Medical Device Safety

April 16, 2019

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

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.”

March 4, 2019

FDA warns surgeons against experimental robot-aided cancer operations

by Patrick A. Malone

The federal Food and Drug Administration finally has pushed back at surgeons and hospitals for experimenting on patients, spending $3 billion a year for surgical robots. The devices should not be used for mastectomies and other cancer-related procedures without caution, regulators warn.

The FDA acted after studies have shown that minimally invasive procedures for early-stage cervical cancer, many robot-aided, were more likely than standard, large-incision surgeries to result in recurrences of the disease and deaths.

Regulators also may have been prodded by their poor history in halting harms to women with so-called keyhole procedures, particularly the nightmares the FDA was slow to react to involving minimally invasive hysterectomies and a tissue-grinding tool called a morcellator.

February 25, 2019

Blood and spit, vampires and dead family secrets

by Patrick A. Malone

Funny the mischief that can happen with a little blood and spit. Seemingly unrelated medical stories last week brought home the lesson of the law of unintended consequences. Those consequences abound everywhere, in health care most especially. So with blood, we’re learning about a bizarre new fountain-of-youth treatment, with echoes of vampires, for seniors who ought to know better. And with spit, we’re learning how seemingly harmless genetic tests can raise from the dead some disturbing revelations about our deceased family members.

Bunk about blood transfusions

The federal Food and Drug Administration has warned older Americans about a new kind of anti-aging bunk flying out of the Silicon Valley: blood transfusions. Companies, dancing on a fine legal line, have hinted that seniors could benefit by getting transfusions of young people’s blood and blood products.

February 15, 2019

Look out, below: A load of dietary super bunk is raining down from celebrities

by Patrick A. Malone

If you’re such a die-hard fan you slogged through that pro football championship that was perfect for the new Year of the Boar, please don’t be so sheepish in your celebrity adoration as to get gulled by quarterback Tom Brady’s health and diet bunk.

His oddball theories well might go into a flaming dumpster, along with notions about special drinks and excess hydration, and yet more broadcast goop from that princess of health woo, Gwyneth Paltrow.

Sure, Brady’s Superbowl LIII win may have made him the goat (greatest of all time) in National Football League history with six rings. He got there, and may stay there, not only with rare individual gifts, hard work, and special talents, but also with peculiar practices, as Vox, an online news site reported:

February 13, 2019

Why are medical bills soaring? Blame a 42% hike in hospital prices.

by Patrick A. Malone

Patients and reformers attacking skyrocketing health care costs may want to focus less on doctors and more on big, shiny hospitals, where in just five years prices soared by 42 percent for inpatient care versus the still sizable 18 percent price hikes that MDs scored.

Those findings are part of a new study that examined medical costs based on actual payments, focusing on common procedures like deliveries of babies (vaginal and cesarean), colonoscopies, and knee replacements. “Hospital prices grew much faster than physician prices for inpatient and outpatient hospital-based care in the period 2007–14 … The same pattern was present for all four of our procedures,” wrote the researchers from Yale, MIT, and Carnegie Mellon. They found that hospital costs also spiked for outpatient care, increasing 25 percent, versus 6 percent for doctors.

This meant that for a knee replacement costing $30,000 or so, the doctors’ mean price was almost $4,900, while the hospital price was almost $25,000. For a $13,000 C-section, the doctor’s mean price was $4,600, while the figure for hospitals was $8,300. These numbers were derived from analyzing hundreds of thousands of procedures.