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To get drugs and devices out faster, the FDA lets companies conduct studies of safety or efficacy after the products are approved. In many cases, such “postmarket” studies are behind schedule or overdue, records show.
Whistleblower lawsuits alleged that Exactech covered up defects in knee implants while patient injuries mounted.
The company faces more than 2,000 lawsuits alleging it sold defective knee and hip implants.
ýҕl Health News and California Healthline staff made the rounds on national and local media in the last two weeks to discuss topical stories. Here’s a collection of their appearances.
The story of MitraClip, a device Dr. Oz helped invent to treat faulty heart valves, is a cautionary tale about the science, business, and regulation of medical technology.
A six-week abortion ban took effect in Florida this week, dramatically restricting access to the procedure not just in the nation’s third-most-populous state but across the South. Patients from states with even more restrictive bans had been flooding in since the overturn of Roe v. Wade in 2022. Meanwhile, the CEO of the health behemoth UnitedHealth Group appeared before committees in both the House and Senate, where lawmakers grilled him about the February cyberattack on subsidiary Change Healthcare and how its ramifications are being felt months later. Alice Miranda Ollstein of Politico, Sarah Karlin-Smith of the Pink Sheet, and Rachana Pradhan of ýҕl Health News join ýҕl Health News’ Julie Rovner to discuss these stories and more. Plus, for “extra credit,” the panelists suggest health policy stories they read this week they think you should read, too.
Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
Most of the doctors the FDA tapped to advise it on an Abbott medical device had financial ties to the company. The FDA didn’t disclose the payments.
The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.
Thousands of medical devices are sold, and even implanted, with no safety tests.
The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.
The FDA and the manufacturer were alerted to Profemur titanium hips breaking inside U.S. patients as of 2005. It took 15 years to recall the devices. Many fractures could have been avoided.
In a torrent of lawsuits, patients accuse Florida device maker Exactech of hiding knee and hip implant defects for years. The company denies the allegations.
ýҕl Health News and CBS News recently reported that multiple lawsuits allege the device has led to grievous injuries to patients’ mouths, resulting in loss of teeth.
U.S. airlines have response plans for passengers who run into health issues in flight, but planes carry limited and sometimes incomplete medical supplies that can put travelers at risk.
About 50% of the covid-19 patients who got the last-ditch life support treatment at Vanderbilt University Medical Center died. Researchers wanted to know what happened to the many patients they had to turn away because ECMO (extracorporeal membrane oxygenation) machines and the specialized staffers needed were in short supply. The grim answer: 90% of those turned away perished.
A 2017 law designed to help lower the cost of hearing aids mandated that federal officials set rules for a new class of devices consumers could buy without needing to see an audiologist. But those regulations are still on hold.
Millions of injuries and malfunctions once funneled into a hidden Food and Drug Administration database are now available.
Hospitals around the country are promoting free hernia screenings that tout their robotic surgery tools. But some experts warn such screenings could lead people to get potentially harmful operations that they don’t need.
An estimated 18 million American adults have sleep apnea. The go-to treatment — a CPAP machine — offers a healthy restful night’s sleep, but many people struggle to use it. As many as 50% of patients stop using the device.
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