Medical Device Safety

July 30, 2019

Voluntary recall of textured device raises more alarms about breast implants

An Irish medical manufacturer voluntarily withdrew its textured breast implant and related tissue expanding devices from markets after the federal Food and Drug Administration tracked a spike in a rare cancer and deaths tied to the products and asked that they be recalled.

U.S. regulators, the New York Times reported, lagged their European counterparts by almost a year in acting to protect women seeking cosmetic and reconstructive procedures involving the Allergan implant:

“Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.”

July 28, 2019

Can lives be saved with lessons learned from a space pioneer’s botched care?

by Patrick A. Malone

Neil Armstrong served as a naval aviator, test pilot, federal administrator, and a university professor. He earned his place in history as space pioneer — the first astronaut to walk on the moon. The American hero, who spoke the legendary phrase about “one small step for man and one giant leap for mankind,” also now offers a textbook case about nightmares in health care. Can others avoid these by learning about what happened to him?

As the nation celebrates the 50^th anniversary of Armstrong’s Apollo 11 flight, an anonymous tipster has disclosed information to two news organizations that his death was due to botched care. His family, which included a lawyer who represented their interests, reached a $6 million settlement with the community hospital involved.

Armstrong was known for keeping out of the media and public glare. His family kept that tradition in keeping private how he died in 2012, why, and the tense negotiations that resulted in the sizable payment to them by the hospital. Full information about his case may never be fully disclosed. But it already provides a possible series of check points for patients to protect themselves and their loved ones in dealing with doctors and hospitals:

July 10, 2019

Critics fear a key watchdog’s decline as FDA eases up its regulatory actions

by Patrick A. Malone

Consumers may want to think long and hard about whether the federal Food and Drug Administration protects the interests of the vulnerable public or profit-raking Big Pharma and medical device makers.

As a scrutiny of data by Science magazine shows:

“From monitoring clinical trials and approving medicines and vaccines, to ensuring the safety of blood transfusions, medical devices, groceries, and more, the U.S. Food and Drug Administration (FDA) is one of the nation’s most vital watchdogs. By several measures, however, FDA’s compliance and enforcement actions have plummeted since President Donald Trump took office … The agency’s ‘warning letters’—a key tool for keeping dangerous or ineffective drugs and devices and tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through 22 May show the agency issued 1,033 warning letters, compared with 1,532 for the most recent equivalent period under former President Barack Obama. Compared with the start of the Obama presidency, Trump-era letters dropped by nearly half. Warnings from the FDA Center for Devices and Radiological Health, which helps ensure the safety and quality of medical devices, and from some of the agency’s district offices—including Philadelphia, Florida, and New York—have dropped even more steeply, by more than two-thirds. Two district offices have not issued a warning in more than 2 years. The numbers don’t just reflect a new administration’s slow start. FDA sent significantly fewer warning letters in the second year of Trump’s presidency than in his first.

June 26, 2019

Concerns rise over costly emergency intervention — a ‘bridge to nowhere?’

by Patrick A. Malone

Medical ethicists and patient advocates are raising concerns about a big, costly, and often unsuccessful procedure that “pumps blood out of the body, oxygenates it, and returns it to the body, keeping a person alive for days, weeks or months, even when their heart or lungs don’t work,” the Kaiser Health News Service reported.

Extracorporeal membrane oxygenation or ECMO (eck-moe) is considered an appropriate treatment for some patients on death’s door.

But hospitals, to maintain their competitive business standing, are battling to get the equipment and staff to provide this therapy, which costs on average half a million dollars per patient. The number of hospitals that can do ECMO has increased from 108 in 2008 to 264 now, with the number of ECMO procedures tripling since 2008 to almost 7,000 in the last count in 2014.

May 31, 2019

FDA’s dubious oversight of heart devices: hidden complaints and shaky tests

by Patrick A. Malone

Cardiac patients may wish to take to heart how news reports have undercut federal regulators’ claims that they provide the most rigorous oversight to medical devices that treat complex conditions in ways that pose the greatest risk. With certain heart pumps and defibrillator units, both implanted in patients, the Federal Food and Drug Administration deserves criticism for putting the interests of device makers ahead of patients, excellent stories by the Kaiser Health News Service and Axios show.

KHN reporter Christina Jewett followed up her investigation into how FDA bureaucrats let device makers file 1.1 million reports of injuries or malfunctions with their products to a little-known internal agency database, discovering how this practice contributed to what one cardiologist described as “the worst cardiac device problem” he has seen in a quarter-century of practice.

The incidents involved the Sprint Fidelis, a small device surgically installed in hundreds of thousands of patients to monitor and supposedly to administer small shocks to deal with their irregular heartbeat. Instead, the device — especially due to problems with its corroding and cracking electrical leads — gave patients random jolts, failed to perform in genuine emergencies, and led to a torrent of complaints and deaths. Doctors, medical researchers, and patients forced into wide public view the substantial defects of the defibrillator, including in congressional hearings.

May 24, 2019

Walmart sees a bigger picture with costly imaging: frequent misdiagnosis

by Patrick A. Malone

As Walmart tries to work with its 1 million-plus U.S. employees in controlling health care costs, the retailing giant has not only struck a blow for quality medical treatment, it also has raised key questions about a costly and booming specialization in health care: medical imaging.

Walmart decided to shake up this diagnostic field by telling its employees to pay more themselves or to first seek CT scans and MRIs at one of 800 imaging centers that a company-retained health care consulting firm has identified as providing high-quality care. Covera Health, a New York City-based health analytics company, “uses data to help spot facilities likely to provide accurate imaging for a wide variety of conditions, from cancer to torn knee ligaments,” Kaiser Health News Service reported.

KHN reporter Phil Galewitz said Walmart targeted improved imaging based on the giant retailers’ experiences already in funneling workers to select facilities its research has found to offer efficient, high-quality care in specific areas, such as organ transplantation, back and knee surgeries, and heart and cancer treatment.

May 13, 2019

Wave of hip implant, opioid, talc suits tarnish a famed ‘family’ brand

by Patrick A. Malone

If consumers ever considered Johnson and Johnson just to be a family friendly health brand, the conglomerate’s legal challenges on three fronts—with problematic medical devices and drugs—may disabuse them of warm and fuzzy views.

As Bloomberg News Service reported, J&J will pay $1 billion to try to extricate itself from 95% of 6,000 lawsuits against it over defective metal-on-metal hip implants that not only caused patients great pain but also had to be surgically removed and replaced. The company still must resolve thousands of suits with patients who haven’t had replacement operations or whose implants were only partially metal.

J&J has battled over its Pinnacle implant from its DePuy unit for at least four years, losing sizable cases in Texas to patients who convinced judges and juries that the medical device maker had misled them about their artificial hips’ durability and risks, including assertions that it caused metal poisoning.

April 22, 2019

After thousands of lawsuits, FDA bans mesh used in pelvic prolapse procedures

by Patrick A. Malone

After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women.

The agency has been slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused pain, bleeding, and scarring. This was not the surgical innovation, they said, that was supposed to remedy the pelvic tissue collapse that can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary leakage.

The FDA issued a series of increasing warnings about mesh, finally reclassifying it in 2016 as high-risk and ordering its makers to produce medical-scientific evidence about the device’s long-term safety.

April 16, 2019

Telemarketing “free” back and limb braces for seniors adds up to a $1.2 billion Medicare fraud

by Patrick A. Malone

Federal authorities have busted up what they say is a $1.2 billion Medicare fraud that should give taxpayers and patients pause about long-distance medical consultations and the huge sums of cash washing around the medical device industry.

Two dozen people, some of them doctors, have been charged in a complex ploy to gull seniors into asking about back, shoulder, wrist, and knee braces that were promoted as free on TV and radio ads nationwide. When the older adults called to inquire about the devices, they were transferred to telemarketing centers in the Philippines and Latin America.

In the far-away boiler rooms, trained operators extracted important personal information from callers, then connected them for “telemedicine” consultations with cooperating doctors. The MDs asked cursory questions before then prescribing the devices, whether needed or not. The orders were filled by select companies, which then would send out the braces and charge them to Medicare.

April 11, 2019

FDA battles sketchy stem cell claims, while big hospitals jump into unproven treatments too

by Patrick A. Malone

When doctors and regulators crack down on the burgeoning and risky use of purported stem cell therapies, some well-known and respected big hospitals and health systems may have their own practices to explain, too.

As Liz Szabo reported for the nonpartisan Kaiser Health News Service:

Swedish Medical Center, the largest nonprofit health provider in the Seattle area … is one of a growing number of respected hospitals and health systems—including the Mayo Clinic, the Cleveland Clinic and the University of Miami—that have entered the lucrative business of stem cells and related therapies. Typical treatments involve injecting patients’ joints with their own fat or bone marrow cells, or with extracts of platelets, the cell fragments known for their role in clotting blood. Many patients seek out regenerative medicine to stave off surgery, even though the evidence supporting these experimental therapies is thin at best …