Aching Back.”

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May 28, 2014

Medical Device Recalls Are Up

If it seems like an awful lot of medical devices are malfunctioning, and being recalled from the market, that’s because they are.

According to analysis from about a recently issued report by the FDA, the number of medical device recalls has nearly doubled over the last decade.

The report, by the FDA’s Center for Devices and Radiological Health (CDRH), covered 2003 through 2012. Even though the number of medical device recalls increased 97% during the study period, the feds said that’s not necessarily a bad thing, because it shows greater scrutiny of what manufacturers are trying to sell to health-care providers and consumers.

“Concerted efforts to improve the quality and safety of medical devices on the part of both CDRH and the industry has resulted in greater numbers of recalls reported — and greater benefit for the public health,” the report says. “We attribute this increase to: enhanced awareness by device firms, including those that were cited for reporting violations; and specific CDRH efforts to improve medical device safety.”

Among the agency’s most common oversight targets:

  • ventilators;

  • infusion pumps;

  • external defibrillators.

But any device can malfunction, can be poorly made, can be improperly used or implanted. So patients and their loved ones should always check out medical devices their doctors recommend. For guidance on what devices tend to be problematic, and what questions to ask, link to our Medical Device Safety page here.

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May 25, 2014

Harmful Spine Treatment Infuse Got an Assist from the FDA

The lawsuit-generating spinal treatment Infuse was approved by the FDA in 2002, and, according to a disturbing investigative report by the Milwaukee Sentinel and MedPage Today, the feds gave it the nod even though concerns about its safety were raised and it had been tested on so few patients as to make conclusions about its usefulness meaningless.

The problems caused by the spinal implant, which is supposed to encourage bone growth and fuse the gaps between vertebrae after fusion surgery, resulted in Medtronic, its manufacturer, recently agreeing to pay $22 million to settle about 950 lawsuits, and reserving another $140 million to settle an anticipated 3,800 additional claims.

"It appears the clinical trials, unfortunately, were not designed to adequately test for safety of the product," said one Sentinel/MedPage source, a chief of spinal surgery at a major metropolitan hospital.

The FDA approved Infuse not as a life-saving drug or an intervention that reduces disability significantly; it was approved as an alternative to traditional spinal fusion surgery.

As the story notes, testing new biologic agents usually requires clinical trials involving 1,000 to 3,000 people. But because the FDA invited Infuse on the market as a combination device, not a biologic agent, its trial involved a paltry 277 subjects. Medtronic’s website refers to Infuse as “biologic device.”

Biologic drugs, as the Sentinel/MedPage story explains, also are known as bio-pharmaceuticals. “They replicate natural substances in the body such as hormones, antibodies, or, in the case of Infuse, growing bone. Traditional drugs are made by combining chemicals. But biologics are manufactured in a living microorganism, such as plant or animal cells, and can pose special safety risks such as infections, immune system disorders and cancers.” One study found that about 1 in 4 of 174 biologic drugs had been the subject of safety-related regulatory actions after they got on the market.

Because Infuse was approved in a "noninferiority" trial, Medtronic did not have to prove it was any better than the traditional treatment.

"It should not have gone through the device approval process," a health researcher in orthopedic surgery told the Sentinel/MedPage "It should have gone through the biological testing process."

The story’s revelations won’t surprise readers of this blog (see our post, “Medtronic Spinal Treatment Is Riskier and No Better than Bone Graft ”); it showed that more than 6,500 reports of Infuse-related problems have been registered with the FDA's medical device reporting system since Infuse was approved.

The complications include cancer, sterility and pain.

Adding another “ick” layer to the approval of a product that harms people, according to the Sentinel/MedPage, is the group of spine surgeons who received millions of dollars in royalties from Medtronic and who had co-authored papers failing to acknowledge the link between Infuse and several serious complications. In some cases, the medical journals publishing the papers didn't fully disclose Medtronic's financial relationship with the authors.

Can you say “conflict of interest”?

So questionable was this product even among orthopedists that The Spine Journal, according to the Sentinel/MedPage, dedicated a whole issue to its deficiencies. It referred to research that found that Infuse had complication rates 10 to 50 times greater than the complication rates estimated in the papers written by the doctors whose priority wasn’t helping patients get well, but helping their own bottom lines.

The FDA, for its part, issued the usual “what, me?” response to Sentinel/MedPage inquiries. An email from its spokeswoman said Infuse was approved based on clinical and nonclinical data that "demonstrated a reasonable assurance of safety and effectiveness," and that an advisory panel of outside experts reviewed the evidence and voted unanimously to recommend approval.

She said the FDA has reviewed the thousands of adverse events reports about Infuse, post-approval studies and medical literature, and continues to believe there is a reasonable assurance of safety.

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May 1, 2014

UCLA Settles Whistleblower Lawsuit Over Conflict of Interest

Later this year, the Physician Payments Sunshine Act takes full effect. It’s part of the Affordable Care Act (ACA, or “Obamacare”), and requires public disclosure of financial relationships between health-care companies and physicians. (See our blog, “Which Doctors Line Their Pockets with Big Pharma Money?.”)

Clearly, it’s overdue. One example why is last week’s settlement by UCLA, whose orthopedic surgery department agreed to pay $10 million to its former chairman. Dr. Robert Pedowitz had sued the University of California system, alleging that its premier medical school allowed doctors to accept payments from the medical device industry that might have compromised patient care.

As explained in the Los Angeles Times, the settlement was reached just before closing arguments were set to begin.

Pedowitz, a surgeon, had been recruited in 2009 to run UCLA’s orthopedic surgery department. He sued in 2012, saying university officials, regents and fellow surgeons failed to act on his complaints about widespread conflicts of interest and later retaliated against him.

During the trial, Pedowitz testified that he was concerned about colleagues who had financial ties to medical device manufacturers and other companies, because such relationships could influence patient care and/or medical research. The best care, and the best research, is objective; it can’t be colored by what the practitioner gets out of it.

Pedowitz also claimed that UCLA allowed potential conflicts of interest because of the potential financial benefit from the medical products or drugs developed by its staff.

Commenting on the lawsuit’s outcome to the L.A. Times, Susan Chimonas, associate director of research at Columbia University's Center on Medicine as a Profession, said some medical schools “can be dependent on the money these big-earning specialties like orthopedic surgery bring in. They are the cash cows and they can set their terms. This is not the first time I've heard of medical schools having policies that are not well enforced."

The case brought to light one UCLA orthopedic surgeon who had received $250,000 in consulting fees from Medtronic, which makes products including Infuse. It supposedly promotes spinal bone growth but, as we wrote last year, involves a risky procedure that isn’t proved to be superior to other spinal treatments.

At trial, Pedowitz testified that he was concerned that the surgeon was trying to enroll patients in a research study involving Medtronic while he was accepting its money. "I saw this as an obvious problem," Pedowitz testified.

The surgeon, Dr. Nick Shamie, testified that he had followed university policy, and hadn’t pursued the study because finding patients had been too difficult.

His wasn’t the only doctor-manufacturer relationship highlighted in the case. And even before Pedowitz joined the university, it had been criticized by Congress after another top spine surgeon failed to report nearly $460,000 in payments he had received from Medtronic and other medical companies while researching their products' use in patients, according to government records.

Several patients, according to The Times, are suing that doctor, Jeffrey Wang, and UCLA for negligence, fraud and malpractice in connection with surgeries involving Medtronic's Infuse bone graft. Wang is no longer with UCLA.

The Pedowitz settlement terms include his departure from the UCLA faculty; in 2010, he had stepped down as department chairman after expressing his concerns to UCLA officials. He filed a whistleblower retaliation complaint in 2011.

Mark Quigley, the attorney who represented Pedowitz, said the lawsuit wouldn’t have been filed had the UC system enforced its own policies. "What good are all the policies if they protect the wrongdoers and fail to protect the actual whistleblower?" he asked.

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April 13, 2014

Who Pays the High Costs of Medicines? Check This Out

In a fascinating set of letters to editor in the New York Times, responding to an article about six-figure prices for some drugs for those with chronic diseases like diabetics, this caught my eye, from reader Ed Schmith:

Last year, according to my calculations, these four [manufacturers], with a total of about $100 billion in sales, had nearly $22 billion in after-tax profits (21.9 percent). By comparison, in a highly competitive industry, Campbell Soup’s net profit was 8.4 percent, and we can choose whether or not to buy its products, a choice not available to those with Type 1 diabetes.

As outrageous as these numbers may seem, it’s really even worse in the United States. As the article points out, countries with universal health care systems are able to negotiate much lower prices with health care providers. As a result, Americans are shouldering not only much of the research and development costs but also the high health care company profits.

Why don't we negotiate with drug and device makers for lower prices? Because Congress banned Medicare from doing so, when it added prescription drug coverage to Medicare. Money talks in our nation's capital. And taxpayers pay the price.

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February 14, 2014

Doctors Call for Lowering Use of Radiation Imaging

Writing last month in the New York Times, Dr. Rita F. Redberg, a cardiologist, and Dr. Rebecca Smith-Bindman, a radiologist, applauded the advances made in preventing and treating cancer. But they also deplored the fact that the rate of cancer “remains stubbornly high and may soon surpass heart disease as the leading cause of death” in the U.S.

Even more alarming to patient safety advocates, their essay, “We Are Giving Ourselves Cancer,” suggests that the reason for cancer’s intractability might be our own fault; we are, they say, “silently irradiating ourselves to death.”

As we have written before, the growth in the use of diagnostic imaging, particularly technology such as CT scans that use high doses of radiation, presents the real risk of overexposure. Redberg and Smith-Bindman, of the University of California, San Francisco Medical Center, note that, between the 1980s and 2006, our exposure to medical radiation has increased sixfold. They say that radiation from a CT scan, which uses multiple X-rays to put together an image, can be 1,000 times higher than a conventional X-ray.

Like all medical procedures, the right one used at the right time can save your life. But the wrong one, or the right one used inappropriately, can present unnecessary risk. The harm from overuse of high-dose radiation imaging, according to the writers, is due simply to the fact that radiation is a carcinogen.

“A single CT scan exposes a patient to the amount of radiation that epidemiologic evidence shows can be cancer-causing,” they write, referring to several studies. In one, children exposed to multiple CT scans were found to be three times as likely to develop leukemia and brain cancer. Another concluded that radiation from medical imaging and hormone therapy were the leading environmental causes of breast cancer, and advised that women reduce their exposure to unnecessary CT scans. (Since that 2011 report, hormone therapy has declined.)

One in 10 Americans, say Redberg and Smith-Bindman, receive a CT scan every year. Many get multiple scans. Much of this inappropriate traffic is due to advertising the technology directly to consumers, and the pocket-lining practices of doctors who have financial interests in imaging centers.

CT technology is expensive, so any facility or person who has invested in it wants to use it.

If you can’t quantify the cancer caused by medical imaging, you can estimate it. The writers refer to a 2009 study by the National Cancer Institute projecting that CT scans performed in 2007 will cause 29,000 excess cancer cases, and 14,500 excess deaths among the patients who had them.

“Given the many scans performed over the last several years,” Redberg and Smith-Bindman write, “a reasonable estimate of excess lifetime cancers would be in the hundreds of thousands. According to our calculations, unless we change our current practices, 3 percent to 5 percent of all future cancers may result from exposure to medical imaging.”

Overuse aside, the doctors say that even when imaging is appropriate, it’s not always performed safely. Like the administration of medicine, the administration of radiation should reflect the lowest dose possible to achieve the desired result. But there is no universally accepted lowest dose standard, so what a patient gets depends on the facility where he or she is getting it. “The dose at one hospital,” the writers say, “can be as much as 50 times stronger than at another.”

And sometimes, the writers say, those measures can vary within the same facility.

One New York hospital the writers studied gave 1 in 3 of its cardiac patients imaging tests with the cumulative equivalent of radiation from 5,000 chest X-rays. And best practice for stress tests is to image a resting heart only after doing so during exercise. But one survey of nuclear cardiologists showed that only 7 in 100 such scans were performed before deciding whether it was necessary to image it at rest — that can decrease radiation exposure by as much as three-quarters.

The American College of Radiology and the American College of Cardiology have issued “appropriateness criteria,” the writers note, to inform doctors about the risks and benefits before ordering a test. And some health insurers scrutinize CT scan orders before authorizing payment for them. So the use of routine, unnecessary medical imaging has begun to slow.

But the danger of too much radiation is still a large problem whose resolution comes only by avoiding unnecessary scans and minimizing the radiation used for appropriate scans.

Redberg and Smith-Bindman call for better monitoring of and guidelines for radiation use. The FDA, they point out, oversees the approval of scanners, but lacks regulatory oversight for how they are used. They call for clear standards devised by professional radiology societies or organizations like the Joint Commission, a health-care certifying and accrediting agency, or the FDA.

Hospitals and imaging facilities shouldn’t be accredited to perform unless they record the doses they use and ensure that they are as low as possible by comparing them to published guidelines.

An ER visit, for example, often begins with the doctor routinely ordering multiple CT scans, sometimes without even seeing the patient first. If this happens to you or a loved one, question it.

The Times writers agree that consumers have a strong role to play in fixing this problem. They invite you to visit the Choosing Wisely website to learn about the most commonly overused tests, and before you agree to a CT scan, they say you should ask:

  • Will it lead to a better treatment and outcome?

  • Would you get that therapy without the test?

  • Are there alternatives that don’t involve radiation, like ultrasound or MRI?

And if a CT scan is necessary:

  • How can radiation exposure be minimized?

To read more about the dangers of radiation, see our backgrounder.

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December 16, 2013

Good Intentions, but Not-So-Good Consequences in Using Unapproved Medical Devices for Rare Diseases

The humanitarian device exemption is a little-known regulation that permits certain medical devices to be used on patients without having undergone the research trials generally required for FDA approval. A recent story in the New York Times showed the potential benefits and pitfalls of giving treatment that hasn’t passed rigorous testing.

The exemption program is based on good intentions. It’s used for small numbers of patients who have no other treatment options. It doesn’t make financial sense for companies to invest in the development and testing of devices for a market of only a few patients, so the exemption requires a manufacturer to show only that a device is safe and has a “probable” benefit. It doesn’t need to prove its effectiveness, which is the usual standard.

The program is similar to one governing drugs for extremely rare diseases, sometimes called “orphan drugs” for “orphan diseases.”

Critics of the practice charge that ineffective products approved for exemption can be sold for years while potentially lifesaving ones might not be able to prove their worth. And an exempted device may be used by doctors in other applications, a practice known as “off-label” use. It’s illegal for manufacturers to promote and market drugs and products for uses other than the ones for which they have been FDA-approved, but it’s not illegal for doctors to expand their application.

The Times illustrated the device exemption with the $500,000 BSD-2000, a device that uses intense heat (hyperthermia) to combat cancer. It is FDA-approved for women too desperately ill with cervical cancer to withstand chemotherapy. That is a tiny population; as one oncologist told The Times, “I see, like, one patient like this a year.”

The BSD-2000 got its exemption in 2011. A few hospitals bought the pricey machine, but failed to participate in a study of patients that the manufacturer agreed to perform as a part of the machine’s approval. Cancer experts were surprised that the FDA had approved the machine in the first place, given its tiny market of suitable patients.

A couple months ago, Dr. William Maisel, chief scientist at the FDA’s device unit, defended the BSD study ordered by the agency. But last month, the agency and the machine’s producer agreed to kill it in favor of a study intended to capture more patients, including some cancer patients on whom the device is expected to be used off-label.

The new study is intended to generate only safety information, not data about the treatment’s effectiveness.

BSD Medical makes another hyperthermia machine, the BSD-500, that the FDA approved in 1983 for the treatment of breast cancer and tumors that lie just below the skin. Although studies have indicated potential effectiveness of the BSD-2000 (devised to treat deep-seated tumors), it has failed since the 1980s, according to The Times, to achieve medical acceptance amid changing cancer treatment strategies and unsuccessful clinical trials.

One hyperthermia expert told The Times that if the FDA approved the BSD-2000 without better data collection, it could retard rather than advance the technology.

Since 1997, when the device exemption program started, about 50 products — heart pumps, orthopedic implants, optical aids — have been approved through it. And patients have benefited — one recently exempted device enhances vision in the nearly blind.

To qualify for the program, products must be intended for conditions that affect fewer than 4,000 patients annually. But the exemption, according to The Times, also has offered a loophole to market devices to far larger groups.

In 2006, the FDA tried to withdraw exemptions for two companies that sold implanted devices to close a tiny opening in the heart based on data suggesting it might reduce the risk of stroke.

The exemption covered patients with a patent foramen ovale (PFO) who had had two strokes despite taking drugs intended to prevent them. But PFO patients who had a single stroke or never had one soon demanded the device, under the presumption that it worked.

The manufacturers voluntarily withdrew them from the exemption program and ran clinical trials in the hope of gaining full approval. But by then, other devices were being used off-label to close PFO. Three studies subsequently failed to show that the devices were better than drugs in preventing strokes.

In 2007, the FDA denied full approval of the BSD-2000 to treat deeper-seated tumors. The agency determined that the results of a company-sponsored clinical trial performed at two hospitals in Holland were inadequate to show that it was safe and effective.

But one group in that study — women with advanced cervical cancer unable to tolerate chemotherapy — survived longer if treated with radiation and hyperthermia than with radiation alone. So FDA officials urged BSD Medical to seek an exemption for that patient group, and the company so.

Some advocates of hyperthermia say they believe that the exemption will lead to other trials that can shed light on the treatment’s value. Or not: The Times’ hyperthermia expert was concerned that justifying the machine’s cost could lead facilities to use the BSD-2000 for different kinds of cancers. Those results, she said, probably will be of little value to anyone.

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November 27, 2013

Medtronic Cardiac Guidewire Warning

The procedure to implant a cardiac stent, which keeps blocked arteries open, includes inserting guidewires to move the device into place. Federal health officials have issued a warning about a defect in some Medtronic guidewires that might cause serious injury, or even death.

The FDA classified the company’s Oct. 21 recall as Class I. That category is for products officials say have the potential to cause the most serious harmful effects. About 15,000 guidewires are involved.

Hospital and medical device distributors were warned that the coating on the wires could break off, reported USA Today, and possibly block a blood vessel. The coating is supposed to make the wires slide through blood vessels more easily.

If you have a cardiac stent procedure planned, make sure your doctor and hospital are aware of the recall for devices manufactured between April and September, and distributed through October. Make sure they've read the alert, and ask if any of their patients experienced problems (if, for no other reason, to focus their attention on the models of concern, listed in the FDA document).

If you have questions, call Medtronic at (877) 526-7890.

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September 26, 2013

Consumer Group Calls for Warranties on Artificial Hips and Knees

Many car buyers are familiar with what’s known as a “lemon law”—the obligation of a car dealer to make good if the car you buy is defective. Consumers Union, the policy arm of the nonprofit that publishes Consumer Reports, is championing the idea of a lemon law—otherwise known as a warranty—for the artificial hips and knees implanted during replacement surgery.

Problems with these devices are well known: For example, see our blog about Consumers Union's effort for more rigorous medical device testing. Joint replacements often fail, the organization notes, and patients and insurers get stuck with the bill, not the manufacturers.

Nearly 1 in 5 hip replacements and 1 in 10 knee replacements each year are revisions, says Consumers Union, and the re-dos are often necessary because the original device was defective. Those follow-up surgeries generally require longer hospital stays than the initial procedures, which means additional risks of infection, bed sores (pressure sores) and other problems that result from additional surgery and bed confinement.

They’re also more expensive for the patient, the insurance company and, where relevant, Medicare.

“[M]anufacturers of hip and knee implants should give patients warranties, guaranteeing to replace defective devices at no cost. That … is not only fairer to patients, but might encourage companies to make their devices safer and more durable,” says the Consumers Union policy statement.

The organization’s Safe Patient Project tapped into an FDA database on hip and knee implant recalls over the last 10 years, and learned that every major manufacturer had recalled a product or line of products.

It cited the approximately 750,000 Americans who received metal-on-metal hip implants since 2003 that were promoted as lasting longer than more traditional devices made with ceramic and plastic. But not only were such devices more likely to fail, as we’ve reported, some patients experienced debilitating symptoms from the metal debris that corrodes over time, including heart damage and neurological problems.

Knee implants, Consumers Union says, haven’t been as deficient or as dangerous, but still, according to the Safe Patient analysis, hundreds of knee-implant components have been recalled since 2003, often because they were shipped with the wrong part, a wrong size part, a missing part or a part built for the opposite side for which it was intended.

In what universe should these errors in management and manufacturing be the responsibility of the patient or insurer?

A Consumer Reports investigation last year on dangerous medical devices found that most hip and knee implants are approved for market without being reviewed for safety and effectiveness under the FDA’s 510(k) law, known as “fast track” clearance. That means manufacturers only have to demonstrate that a device is “substantially equivalent” to a product on the market—it doesn’t have to go through rigorous testing to which completely new devices are subject.

“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” Lisa McGiffert, director of the Safe Patient Project, said in the policy statement. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when they fail.”

Safe Patient wants the makers of hip and knee implants, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc. and Zimmer Holdings Inc., to provide a 20-year warranty that:

  • covers the full cost of revision surgery, including the device itself, the surgeon and hospital costs and patient out-of-pocket costs;

  • establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient; and

  • does not eliminate the patient’s right to sue if he or she uses a warranty.

If you believe in your product, you should be willing to make such a promise to the people who buy it.

To review Consumer Reports’ hospital surgery ratings for hip and knee replacement, link here. For the organizations advice on smarter hip and knee replacement, link here.

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September 15, 2013

Complications of Robotic Surgery Are Under-Reported

By now, the problems stemming from use of the Da Vinci robotic surgical device are well known. We’ve blogged about its adverse outcomes for hysterectomies, prostate cancer, and a host of other disorders.

Now, a study published in the Journal of Healthcare Quality finds that of the approximately 1 million robotic surgeries performed since 2000, only 245 complications -- including 71 deaths -- were reported to the FDA. That’s a remarkably low number -- and a suspect one too.

By law, when a device malfunctions or there’s an adverse event with a device during a surgical procedure, the hospital where it occurred must report it to the manufacturer. That company is required to report the incident to the FDA. The study’s researchers say it’s not always happening.

As reported on HealthLeaders Media, “Injuries and death resulting from the minimally invasive Da Vinci surgical robot … have got to be far more numerous than the 245 cases reported to the U.S. Food and Drug Administration so far, Johns Hopkins University researchers contend.

“The team, led by laparoscopic pancreas surgeon Marty Makary, MD, drew that conclusion because he and his research team were able to find eight cases of patient harm or death from robot complications in public court records or media reports.

“But no report was made to the FDA's Maude (Manufacturer and User Facility Device Experience) database for five of those cases and for the other three, the report was improperly filed or filed late, after the adverse event was reported by a major newspaper.”

Robotic surgery is promoted as a minimally invasive procedure suitable for a range of problems involving body parts as diverse as gallbladders and heart valves. The surgeon directs remote-controlled instruments from a console. In some cases the instruments can work in smaller spaces than human fingers can.

But in addition to adverse outcomes, there have been problems with training on the device, and although robotic surgery is more expensive than more traditional laparoscopic procedures, the outcomes are equivalent.

Still, 11 years after FDA market approval, more than 1,400 units were operating on U.S. patients, and they were in as many as 400 in hospitals around the world.

Makary, an outspoken critic of deficient health care, said that if 6 in 10 of those very severe cases weren’t properly reported, there were probably many more that were less serious that also weren’t reported.

Makary wonders why, more than 10 years after Da Vinci was approved by the FDA, it’s the subject of debate. What took so long? “The data,” he said on HealthLeaders, “could have been captured and analyzed in the first few years and we could have had the discussion about which procedures robotic surgery provides benefit for, and for which procedures there is no difference, and for which procedures are there added risks and costs that make it unwise.”

Makary is no Luddite: He supports the development of new technologies for medicine, but to do so without rigorous tracking of their outcomes is an exercise untethered to utility. "[W]e have to evaluate new technology properly,” Makary told HealthLeaders, “so we don't over-adopt -- or under-adopt -- important advances that could benefit patients."

You can’t evaluate safety if the system of collecting data is subjective and covert. There’s a reason the FDA demands accounting and accountability, but as the Hopkins study shows, the demand does not result in universal compliance.

The researchers found that of the reported Da Vinci complications, the procedures most often associated with death were gynecologic (22 of the 71 deaths), urologic (15 deaths) and cardiothoracic (12 deaths). The cause of death most often was excessive bleeding. For adverse outcomes other than death by far the most complications were for hysterectomies—43 out of 100 injuries.

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September 4, 2013

FDA Cautions Consumers About Hyperbaric Oxygen Therapy

Michael Jackson did it. Tim Tebow did it. Countless patients in search of relief for ear infections, burns, traumatic brain injuries and a host of other ailments have done it.

So does hyperbaric oxygen therapy (HBOT) work?

According to, probably not. At least not for those problems, nor a long list of others for which people have tried it.

A review of scientific literature, Slate reported, showed the therapy might offer some help to people suffering from migraine and cluster headaches, and if treatment is begun quickly, maybe for hearing loss and heart attacks. The best evidence of the value of HBOT is to treat chronic wounds, especially those related to diabetes, and for treating decompressions sickness, commonly called the bends, or divers’ disease, because it can strike deep-sea divers during improper ascent.

But there’s little evidence to support using a hyperbaric therapy, in which patients lie down to breathe oxygen in a pressurized chamber, to alleviate muscle soreness and whatever it was Jackson thought it could cure.

That’s why last month the FDA issued a consumer update on the practice. “[H]yperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes,” the material said. “But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.”

The device has been approved for treating decompression sickness, but not for the universal treatment for which it’s often promoted. The FDA, according to the consumer alert, “is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health.”

The potential harm, the agency says, is when a patient delays or forgoes a proven medical therapy in favor of this flavor-of-the-month approach. By doing so, the original complaint, in the best case, doesn’t improve, and in the worst case, deteriorates.

The safety and effectiveness of HBOT has not been established for:

  • Alzheimer's disease
  • asthma
  • Bell's palsy
  • brain injury
  • cerebral palsy
  • depression
  • heart disease
  • hepatitis
  • migraine
  • multiple sclerosis
  • Parkinson's disease
  • spinal cord injury
  • sport's injury
  • stroke
The FDA has received 27 complaints from consumers and health care professionals over the last three years about treatment centers promoting the hyperbaric chamber for uses not cleared by the agency.

HBOT involves breathing oxygen in a chamber in which the atmospheric pressure is increased as much as three times higher than normal. That enables the lungs to process much more oxygen than would be possible breathing oxygen at normal air pressure.

Some tissue injuries heal better with more oxygen, and hyperbaric oxygen therapy increases the amount of oxygen dissolved in your blood. That can improve oxygen delivery for vital tissue function to help fight infection or minimize injury.

Hyperbaric chambers are medical devices that require FDA clearance. Thirteen uses of a hyperbaric chamber for HBOT have been cleared by FDA. They include treatment of air or gas embolism (dangerous "bubbles" in the bloodstream that obstruct circulation), carbon monoxide poisoning, decompression sickness and burns caused by heat or fire.

The risks of HBOT range from the relatively mild, such as sinus pain, ear pressure and painful joints, to the serious—paralysis and air embolism. And because hyperbaric chambers are oxygen-rich environments, there’s a risk of fire.

If you're considering using HBOT, discuss other possible options with your doctor. If you experience or have experienced problems with HBOT, report them to MedWatch, the FDA’s safety information and adverse events reporting program.

To read news and other articles about FDA-regulated products, link to the agency’s Consumer Updates page.

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August 21, 2013

Surgical Errors -- When Technology Is the Problem

Surgical errors are a common cause of medical malpractice lawsuits. Sometimes it’s the result of an horrific human mistake such as operating on the wrong body part or leaving a tool inside the patient. A new study shows that a significant number of surgical mistakes are caused by problems with the equipment or technology used.

We love technology, whether it’s our mobile device, our car’s GPS or a medical tool that makes us better. But using the wrong tool in a medical setting, or using it improperly, can be deadly.

For example, we’ve discussed the ongoing problems with the Da Vinci robotics system that’s promoted for a wide range of surgeries including those for bladder, colorectal, gynecologic, kidney, prostate and throat cancers.

The new study, published in BMJ Quality and Safety, involved a review of more than 19,000 scientific studies that examined problems arising during a variety of surgeries.

As discussed on, nearly 1 in 4 of all surgical errors was associated with the failure of equipment or technology.

Additional analysis found that more than 4 in 10 errors had to do with how the machines were configured or calibrated; nearly 4 in 10 concerned the lack of availability of equipment, and more than 1 in 3 involved malfunctioning machines.

Sometimes, as we’ve written, mistakes are made because people aren’t trained properly in the use of the equipment.

Regarding the severity of operating room errors, 1 in 5 was classified as “major”; 13 in 100 of those were the result of technical failures, and 8 in 100 were about problems in communication.

Surgical errors are demonstrably reduced when hospitals implement certain procedures, including safety checklists, (see our blog, “Checklists for Surgery Safety Cut Death and Injuries.”) and the BMJ study bolstered this approach. In operating rooms where equipment safety checklists were followed before surgery, the number of errors was cut by half. When equipment-specific checklists were employed—that is, certain guidelines are followed for certain tools—errors dropped by nearly 61%.

As AboutLawsuits noted, medical mistakes affect as many as 16 in 100 inpatients, and nearly half of reported medical errors concern surgical procedures.

If you or a loved one is scheduled for surgery, make sure you understand the procedure—who is performing it, what are his or her credentials (how many similar procedures has he or she done; is he or she board-certified in the specialty) and whether a certain technology or tool is being employed.

If it is, investigate its safety record on the FDA’s website and ask if your caregiver has a financial stake in the equipment. Keep in mind that practitioners and hospitals that have invested heavily in new technology are especially keen to use—and charge for—it. Those financial interests might impair the providers’ objectivity when it comes to the appropriate use of technology in your situation. (See our blog, "Conflicted Care: Physicians with a Financial Stake in the Medical Devices They Use.")

Sometimes, device sales representatives are admitted to an OR to advise the surgical team on the proper use of their product. These situations are fraught with the potential for abuse. You have the right to know if this situation pertains to your case. If so, ensure that your caregivers follow guidelines for outsiders in the OR devised by the ECRI Institute, an independent, nonprofit organization that researches safety, quality and cost-effectiveness of patient care.

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August 12, 2013

Conflicted Care: Physicians With a Financial Stake in the Medical Devices They Use

In reflecting on five years of “reading medical journals and writing to inform patients of the hazards of medical care,” patient safety advocate John James says he has “learned some difficult realities.”

Our blog posts frequently mirror his observations.

“Perhaps foremost is that when people want to believe that their health-care system is safe and just, their opinions are not going to be easily swayed by data and facts, regardless of how reliable the source may be. Secondly, people want to believe that physicians always have their interest at heart; this naïve supposition is not easily replaced by caution when seeking medical care. Thirdly, most people are less interested in preventing their own poor health than getting treatment when a preventable disease has gotten the best of them. Finally, most people cannot view the health-care industry in terms of how it affects less fortunate Americans – for them it is about me and my health care.”

In a poignant example of his second point, consider a recent fraud alert issued by the Department of Health and Human Services’ Office of the Inspector General. It addresses physician-owned businesses that market implantable medical devices “ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).”

We wrote about the alert when it was issued in the spring, and now, the Wall Street Journal probes the smelly entities knows as physician-owned distributorships (PODs).

“Surgeon in Probe Is Working in Detroit-Area Hospitals,” concerns the story of Dr. Aria Sabit. He had a decided preference for an obscure brand of spinal implants, but many of his surgeries had tragic outcomes. Dozens of medical malpractice lawsuits were filed. The California medical board, the FDA and the Department of Justice, the Journal reports, are investigating Sabit because he had “an ownership interest in the company that distributed, and profited from, the surgical devices he switched to, people familiar with the matter say.”

Federal prosecutors say Sabit is part of a broader civil investigation into a network of doctor-owned spinal-implant distributorships operated by two former medical-device company employees that earned millions of dollars for its investors over six years.

“Physician-owned distributorships … have proliferated in medicine,” the Journal writes. “Distributorships, whether owned by physicians or not, act as intermediaries between medical-device makers and hospitals: In exchange for marketing and stocking devices, the distributors get a cut of each sale. When surgeons own the distributorship, that commission goes into their pockets. And [because] surgeons often dictate to their hospitals which devices to buy, they can effectively steer business to themselves.”

Apparently, Sabit’s dicey doings didn’t dissuade other hospitals from seeking his “talents.” Sabit, the Journal reports, is a senior staff member at a Michigan hospital, and has privileges at several others in the region.

He continued to use spinal implants from Apex Medical Technologies, the distributorship in which he had an ownership, on patients in Michigan until last June.

In depositions for the malpractice cases filed against him in California, Sabit has been … inconsistent, sometimes saying he didn’t receive monetary benefit from Apex implants, sometimes saying he didn't know if he did.

“A Detroit Medical Center spokeswoman,” according to the Journal, “says it wasn't aware that Dr. Sabit owned part of a spinal-implant distributorship. ‘We are currently looking into this,’ she said.”

The spokeswoman told the paper that the medical center wasn't aware of any problems during Sabit's time in California when it recruited him to join its surgical staff in 2011, and only later learned about the malpractice suits when they were filed. He, of, course, has denied the allegations.

Another Wall Street Journal story, “Does My Surgeon Profit From My Implants?” delineates how the owner-and-provider role common among spine, hip and knee surgeons is spreading to cardiac surgeons, and how difficult it is for patients to know if their surgeon is involved in a POD, unless the doctor discloses the information.

Incorporation documents for PODs in the Reliance Medical Systems network, the Journal reports, name Adam Pike and Bret Berry or one of their business associates as officers. They say nothing about any surgeons or their ownership structure. “The only clue about the companies' business,” the story says, “is in their names, which all include the terms "Spine," "Spinal," "Medical," or "Surgical."

Pike is listed as a "registered agent," and Pike Industries Inc. and Berry Medical Enterprises Inc. are "managing members/managers." The company’s address is a post office box in Jacksonville, Fla.

This sounds more like a covert mail drop than a legitimate business.

The Journal says that Pike and Berry shared ownership of each POD with a different group of surgeons. Each investor got an equal stake and received an equal profit distribution based on the POD's overall sales.

The Reliance network grew to include at least 11 PODs in six states by last year, when Pike and Berry bought out all the surgeon investors when PODs starting drawing scrutiny from the Justice Department.

As we suggested earlier this year, if your doctor recommends a procedure, or if you are having surgery to implant a medical device, find out:

  • What is the purpose of this procedure/device, what results can I expect, and how soon?

  • Are there alternatives?

  • Why am I having the procedure at this particular facility?

  • What is your financial interest in the equipment used or the facility where it’s performed?

To report suspected fraud involving physician-owned entities, contact the Office of the Inspector General’s hotline at (800) 447-8477, or online here.

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July 15, 2013

Manufacturer Knew Vaginal Mesh Product Wasn’t Fit for Human Use

Ever since it came on the market, vaginal mesh has proved problematic and has become the subject of thousands of lawsuits. Used surgically to treat prolapsed pelvic organs (those that have dropped out of normal position) and urinary incontinence, mesh products were marketed to doctors as an easier way to do a surgery that had required special additional training.

We’ve written about how these products have punctured organs and migrated out of position. Last month, Bloomberg reported that one vaginal mesh manufacturer, CR Bard Inc., sold a vaginal mesh product made of plastic that the company itself had said was not suitable for human implantation.

That disclosure came in a lawsuit over Bard’s Avaulta line of implants that claimed that managers at Bard’s Davol unit used a resin-based plastic made by Chevron Phillips Chemical Co. after the material’s supplier officially warned that it shouldn’t be implanted permanently in people.

In emails from 2004 and 2007, a Davol executive warned colleagues not to tell Chevron Phillips or other resin makers that the company was using the material in medical devices placed in humans.

As reported by Bloomberg, one email from a Bard vice president said suppliers such as Chevron Phillips “will likely not be interested in a medical application due to product-liability concerns. It is likely they do not know of our implant application. Please do not mention Davol’s name in any discussion with these manufacturers.”

As Bloomberg noted, medical device manufacturers have used polypropylene for years to make products such as sutures, catheters and artificial-heart components because that material is considered to be “biocompatible” and won’t be rejected by the human body.

The required safety document that Chevron Phillips filed with the U.S. Occupational Safety and Health Administration about the polypropylene used in some Bard hernia and vaginal implants said:

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.

“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use.”

It said that the resin-based plastic “may react with oxygen and strong oxidizing agents, such as chlorates, nitrates and peroxides,” and the plaintiff’s lawyers said human bodies can produce such oxidizing agents, causing the mesh to erode.

Plaintiff Donna Cisson’s trial began last week in West Virginia. But two days into it, the judge declared a mistrial because, contrary to a prior ruling that marketing information wouldn’t be allowed, one witness mentioned that Bard had withdrawn its products last year. Cisson claims the mesh caused her pain, bleeding and bladder spasms that required follow-up surgeries. She may seek punitive damages if jurors eventually hold Bard liable for compensatory damages and find the company’s conduct justifies the additional amount.

The judge in her case is overseeing 20,000 lawsuits against Bard, Johnson & Johnson, American Medical Systems, Coloplast Corp. and Cook Medical Inc. alleging injuries from vaginal mesh implants. The companies have denied wrongdoing in court filings. In addition to Cisson’s claims, other plaintiffs who had the mesh implanted to support weakened pelvic muscles and treat urinary incontinence suffered organ damage and painful sexual intercourse. They said the mesh degrades and shrinks over time.

The FDA issued a consumer alert about vaginal mesh in 2011, saying that “Surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI) that involves the placement of a mesh material through the vagina may expose women to a greater risk of complications than would other forms of the surgery.

“The number of problems reported to FDA has continued to climb since the agency first issued a safety communication about surgical mesh in 2008. It is not clear that POP repair through the vagina with mesh is more effective than traditional nonmesh repair in which surgeons repair the damage with stitches alone. FDA continues to evaluate the effects of using surgical mesh to repair SUI.”

The Bloomberg story said that 300,000 women had pelvic organ prolapse surgery in 2010, and that mesh was used in about 100,000 of those procedures. Of the more than 250,000 surgeries for incontinence that year, about 8 in 10 involved vaginal mesh implants.

Last year, the FDA ordered Bard, J&J and other mesh makers to conduct three-year studies of rates of organ damage, infection and painful sex linked to the devices after women’s groups called for their removal from the market.

These manufacturers are used to litigation: In February a jury decided that J&J and its Ethicon unit must pay more than $11 million in damages to a woman who blamed the company’s Gynecare Prolift implant for her injuries. Last year a jury awarded $3.6 million to a woman who blamed Bard’s Avaulta Plus implant for injuring her.

The Avaulta product was pulled off the market last year after seven years. J&J said last year it would stop selling four lines of vaginal-mesh implants, claiming that the reasons were not related to safety.

In the Cisson case, Bloomberg said, the mesh was cleared through the FDA’s 510(k) process. That allows medical devices to reach the market without human testing if they are similar to products currently on the market. Several companies were marketing vaginal-mesh implants when Bard’s Avaulta Plus was approved in 2007.

Erik Gordon, a business professor at the University of Michigan, told Bloomberg that the Avaulta case is an abuse of the 510(k) process. “The alleged conduct is unconscionable,” he said in an e-mail. “How can anyone ever trust a company that knowingly disregards safety warnings from its own supplier and covers up its conduct?”

According to Bloomberg, a gynecologist who worked as a Bard consultant on the vaginal implants testified in a deposition that he suggested clinical trials of the devices, but that Bard rejected the idea because the vaginal-mesh technology was developing so quickly that a multiyear clinical trial would cost several million dollars and that results would be outdated in the three or four years it would take to get the study published.

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June 27, 2013

FDA Issues Alert on Preventing Medical Device Hacking

A couple of years ago, we wrote about the vulnerability of certain insulin pumps to outside hackers. Since then, many more many medical devices with embedded computer systems also seem to be vulnerable to cyber security breaches. Add to that the increasingly interconnected nature of hospital networks and smartphones, and the risk of cybers ecurity breaches affecting medical device operations is compounded.

A hacker messing with your medical device can make you sicker, or even put you at risk of death.

The FDA gets it. The agency has issued an alert recommending that medical device manufacturers and health- care facilities take steps to assure that appropriate safeguards are in place to reduce the risk of failure due to cyberattack. Such attacks can result from malware sent directly to the medical equipment or by unauthorized access to configuration settings in medical devices and hospital networks.

At this point, the alert is strictly a warning—the FDA is not aware of any patient injuries or deaths associated with hacking, nor does it have any indication that any specific devices or systems in clinical use have been purposely targeted.

So this is a heads-up announcement for manufacturers, hospitals, medical device user facilities, health-care IT professionals and biomedical engineers to make medical devices secure, and keep those protections up to date.

For manufacturers, the FDA recommends:

  • Taking steps to limit unauthorized device access to trusted users, particularly for devices that are life-sustaining or could be directly connected to hospital networks. Such security controls can include: user authentication via password, smartcard or biometric; strengthening password protection; limiting public access to passwords used for technical device access; physical locks; card readers; and guards.

  • Protecting individual components from exploitation and developing strategies for active security protection such as timely deployment of routine, validated security patches and methods to restrict software updates to authenticated code.

  • Designs that maintain a device’s critical functionality, even when security has been compromised, known as “fail-safe modes.”

  • Providing methods for retention and recovery after security has been compromised.

For health-care facilities, the FDA recommends:

  • Restricting unauthorized access to the network and networked medical devices.

  • Ensuring that antivirus software and firewalls are up-to-date.

  • Monitoring network activity for unauthorized use.

  • Protecting individual network components through routine and periodic evaluation, including updating security patches and disabling all unnecessary ports and services.

  • Contacting the specific device manufacturer if you think you have a cyber security problem related to a medical device.

  • Developing and evaluating strategies to maintain critical functionality during adverse conditions.

If you or a loved one is being treated with a programmable, chip-embedded medical device, find out who the manufacturer is and what safeguards are included in its design. If your practitioners can’t provide this information, that’s a red flag—they should be as concerned with cyber protection as you are.

Also, ask your practitioner s what safeguards their facility has in place to protect against hacking. Use the list above to ensure they have adequate standards, and that they are being followed.

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June 26, 2013

Medtronic Spinal Treatment Is Riskier and No Better than Bone Graft

In another example of newer-not-better, two new studies suggest that a controversial product intended to promote spinal bone growth provides no benefits over traditional spine surgery, and comes with the added risk of serious side effects.

As reported on, the independent reviews published in the Annals of Internal Medicine (here and here) analyzed data from all clinical trials for Infuse, manufactured by Medtronic.

The extra scrutiny was the result of Medtronic’s efforts to hide complication rates and potential side effects in earlier studies. If your product included a possible risk of cancer, you, too, might want to keep that discovery out of sight.

Infuse, as explained on, is a bone morphogenetic protein, or BMP, that’s implanted to encourage bone growth and fuse the gaps between vertebrae. Medtronic promotes Infuse as an alternative to traditional spinal surgery that harvests bone from another part of the body or a cadaver to encourage fusion of the vertebrae.

The FDA approved Infuse only for limited applications, but it has been used widely for off-label uses—those not officially approved, but not prohibited, although the manufacturer may not promote those uses. BMP is approved for tibia fractures, facial surgery and fusing damaged vertebrae in the lower spine, but when used in the upper and cervical spine, it has been linked to reports of cancer, sterility and pain caused by excessive bone growth.

Several lawsuits by patients experiencing these side effects have been filed.

The gravity of the issue is indicated by the fact that, according to an editorial in the Annals of Internal Medicine, two systematic reviews of this scale have never before been published simultaneously. One study was done by researchers in Oregon, and the other by researchers in England.

Both groups were given detailed data from 17 spinal studies using Infuse on more than 2,000 patients. They also got safety reports filed to U.S. regulators and other publications about the product.

As summarized by About, “Researchers indicated that it was hard to find a good reason to actually use Medtronic Infuse, and they also found significant reporting bias in previous studies by Medtronic, which overstated the benefits of the bone growth product.”

And from the Oregon researchers: “Our study shows that adverse events were underreported for more on- and off-label uses, with results not previously available to the public. Journal practices for sponsored supplements, trial registration and conflict of interest disclosure may have contributed to publication of an incomplete and sometimes misleading evidence base.”

Medtronic, according to, is the world’s largest manufacturer of spinal treatments.

Last year, Congress concluded that Medtronic had manipulated previous medical studies that appeared to minimize Infuse risks and overstate its effectiveness. The company paid $210 million to authors of studies sponsored by the company. The studies seem purposefully to have left out findings that suggested Infuse could increase the risk of male sterility, bone growth problems, cancer and back and leg pain.

That’s bad enough, but investigators said Medtronic officials also inserted language into scientific studies suggesting Infuse was better and less painful than the bone graft technique. One email exchange, according to, revealed that Medtronic employees urged that a complete list of adverse events linked to Infuse not be published in a 2005 study.

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June 4, 2013

FDA Launches First-Ever Probe of Medical App for a Mobile Device

Last year we blogged about the popularity of medical smartphone applications and referred to an investigation showing that the quality of much of the health information available via these apps is questionable.

That’s why although health apps might be fun and even informative, no one should rely solely on them for sound scientific diagnosis or treatment. Last month, the FDA reinforced this idea when it flagged an iPhone app as the first target for establishing regulatory boundaries for mobile medical diagnoses.

As reported by, uChek, a smartphone app enabling users to check levels of blood, protein and other substances in their urine, was not approved by the FDA; the feds sent a letter of inquiry to Biosense Technologies, the app’s developer, seeking specific data about how the system works. It was the first such medical device letter directed to a smartphone app developer.

App users, such as people with diabetes who want to check their glucose, dip a test strip in their urine then use the phone’s camera to read the result via a small automated device that generates a value. The test strips are made by Siemens and Bayer, and are approved only for visual, not digital, review. The FDA’s letter, reports Bloomberg, says that the automated reading requires separate approval as a medical device.

As we blogged last year, the proposed FDA standards for mobile device apps that diagnose or treat conditions remain under Congressional review. Proponents of regulation want to set app standards similar to those for other medical devices like heart stents and ultrasound equipment. A spokeswoman for the FDA told Bloomberg that “We intend to finalize the guidance this year. The FDA has proposed a regulatory approach that limits its immediate oversight to a specific, small subset of mobile medical applications that are medical devices and present the greatest risk to patient safety if they don’t work as intended.”

The uChek app became available earlier this year. It’s free, but users must purchase the test strips and the $40 automated reader. In its letter to Biosense, the FDA said the company might need to gain approval for the whole system, not just the app.

Depending on how the company responds to the FDA letter, Bloomberg says, the agency might follow up with a stronger warning enumerating specific violations of the law that must be addressed immediately.

If you want to learn more about health and medicine apps for mobile devices, visit iMedicalApps, where health-care professionals assess various products by app type, medical specialty and app name.

Another new resource for assessing the value of medical mobile device apps is Happtique, whose Health App Certification Program (HACP) is meant to advise both providers and consumers on apps that deliver credible content and protect user data.

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May 29, 2013

IUD Poses Problems for Thousands of Women

As promoted by Bayer, its manufacturer, the Mirena IUD is a highly effective birth control device that can remain in the uterus for as long as five years. The product website also warns that it’s not indicated for women with a pelvic infection, who get infections easily or those who have certain cancers.

What the website doesn’t say is that the FDA has received more than 47,000 reports of injuries and complications from people who have used the device. According to, Adverse Events, a private company, analyzed adverse event reports submitted to the feds to come up with these troubling figures.

Most of the problem reports concern the IUD:

  • being expelled from the body (3.6 in 10 reports);

  • migrating outside their placement position in the uterus (1 in 10 reports);

  • causing vaginal hemorrhaging (slightly less than 1 in 10 reports).

Adverse Events analyzes reports submitted by consumers and health-care professionals to the FDA’s Adverse Events Reporting System (FAERS) and summarizes them in charts and graphs of timelines, side effects and demographic information. The Mirena report concerns thousands of reports the FDA received between November 1997 and August 2012.

The Mirena IUD prevents conception by releasing a synthetic hormone, levonorgestrel, to prevent the ovaries from releasing eggs into the uterus. Some women use it to treat heavy periods.

The Mirena website list of possible side effects includes migrating through the uterus wall, but, as AboutLawsuits says, concern has ratcheted up and a“growing number of women throughout the United States are now pursuing a Mirena injury lawsuit against Bayer.” They claim that the company failed to adequately warn about the risk of complications, “which could cause infections, damage to internal organs and often results in the need for surgery to remove the IUD.”

According to the reports, about 6 in 100 women were hospitalized because of the Mirena problems, and Adverse Events said more than 50 deaths might have been associated with the adverse event reports it reviewed.

Millions of women have had a Mirena IUD implanted, and AboutLawsuits says that as of early April, at least 50 lawsuits had been filed throughout the federal court system, and that’s probably just the beginning.

If you have a Mirena IUD, discuss the benefits and risks of it with your doctor, and ask about alternatives for contraception or other problems for which you have the IUD. If you’ve had problems with the device, report them to the FDA’s MedWatch program.

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May 7, 2013

Consumer Group Calls for More Rigorous Medical Device Testing

The proliferation of lawsuits over adverse events associated with invasive medical devices including metal-on-metal hip implants and transvaginal surgical mesh speak to a recent call by Consumers Union to strengthen the testing requirements for high-risk implants.

Consumers Union, as described by, is the lobbying arm of Consumer Reports. Last month, it sent a letter to the FDA urging it to require full research and testing under the agency’s premarket approval (PMA) process for Class III implantable devices.

The FDA has three classes of medical devices categorizing approximately 1,700 different generic types. Each type of device is classified, according to the agency, “based on the level of control necessary to assure the safety and effectiveness of the device.”

Class I devices require the least amount of regulatory intervention, and Class III, such as the hip and mesh implants, the most. For Class III devices, PMA is required unless there’s a substantially similar product already on the market. If so, newer versions of it get what’s known as a 510(k), or fast-track exemption, excusing it from all the testing required of the earliest device.

As reported on AboutLawsuits, many fast-tracked Class III devices are quite dissimilar from the originally approved device they are based on. Often, they are marketed as using new techniques and new designs “at the very same time the FDA is approving them for being identical enough to an existing device so as not to warrant clinical trials.”

Many 510(k) devices now on the market weren’t clinically tested before the 510(k) program or PMA process existed. So potentially dangerous new devices, notes AboutLawsuits, are given “grandfathered” approval without warranting it. A Consumer Reports investigative study that we wrote about last year concluded that most medical devices being implanted in U.S. patients have not been tested.

Thousands of people, the Consumer Union letter says, have suffered severe and debilitating injuries from implants that weren’t thoroughly evaluated by the FDA, and the agency should reclassify all high-risk implantable medical devices to require that those receiving PMA undergo clinical trials to prove that they are safe and effective.

FDA action seems to prove this case: In January, the agency issued a safety warning about metal-on-metal hip implants that said they have “unique risks” including soft tissue damage and other problems. (See our blog about a large damages award to a patient who learned this sad truth.)

Transvaginal mesh also should fall under this scrutiny, the Consumers Union letter said, because it has been known to puncture organs and cause autoimmune disorders. And it, too, was the subject of an FDA warning and a subsequent letter to manufacturers ordering additional studies to evaluate their risks.

According to AboutLawsuits, “many manufacturers have decided to cease commercialization of their products, hoping to avoid the need for testing that many believe should have been done before the devices were ever sold in the United States.”

If you want to report or research adverse events associated with medical devices, visit the FDA’s MedWatch site. For additional guidance on informing yourself about medical devices, and protecting against their risks, see our blog “Protecting Yourself from Dangerous Medical Devices.”

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April 4, 2013

More Evidence to Let Caution Be Your Guide in CT Scans

Computed tomography (CT) is a scan of internal organs that creates cross-section images using X-rays. It’s a very popular kid on the medical technology block:

  • Between 1980 and 2007, the number of CT scans performed in the U.S. increased from 3 million to 70 million.

  • An estimated 29,000 future cancers, according to a National Cancer Institute study, will be related to scans done in 2007 alone.

  • An estimated 1 in 3 imaging exams do not help the patient nor contribute to better outcomes.

This last, cold reality was delivered recently on by Dr. Toni Brayer, an internal medicine practitioner. We have raised the flag of CT risks many times, and an increasingly larger segment of the medical community is concerned about the radiation this technology relies on.

We’ve also discussed the fact that a lot of patients are unaware that a CT scan involves radiation, or that radiation can be harmful. Brayer notes that a new study from the University of Washington shows that 1 in 3 people did not know that a CT scan exposed them to radiation, and those who did underestimated the amount of radiation it delivered.

“A CT scan,” Brayer writes, “delivers a mega-dose of radiation, as much as 500 times that of a conventional X-ray.”

The more scans you have, the higher your risk. Radiation risk is cumulative.

Brayer explains a medical situation called “incidentalomas”; that’s when you get, say, an X-ray for a suspected case of pneumonia that also shows something that can’t be explained. So the radiologist might recommend a follow-up CT scan to diagnose that, and you’re on your way to possibly unnecessary—and dangerous—overexposure to radiation.

A better approach taken by Brayer and other clinicians not under spell of “more more more” is to weigh the risks of getting the additional scan with its possible benefits. That often leads clear thinkers, who know that “defensive medicine” (when doctors overprescribe tests in order not to be accused of missing something) is misguided, to address the infection now and repeat the chest X-ray in a few months to see if the unknown spot remains.

Brayer applauds the ability of CT technology, but encourages everyone to understand it better. Her advice:

  • If a doctor orders a CT scan for a child, the parent should ask the technician to use pediatric-appropriate settings. (Children are especially vulnerable to the risks of excess radiation.)

  • Do not let a doctor or facility repeat a scan that was done recently (for example, if you get second opinions or are seen at a different place). All scans can be electronically shared.

  • Ask if a “low-dose” scan is appropriate.

  • Avoid using the emergency department for health care—your chances of getting a CT scan for a variety of complaints are extremely high. (See our blog, “Emergency Use of CT Scans Soars.”) The overworked ER doc wants to cover all possibilities, even those that have low probability, in the least amount of time—bingo! Order a CT scan.

  • Ask “How could the test result change my (or my child’s care), if at all?”

  • Ask, “Can you recommend an alternative, such as an ultrasound or MRI, that doesn’t involve radiation?”

To learn more about radiation overdose injuries, see our backgrounder.

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March 10, 2013

What Does Johnson & Johnson Have Against Patient Safety?

This year is not turning out well for Johnson & Johnson. Things wouldn’t be so grim for the huge conglomerate—which markets a range of products from gauze to baby shampoo to surgical implants—if its priority were patient safety instead of hawking products it knows to be deficient.

The first piece of bad news for J&J was delivered by a jury in Atlanta that ordered the company to pay more than $11 million in punitive and compensatory damages to a former hospice nurse. Her misfortune was having surgery to implant vaginal mesh sold by a J&J subsidiary. The mesh was supposed to support pelvic muscles and internal organs but proved so harmful that the patient underwent 18 subsequent surgeries to relieve the resulting pain.

As recounted in a story on, the nurse missed so much work because of the surgeries that she was fired.

The device was first sold by J&J in 2005, and was withdrawn from the market last year because there were so many problems and so many lawsuits. According to the MedCity story, thousands of implant cases have been filed against several different manufacturers of vaginal implants, and this was only the second verdict. Both were in favor of the plaintiffs.

The civil justice website Pop Tort noted last year that the FDA had approved surgical meshes for procedures like abdominal surgery. But J&J was marketing them to women with pelvic prolapse—when muscle and organs lose their strength and resilience, often as a result of childbirth. The mesh was supposed to offer support and treat prolapse problems such as incontinence. What it did was disintegrate, grow into tissue and become impossible to remove. Some patients were severely injured, and some died.

McNeil Consumer Healthcare, the J&J branch that manufacturers several of its products including the recalled vaginal mesh implant, shuttered the plant that made it in 2010. It won’t reopen until a federal judge approves.

Still, after the damage award the company claimed that the implant was not defective in design, that J&J did not misrepresent the product to surgeons and that the jury was confused. That sure sounds like “blame the messenger.”

Also in February, as Pop Tort reported, the U.S. attorney’s office and the Justice Department were investigating J&J's marketing of its DePuy ASR hip replacement, which we’ve written about before. It was recalled in 2010 after data revealed that as many as 30 in 100 such artificial hips would fail within the first six years. And because it’s a metal-on-metal device, it also posed risks of poisoning the people who received it as tiny bits of metal eroded into surrounding tissue.

Before it was recalled, according to, more than 90,000 implants had been sold throughout the world.

The first trial went to the jury at the end of February after witnesses who used to work for DePuy testified that the company knew the product was deficient long before it was recalled. Last Friday, the verdict was announced: Johnson & Johnson was ordered to pay $8.3 million in damages.

Some 10,000 lawsuits have been filed over the ASR device. And several other metal-on-metal hip implants have demonstrated similar problems—the FDA has told doctors that they should be considered only if other artificial hip implants weren’t appropriate. Future metal-on-metal designs must undergo extensive human trial before they’re allowed to be sold.

On March 1, according to Pop Tort, the FDA announced a Class I recall—the most serious class, denoting “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death”—of J&J’s LPS Diaphyseal Sleeve. It’s used in reconstructive knee surgery. The device, said the FDA, has the “potential for fractures,” which could lead to loss of function, loss of limb, infection, compromised soft tissue or death. The agency has received 10 reports of the device malfunctioning:

Clearly, something is rotten in the state of Johnson & Johnson. As Pop Tort suggested, “From now on, Johnson & Johnson needs to stick to cotton swabs. The outer ear is as far inside the body we would like J&J products to go, thank you very much.”

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February 6, 2013

Some Hospitals Reuse Insulin Injector Pens

You might remember a blog we wrote last year about safe injection practices, and how hepatitis, HIV and infections can be spread when hygiene is not a priority.

Nothing is stupider than reusing invasive medical equipment, but a couple of hospitals in New York don’t seem to have a very high safe-injection IQ. As reported on last month, Buffalo Veterans Administration Center and Olean General Hospital have both been found to have reused insulin pens on different patients.

Such devices are designed to be reusable, but only for the same patient, and only when the needles are changed after each injection. Although the hospitals used new needles for each patient, blood can still back up into the pen, which makes them safe only for one user. But the New York hospitals apparently allowed multiple patients to use a single pen. All of them are now at risk of hepatitis C and HIV.

Olean General warned 1,915 patients that they might have been exposed between November 2009 and Jan. 16, 2013, and Buffalo Veterans warned more than 700 patients who might have been exposed between October 2010 and November 2012. So far, there are no reports of disease transmission caused by the improper use of the insulin pens, but the incubation period for HIV can be two years. Hepatitis C can incubate for six months.

If you or a loved one received an insulin pen injection at either of these facilities, contact them immediately to receive free blood tests. In addition, Olean has a call center for anyone with questions—(888) 980-1220.

For everyone else, the lesson is always to watch the preparation of an injection. If you don’t see how the medication was prepared, whether it involves a pen, syringe or IV tube, ask the doctor, nurse or other health-care aide who is giving it to you if the both the dispenser and the needle are fresh. If you have any question that they aren’t, decline the medication until you are allowed to see its preparation.

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January 26, 2013

Internal Memos Focus Spotlight on Hip Implant's Design Flaw

How does a medical device company talk internally about design flaws discovered in a hip implant it is promoting to thousands of surgeons?

“We will ultimately need a cup redesign, but the short-term action is manage perceptions.”

That's what one sales official of DePuy, the Johnson & Johnson unit that makes hip implants, wrote in an email to a colleague in 2008, about its ASR hip device.

The "cup" this official referred to is the acetabular or socket component of the metal-on-metal ball-and-socket hip replacement.

And in a report the previous year about engineering tests on the ASR hip, the company's officials wrote:

“The current results for A.S.R. do not meet the set acceptance criteria for this test."

That was a reference to excessive wearing of the device, which was thought to lead to the high rate of failures of the ASR implant.

The upshot is that thousands of patients continued to get the defective device placed in their bodies before DePuy finally admitted the design defect and recalled the device in 2010.

Meantime, it was "managing perceptions."

The newly revealed internal documents were disclosed in a product liability trial of the first lawsuit against DePuy to reach the courtroom. Barry Meier of the New York Times wrote the report quoting the DePuy documents.

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January 26, 2013

Lawsuit Over Hip Implants Shows Company Hid Own Estimate that Huge Numbers of Patients Were Harmed by Defect

In 2010, Johnson & Johnson recalled an all-metal hip implant device because of a high failure rate and because the grinding of its components released tiny bits of metal that damaged tissue and bone. The company conducted an internal review of the device in 2011 that showed the implant would fail within five years in about 4 in 10 patients.

Only now, as reported by the New York Times, is that information coming to light.

J&J’s report is among hundreds of internal company documents, says The Times, expected to become public as the first of more than 10,000 lawsuits by patients who got the implant, the Articular Surface Replacement (ASR), went to trial yesterday.

Hip implants made of metal and plastic instead of the metal-on-metal design of the ASR often last for 15 years before they wear out, according to The Times. They can fail prematurely for a variety of reasons, but not at the rate of the recalled device. A premature replacement rate would be about 1 in 100 after a year, and 5 in 100 after five years.

J&J never released the dismal five-year failure results for the ASR. “But at the same time that the medical products giant was performing that analysis,” says The Times, “it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.”

We’ve written about the problematic history of metal-on-metal hip implants, and the new disclosure about hidden company documents once again puts Johnson & Johnson’s DePuy Orthopaedics division in the hot seat: What did company officials know about the device’s problem before its recall? What actions did they take or fail to take?

How many more failures of this shoddy device are about to occur? How many more patients who had the surgery are facing more painful and expensive surgeries to replace it?

As The Times reports, last year J&J took a $3 billion charge so that money could be reserved for patients and lawyers involved in the upcoming product liability lawsuits. DePuy, The Times says, has offered to cover the cost for patients to correct the problems.

That’s nice, but, really, if the company knew of the high potential for such problems and did nothing to address them before they harmed thousands of people, is that really much consolation?

The discovery last week of the internal report is only a tiny bit of what will become public knowledge if the company doesn’t settle, and the lawsuit proceeds to trial. Plaintiffs’ lawyers have been preparing for two years, and who knows what other ugly secrets J&J was protecting.

Approximately 93,000 people around the world have received an ASR; more than 31,000 of them live in the U.S. Some 7,000 separate ASR lawsuits have been consolidated in a federal court in Ohio, and another 2,000, says The Times, have been consolidated in a California state court.

The California case that brought the internal report to light involved a cancer patient who might not live much longer. The paper said DePuy has settled some ASR cases before trial, and it may do so in his.

Cold comfort, indeed. But a testimonial, at least, to the power of lawsuits to unlodge secrets of corporate wrongdoing.

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December 6, 2012

Portable Bed Rails Can Kill or Hurt People They're Supposed to Protect

Bed rails seem like such a good idea—metal bars installed on beds to help people pull themselves up or get out of bed, and to prevent them from rolling out of bed. But the clamor to make them safer is growing louder because some portable bed rails promoted as a safety device can pose a risk of injury and death.

Recent articles published in the journal Biomedical Safety & Standards(BS&S) and the New York Times describe a longstanding awareness of the problem, and illustrate it with sad tales of people losing their lives when their caregivers thought they were safe.

Two consumer watchdog organizations, Public Citizen and the National Consumer Voice for Quality Long-Term Care, have asked the Federal Trade Commission to stop one manufacturer from making false claims. Last year, a similar appeal was made to the FDA, and to recall certain bed rail models. Safety advocates want the feds to study the design and use of all similar devices that pose risks from entrapment and strangulation.

The groups said that more than 525 deaths had been reported to the FDA, and more than 155 to the Consumer Product Safety Commission (CPSC). The actual number of incidents, however, is probably much higher—home users and maybe even some health-care providers might not know that such events should be reported to these agencies. As BS&S reports, “Some facilities may seek to conceal a person's cause of death for fear of liability or suggest that the patient bore some responsibility for the event.”

Bed Handles Inc. still claims that its Bedside Assistant “makes any bed a safer bed,” and “stable in all directions and can be firmly pulled, pushed, lifted, and leaned on,” Claims for other portable rails, BS&S says, are similarly inaccurate.

In 2008, the Consumer Product Safety Improvement Act set mandatory safety standards for many infant nursery products, including portable children's bed rails in light of well-documented injuries and deaths in young children. After the standards were implemented, childhood crib and bed-related injuries declined significantly. In 2012, the CPSC enacted Safety Standard for Portable Bed Rails, but only for those affixed to beds for youngsters, not adults.

But elderly patients are particularly vulnerable to falls, which can be catastrophic. According to BS&S:

  • The presence of bed rails does not deter adults or children from trying to get out of bed.

  • There is no evidence that side rails prevent falls.

  • Other evidence-based methods reduce the incidence of bed-related falls--lowering bed height and placing anti-slip matting at the bedside.

  • Bed rails can be more dangerous to patients than falls.

  • A fall with a bed rail in place is more dangerous than a fall without a rail.

According to CPSC Commissioner Robert Adler, older people comprise 13 of 100 Americans, but they suffer 60 in 100 deaths associated with consumer products. Injury-related emergency department visits by people 75 and older are double those of people 65 to 74.

As reported by The Times, from 2003 to 2012, 36,000 mostly older adults — about 4,000 a year — were treated in emergency rooms with bed-rail injuries.

Clara Marshall, whose story was told in The Times, was a member of that at-risk older demographic. In 2006 she was suffering from dementia, and her family moved her into an assisted living facility offering round-the-clock care. Five months later, she was found dead in her room from apparent strangulation. She caught her neck in bed rails that were supposed to keep her from rolling out of bed.

Her daughter, Gloria Black, contacted the CPSC and FDA, and learned that both agencies had known for more than a decade about deaths from bed rails. In 2010, after appeals by Black, the CPSC helped prompt a review of bed-rail deaths. “I wish it was done years ago,” Black told The Times. “Maybe my mother would still be alive.”

If safety experts call for more and stronger warnings, regulatory questions trump common sense: Who’s responsible for bed rails, the FDA, which monitors medical devices, or the Consumer Products Safety Commission, which monitors consumer products?

“This is an entirely preventable problem,” Dr. Steven Miles of the Center for Bioethics at the University of Minnesota, told The Times.

To review product recall information and file a report with the CPSC, link here. To review device recalls and alerts and file a report with the FDA, link here.

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November 14, 2012

The Dangers of Hospital Alarm Fatigue Gain Wider Appreciation

Anyone who has spent time in a hospital—as a patient, visitor, family member or medical professional—knows that they can be noisy, frantic places. Contributing to the cacophony is what’s known as “alarm fatigue,” or the deadening effect on medical personnel of the myriad sounds issuing from monitoring devices, particularly in critical care units. We first wrote about alarm fatigue last year. If you’re exposed to these beeps and whines long enough, you become desensitized to them.

They're the electronic Boy Who Cried Wolf.

That’s a hazard for patients who rely on the optimal operation of these machines to remain alive. As noted in a story on, many monitor alerts don’t necessarily communicate a specific, urgent condition; they communicate an abundance of information, some of it much more important than the rest. So their sheer volume—in number and sound—that health-care professionals are supposed to interpret and respond to can increase the risk that an important alert will be missed until it’s too late.

MedCity refers to a report from last year by the ECRI Institute that called alarm fatigue a top health technology hazard for hospitals. ECRI is an independent, nonprofit research organization devoted to improving the safety, quality and cost-effectiveness of patient care. The FDA as well has begun to study the problem of alarm fatigue in an effort to improve training for alarm safety and standards.

MedCity interviewed Dr. Joseph Frassica, chief medical officer of Philips Healthcare (manufacturers of medical devices and consumer health products), who serves on an alarm steering committee with other members representing the Joint Commission (which accredits hospitals), the FDA, device manufacturers and medical professionals. The committee is developing recommendations for resolving alarm fatigue, and a timeline to implement them.

Frassica said the risks of alarm fatigue have been around since the invention of the EKG machine, which studies and records the electrical activity of the heart. Now that the FDA has boosted the profile of alarm fatigue, the medical community is looking at the amount of information machines generate and how to prioritize patient alerts.

Four ideas have emerged:

1. More specific alarms. “[N]o longer is it OK to have very sensitive alarms that are nonspecific,” Frassica told MedCity, referring to the need for the sensitivity to signify an urgent condition. “Most of the industry is working on building more specificity into their systems.”

2. Customizable or flexible alarm settings. More patient-specific and/or provider-specific alarm settings are under review that would enable institutions to set parameters and thresholds to match their own scoring criteria. The idea is to help caretakers to detect subtle signs of patient deterioration earlier and to generate a log so that nurses taking a blood pressure reading every shift, for example, can report an early warning score to a central system. That addresses the possibility of crucial information being missed when shifts change. Health-care organizations would review alarm logs to see which ones have a high volume and to define parameters that would generate an alert or alarm.

“We know that most of our monitoring systems are built for very sick patients so the triggers are cued to patients that are likely to have an event,” Frassica told MedCity. “If you take that monitoring and put it on patients who are not as sick, alarms might be triggered by patient activities that are nonactionable events, like shaving or [using the bathroom].”

3. More interaction among medical device alarms. This is about intelligent machine design. This is about devices that map data from different sources to render a visual display that helps clinicians identify trends in a patient’s condition quickly at one glance.

4. Creating an alarm escalation plan. Johns Hopkins Hospital in Baltimore eliminated duplicate alarms and used the experience of nurses to develop a system to triage alarms via their pagers. It also switched some alarms from alerting by sound to alerting by display. The ECRI Institute recognized Johns Hopkins for its efforts at addressing alarm fatigue.

Reducing alarm fatigue remains in its infancy, but at least there’s an industry-wide recognition that it threatens patient safety and generally can impair the quality of care. It also reinforces the wisdom of hospital patients having an advocate at their bedside for the duration of their stay.

For more information, see our newsletter, “Protecting a Loved One in the Hospital.”

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September 17, 2012

Medical Device Maker Withdraws Libel Claim

Chalk one up for the truth-tellers. And one big black eye for sellers of dubious medical devices who try to use the courts to bully skeptics.

Late last month, Advanced Aesthetic Concepts, a medical device distributor, filed a libel claim against FairWarning, an investigative journalism organization, and Public Citizen, a consumer advocacy organization. The company claimed that they had made false statements about its “fat-melting device” called LipoTron 3000, causing economic harm.

The company also claimed that after the article was published, Public Citizen defamed it in letters to the FDA and state medical boards encouraging them to take enforcement action.

In addition to the organizations, two whistleblowers were targeted in an earlier lawsuit. One is a former LipoTron distributor who provided sales records and other documents to an agency investigator. The other was a marketing consultant accused of disparaging the product on the Internet and through social media. That lawsuit was amended to add the libel claims against the organizations.

Little more than a week after it filed the claim, Advanced said, essentially, “Never mind.” It dropped the lawsuit against FairWarning and Public Citizen. And it won’t say why.

After Advanced filed a one-paragraph dismissal, its lawyer declined to explain. “A suit was filed, and a suit was dismissed, and that’s the way we’re leaving [it],’’ he told FairWarning.

But it’s not dropping its claims against the whistleblowers, who were sources for the FairWarning story after they had been sued by Advanced for defamation for documents given to the FDA in 2010.

The LipoTron supposedly eliminates fat using radio frequency waves instead of invasive surgery such as liposuction or a variety of bariatric surgical procedures to reduce stomach capacity. It’s distributed by Advanced and manufactured by RevecoMED.

The libel/defamation lawsuit claimed the defendants have falsely stated that the LipoTron has been marketed without FDA approval; that the feds are conducting an investigation; and that the defendants inaccurately equated the LipoTron with the Lipo-Ex program, which involves multiple treatments and devices, including the LipoTron.

But FairWarning has documents and interviews with insiders supporting its conclusion that the FDA is investigating LipoTron sales. The FDA has declined comment. FairWarning reported that the LipoTron has not been cleared or approved by the FDA for weight-loss treatments, which would make it illegal to market it for that purpose. It was registered last year, after years of sales, for a different use.

Twice Reveco tried unsuccessfully to get FDA clearance. In 2011, the Texas State Department of Health Services issued a warning letter to Texas-based Advanced for marketing the LipoTron without FDA clearance.

About the same time, Reveco registered the LipoTron as an electronic massager, which is classified by the FDA as a Class 1 device. That category doesn’t require agency review because it represents low-risk equipment, such as elastic bandages. (See our explanation of FDA device classifications and our blog, “Protecting Yourself from Dangerous Medical Devices.")

Allison Zieve, general counsel of Public Citizen, offered one reason for Advanced’s abrupt change in legal strategy: “Maybe they realized they screwed up,’’ she said, and decided to steer clear of those “they thought most likely to put on a good defense.”

One of the whistleblowers called the lawsuit a face-saving move, and that Advanced knows “the truth’s been told about them all along.” She thinks the company is going after her and the other individual because they’re “considered the weakest link because they think we can’t pay for a defense.”

Sounds plausible when a loser desperately wants to look less pathetic.

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August 12, 2012

Are Europeans Better at Bringing Medical Devices to Market?

Some advocates argue for lowering FDA standards for medical device approval in order to hasten American’s access to superior treatment. They say it takes longer in the U.S. to bring new technology to market than it does in Europe, and our care can be inferior as a result.

Sometimes this blog objects to how the FDA works (See “FDA Workers Say Outsiders Influence Medical Device Decisions” and “Are Medical Device Industry Dollars Funding Lax Oversight?”), but the “first to market” push is a bogus race.

Results of research recently published in the New England Journal of Medicine (NEJM) quantifies this nonsense. Its data show that it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices in the United States as it does in the four largest European markets--Germany, France, Italy and Britain. The reason is because in those countries, access generally is delayed until decisions are made about how medical providers get reimbursed for using the new stuff. That process often takes substantially longer in Europe than in the United States.

The researchers looked at three comparative factors--how innovative was the device; how long it took from the submission of the application to its appearance on the market; and how many patients got access to it as defined by the time it took for the reimbursement decision.

Innovation was deemed important because the FDA requires the strongest evidence of clinical benefit for new medical devices, and such products inspire the most debate about the relative effectiveness of approval processes elsewhere. Previous studies have shown that lower-risk (less innovative) devices reach the market at about the same rate in the U.S. and Europe.

Measuring the time it takes from when the approval application is made to when a device is accessible on the market is important because previous studies compared dates of application and market access by chronology, but application dates vary among countries, so there’s no single start point.

Determining patient access to a device according to when the reimbursement decision is made instead of when it’s approved is important because access to a new device doesn’t happen on a broad scale until a third-party payer forks over the price of using it. Previous U.S.-vs.-Europe studies used the approval date to mark the time of product availability, but innovative, high-risk devices don’t reach the market that soon. Only patients who can afford to pay out of pocket benefit immediately on approval. Insurers take longer to decide whether to approve the treatment, and at what cost. Public underwriters generally take longer than private insurers to make reimbursement decisions. Significantly more Europeans than Americans have public insurance.

Last year, the FDA approved 40 applications for pre-market approval (PMA is the most stringent approval process). The average review time was 13.1 months; of that, it took the FDA 8.4 months to review the application and the applicant took 4.7 months to address deficiencies in the application (called “sponsor time”). Some devices require more extensive review if they have limited or conflicting evidence of clinical benefit. Those cases averaged 8.6 months over the last five fiscal years

It’s difficult to obtain data on how long private insurers take to make coverage decisions, but anecdotal information from private insurers indicates it takes a few weeks to a few months after FDA approval, depending on the amount and quality of evidence of clinical benefit.

Most of the 27 member countries of the European Union have publicly financed health-care systems, which cover approximately 8 in 10 people in the four largest device markets. The process to obtain approval throughout the EU is conducted by for-profit, third-party agencies accredited by a member country to assess device safety and performance. The agencies, however, do not evaluate effectiveness, which requires more clinical data. It is estimated that this process takes 1 to 3 months, excluding sponsor time.

But most European patients do not have access to innovative, high-risk devices as soon as they are approved by the whole EU—each country decides reimbursement policy separately. Even though the whole EU can grant device approval based on fewer clinical data than are required for FDA approval, European standards for reimbursement are often similar to or higher than those the FDA imposes for device approval. European countries might require additional data on safety and effectiveness, as well as on cost-effectiveness.

Among the four main countries, the time for reimbursement decisions varies: Germany averages 71.3 month, France ranges from 36 to 48 months, Italy ranges from 16.4 to 26.3 months and Britain averages 18 months.

The NEJM researchers concluded that the public reimbursement decision process in the U.S. (Medicare, Medicaid, etc.) takes about as long as it does in Italy and Britain, about half as long as France and less than one-third as long as Germany. The difference is even greater when it comes to private insurers.

The point, say the researchers, is that one cannot make sweeping generalizations about the efficacy of bringing new medical devices to market unless one examines how soon the most people gain the benefit of the new device.

There’s enough political and commercial noise about how good or inept is the FDA when it comes to medical device review and approval without complicating the issue with misleading statistical comparisons and sweeping, perfect-world pronouncements. Medical devices have the power to heal or harm, and the faster-is-better philosophy not only isn’t true in national comparisons, it isn’t good health policy.

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July 4, 2012

When a Medical Device Warning Was Ignored, the Patient Died

Last month, we wrote about the danger of drug and medical device warnings and recalls that go unnoticed by hospitals and doctors, much less patients. A recent story reported by CNN demonstrates the tragic consequences of such ignorance.

When Florinda Gotcher entered the hospital to donate one of her kidneys to her brother, recalled her daughter, Melinda Williams, "She was so happy. She was overwhelmed that she was able to save her brother's life."

Kidney donor surgery is relative safe: According to CNN, in 2010, the year before Gotcher's surgery, 6,276 people donated a kidney. Thirty days later, they were all still alive. Mere hours after her surgery, Gotcher was dead.

Williams said that surgeons from University Medical Center in Lubbock, Texas told her Gotcher experienced massive, sudden internal bleeding after her laparoscopic procedure, and that they’d done everything possible, but that nothing could save her.


Kidney donation surgery requires cutting the renal artery. If it’s not properly closed, patients bleed to death. Staples or clips typically are used to close the artery, and both methods are considered safe. Except for laparoscopic kidney donation.

Clips are not indicated for the arterial stump because they can slip off. Four people are known to have died from exactly this circumstance, and 12 others suffered injuries. When Gotcher was taken back into the operating room after her collapse, her clips were found floating in the pool of blood that had collected in her abdomen.

This should have surprised no one, as the clips’ manufacturer, Teleflex, in 2006 began sending warning letters to hospitals that the clips were unsafe for use in laparoscopic kidney donor surgeries. Hospitals received at least three and as many as six such letters.

In addition, the product package bears a warning symbol directing doctors to review the instructions accompanying a separate tool used to apply the clips, which make clear that the clips should not be used on kidney donors.

Officials at University Medical Center acknowledged receiving the letters in 2006, but said they hadn’t purchased those clips that year. By the time they did, the letters had been forgotten, simply one more of the dozens the hospital received every year concerning safety issues.

Many medical professionals believe warning letters don’t go far enough, and that warnings should be posted directly on the devices themselves. The FDA disagrees, stating that the letters are “effective,” never mind that only about half the hospitals mentioned in documents obtained by one researcher acknowledged receipt of the warning notifications.

And the agency appears to have undercut its initial analysis, given that after Gotcher’s death it issued another notice reminding surgeons of the clips’ unsuitability for kidney donor surgeries.

As the FDA told CNN, "despite repeated efforts to communicate this important safety information, some transplant surgeons continue to improperly use these clips. While the FDA can warn against the unsafe use of a medical device, doctors are not prohibited from using cleared or approved devices for an unapproved use within their practice of medicine."

University Medical Center settled a lawsuit over this tragedy, and acknowledged that its process to track warnings failed. Now it uses an outside contractor to document and track warnings and recalls.

But it’s too late for Florinda Gotcher.

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June 21, 2012

Danger Lurks when Drug Recalls Go Unnoticed

If you take drugs, especially long-term prescriptions you renew automatically, here’s another reason not to be complacent in the administration of your health care. A report published this month in the Archives of Internal Medicine found significant flaws in how drug recalls are communicated to medical providers and the consumers affected by them.

Recalled drugs are denoted by “class,” which categorizes them according to the degree of danger.

Class III recalls concern products not likely to prompt an adverse health reaction. They might violate FDA labeling or manufacturing regulations, such as a container defect or odd color.

Class II recalls concern products that might prompt a temporary or minor health issue, such as a drug that isn’t as strong as advertised, but isn’t used to treat life-threatening situations.

Class I recalls concern dangerous or defective products that pose a danger of a serious health problem, or even death. They might be contaminated with a toxin, or contain unlabeled allergens. Defective high-risk devices, such as heart valves, also fall into this category.

The new study, as reported on, found scary flaws in the FDA’s notification system for Class I drug recalls.

“Clinically important drug recalls occur nearly once per month in the United States,” the researchers wrote, “and usually involve thousands of affected units distributed nationwide or beyond. Despite recent efforts by the FDA to address the drug recall burden, health-care providers may be inadequately informed about clinically important recalls that threaten patient safety.”

The FDA is supposed to issue Class I recall notifications through its Recall Alert System and its MedWatch adverse event reporting program. But between 2004 and 2011, the researchers found that 91 of 1,700 drug recalls were unreported Class I recalls.

Of the 91 Class I recalls, the Recall Alert System issued notices for only 55. MedWatch issued notices for 18 of the remaining 36 that were classified as Class I. But 18, or about 1 in 5, were not reported to doctors by any FDA system.

Not only is the lack of information a shocking deficiency of dangerous proportions, but doctors can be confused about which recalls are important and which aren’t—both systems purport to report every drug recall regardless of its intended consumer. Drugs used to treat animals are reported the same way as Class I drugs, and that could be lethal for humans.

“[T] he Class I recalls that are communicated through the Recall Alert System,” the researchers wrote, “become buried in a system that is also used for recalls that have little or no bearing on patient care. It may be difficult for providers who subscribe to and rely on these alerting systems to identify those recalls that are of particular importance.”

The researchers said their analysis was limited because only 5 in 100 reports for Class I recalls noted adverse events, which they thought underestimated the true frequency with which recalled drugs cause harm. They cited as an example heparin, whose recall report in 2008 did not mention adverse events. But the FDA found several, including deaths, associated with contaminated heparin.

They also did not evaluate other means by which health-care professionals might receive drug recall information, such as “Dear Doctor” letters from manufacturers.

But they concluded that a comprehensive new strategy is required to ensure that medical providers are notified efficiently and fully when Class I recalls occur.

In addition to improving communication, they also called for a system to track the distribution of affected products throughout the supply chain, all the way to the consumer. Electronic tagging (radiofrequency identification technology) would enable pharmacies to identify and notify affected individuals as soon as a recall is initiated.

If you take a certain drug or drugs, you should regularly check MedWatch for information. In addition, you can subscribe here to a recall information mailing list distributed by the U.S. Consumer Products Safety Commission.

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May 14, 2012

Glitches on the Path Toward a High Quality Electronic Medical Record System

Early in 2009, President Obama signed the American Recovery and Reinvestment Act (ARRA). Commonly known as the Stimulus, or Recovery Act, it was intended to juice the sluggish economy, and it reached into all corners of our culture. One of its effects on health care was the establishment of a national electronic medical record (EMR).

Financial incentives were provided for medical providers to transition to electronic record-keeping. Well-designed and well run e-record programs improve efficiency and enhance patient safety, but they require conscientious attention on the part of designers and providers.

One such provider, a cardiologist and a fan of EMR, recently had an experience that prompted him to wonder if electronic record-keeping systems should be considered medical devices, and therefore subject to all the same kind of regulatory oversight given, say, a heart defibrillator.

Dr. Wes Fisher received a medical record from a major medical center that employed an EMR manufactured by a well-established, billion-dollar corporation. As recounted on, he saw “one of the better examples of how EMRs are contributing to misinformation and confusion when health-care is delivered.”

The report was an internal medicine consultation of a hospital patient whose “medications” portion of the internist’s notes are posted on the KevinMD website exactly as received in the EMR, and identified as “Active Medications.” All told, 55 entries for medications were listed, and Fisher was “terrified."

Some medications were listed multiple times, sometimes with different dosages. Some drugs lacked dosages, such as warfarin, a blood-thinner that must be carefully dosed and monitored. Meds typically prescribed for outpatients are listed along with those typically prescribed for inpatients, making any reviewer of this record unclear what meds this patient is actually taking.

Fisher in no way excuses the internist, or any other doctor, from responsibility over the quality and accuracy of any medical record, whether it’s confined to an office or disseminated to other providers, facilities and insurance companies. But his overriding concern is that when EMRs are poorly developed and/or hospital administrators buy products capable of providing “useless and potentially lethal information about our patients” (his italics), doctors must speak up.

“So how will we measure problems with EMRs?” he asks. “It seems industry representatives would rather not address these concerns. We should ask ourselves, is anyone thinking about this?”

Fisher suggests the creation of an EMR registry similar to the data repository mandated by the Center for Medicare & Medicaid Services (CMS) for implantable cardioverter defibrillators (the ICD Registry). Its purpose would be to track adverse patient outcomes resulting from software systems and would enable EMR manufacturers to learn and improve from everybody’s mistakes.

To learn more about your rights in compiling, keeping and disseminating your medical records, read our newsletter article, “Why Getting and Reading Your Medical Records Can Save Your Life.”

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April 17, 2012

Implantable Defibrillator Problems Devolve Into a Blame Game

For some people with heart rhythm abnormalities, an implantable cardiac defibrillator (ICD) can be a lifesaver. The small, electronic device is surgically implanted inside the chest to prevent cardiac arrest from hearts that beat abnormally fast (“tachycardia”). An ICD monitors the heart rhythm, and if it senses tachycardia, it delivers an electrical shock to restore the rhythm to normal.

The devices, which are a couple of inches in size, include cable-enclosed wires, or leads, that connect to the heart. As we recently reported, such defibrillators represented nearly 1 in 3 recalled medical products from 2005 through 2009, and a 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

A story in The New York Times earlier this month focused on one manufacturer of ICDs with an unacceptable number of adverse events. The Riata wires in devices made by St. Jude Medical have a tendency to work their way out of the cable coating, causing the device to fire wildly. That’s life threatening to anyone who hosts such a device.

“St. Jude officials have acknowledged that reports show that at least 20 patients have died in such episodes,” The Times reported, “but say that such incidents are not unique to the Riata and that the rate of the fatal episodes is comparable to that of other devices.”

As The Times noted, last year researchers reported that among patients tested, wires protruded out of 15 in 100 St. Jude leads. As doctors and the medical device industry grapple with the scope of the problem, worry only intensifies because the wires are dangerous to remove, and potentially dangerous to leave implanted.

Three highly visible lead episodes in the last seven years, according to The Times, have raised questions about the FDA’s scrutiny of heart devices. St. Jude’s primary competitors—Guidant/Boston Scientific and Medtronic—have also experienced patient injury or death with their flawed products.

Despite pronouncements by St. Jude executives that it has warned doctors about problems with its leads, medical experts say the company was slow to inform doctors of the 128,000 patients with its device. Giving credence to that claim is the fact that the adverse events associated with St. Jude’s leads were not discovered by its own monitoring system, but by outside researchers

St. Jude took both the Riata and the Riata ST models off the market in late 2010. It continues to sell the Durata, which features extra insulation to keep the wires confined.

The medical journal Heart Rhythm published the article by Dr. Robert Hauser of the Minneapolis Heart Institute Foundation about deaths associated with the Riata lead. St. Jude objected, claiming that it contained several errors, and has called for a retraction.

Company executives said Medtronic was just as culpable, if not more, than St. Jude because it also produced flawed products and intimated that Durata also carried risks of failure. They said Riata looked worse than competitors only because St. Jude had been more complete in filing reports to the FDA than Medtronic.

As Global Data, a research and analysis concern, described it, “The gloves are off and the fight has begun. St. Jude … must defend its honor against a report … [that] compared 71 deaths associated with St. Jude’s Riata and 62 associated with Medtronic’s Quattro Secure, a competing product. Of the Riata deaths, 22 out of 71 were identified as resulting from lead failure as compared to 5 out 62 Quattro Secure deaths. The study suggests that unlike the Medtronic leads, the St. Jude Riata lead deaths were caused by electrical malfunction at high voltages. This differs from the previous conclusion that externalized cables (lead wires coming out of their insulation) were the culprit.”

Merrell Goozner, writing on GoozNews, offered additional perspective on the subject last week. When St. Jude Medical accused Hauser of undercounting the deaths associated with rival devices, he wondered why the phrase “falling out among thieves” came to mind.

“St. Jude and Medtronic are not thieves, of course,” he wrote. “They merely take advantage of a flawed Food and Drug Administration process for approving new devices, where updated devices can enter the market without extensive clinical trial testing because they are only minor variations from earlier technology. When the ‘minor’ variation turns out to be flawed electronic leads that cause the device to repeatedly misfire, leading to the equivalent of a mule kicking the nonpatient in the chest, … then perhaps we have a problem with our regulatory system.”

Goozner, who noted that Hauser also has written about the regulatory mess in the New England Journal of Medicine, examined who supports the Minneapolis Heart Institute. Medtronic, he wrote, has given more than $1 million to the organization and St. Jude/ Boston Scientific have given as much as $999,999. The trial lawyers who sued Medtronic also gave more than $1 million.

“So here I think we have finally found the solution to the vexing conflict-of-interest problem,” Goozner concluded. “Rather than banning people with conflicts of interest from writing editorials and commentaries in leading medical journals (which, if properly reported, might have caused NEJM editors to pause before letting Dr. Hauser write his piece), editors should simply insist that they take money from everyone. It clearly hasn’t dissuaded Dr. Hauser from doing yeomanlike work on behalf of the public health and safety, for which he is to be congratulated.”

This corporate spitting match ignores the overarching concern: What if you’re an ICD patient?

St. Jude says it’s conducting a study of patients with the Riata lead, and will advise doctors how to manage such patients. That’s nice, but it’s not enough.

A story late last week in the Wall Street Journal said that the FDA, pushed by doctors to strengthen safety reporting requirements for medical devices, is planning to introduce a safety-monitoring program whose purpose is to remove faulty devices from the market quickly. Supposedly, the plan assigns each medical device a unique number to enable tracking its malfunctions.

Let’s hope that happens. In the meantime, if you have an ICD, find out if its among the ones detailed above; if so, your cardiologist should be able to address your concerns. If you’re not satisfied, seek a second opinion. Keep the FDA MedWatch program apprised of any problems you have. If you wish to research voluntary reports made to the Manufacturer and User Facility Device Experience (MAUDE) database consulted by the Heart Rhythm researchers, link here.

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April 16, 2012

Da Vinci Robotic Surgery Racks Up More Trouble

It’s another episode in the continuing drama of technology lust. Device manufacturers love to market their new, advanced and invariably expensive wares, hospitals love to leverage them for marketing and bill-enhancement, and doctors love them like middle-schoolers love the latest version of the iPad.

But the Da Vinci Surgical System continues to rack up a troubling record of patient harm. The robotic device, used in a variety of surgical procedures, enables surgeons looking at 3-D images through eyeholes to maneuver multiple arms with a joystick and perform surgery through tiny incisions. We’ve raised previous concerns about Da Vinci, and its most recent problem reports involve accidental tears and burns to internal organs, according to Some of these adverse effects require multiple surgeries to repair, and some its patients have died.

Intuitive Surgical Inc., which manufactures Da Vinci, promotes the robot’s treatment of bladder, colorectal, gynecologic, kidney, prostate and throat cancers. It’s also marketed for coronary artery disease, endometriosis, heavy uterine bleeding, kidney disorders and obesity.

Questions about whether surgeons are being trained adequately in the use of the machine, and whether the higher cost of using it is worthwhile, are growing louder. A recent report by the Office of Medical and Scientific Justice joined the chorus of concern.

Da Vinci is complicated, and the journal Reviews in Urology said it can take 200 cases for some surgeons to become proficient with robotic surgery. Often, patients experience inferior outcomes while their doctors are scaling this learning curve. Some surgeons, the journal reported, simply don’t have patient volume sufficient to master the technique.

At a cost between $1 million and $2 million, the machines are used by hospitals to gain competitive edge, and surgeons may feel pressure to employ Da Vinci before they’re ready. In fact, the Journal of Clinical Oncology suggested that the increased cost of this technology over that of a traditional hysterectomy did not bring a noticeable benefit. The journal also said that women treated for endometrial cancer had about the same complication rates through traditional laparoscopy as they did with Da Vinci surgery, but that Da Vinci cost about $1,300 more.

Lawsuits prompted by the most common problems involve tears and burns to blood vessels, intestines and reproductive organs, complicated by the fact that problems generally aren’t apparent until after surgery, resulting in delayed treatment.

One lawsuit concerns a woman who suffered an artery burn during her hysterectomy. That prompted blood to pump directly into her body cavity, requiring three subsequent emergency surgeries. She died a couple weeks after the initial surgery. The lawsuit claims that Intuitive Surgical failed to adequately research the device or warn patients and the medical community that its use comes with substantial risk of complications and injuries.

Is Da Vinci defective? Is it defective only in less than skilled hands? Is it defective only for some applications?

Maybe lawsuits will answer these questions, maybe not. In the meantime, find out if there is a safer, equivalent means of performing your surgery. If your surgeon is adamant about using the device, ask how many such procedures he or she has performed. Ask how long the hospital has owned the device, and if you can see adverse reports about it. Consult the Manufacturer and User Facility Device Experience (MAUDE), a public database of voluntary reports of adverse events involving medical devices.

Just because your surgeon, your hospital and a manufacturer are excited about technology doesn’t mean it works for everyone.

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April 10, 2012

Protecting Yourself from Dangerous Medical Devices

The invasive medical devices known as transvaginal mesh, metal-on-metal hip implants and the Lap-Band gastric band have gotten quite a bit of attention lately, most of it bad. We’ve written about all of these products, and they remain prominent poster children for poor regulatory oversight thanks to a recent investigation by Consumer Reports.

It concerned the millions of Americans who have had medical devices implanted without the products’ safety having been fully vetted. “Often,” according to Consumer Reports, “the only safety ‘testing’ that occurs is in the bodies of unsuspecting patients.”

The three devices mentioned above are hardly alone. The investigation looked at a variety of devices, including artificial joints and heart defibrillators subject to the FDA’s 510(k) approval process. That’s shorthand for the process by which medical devices are able to be marketed with so-called “fast-track” approval because they are substantially equivalent to another product already on the market. Initially, the fast-track option was intended for more basic medical equipment, such as bandages, that didn’t require clinical trials to determine efficacy, safety and side effects.

Now, in many cases, manufacturers of higher tech, more invasive devices need only fill out forms and pay $4,000 to move their product to market. Most patients are unaware that many of the devices have never been tested. Is it any surprise that problems have occurred, lawsuits filed and recalls implemented?

Not only is oversight lacking for “substantially equivalent” devices, Consumer Reports contends that safety studies for the smaller number of high-risk products for which they are required are small and less rigorous than those required for prescription drugs.

The U.S. Government Accountability Office (GAO) and, as we reported, the Institute of Medicine (IOM) have called for a 501(k) re-do, but legislation that essentially keeps the cozy relationship between the FDA and manufacturers intact is brewing.

Consumer Reports identified three areas of primary concern:

  • Medical devices often aren’t tested before they come on the market.

  • There’s no systematic way for the government, researchers or patients to spot or learn about problems with devices.

  • Without major changes in the system, there’s not much that patients can do to protect themselves.

Exemplary of the first concern is transvaginal mesh. It’s intended to treat prolapsed pelvic organs—those that have dropped out of normal position. The first such products came on the market in the early 2000s and were marketed to doctors as an easier way to do a surgery that had required special additional training.

“Despite thousands of reports of adverse events,” Consumer Reports said, “repeated alarms by women’s-health and consumer-health advocates and multiple lawsuits, these products are still being sold—and are still classified as ‘moderate risk’ devices.”

Mesh manufacturers took advantage of the “substantially equivalent” law. They claimed the female pelvic mesh was similar to an earlier mesh used to repair abdominal hernias that was sold in the 1950s. Never mind that those products were designed to be used in a different part of the body and inserted laparoscopically, not through open surgery.

In January, the FDA ordered 33 companies to conduct the first-ever post-market safety studies of transvaginal mesh. The agency is thinking of reclassifying those mesh kits to the highest-risk, Class III, which would require clinical tests before market approval. That decision can take years.

The second area of concern helped Lap-Band notch its dismal track record. Its initial approval was based on a single study involving 299 people, half of whom reported nausea, vomiting or both. One in 4 had their bands removed before the end of the three-year study because of complications or failure to lose enough weight. What are the chances people would choose this procedure if they knew half of its other patients had to have it removed?

The Lap-Band clinical trial was fairly typical of such pre-marketing studies. The journal Archives of Internal Medicine looked at 123 studies done on high-risk cardiovascular devices that received FDA approval between 2000 and 2007. Only about 1 in 4 met the gold standard of being randomized clinical trials, according to the report. Per its manufacturer’s 2010 annual report, 650,000 had been sold.

Lack of access to information harmed an orthopedic surgeon, someone you’d think would be best positioned to know about the problems with the DePuy ASR XL metal hip implant. But he, too, became a victim of its deficiencies.

The FDA had cleared the ASR XL without clinical testing based on “substantial equivalence” to earlier devices, even though such metal-on-metal hips had been deemed high priority for requiring advance clinical trials. The ASR XL was introduced in 2005. In 2006 the surgeon’s arthritis prompted him to have it implanted.

A year later, pain was constant and the chromium and cobalt levels in his blood were elevated. His sleep was disturbed, he had mood swings, anxiety, hearing loss and visual problems. He questioned DePuy’s engineers, who denied having heard any such reports. He continued to research the subject and began uncovering evidence that metal debris from joint implants can be poisonous.

Other countries keep records of every joint implant, and how it performs. Adverse events from DePuy’s metal implant had been appearing by the time the orthopedic surgeon began researching. The United States has no such public registry.

The surgeon underwent removal and replacement with a ceramic and plastic model. His symptoms have improved markedly.

The FDA has a voluntary system for doctors, manufacturers and patients to report problems with medical devices. Called MedWatch, it’s where only a fraction of device problems ever get reported. Consumer Reports says from 2009 through 2011, the agency received 20,518 reports of injuries from metal-on-metal total hip replacements. Of those, 15,137 concerned the now recalled DePuy hip. Many of the remaining complaints concerned several other brands and models that are still on the market in the U.S.

DePuy recalled all 93,000 ASR XL hips worldwide in 2010.

Consumers Union, the advocacy arm of Consumer Reports, says that the FDA should:

  • Require that implants and other “life-sustaining” devices be tested at least as rigorously as drugs.

  • End the practice of “grandfathering” high-risk new implants and life-sustaining devices.

  • Create a “unique identifier system,” or IDs for implants, so that patients can be quickly notified about recalls and safety problems.

  • Create national registries so that problems can be spotted quickly and patients notified.

  • Increase the user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.

Consumer Reports sponsors a “Share Your Story” link on its Safe Patient Project site whose intention is to lobby for legislative change of flaccid regulations.

To protect yourself now from deficient oversight or the damage done by defective devices:

Consider alternatives. Ask your doctor what will happen if you don’t get the implant. Many women who received transvaginal mesh for prolapse repair, for example, probably never even needed surgery. And there are nonmesh alternatives.

Research the device. The FDA website offers a wealth of information about device safety warnings, complaints and recalls. A simple Google search can yield important information, provided you’re certain of a site’s authenticity and authority. If the results include a lot of law firms looking for clients injured by a given device, Consumer Reports advises asking your doctor some hard questions.

Search also for patient forums about particular products. That information isn’t scientifically validated, but you’ll get a sense of whether patients are reporting trouble with the device.

Write down what you got. Ask your doctor for the brand name, model and serial number of your device. If you hear about a warning or safety recall, from the FDA or elsewhere, you’ll know whether yours is one of the problem models.

If you learn about problems with your device, contact your doctor and ask what warning signs to watch for. Search the FDA website to find out if it’s safe to keep the device in your body.

Not all problematic devices must be removed. If yours isn’t causing problems, it’s likely you needn’t do anything but remain attuned to its performance.

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March 21, 2012

FDA Workers Say Outsiders Influence Medical Device Decisions

Lots of people are unhappy with the process by which the FDA approves medical devices, including patients who’ve suffered harm from deficient products and manufacturers who claim burdensome bureaucracy stands between them and profit.

Congress has acknowledged that the process is less than ideal, and supposedly is trying to establish fair access to safe new technology. Pending legislation includes efforts to speed up device approval, many of which we recently suggested were tainted with lobbying dollars. Patient advocates want the FDA to spend more time reviewing implantable and life-sustaining devices.

Now, a survey by the Union of Concerned Scientists (UCS) captures the conflicted feelings of some FDA employees. Many believe that political and corporate interests wield too much influence when the agency is considering the value and marketability of medical devices.

According to a story in the Minneapolis Star Tribune, some employees feel pressured to approve devices despite misgivings they might have about their safety.

Survey participants were asked, “Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?” One in 4 said yes.

The results were decidedly more cynical than a similar poll in 2006. At that time, most employees of the FDA’s Center for Devices and Radiological Health trusted agency leadership and felt it was headed in the right direction.

This time around, as the Star Tribune reported, “dozens of employees reported experiences in the past year where they believe the medical device industry hurt public health by withholding information or by forcing changes in FDA policy.”

Dr. Jesse Goodman, chief scientist and deputy commissioner for science and public health, applauded the growing worker confidence to be candid, then undercut the survey’s message by saying that the survey’s response rate was low enough to make “definitive conclusions difficult.”

But maybe he did get the message. He also told the Star Tribune that some things in the survey "should still concern us. … some scientists still fear retribution for sharing concerns about the FDA. Some believe that business interests frequently influence science-based regulatory decisions."

UCS got responses from 997 employees across the agency—17 percent of those asked. Of the respondents, 158 worked in the center for devices.

Some respondents reported experiences within the last year in which they lacked complete scientific data to make conclusions about outcomes for devices seeking approval.

In addition to expressing concern about undue influence for approvals, some survey participants called into question the FDA’s ability to monitor the performance of medical devices once they were on the market. Again, 1 in 4 said they lacked confidence that the FDA had enough authority to assure patient safety for available devices. Many members of the medical profession share this concern.

"When inappropriate influence clouds scientific judgment at the FDA, public health and safety suffer," said Francesca Grifo, director of the Scientific Integrity Program for UCS.

To voice concern about malfunctioning medical devices and for guidance where to register your beliefs about the process, visit the website of the Consumer Union’s Safe Patient Project.

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March 4, 2012

Are Medical Device Industry Dollars Funding Lax Oversight?

No one is unaware of the influence wielded by lobbyists during the sausage-making mess that is our federal legislative process. For these lobbyists, and especially medical industry lobbyists, what they can keep out of laws is just as important to them as what goes into the laws. And that spells Trouble with a capital T for patient safety.

Manufacturers of medical devices, like their Big Pharma brethren, boast a robust army against efforts to empower the FDA with greater oversight of their wares.

According to Public Citizen, the manufacture of high-risk devices such as heart and brain stents, artificial joints and implantable defibrillators is a $350 billion industry that, since 2006, has spent nearly $20 million in campaign contributions. The industry has spent $33.3 million overall to lobby the people who are considering at least 14 bills to hasten the introduction of their products to the consumer market, many by weakening the review process intended to protect patient safety.

Public Citizen reports that the average number of high-risk product recalls in 2011 was more than twice as many as recent years. The organization says that more than 200,000 injuries and malfunctions, and 2,000 deaths attributed to medical devices are reported annually to the FDA.

Medical device safety weighs heavily in this practice, and we vigilantly follow its checkered progress.

Some medical devices deemed high-risk reach the consumer market with virtually no testing required, thanks to an FDA process known as 510(k) fast-track approval. If a device is described as “substantially equivalent” to one already on the market, it qualifies for fast-track approval. The problem, of course, is how “substantially equivalent” is defined.

A recently story in the Minneapolis Star Tribune perfectly captured both the poignancy and difficulty of imposing responsibility on manufacturers reluctant to exercise what seems to many people is basic human decency.

Steven Baker testified last month as part of the Consumer Union Safe Patient Project. He lives with excruciating elbow pain from the FDA-approved medical device that he says never worked right.

Jim Shull testified about the constant pain from permanent nerve damage and the loss of his livelihood thanks to a malfunctioning 501(k)-approved surgical mesh that was implanted during his hernia operation. The FDA had issued a public health warning for a similar product, synthetic trans-vaginal meshes, which we reported last year, but there was no such notification for hernia meshes.

According to the Star Tribune, “[R]ules to create an identification system for medical devices to help recall unsafe products remains stalled, several months after they should have been published. The medical device industry has called the ID system burdensome.”

Medical device manufacturers claim that inefficient approval procedures unnecessarily delay the introduction of products that could cure or relieve medical problems. Still, as the newspaper reported, most of the testimony before the congressional committee was about getting medical devices to market faster. “There was little talk about protecting patients.”

If you find that unacceptable, if you have a story to tell about the harm caused by a device that wasn’t sufficiently reviewed, visit the Safe Patient Project’s website where you can make your experience and feelings known to authorities. It also keeps you apprised of the progress of oversight legislation, including committee testimony.

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February 29, 2012

A Higher Gear for Medical Device Followup

When Congress authorized creation of the Sentinel Initiative in 2007, it was concrete acknowledgment that the failure to follow up on the performance of medical devices recently approved by the FDA was compromising patient safety.

Five years later, medical device followup is still a work in progress, and there’s no reason it can’t be moving along at a friskier pace. In a commentary published in the New England Journal of Medicine, Dr. Robert G. Hauser submits that “patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration … despite multiple recalls and some tragic adverse events.”

He cites one particular case involving an implantable cardioverter-debrillator (ICD) that has been implanted in 79,000 heart patients in the U.S. alone. ICDs are used to treat sudden cardiac arrest with a shock, or electrical impulse, via a small device implanted near the heart. But it’s hardly the only “livesaving” device that can put life at risk.

Hauser names two other ICD components used by more than 350,000 patients that might cause problems that, with a bit of foresight, could be consigned to irrelevance. He asks: “Why are we placing patients at risk when the tools and technology are available to monitor vital medical devices such as ICDs, heart valves and coronary stents? The problem is that our current passive postmarketing surveillance system fails to detect significant device defects before large patient populations have been exposed. Consequently, we repeatedly find ourselves reacting ineffectively, even dangerously, to big problems with devices by subjecting patients to care strategies that are not supported by solid clinical evidence.”

We need to collect more data, he says, in order to:
1. identify adverse events even if they’re infrequent and;
2. review information as it pertains to certain patient groups.

That means using existing clinical registries and remote monitoring databases to improve surveillance of medical devices. Data should be collected on an ongoing basis, and compared with established medical products that have been shown to be reliable. The point is to detect problems early and collect information to guide patient care toward best practice. “[M]anufacturers,” Hauser writes, “should conduct postmarketing studies of this type for marketed … devices that sustain or support life.”

Seems like a no-brainer, as the creation of the Sentinel Initiatives reflects. It’s supposed to augment the current after-the-fact process of reporting adverse events by implementing a real-time network that’s faster and more efficient, and capable of spreading the word to health-care providers and the public.

The Sentinel Initiative’s ambitious reach is to collect electronic health data from 100 million people by the end of this year. The initiative must set priorities, develop tools to analyze the data and design a public-alert procedure when a safety signal is detected. Hauser says we’re years away from a fully operational Sentinel network.

More than 150,000 U.S. patients rely on lifesaving medical devices, Hauser says, and he wants professional organizations, the medical device industry and the FDA to muster the resources now to improve their surveillance once they’re on the market. We’d add that a rising chorus of patient voices could boost this sense of urgency.

If you think tracking the usefulness and safety of medical devices long after their hosts have been released from the hospital isn’t happening fast enough, make your feelings known to your congressional representatives and to the FDA by linking here.

If you’re interested in the specific projects being reviewed by the Sentinel Initiative at any given time, link here.

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February 27, 2012

Sending Deficient Hip Implants Overseas

File this story under: exporting your problems.

That’s what Johnson & Johnson did after the FDA said the company wasn’t allowed to market its artificial hip in the U.S. because J&J’s own studies showed the device was unsafe.

As recounted in the New York Times, not only did J&J pawn its questionable product off on Europeans, it continued to sell a related model in the U.S. that had been made available temporarily only because of a regulatory loophole enabling it to escape the scrutiny of a safety review. In December 2010, The Times called that device “[o]ne of the most troubled orthopedic implants of the past decade.”

It’s not known how many people overseas got the banished replacement hip after the FDA failed to approve it in 2009, nor how many U.S. patients got the similar implant. The two were on the market for eight years and implanted in about 93,000 patients worldwide; about one-third of them were in the U.S.

The problem for both models was the all-metal hip socket cup. These components have long been problematic, and we’ve written about them before, most recently here and here.

Citing declining sales, the DePuy orthopedic division of Johnson & Johnson began phasing out the “articular surface replacement” device known as ASR in November 2009. They were recalled formally in August 2010 because of high failure rates much earlier than their purported 15-year lifespan.

Generally, regulatory standards in other countries for approving the sale of medical devices are lower than here, so there’s no claim that Johnson & Johnson broke the law. And Britain’s Medicines and Healthcare Products Regulatory Agency told The Times that companies were not required to notify it when the FDA failed to approve a product for U.S. consumption that was used in patients there.

But what’s legal and what’s moral aren’t always the same.

But maybe J&J’s squishy moral standards are coming home to roost. As noted by The Times, the FDA rejection may exacerbate the company’s legal and financial problems surrounding the ASR. In January, J&J took a special $3 billion charge, largely to address anticipated legal and medical expenses associated with the recall. Thousands of lawsuits involving the device are pending, including some from patients crippled by metallosis, a form of poisoning by implants shedding metallic debris.

And let’s not forget that, before the recall, when complaints about the ASR were building, DePuy defended it by claiming that any failures were those of the surgeons, who didn’t properly implant the hip cup. So here we have a company that can’t cop to its own shortcomings, and, worse, ships them overseas in hopes nobody notices.

The lack of transparency in medical device approval remains a real threat to patient safety. The FDA’s process is confidential, a practice it justifies because it might include proprietary business information. But when it comes to developing a product that creates so much harm, is this a business model anyone would replicate?

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January 4, 2012

Robot Surgery of the Prostate: No Evidence of Better Outcomes for Patients

Surgery with the da Vinci robot to remove a cancerous prostate gland is guaranteed to dazzle the patient with the high-tech wizardry of it all. Problem is the outcomes in side effects that can disable men after prostate surgery -- incontinence and sexual dysfunction -- are no better than with conventional surgery. And the robot costs a lot more.

The latest of several studies to reach the same conclusion about the robot being less than it's cracked up to be is published in the Journal of Clinical Oncology. The authors randomly surveyed men who had had either robot or traditional surgery and found that both had high rates of sexual and urinary complications, with no advantage for the robot.

Dr. Michael Barry and his co-authors questioned whether this might be a case of "gizmo idolatry," the tendency in medicine to adopt new and expensive technology before there is real evidence of improved patient outcomes.

We've written before on our patient safety blog about benefits of the robot being oversold. Another critical issue for patients is the experience of the surgeon; the robot takes a lot more practice to get up to speed and reduce complication rates than does ordinary surgery.

As health care journalist blogger Gary Schwitzer notes, the marketing of the surgical robot gets hyped even more by naive news coverage with headlines like:

* Robot doctor – surgery of tomorrow
* Da Vinci puts magical touch on the prostate
* Cancer survivors meet lifesaving surgical robot
* Robotic surgeon’s hands never tremble
* Da Vinci is code for faster recovery

Once again, the take-home for patients is: Don't be dazzled by technology. What you want is a surgeon with a proven track record. Ask pointed questions, and don't assume that machines work better than experienced hands.

Article first published as Robot Surgery of the Prostate: No Evidence of Better Outcomes for Patients on Technorati.

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December 23, 2011

Tried and True Beats the New in Medical Devices, Yet Again

If you're facing a hip or knee replacement, today's story in the New York Times is a fresh reminder of something we patient safety mavens see over and over with new drugs and devices: the new ones often work no better, and sometimes worse, than older versions on the market for a long time. But it takes much longer for the safety track record to develop for the new devices, and meantime billions in profits have been pulled down.

Barry Meier of the Times is on top of this story, as he is on so many of the ongoing troubles in the medical device industry.

The new study finds that new technology in hip and knee replacements, such as metal-on-metal hip joints, don't turn out to last any longer than their older cousins. Many Americans who have had early failures of new hip replacements can attest to that.

Another interesting angle is the source of the study: an Australian patient registry. We don't have such mandatory registries in the United States. When all patients are entered into a common database, it's easier to pick up early warning signals of safety issues.

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December 6, 2011

Study Shows No Advantage to Metal Hip Replacements

A new study in BMJ , the British medical journal, has revived interest in the issue of the kind of materials best used for hip replacements.

Problems have long been reported from many quarters when metal is used to refashion both sides of the ball-and-socket hip joint. We wrote about one manufacturer’s defective product last year.

The trouble comes when the metal parts abrade each other, releasing tiny bits of metal into the surrounding tissue. Essentially, it’s metal poisoning, called metallosis, characterized by pain and inflammation that impedes the ability to walk.

In 2009, the FDA initiated a comprehensive evaluation of approved implants. And in May, the agency requested more information from metal hip replacement manufacturers to quantify and address the problem.

Now, the FDA-sponsored study results in BMJ “do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.”

That means earlier technology, which used ceramic or, essentially, plastic, are just as effective as the latest technology—metal. Although metal conferred no advantage, the study showed, it was burdened with more problems that not only left patients uncomfortable and mobility-challenged, but possibly at a greater likelihood of needing follow-up surgery.

Many lawsuits have been filed involving metal-on-metal hip implants.

The study examined 3,139 hip-implant patients and data from more than 830,000 operations worldwide. “Evidence on implant revision did not favor metal on metal implants,” researchers wrote.” There is limited evidence regarding comparative effectiveness of various hip implant bearings, and the results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional bearings.”

More than 700,000 joint replacements are performed every year in the Unites States; about 270,000 are hip replacements, and that number is expected to double over the next decade. The cost of the procedure is expected to rise as well.

Joint replacement, the study notes, is a generally successful operation that addresses a significant health issue. The recent popularity of metal is due in part because it enables the use of larger femoral heads (top of the thigh), which supposedly reduces the risk of dislocation and improves the functional outcomes in younger patients. But its use for older patients, according to one study, was popular as well, with 1 in 3 such patients receiving metal-on-metal implants.

Hip replacement surgery can be a godsend for people suffering from this degenerating joint problem. But if you’re scheduled for the procedure, ask your surgeon which device he or she is planning to use, and research its history. If it’s a metal-on-metal device, at least seek a second opinion.

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November 16, 2011

Science Panel Calls for Greater Oversight of Electronic Medical Records Technology

Last week, the New York Times summed up pretty well what a lot of people have been thinking: “Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study…”

The paper was referring to “Health IT and Patient Safety: Building Safer Systems for Better Care," a report by the Institute of Medicine (IOM) calling for greater oversight of health-care technologies.

The U.S. Department of Health and Human Services (HHS) requested the IOM to evaluate electronic health records in the first place out of concern that some such products raised safety risks for patients. Practitioners were wondering if the boom in digital record-keeping is fostering a rash of medical errors thanks to balky, difficult or malfunctioning technology.

The report doesn’t decry the move – for reasons of both cost and care efficiency – from paper to electronic records, it just emphasizes that oversight must be part of the deal: “To achieve better health care, a robust infrastructure that supports learning and improving the safety of health IT is essential. Proactive steps must be taken to ensure that health IT is developed and implemented with safety as a primary focus. If appropriately implemented, health IT can help improve health care providers’ performance, better communication between patients and providers, and enhance patient safety, which ultimately may lead to better care for Americans.”

The IOM said an investigative agency -- like the National Transportation Safety Board, which investigates airline accidents and examines safety issues -- should be established for health-care technology. And that it should include tracking the safety performance of electronic health records.

So far, such efforts have yielded mixed results: There are tales of success, such as hospitals that use computerized, bar-coded prescription systems, but also tales of patient harm, such as delayed treatment due to lost data and/or problems with human-computer communication.

The IOM advised the Department of Health and Human Services (HHS) to devise a plan within 12 months to monitor patient safety risks associated with health IT, and to report on that progress every year. If, within a year, such progress is insufficient, the scientists’ group said the FDA should regulate these technologies, and that the agency should start planning for that now.

The IOM report is big on transparency. It is the government’s job to ensure that the private sector demonstrates concern for consumers by freely exchanging information about product use, “including details relating to patient safety.” You can’t establish a body of knowledge and develop a functioning market of safe products if you don’t share details of their risks.

This is thwarted today by the common practice of including nondisclosure clauses in contracts with vendors of IT health products. Such provisions impede efforts to improve safety by discouraging users from sharing information.

The report notes that clauses that limit liability (known as “hold harmless”) also undermine best-product practice by shifting liability “from the vendor to the users when an adverse event occurs.” As the story in The Times said, “Such language often limits the freedom of doctors and hospitals to publicly raise questions about software errors or defects.”

No one wants to stifle technological developments or the will to manage health care more efficiently. The key, as the IOM says, is to foster innovation without compromising safety.

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October 31, 2011

Hacking Into Your Body

As if there aren’t enough things to think about when a medical device is implanted into your body, here’s a new, 21st-century concern: hacking!

As reported on, Medtronic, the manufacturer of the Paradigm insulin pump, is investigating the cybersecurity of the drug delivery device used by diabetics in lieu of daily injections. The concern is that the pumps could be hacked, and reprogrammed to overdose patients with insulin.

McAfee, a name known among computer users for its security software, identified the flaw, and indicated that the problem might not be limited to this particular piece of equipment. As medical devices increasingly rely on wireless technology for delivering meds such as antibiotics, chemotherapy and anesthesia, their software could be vulnerable to outsiders less concerned with medicine than life-threatening havoc.

So far, Medtronic has reported no hacking problems among its 200,000-some insulin pump patients.

But FDA warnings are nothing new to Medtronic; we recently wrote about problems with another of its infusion pumps, and a couple of years ago a Paradigm model was recalled.

But, really, hacking?

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October 1, 2011

More Bad News about All-Metal Hip Implants

All-metal hip implants are proving to be a brewing epidemic of injury to patients: the failure rate is much higher than metal-plus plastic or ceramic hip implants, and now, doctors are finding that the metallic debris from wear and tear incites an immune reaction from the body that causes tissue damage.

When tiny fragments of metal wear off of the hip, the body responds by having scavenger cells gobble up the metal. These cells can chew the metal into smaller fragments, but those fragments include electrically charged ions, which can trigger damage to surrounding tissue and early implant failure.

Read more in this article by the New York Times' Barry Meier, who owns this failed hip implant story.

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August 24, 2011

Hip Implant Complaints Flood FDA

The Food and Drug Administration has received more complaints about defective metal-on-metal hip implants in the last six months than in the total previous four years combined, according to a report in the New York Times.

The defect complaints mainly concern the DePuy (Johnson & Johnson) A.S.R. hip implant device but also include the Zimmer Durom cup.

Reader comments to the Times include many who raise these questions:

* Why is there no national registry of devices implanted in the human body, to make it easier to catch up with defect issues before they become widespread? Other countries have this.

* Why does the FDA not mandate independent testing of permanent devices like hip implants before they are marketed? Why do the manufacturers control all the testing?

* Why couldn't the FDA foresee the issues with metal-on-metal hip implants which had been forecast in the medical literature for many years?

My take: Our system of regulating medical devices is badly flawed and in need of a big overhaul. This is the same conclusion reached recently by an independent panel of the Institute of Medicine.

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August 4, 2011

Unsafe Medical Devices: The Problem Isn't "Over-Regulation"

The latest report from the prestigious Institute of Medicine -- about the nonsensicality of the current system where dangerous medical devices can get approved for sale with a grandfathering process called 510-k -- prompted this letter to the editor that summed it all up:

The problems are not new. They reflect an underfinanced and underpowered Food and Drug Administration, successful efforts by the device industry to block or blunt regulation, and the industry’s relationships with corruptible surgeons and members of Congress.

In the current ideological climate, we will hear a great deal about the dangers of “overregulation.” One must hope that the F.D.A. will be allowed to pay more attention to the Institute of Medicine than the onslaught from industry lawyers and lobbyists.

The author is HENRY GREENSPAN, who teachers ethics, politics and regulation at the University of Michigan, writing in the New York Times.

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July 31, 2011

Science Panel Says Oversight of Medical Device Safety Needs Big Overhaul

It's another science-versus-commerce face-off.

Last Friday, the Institute of Medicine released a report commissioned by the FDA that proposes a vastly different and more rigorous approval process for medical devices. In the wake of several recent, well-publicized recalls of devices causing grievous injury, such as hip implants, the report has generated attention well beyond the medical-regulatory nerd community.

As the IOM, an arm of the National Academy of Sciences, explained, "Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process.... Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market."

So the FDA asked the IOM to answer two questions:

  • Does the current 510(k) process protect patients optimally and promote innovation in support of public health?

  • If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The answers? No, and (we're paraphrasing here) you need a makeover.

"The IOM finds that the current 510(k) process is flawed right from its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process ... the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."

Before the report was released, the medical device industry issued a pre-emptive strike. As reported in the New York Times, the industry called the report biased, and claimed that a greater regulatory burden would retard innovation, cost jobs and harm patients. "An official of a group that represents surgeons who implant hips and other artificial joints," the paper reported, "has also voiced support for a recent filing by a pro-business organization that challenged the scientific report’s credibility and argued that the F.D.A. was statutorily required to ignore it."

If it's not surprising that device manufacturers would object to greater scrutiny and bureacracy, it's highly unusual for any business interest to orchestrate a campaign against a thoroughly vetted recommendation before its report has been published. The IOM, The Times said, "was unaware of a previous instance in which one of its reports, sight unseen, was the target of a similar effort to invalidate it."

Ralph F. Hall, a professor of law at the University of Minnesota who also represents the medical device industry, denied that the pre-publication diss was intended to undermine its message, but only to question the IOM's methods of review. “I could have waited until the report came out,” Hall told The Times. “That seems intellectually less than satisfactory with me.”

So, someone whose professional obligation is to thoughtfully and thoroughly examine circumstances and then carefully apply the law to them is OK with assumptions about something unseen and indictments of a 12-person panel of doctors, lawyers, and academics who did perform the necessary due diligence?

The FDA commissioned the report, but it isn't required to take its advice. In fact, as noted by MedPage Today, Jeffrey Shuren, M.D., and director of the FDA's Center for Devices and Radiological Health, said the agency isn't keen to dump the fast-track approval process for moderate-risk devices. "FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said.

Still, the agency will invite the public to comment on the report, and hold a public meeting in the next few weeks.

Patient and consumer advocates applaud the IOM report. Diana Zuckerman, president of the National Research Center for Women and Families, told MedPage Today that there are four major problems with the 510(k) process:

  • it doesn't require device-makers to submit clinical trials;

  • it doesn't mandate inspections of manufacturing facilities;

  • it doesn't require post-marketing studies;

  • it doesn't give the FDA any authority to rescind approval if the device is found to be unsafe or ineffective.

Most devices, from low-tech tongue depressors to something more complicated, such as pacemakers -- are fast-tracked with 510(k) approval. That requires companies seeking approval for a low-to-moderate risk device to prove that it's substantially similar to another device on the market. Completely new and high-risk devices, such as an implanted heart defibrillator, must provide clinical data demonstrating safety and effectiveness.

As noted in The Times' story, so-called metal-on-metal artificial hips (the subject of much scrutiny and many lawsuits), seemed to work well when tested on mechanical simulators. But they failed when implanted in patients.

No one questions the fact that governmental oversight agencies can be inefficient and slow. But when the use of a product or device presents life-or-death issues, can you be careful enough?

To make your feelings known about the IOM report and to find information about recalled products and devices, contact the FDA's Center for Devices and Radiological Health:

(800) 638-2041;

Food and Drug Administration

10903 New Hampshire Avenue


Silver Spring, MD 20993

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June 30, 2011

The Going Rate for Compromising A Surgeon's Principles and Patient Safety: $16 Million

That's the sellout price for a spine surgeon. Give or take a few million.

Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine Journal about industry-sponsored research in general and the use of a bone growth product in particular.

As noted in the New York Times, “It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”

At the center of attention is Infuse, a product manufactured by Medtronic that’s used in more than 100,000 spinal fusion surgeries in the U.S. each year to encourage growth of new bone so the spine fusion "takes." The Spine Journal articles claimed that researchers subsidized by Medtronic exaggerated the benefits of Infuse and minimized the risks.

All surgical procedures and all medical products carry some element of risk, large or small. Dumbfoundingly, some of Infuse’s defenders claimed it had no risk. None. Zip. Nil. Uh-huh, and I’m vacationing next month on Jupiter.

In a joint editorial, five doctors wrote, “It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.”

Objective research and the “do no harm” vow apparently have their price, and for some of the so-called “scientists” championing Infuse, it is $12 million to $16 million—the median amount collected by researchers from Medtronic. Median. That means half got more. Clearly, for Medtronic, corrupting science is a good investment: In the most recent fiscal year, Medtronic earned an estimated $900 million from Infuse.

Infuse was approved by the FDA in 2002 for one type of spinal fusion, and as required, Medtronic reported complications in its use that the agency considered sufficiently significant to require the company to list them on the product label. But, as the New York Times explained, “in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.”

In addition to its approved use, Infuse is used for other spinal procedures. The Justice Department, however, has been conducting a criminal investigation to determine whether Medtronic illegally promoted such off-label uses, which the company denies.

At this point, Medtronic's credibility, and that of the people who speak for its scientific authority, is thin.

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June 26, 2011

Defective Hip Implants Prove that New Isn't Always Improved in Medical Devices

DePuy's now notorious metal-on-metal artificial hip, known as the ASR, was marketed as the next great thing in orthopedics, but actually was a recycled old design that ignored warnings from industry insiders that the all-metal construction was subject to dangerous flaking of metal fragments inside the patient's body.

That's the conclusion of a new takeout on the artificial hip saga from the New York Times' Barry Meier, who has written extensively on the DePuy debacle and other defective products in the medical device world.

The article also discusses a disturbing loophole in FDA regulations that allowed products like the DePuy ASR onto the market with little testing, because the manufacturer could argue that they were close enough to an old design that they should be grandfathered into approval.

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March 23, 2011

“Alarm fatigue” endangers hospital patients

“Alarm fatigue” caused by the rising use of monitors is distracting and numbing hospital personnel with deadly results, the Boston Globe reports.

An investigation by the newspaper reveals that more than 200 hospital patient deaths in the U.S. between January 2005 and June 2010 are linked to problems with alarms on patient monitors that track heart function, breathing, and other vital signs.

Typically, the problem isn’t the equipment, but rather the failure by medical personnel to react with urgency or notice the alarm. As monitor use continues to increase, the audible beeps from the machines can become so relentless that nurses become desensitized. How relentless? At a 15-bed unit at Johns Hopkins Hospital in Baltimore, staff documented an average of 942 alarms per day — about 1 critical alarm every 90 seconds.

Nurses said the number of alarms can be so overwhelming that they turn into background noise — although a dozen nurses interviewed by the Globe said they have never seen a nurse purposely ignore an alarm. The problem, says one nurse, is that “everyone who walks in the door gets a monitor. We have 17 [types of] alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes . . . background.’’

In addition, the devices themselves have flaws that contribute to alarm fatigue. For example, monitors can be so sensitive that alarms go off when patients sit up, turn over or cough. Some studies have found more than 85 percent of alarms are false (i.e. they go off when the patient isn't in danger. Over time this can make nurses less and less likely to respond urgently to the sound.

In many cases, of course, nurses miss alarms warning of problems that aren’t life-threatening. But even the highest-level crisis alarms, which are typically faster and higher-pitched, also may go unheeded.

In one extreme case, a cardiac monitor blared 19 dangerous arrhythmia alarms for nearly 2 hours before staff silenced the alarms temporarily without treating the patient, who died. In other instances, staff have misprogrammed complicated monitors or forgotten to turn them on.

Hospitals that have experienced alarm-related deaths have aggressively addressed the issue, hiring nurses and technicians whose sole job is to monitor the monitors and modifying monitors to make them less sensitive to unimportant changes and less prone to false alarms. But overall, hospitals and the medical device industry have yet to seriously tackle the issue.

Source: The Boston Globe

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March 19, 2011

George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group

If you wanted to lobby for a law that wipes out the rights of patients to hold hospitals, drug manufacturers and doctors accountable when they hurt people by carelessness and wrongful conduct, what would you call your group?

"Protect Patients Now!" It has a nice ring, doesn't it?

However, the people behind this campaign, which was launched in Washington to advocate for the H.R. 5 "tort reform" bill in Congress, are anything but patient advocates.

The campaign comes from a group called the Health Coalition on Liability and Access. A list of the coalition's members can be found on its website, and includes:

* Major medical malpractice insurance carriers (Pro Assurance, The Doctors' Company, Medical Protective);

* Doctors' lobbying organizations, especially those who have been active in political efforts to curb lawsuits (the AMA, plus neurosurgeons' and orthopedic surgeons' societies and others);

* Long-time "players" in the legal "reform" space, particularly the American Tort Reform Association, which got much of its seed money from the tobacco industry.

The coalition calls itself a "grassroots advocacy organization" but conspicuously absent from its membership are any of the consumer groups — Consumers Union and Public Citizen, to name two — who have been pushing the medical industry to make health care safer (and thereby solve its lawsuit problem).

H.R. 5 was sent to the floor of the U.S. House of Representatives this week by a party line vote of the House Judiciary Committee. The bill gives special breaks in the form of damage "caps" and other special treatment not only to all physicians, nurses and other individual caregivers, but also to drug manufacturers, nursing homes and hospitals.

The idea of H.R. 5 is that by making the medical industry less legally accountable for the harms it causes, Congress will free up the industry to become safer and provide cheaper care to more Americans.

I did not make that up.

The American Association for Justice (of which I am a member) has an online petition for concerned consumers to send a message to their Member of Congress about this bill.

Article first published as George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group on Technorati.

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March 11, 2011

"When you're a hammer, everything looks like a nail"

Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would.

Although heavily marketed, robotic surgery has never been proven to reduce the two big risks of prostate removal: incontinence and impotence. And each surgery with a robot is about $2,000 more expensive than those done the traditional way.

An excerpt from a New York Times piece on the new study:

One reason for the increase in operations in hospitals that own a surgical robot may be that the technology helps a hospital lure potential surgical patients away from the competition. But the data also suggest that once a hospital obtains a robot, patients who might be candidates for nonsurgical options are more likely to be steered toward robotic surgery instead.

“This may be the medical embodiment of the phrase, ‘If you’re a hammer, everything looks like a nail,’”said the lead study author, Dr. Danil V. Makarov, assistant professor of urology at New York University’s Langone Medical Center. “If you have the technology, it will get used.’’


“If you’re a hospital and you get a robot, clearly you want to use it,’’ said Dr. David Penson, a study co-author and director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. “There are some real pressures here that have nothing to do with science,” he said. “We have this interplay of patients’ fascination with technology coupled with business interests on the part of the hospital and device makers, pushing people to try a new technology perhaps before it’s been fully tested.’’

And here's a good bottom line point for patients, also from the Times article:

“For patients, there are a lot of choices in prostate cancer,’’ said Dr. Makarov. “Knowing that technology can influence both what they want and what their physician may advise them should make them a little more skeptical and maybe make them ask a few more questions.’’

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March 8, 2011

The Coming Cancer Epidemic from Overuse of CT Scans

The medical community is waking up to an enormous problem with radiation – mainly X-rays and CT scans — used to diagnose disease and injury. Patients are getting too much radiation, and the excess itself causes injuries, many years down the road, in a big uptick in the risk of cancer.

Even a “routine” CT scan of the abdomen, ordered thousands of times every day in the United States for patients with belly pain, carries a large risk of downstream cancer, just from that single scan.

Dr. Rebecca Smith-Bindman, MD, of the University of California San Francisco, estimates a 20-year-old woman who undergoes a CT scan of the abdomen and pelvis has a one in 250 chance over her lifetime of getting cancer just from that single dose of radiation. This number was in a talk she gave recently at UCSF, as reported by her colleague Bob Wachter, MD, a patient safety expert at UCSF.

More scary statistics are in two articles Dr. Smith-Bindman and her colleagues published in Archives of Internal Medicine in 2009. There, they estimated that a single CT scan of the heart’s arteries (called a CT coronary angiogram, and promoted as being safer than the usual test called a cardiac catheterization) would cause cancer in one in 270 women and one in 600 men who underwent the test at age 40.

One problem is a huge range in the amount of radiation used at different facilities. Dr. Smith-Bindman’s group found a 13-fold variation from the lowest to the highest radiation exposure between scanners running the exact same imaging study.

She blames lax regulation by the Food and Drug Administration and lack of aggressive self-regulation by the medical physicists, working in hospitals, who are supposed to protect patients.

Most patients have no idea of the amount of radiation in one CT scan. It’s estimated to be about 200,000 times more than the radiation you get from going through an airport whole-body scanner, or about 450 times more than a simple chest X-ray.

Once people start to appreciate the risk, they realize that the pretty pictures produces by CT scans can have a very expensive cost down the road. It's something to remember the next time you see a billboard advertising “whole body scans” for healthy checkups, or “virtual colonoscopies” (to pick two examples of the heavily hyped types of CT scans now available).

Article first published as The Coming Cancer Epidemic from Overuse of CT Scans on Technorati.

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February 18, 2011

Is Grandfathering of Medical Devices Bad for Your Health?

The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it's similar to something already on the market, according to a recently published study.

Of the 113 devices recalled from 2005 to 2009 because the FDA determined they could cause serious health problems or death, 80 (71%) were reviewed using the “510(k) process,” which is meant to assess devices deemed to involve low or moderate risk. Only 21 devices (19%) had been approved through the more rigorous premarket approval (PMA) process, which requires clinical testing and inspections. (Eight other devices were exempt from any FDA regulation.)

Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review. A 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

Originally, the 510(k) process was specifically intended for devices with less need for scientific scrutiny, such as surgical gloves and hearing aids. It did not require clinical trials or manufacturing inspections to demonstrate safety and efficacy. Instead, it only required proof that the device was substantially equivalent in materials, purpose, and mechanism of action to another device that was already on the market, with the previous device serving as the “predicate” device with which the new device would be compared.

This approach was justified as a way to give manufacturers the opportunity to make small improvements on the devices already on the market and to allow companies with new products to compete with very similar devices without using the more extensive PMA process. If the FDA determined that the product was reasonably safe and effective according to the 510(k) review, it was said to be cleared for market rather than approved.

However, in 2002, Congress passed the Medical Device User Fee and Modernization Act, which shifted the regulatory standard to "the least burdensome approach in all areas of medical device regulation." This had the practical effect of making 501(k) the dominant mechanism for new device clearance, with the FDA now reviewing only 1% of medical devices using the more rigorous PMA process.

To decrease the number of high-risk recalls, the study recommends:

1. The FDA fully implements current law that subjects "life-saving and life sustaining" (Class III) devices to the PMA process.
2. The FDA's definition of a high-risk device takes into account the potential risks if the device fails.
3. The FDA expands the use of their authority to inspect the manufacturing of 510(k) devices just as they do for devices approved through the PMA process; and
4. The FDA strengthens their authority to use special controls for 510(k) devices as they do for PMA devices, such as postmarket surveillance, performance standards, and product-specific and general guidance documents.

Source: The Los Angeles Times

You can read the complete study here.

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January 18, 2011

Patients ask judge to bar equipment maker from selling to back surgeon

Former patients of an orthopedic surgeon in Dayton, Ohio, have petitioned a federal court to force a medical device company to stop selling him medical equipment. The complaint, filed in U.S. District Court against Roswell, Ga.-based Mylotec Inc., also seeks damages for 19 former patients of Dr. Lawrence Rothstein.

According to the complaint, Mylotec allegedly sold video-guided catheters to Rothstein, even though the catheters were not FDA approved for use with a laser. “Myelotec representatives were present during many of the spinal surgeries conducted in Ohio and knew or should have known that the company was placing patients at risk by promoting and permitting the alteration of its devices for non-FDA approved surgical use,” the complaint says.

Rothstein claims to have pioneered a non-invasive laser spine surgery called AccuraScope. The former patients allege Rothstein’s surgery left them with nerve damage, pain, weakness, numbness, paralysis and incontinence.

Rothstein declared bankruptcy in June 2010. At that time, there were 19 active malpractice cases against him. Previously, he had settled at least three cases and lost two trials, including a $5 million judgment for a Clark County woman who was left with permanent brain damage due to an overdose of pain medication. The bankruptcy case – which is still pending – halted the remaining malpractice cases.

Source: Dayton Daily News

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December 17, 2010

Defective DePuy Hip Implant Shows Big Hole in Regulatory System

Patients naturally assume that when a sophisticated metal implant like a hip replacement is surgically placed into their bodies, it must have been thoroughly tested before wide use. The now-recalled DePuy ASR hip replacement shows how wrong that assumption is.

A medical device manufacturer in the United States can cobble together new components into an old, already-approved device, and the new hybrid device is essentially grandfathered into government approval since it in theory closely resembles the old device.

As explained by New York Times reporter Barry Meier in a long outtake:

Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients.

That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the A.S.R., that process unfolded with devastating results.

Read more here.

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November 9, 2010

FDA recalls infusion pump and tissue stabilizer

The Food and Drug Administration has issued Class I recalls of Hospira Symbiq One- and Two-Channel infusers and Medtronic Octopus Nuvo tissue stabilizers.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The FDA is recalling Hospira’s infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death in: patients receiving critical therapy, pediatric patients, and neonates. The company mailed an “urgent device field correction” to affected customers and issued a recall notification in February 2010. All the affected units were distributed from Dec. 23, 2006 to January 22, 2010.

Medtronic’s Octopus Nuvo tissue stabilizers were manufactured from February 19, 2010 through August 28, 2010 and distributed from March 8, 2010 through September 7, 2010. The device stabilizes and minimizes the motion of selected areas of the beating heart during minimally invasive cardiac procedures while directly visualizing the heart through a small cut in the chest cavity. The FDA ordered the recall because of the possibility that a component of the device could fracture during use and fragments could fall into the patient’s chest cavity and/or damage the heart tissue, causing serious injury or death. Fortunately, no action from patients is required, since any adverse event related to the device would occur at the time of surgery.

Medtronic sent an “urgent medical device recall notice” to its customers on September 14, requesting that they discontinue use of the device, quarantine all unused devices and return unused devices.

Hospira recall source: Bioscience Technology

To view the FDA ruling on Hospira, click here.

Medtronic recall source: Operating Theatre Journal

To view the FDA ruling on Medtronic, click here.

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October 28, 2010

DePuy Hip Recall Shows Need for Early Warning System on Defective Medical Devices, Drugs

Most consumers are shocked when they learn the reality of the early warning system for defective medical devices and drugs in the United States. Unlike Europe and most other advanced countries, there is no systematic, mandatory national registry of failures to provide an early warning system.

Manufacturers are required to send to the FDA reports of drug adverse reactions and device failures. But the manufacturers have no legal obligation to collect such data in the first place, except in the rare instances when the FDA uses its power to require such on a case-by-case basis.

The DePuy hip replacement recall in August 2010 repeats a familiar pattern. Hip replacement surgeons knew they were experiencing a lot of failures with the DePuy hips, but no one had systematic data, and everyone assumed the manufacturer knew what was up and would report promptly.

In March 2010, the company warned doctors there might be a high failure rate. Then in August, it issued the recall. Now many patients have hired lawyers to pursue lawsuits, but a better warning system might have prevented many of them from getting the defective device installed in the first place.

The New York Times has more here.

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August 21, 2010

Easily Mixed-Up Medication Tubes Cause Patient Deaths and Injuries

For years, patient safety experts have known that medical devices, like tubes that deliver food and drugs to hospitalized patients, need to be designed so that predictable mix-ups don't hurt patients. If a tube is safe if it goes through the nose to deliver food to the stomach, it should not be possible to hook up the same tube to a line that delivers medication to a blood vessel, since that could kill the patient.

But this basic safety philosophy -- which permeates other high-risk industries like aviation and nuclear power -- still hasn't penetrated the medical industry, as a new report in the New York Times documents in distressing detail.

Partly to blame is the U.S. Food and Drug Administration, which could set up uniform rules that would bar as unsafe any medical devices where fatal mix-ups could be easily made by hurried nurses or other caregivers.

The way the agency does its work is the problem. When the FDA has tried to act on a case-by-case basis with an application from a manufacturer for a new product, efforts by FDA safety reviewers to solve the problem have been met with cries from the new manufacturer that it is being unfairly singled out.

Efforts to have industry-wide regulations have met with years of bureaucratic delay and industry resistance.

Here's a quotable quote from former FDA official Dr. Robert Smith:

“F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die.”

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August 1, 2010

Radiation Overdoses and Regulatory Ineptness

When is a radiation overdose not an overdose? When the facility giving the CT scans says so. At least that's what the Food and Drug Administration concluded when it dropped a safety investigation of the Huntsville, Alabama Hospital.

Now the FDA, which monitors radiation safety for the medical industry, is considering re-starting its investigation, once a New York Times reporting team found that the doses of radiation given to patients at the Huntsville Hospital were 13 times the normal dose for this type of scan, called a CT brain perfusion scan. The scan is used to test patients for stroke.

Even a properly done CT brain perfusion scan delivers about 200 times more radiation to a patient's head than a skull X-ray.

According to the Times, the hospital claims it used higher doses to get sharper images.

A quotable quote from the article, the latest in a series about medical radiation overdoses:

“It is absolutely shocking and mind-boggling that this facility would say the doses are acceptable,” said Dr. Rebecca Smith-Bindman, a radiology professor who has testified before Congress about the need for more controls over CT scans.

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May 28, 2010

Surgery for Back Pain: Less Is More

Nearly every week, I hear about a patient who had surgery to relieve terrible chronic back pain and ended up far worse off than before. One of the biggest problems is that money motivates surgeons to talk patients into much bigger and more complex operations than they really need -- and then those surgeries result in predictable complications.

The greed allegation sounds a bit harsh, but it comes straight from the top: The Journal of the American Medical Association, in an editorial by a leading Stanford orthopedic surgeon, Eugene Carragee, and in a study carried out by a group of doctors at Oregon Health and Science University led by Dr. Richard Deyo.

The Oregon study found that the rate of complex surgeries for back pain in Medicare patients jumped by 15-fold over a recent five-year period, but there was nothing in the patient population -- like increasingly complicated back deformities -- to justify the increase.

Joanne Silberner of NPR reported:

Deyo says there's no reason to think people suddenly started developing the spinal deformities that justify the complex surgeries. He offers several possibilities for the upswing. "Many surgeons genuinely believe that the more invasive procedures offer some benefits," he says. "But certainly there are important financial incentives at play as well." Surgical fees for simple decompressions are about $600 to $1,000. The complex surgeries earn surgeons as much as 10 times more. He says another possible factor is the tendency for both doctors and patients to go for a new, more expensive approach just because it sounds better.

The problem is that the more complex surgeries carry at least double the risk of a bad outcome, according to the Deyo study.

Most back pain that isn't relieved effectively with medicines or other non-surgical therapies is caused by disk herniation or spinal stenosis. Spinal stenosis is growth of bone near a nerve coming out of the spinal cord which presses on the nerve root and causes pain to radiate down a leg. The vast majority of patients who need back surgery because of spinal stenosis can be benefited from a fairly simple lumbar decompression. This involves removing bone, ligament and facet joint material which is compressing the nerve root. This operation has a high degree of success as it's been developed over the last 20 years.

According to Dr. Carragee's editorial, if the patient also has some deformity of the spine -- front to back or side to side -- the simple lumbar decompression can result in spine instability with increased deformity, so those patients might need a fusion where adjacent vertebrae are fixed together with bone grafts. But even here, simpler techniques get just as good results than more complex procedures that add metal or other instrumentation into the back.

A very small minority of patients, says Dr. Carragee, have spines that are so collapsed and twisted that the spine is unbalanced and tilted forward and the patient has severe pain and poor quality of life. These are the patients who might qualify for the complex surgeries now being done so commonly. Techniques have improved in the last ten years, but the surgeries in these patients still carry a very high complication rate -- 30 to 40 percent. And a lot more patients are getting the complex, multi-level surgeries than is warranted by the medical evidence, according to Dr. Carragee and other researchers.

Consumer Reports has rated spinal surgery as No. 1 on a list of overused tests and treatments.

As quoted by NPR, Dr. Deyo said he would like his study to alter the practice of medicine. "The effect I would hope it would have is to have surgeons and patients choose the least invasive procedure that would accomplish the surgical aim," he says. But he's pessimistic about it, unless there's a change in the financial incentives.

This is yet another area of medicine where it pays for patients to be skeptical and to get multiple opinions. It fits our natural instincts to think that bigger and more elaborate surgeries have a higher likelihood of success, but the human body proves over and over that it prefers minimal interventions.

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April 8, 2010

FDA Tightens Safety Rules for Radiation Therapy Machines

The Food and Drug Administration has canceled its policy of giving rubber-stamp approval to marketing of powerful new radiation therapy equipment like linear accelerators. From now on, the manufacturer of the machine is going to have to prove the equipment has proper safety checks to prevent dangerous overdoses of radiation to patients.

The New York Times ran a series in January 2010 that exposed some horrific tragedies that occurred, particularly when hospitals rushed into operation new and complicated equipment without thorough safety checks and training of technicians. The series also showed that the equipment often lacked simple fail-safe devices such as a way of preventing the machine from delivering a walloping overdose of radiation even if one had been inadvertently programmed by a technician.

But since the FDA only has power over manufacturers and not over hospitals themselves, it still will be possible for poorly trained technicians to cause errors that hurt patients by either delivering overdoses or underdoses of radiation.

In a follow-up article, the New York Times' Walt Bogdanich quotes Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, as saying the more serious problems stem from shortcomings in staffing, personnel competency and hospital quality assurance programs:

“I’d also caution that however commendable tougher standards for premarket approval of software may be, its not clear that F.D.A. has the expertise to police this,” Dr. Amols said. “In fact, I’m not sure anybody does. That’s one of the big problems with software. It comes down to a qualified user recognizing that something is amiss.”

While the government regulators are getting their act together, my advice for patients is to always make sure you get radiation therapy at only a leading center that has been doing it for a long time. Make sure the center employs licensed, certified technicians to operate the therapy machines. Don't be dazzled by the new smell and clean look of a spanking-new therapy center. That could be a sign that people aren't well trained yet to keep you safe.

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February 10, 2010

FDA Has New Initiative on Excessive Radiation to Patients

The scandal about injuries to cancer patients from malpractice in radiation therapy has had one beneficial side effect: the Food and Drug Administration is gaining urgency and attention for its new initiative to reduce unnecessary radiation in diagnostic imaging of patients.

Here is a link to the FDA's White Paper on its steps to make sure patients get only the dosage of radiation needed, at the right time and in the right way.

One part of the project is to make it easy for patients to keep track of how much radiation they've had, because accumulated dosing is what causes long-term injuries. The FDA says it is working

to develop and disseminate a patient medical imaging record card.26 FDA will make this card available on our website. While ultimately the best way of tracking a patient’s history of radiation exposure will be to incorporate it into that patient’s paper or electronic medical record, a personal record card will give patients and their caregivers a means, in the short term, of tracking their own medical imaging histories and sharing this information with their physicians. This will help facilitate critical discussions between patients and providers about the best available clinical options.

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January 31, 2010

Better Care with the Tried and True, or the Seduction of the New?

Time and again in U.S. health care, new technologies are hurried into wide use with little testing, scant training of their human operators, and lack of solid evidence that newer really is better. After the flush of optimism has faded, billions of dollars later, we learn how to judiciously use the new equipment, but only after patients have been hurt or killed by the rush to the new.

The latest example is the deployment of new radiation therapy machines on cancer patients with operators who are not properly trained or credentialed and equipment that has not been tested or calibrated. The New York Times' recent investigative series on the subject prompted one knowledgeable reader, Dr. Joseph Imperato, medical director of the Center for Advanced Radiation Medicine at Lake Forest (Ill.) Hospital. to write this:

To the Editor:

As a radiation oncologist practicing for 25 years, I believe that there is a crucial part of the story of radiation mishaps that has not been mentioned: the “nuclear arms race,” in which people want the newest technologies, without stopping to think about who is operating them.

In the past, academic medical centers were typically the first to obtain and use new technologies. The equipment would be thoroughly vetted and reported on in peer review articles before being accepted and used by the smaller community hospitals.

Now the reverse is true. Small community hospitals often far outpace academic medical centers. One example is the proliferation of proton centers run by for-profit companies. Often the staff has limited knowledge and experience with this extraordinarily complex equipment. And new technologies are often assumed by the public to be better, even though there is often little firm clinical data to support that.

As we struggle as a country to come to grips with health care costs, this is one area where there is great opportunity for savings. Clinical reviews can prevent the proliferation of needlessly expensive technology. What the public must come to grips with is that “new” is not automatically “better.”

See the Times' letters section for more.

In my book, "The Life You Save," I have several chapters that speak to this issue, particularly with new drugs. What patients need to understand is that whatever the technology, the early years of use are in essence a continuation of the testing phase. If you are comfortable with being a guinea pig, that's fine, but very often you can get better, safer care with the tried and true. And if the new technology looks enticing, go with an operator who has the most experience using it, because practice does make perfect.

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January 28, 2010

Preventing Malpractice in Radiation Therapy

What can cancer patients do to protect themselves from malpractice in radiation therapy? This urgent question arises from a lengthy series of investigative reports in the New York Times. The articles exposed serious patient injuries that stem from therapists who are overwhelmed and inexperienced, lax regulation and indifference by hospital administrators.

A key part of the problem is that technological sophistication has outrun the ability of the humans running the radiation machines to monitor the safety of the radiation beams they train on patients' bodies.

Another issue is that no central agency is responsible for inspecting the machines and credentialing the people who run them. Depending on the type of radiation involved, the Food and Drug Administration, the Nuclear Regulatory Commission and various state health agencies could have jurisdiction. Or worse, each could claim that someone else has the jurisdiction, and the patient can slip through the cracks.

There is one simple way that patients can take some measure of self-protection. That is to make sure that the radiation therapy center treating you has significant experience, in years not months, with the specific machine being used on you. Too often, hospital administrators buy a fancy new machine, advertise it heavily in glossy brochures, but don't take the time to make sure the machine is properly calibrated and that the medical physicists who operate the machine are fully trained.

You should also ask if the machine treating you has been inspected recently by an independent agency. One federally funded inspection and testing service is the Radiological Physics Center, operated out of MD Anderson Hospital in Houston. It does inspections for any radiation center that wants to receive federal funding for clinical trials. The Center found in 2008 that nearly three in ten hospitals it inspected failed to accurately irradiate a test dummy using IMRT technology.

The Times also found rampant problems with fake credentials among medical physicists, who are in charge of making sure patients get the right dose of radiation. The American Board of Radiology certifies medical physicists in one of three sub-specialties. You can check if a physicist is certified at the umbrella website for all medical board certifications, the American Board of Medical Specialties. Click here to go to the login page to search for a medical physicist's certification. The same page will let you search for whether a doctor is board-certified in any of the ABMS specialties or sub-specialties.

Also, the American Board of Medical Physics runs some certification programs. Its website has lists of diplomates but lacks any searchable database of qualified physicists. So the ABMS website is a better choice.

I recommend that patients ask questions to find out the qualifications of the persons running your radiation treatment program. If they lack certification, why take a chance?

I discuss the certification issue in detail in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." Many of the most egregious cases of malpractice that I have prosecuted for victims' families have involved doctors who lacked basic board certifications. Click here for more information on the kinds of malpractice cases we work on.

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September 15, 2009

New Patient Safety Report Cards in Pennsylvania

Pennsylvania continues to lead the nation in showing how public health authorities can cast a little disinfecting sunshine onto the patient safety practices of hospitals.

In its latest report, the Pennsylvania Patient Safety Authority says that in 2008, a total of 194 surgery patients were sewed up with a foreign object still inside them. They have a term for it: RFO, for Retained Foreign Object.

To avoid leaving behind a sponge, needle or other instrument, the nurses and doctors involved in any surgery are supposed to go through a counting ritual. The problem is that the count doesn't always end correctly. In fact, the same Authority reported that last year, there were over 2,000 instances of incorrect counts, which doesn't always mean an object has actually been left behind.

One technique to follow up when there has been a discrepancy in the count is to do an x-ray of the affected area. That should show up any hidden objects.

The RFO problem is expensive for patients and hospitals. According to the Consumer Union Safe Patient Project, the average cost of a hospital stay for the corrective surgery and other problems that come from a retained object is $62,631.

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August 6, 2009

Does My Doctor Have a Conflict of Interest? Why You Should Care

Whether or not a patient should get an expensive imaging scan or some other elaborate and expensive test is not always clearcut. But what should be clearcut is that doctors should not have a thumb on the scale when they're balancing harms versus benefits. The balancing ought to be focused entirely on what's in the patient's best interest. The news story about what happened when a group of urologists in Iowa ordered a new CT scanner for their office sheds light on this conflict of interest issue.

According to the article by Shankar Vedantam in the Washington Post, the doctors at Urological Associates in Iowa were ordering fewer than one dozen CT scans per month for their insured patients in the months before their office bought its own CT scanning machine. That number jumped to 55 scans per month soon after the doctors got their own machine and started getting direct insurance payments for its use.

Defenders of the doctor-owned machines say it's more convenient for patients not to have to go to some other building for their scan. That's no doubt true -- if the scan is really needed in the first place. The problem is that self-interest colors the doctor's calculation, whether subtly or blatantly.

You might say "so what," but no test is without its downside, and excessive radiation from unnecessary CT scans can ultimately cause cancer in some patients -- as many as one in one hundred cancers are traced to radiation exposure. Not to mention bankrupting our health care system in the meantime.

Congress is considering outlawing the practice of what is called "self-referral," referring the patient to a test on a machine that the doctor owns. At the least, Congress should make it mandatory that doctors disclose any self-interest they have in testing, so that patients can take it into account in deciding whether they want the test.

I discuss doctor conflicts of interest in Chapter 9 of my new book, "The Life You Save." Chapter 9 is called "The Second Opinion: Always Your First Choice." It explains why you the patient need to understand if your doctor may have some ulterior influence on his or her thinking, and how it's always a good idea to get a second opinion before undergoing any major procedure.

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August 5, 2009

The Medical Industry's Own "Steroids in Baseball" Scandal

Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are "ghost-written" by drug manufacturers.

According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth's hormone replacement drugs Premarin and Prempro show that over several years, Wyeth repeatedly hired ghost writers who placed 26 articles in 18 prestigious medical journals, all promoting the drugs in the guise of objective analysis by medical experts:

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The Times article made an interesting comparison to professional baseball's steroids scandal.

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

“The filter is missing when the reader does not know that the germ of an article came from the manufacturer,” said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

The same concern about ghostwriting applies to patients who read literature on the Internet. People can be easily misled if they think an article is truly objective.

My advice, as I write in my book, "The Life You Save," is to rely on truly independent groups like the Medical Letter and Public Citizen's Health Research Group for objective information about drugs.

Some top medical journals like the Journal of the AMA now require authors to fill out detailed forms describing exactly how much input they had into the writing of an article. But many do not have such requirements. Consumer, beware.

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