Medical Device Safety

May 31, 2019

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

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 …

April 2, 2019

FDA ripped over breast implant safety as agency seeks mammogram change

by Patrick A. Malone

Uncle Sam has paid what critics have called long overdue attention to women’s breasts and how surgeons and diagnosticians treat them.

In an angry and emotional public hearing, women ripped the federal Food and Drug Administration for lax oversight of implants that surgeons use to augment and reconstruct breasts, even as the agency proposed its first changes in 15 years to guidelines about mammograms for patients with dense breast tissue.

The FDA has been under fire for decades over breast implants, mostly banned in 1992 but allowed anew in 2005. Experts long have debated whether materials in the implants, notably silicone and not necessarily saline fillings, may be injurious to women’s health. New concerns have developed over surface texturing on the devices, which are supposed to help in the surgery but may affect tissues around and near the breast, leading to spikes in reported cases of rare cancers.

March 25, 2019

Electronic records mess threatens patient safety, investigation finds

by Patrick A. Malone

Tempting though it may be to dismiss doctors’ howls about electronic health records—maybe they’re Luddites or they’re just another group of high-paid workers beefing about their job tools—the persistent and significant nightmare of the complicated computer systems has been this: Do they harm patient care?

The answer now may be: Yes, billions of taxpayer and private dollars spent on EHRs may be reducing patient safety.

That’s the finding of the independent, nonpartisan Kaiser Health News Service, based on its extensive investigation in partnership with Fortune Magazine. The two media operations reported that:

March 13, 2019

Bureaucrats let medical device makers hide 1 million reports of patient harms

by Patrick A. Malone

If a surgical staple gun malfunctioned so seriously that it generated not a few dozen formal complaints but more than 10,000 reported incidents, shouldn’t patients, doctors, and hospitals have the right to know that information from the federal agency overseeing the safety of medical devices?

Apparently not. Or maybe not without a big kick in the pants from journalists.

Instead, the staff at the federal Food and Drug Administration turned a move to ease paperwork and bureaucracy into a giant and little-known system that lets medical device makers hide serious and significant numbers of reports about failures and flaws with at least 100 products, a Kaiser Health News Service investigation found.

March 12, 2019

For diabetics and dialysis patients, glimmers of better news on costs of care

by Patrick A. Malone

Diabetics and those with failing kidneys may have gotten a glimmer of relief from the staggering costs of caring for their conditions, as Big Pharma relented a tad with news it will put out a less-costly insulin product and federal officials suggesting Uncle Sam soon may be upsetting the flush profits of the dialysis industry.

DaVita Inc. and Fresenius Medical Care AG run more than 5,000 U.S. dialysis clinics and control around 70 percent of the market, Reuters news service reported in a story describing how Alex Azar, the powerful head of the federal Health and Human Services department, wants “a new payment approach for treating kidney disease that favors lower cost care at home and transplants.”

Why? As Reuters explains, “The goal is to reduce the $114 billion paid by the U.S. government each year to treat chronic kidney disease and end-stage renal disease, a top area of spending.”