Articles Posted in Medical Device Safety

A U.S. Senate Committee has ripped a medical device maker, hospitals, and federal regulators for their shameful roles in allowing scores of patients to be sickened and some to die due to defects in a flexible, state-of-art scope used in gastrointestinal procedures. The committee’s findings and some other recent reports ought, in particular, to raise lawmakers’ hackles about the cozy relationships between regulators and industry and how these work to the public’s detriment.

I wrote recently about this scandal, uncovered by the Los Angeles Times. The paper’s investigation found three infection outbreaks linked to Olympus scopes and blamed 21 deaths on dirty scopes.

Senate investigators found the situation was far more widespread — with 25 outbreaks — and the conduct of the various parties even more problematic. We already knew that Olympus dissembled throughout the growing crisis. It blamed others for faulty cleaning. It told European customers there might be problems with the devices but failed to warn users in the bigger, more profitable American market. Olympus, though it knew of spreading concerns, sought to persuade affected hospitals that they were alone in their problems. The company moved as slowly as it could in filing incident reports with federal regulators.

The Times filled in some blanks about the actions of the Food and Drug Administration, the federal watchdogs of medical devices on the public’s behalf. Senate investigators assailed the FDA for its bungling and delay. The agency spent 17 months in back and forth chatter with Olympus, examining issues of hygiene and proper cleaning of the devices without grasping the larger and deadly woes, the Senate report says. The FDA also ran — and still runs — a haplessly passive system to collect critical information that could provide warnings about device dangers. Regulators, for example, ask manufacturers and hospitals to file incident reports when harms or deaths occur; in this case, the maker and hospital either failed to file the reports or did so in such slow and delayed fashion that the information was unhelpful. The agency also grants anonymity to hospitals, in particular, when they do file reports, making it harder to see patterns and outbreaks.

Sen. Patty Murray (D-Wash.), a ranking member of the Health, Education, Labor, and Pensions committee that investigated the dirty scopes’ outbreaks, including one at a Seattle hospital, observed:  “Patients should be able to trust that the devices they need for treatment are safe and effective. Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented …” Murray also has posted a news release saying that, under her committee’s prodding of the FDA, Olympus has recalled all its scopes and will replace and repair them with a new design that experts say will avert the spread of infections.

What’s next?

OK, Congress, now that the media had to provide the digging and spotlight to disclose bad conduct with this medical device, how about fixing the glaring problems with the regulatory agency?

It’s also under fire in another medical device situation. As the folks at the Health News Review point out, NBC, to its credit, has stayed atop a running story about Bard, a big medical device manufacturer based in New Jersey. Bard, NBC reports, has made a “blood-clot filter associated with 27 deaths and hundreds of problems.…[The firm] replaced the device with a modified version that it knew had similar and potentially fatal flaws soon after it was put on the market.” A U.S. senator has written the FDA to ask what it’s doing about this case.

Meantime, a healthcare industry trade publication, deserves credit for tracking the unseemly, tight ties between the FDA and medical device manufacturers. I’ve written about Congress’ big, end-of-the-year budget crunch and how it boosted federal support for healthcare. I said then that taxpayers needed to keep a close watch on all the sizable legislative actions connected with healthcare funding.

Too cozy for comfort

Indeed, InsideHealthPolicy has reported that, in the hectic wind-down of 2015: “FDA and the largest medical device lobbying group worked together to develop proposed legislative language for most of the medical device provisions included in the House-passed 21st Century Cures bill, one of the largest FDA reform bills to pass the House in recent years, and are developing a synchronized regulatory strategy for the Senate version.” The trade publication found this in internal emails and documents obtained under the Freedom of Information Act.

The Health News Review folks add more context and other information on the cozy dealings, as reported by other media, including the outrage by consumer advocates at being shut out in the drafting of the FDA “reform” legislation.

Americans, I hope, are now permanently wary of any actions by Big Tobacco. Recent, soaring drug prices have sharpened our doubts and guard about Big Pharma (even as we give thanks and credit for therapies that work, are affordable, and available). Big Med Device Makers look hell-bent on not just creating and selling potentially life-changing things but also in gaining the notoriety and ill will that took some other corporate bad actors time to earn. We’ll all need to pursue multiple fronts — personal, electoral, legislative, through the civil justice system, and others — to keep in check the avarice and down-right villainy of the malevolent among these interests.

Twenty-one patients died and at least two dozen others fell ill from infections now linked to a flexible, state-of-the-art scope used in gastrointestinal examinations, even as the medical device’s manufacturer for years kept selling the instrument and failed to alert hospitals about growing dangers, the Los Angeles Times has reported. The paper detailed its findings about a nationwide outbreak that became public only after problems were publicized at a major, Southern California medical center.

The manufacturer, Olympus of Japan, blamed others and improper cleaning for deadly infections tied to its instrument. It also kept hospitals and regulators in the dark about problems with the devices, allowing each of several hospitals involved to think it was the only one having issues, the paper reported. It quoted a gastroenterologist at one affected hospital as saying the company’s silence was “unethical, irresponsible, and dangerous.”

Only after the Times published reports of three Southern California deaths did federal regulators issue a nationwide warning, and investigations in LA, Pittsburgh, and Seattle were tied together. These indicated that, what the manufacturer had called improvements in the scope’s design and had led to a higher costs for the devices, permitted a grimy film to develop in Olympus scopes; this residue harbored patient tissue and deadly microbes that were fatally spread. The company was brought in to see how hospitals tried to clean the scopes, offering no adverse commentary about intensified procedures that ultimately proved inadequate.

The Times also has posted a companion story describing Olympus’ woes with another of its scopes, this device to examine bronchial passages. As investigators discovered with these scopes, they, too, spread infections because their design hampered sterilization. Then, the company and its slow response prompted researchers from Johns Hopkins, an affected institution, to publish a 2003 letter to the New England Journal of Medicine, calling on manufacturers to accept the importance in device design of instrument cleaning to patient safety.

Such warnings apparently aren’t getting heeded as they need to be, as I’ve written before. I noted as recently as this fall that federal regulators had again issued extensive warnings to hospitals about hygiene, scopes, and other medical devices, particularly those that get re-used. Let’s also be clear: technology’s advances have created real challenges for experts in tracking and assessing safety issues as more new and redesigned devices roll out. The U.S. Government Accountability Office, a congressional watchdog, has put heightened oversight of medical devices as one of its “high risk” issues demanding urgent improvement.

As the Times stories make clear, however, fancy new hardware commands big dollars in health care. Lobbying of lawmakers by interests in this area are formidable. Further, it can be hard to create sufficient public clamor to prompt tough action by regulators and lawmakers because patients are affected piecemeal by many and different medical devices. News reporting in this area deserves credit for helping to clean up problems. It also may take concerted work in the civil justice system to hit bad actors with verdicts sizable enough to prompt more responsible action.

Here’s another device you probably don’t need. Or do you?

That’s the question Austin Frakt, who writes for the New York Times, tried to answer for himself when his cardiologist told him that one of his heart’s chambers sometimes pumped when it shouldn’t. The doctor had been “99.9% certain” that it wasn’t worrisome, and doctor advised against additional tests and visits.

But even though he’s a health economist, and knows that many commonly prescribed tests aren’t necessary, Frakt is only human. “As a patient,” he acknowledged in his story in The Times, “I’m not confident I know which ones.”

His heart palpitations persisted, and so did his concern. “Was I the patient for whom additional tests would be beneficial or wasteful?” he wondered.

He opted to try the monitor. That involved attaching electrodes to his chest so that his heart’s rhythm could be relayed over wires to a recorder on his belt. It wirelessly communicated the heart data to his physician, continuously monitoring for electrical signals of a heart attack.

As Frakt wrote in The Times, “Some [technologies] are valuable for some people but are used in a great many more for whom it is wasteful. When applied to the population with the right risk factors, various tests of the heart can save lives. When applied to a population at very low risk, a great deal of it does little but add to our health care bill, waste patients’ time and lead to unnecessary procedures, which carry their own risks.”

Although Frakt was amazed by his hear monitor’s wizardry, that didn’t overcome the unpleasantness of wearing it. The wires tickled his torso and made his clothing look bulky. The belt recorder poked him in the waist and impaired his range of motion. Not to mention the weird looks he got when somebody noticed the monitor.

“It was hard to forget I was a patient,” he wrote. “I felt tethered to, not freed by, technology. These inconveniences were like small physical and psychological co-payments, increasing the cost of the test to me, the patient.”

If you have an increased risk of heart problems, if you have a history that demands you carefully monitor your heart’s health, these are minor inconveniences, and maybe the monitor is a useful health-care tool. But if you’re not a heart patient or strong potential patient, really, is this something you want to pay for, be inconvenienced by and possibly stress out over its presence?

For Frakt, although the financial cost of the device wasn’t a concern, the psychological cost was too high, given that he wasn’t sure that he needed monitoring around the clock. “Within a day,” he wrote, “I unplugged and immediately felt liberated.”

As it turns out, his condition was benign.

But as the physical, mental and financial burden of collecting data about the human body declines, more people will use technologies like the heart monitor. Some are curious, some just like new gadgets and some are the “worried well,” people with no reason to suspect illness lurks, but still worry about it anyway.

The popularity of fitness monitors  attests to our cultural embrace of little tools that are all about me me me, even when there’s no medical reason for constant monitoring. And even though a lot of health data trackers now on the market aren’t always reliable, Frakt said that widespread monitoring eventually might enhance researchers’ ability to understand the early cues to potential problems. “It might save lives,” he said.

Today, wearable heart monitors for stroke patients are useful in diagnosing irregular heartbeats and alerting doctors to the need to intervene. Implantable defibrillators are proven tools to decrease risk of mortality for some patients with heart failure by shocking their hearts back into normal rhythm.

“But,” Frakt wrote “[t]hese examples are for technology targeted to specific groups with significant heart problems, the people we know will benefit most. What happens when millions of healthy people start recording their hearts’ rhythms just because they can? Even though the devices that enable this may be cheap, collectively we may pay a lot if doing so leads to over-diagnosis and unnecessary procedures. People who need wearable health monitors the least may be among those most likely to use them.”

Frakt isn’t just an economist, he’s a bit of a poet. Regarding our attraction to new technology, he concluded in his story, “Each time it feels right, but so often it doesn’t last. It’s like falling in love.”

Earlier this year, both patients and providers were shocked when a rash of hospital patients got seriously ill or died after medical devices used to examine their gastrointestinal tracts infected them because they were not sufficiently cleaned after previous use. 

Now, it seems, inpatients aren’t the only ones who need to worry about contaminated medical instruments — according to an advisory issued by the Centers for Disease Control and Prevention ( CDC) and FDA, a wide range of reusable diagnostic instruments used in doctors’ offices and other outpatient facilities are vulnerable to the same risk of carrying other patients’  bacteria.

And last week, the FDA followed up that notice with a warning that bronchoscopes specifically can transmit infections if not adequately cleaned — 109 such adverse events have been recorded by the agency in the last five years, according to Bloomberg.com. Bronchoscopes are instruments inserted into the mouth or nose and through the windpipe (trachea) to examine the lungs’airways.

This widespread vulnerability to infection is especially worrisome, given that a couple of months ago, an FDA panel advised not banning the duodenoscopes that caused the outbreak that got so much attention because there’s no other option for treating certain life-threatening conditions. In other words, these are bad tools, but in some cases, the only ones.

So some people with certain conditions remain at risk if they have an endoscopic procedure, but those scopes aren’t the only ones of concern.

According to Medscape Medical News, the feds’ advisory was a strong consciousness-raising effort to get all clinicians and facilities to clean, disinfect and sterilize all reusable, invasive tools as if peoples’ lives depended on it … because it can. (The advisory specifically called for providers to test patients for whom they have used certain scopes for blood-borne pathogens, including hepatitis B virus and HIV.)

The feds didn’t cite specific examples of contaminated reusable medical devices, but a CDC spokesperson told Medscape that inspection of clinics operated by Kadlec Health System in Washington revealed “inconsistencies and potential inadequacies” in how reusable devices were disinfected and sterilized, and that the clinics had suspended some procedures as a result.

The Bellevue Clinic and Surgery Center of Seattle Children’s Hospital notified about 10,000 patients recently that they might be at risk for infection because of improperly cleaned surgical instruments dating to 2010; a community health center in Tucson, Ariz., told its dental patients earlier this year that they should be tested for possible infection after discovering that some equipment had not been sterilized; in Pennsylvania last year, a surgery center’s physicians didn’t perform high-level disinfection of sigmoidoscope components, nor sterilize various forceps.

Joseph Perz, an epidemiologist at the CDC’s Division of Healthcare Quality Promotion, told Medscape that improper cleaning of reusable devices “is not just associated with the hospital environment. Autoclaves are ubiquitous. They’re in doctors’ offices and clinics.”

An autoclave is a container in which chemical reactions, high pressure and high temperatures sterilize equipment. As Perz said, “We take it for granted, but people are using autoclaves without giving enough thought to doing every single step correctly.”

The federal advisory included instructions for medical personnel to follow proper cleaning procedures, and allow enough time for thorough disinfection. If you’re concerned about instruments your medical caretakers use, ask if:

  • the personnel responsible for disinfection have been trained not only when they’re hired, but annually, and whenever new equipment is introduced; ask if they’re required to demonstrate competency to their trainer;
  • the facility monitors and documents adherence to procedures for cleaning, disinfecting, sterilizing and storing reusable devices, and does it share the results with staff;
  • when the facility shops for a reusable medical device, it consults with its reprocessing personnel to ensure that infection control is considered in the purchase decision (some devices are more difficult to handle than others).

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.

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.

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.”

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.

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 ProPublica.org, 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.

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, AboutLawsuits.com 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 AboutLawsuits.com. (“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 AboutLawsuits.com, “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.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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