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KHN filed multiple Freedom of Information Act requests over months, and the FDA responded Wednesday saying the data about device malfunctions is now publicly available online.
The Food and Drug Administration released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices. Here鈥檚 what we鈥檝e learned so far.
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren鈥檛 reported through its traditional public reporting system.
The Food and Drug Administration allowed one company to send 50,000 reports of harm or malfunctions to an internal database even as patients worried about faulty defibrillators lodged in their hearts.
In the wake of a KHN investigation, the agency will no longer let device makers file reports of harm outside a widely used public database.
KHN ethnic media editor Paula Andalo appeared on Telemundo, where she offered advice about how to avoid overpaying for medical equipment you may not need.
Kaiser Health News gives readers a chance to comment on a recent batch of stories.
In the wake of a KHN investigation, Scott Gottlieb says releasing the records is in the public interest.
For almost two decades, device makers have sent reports of incidents to databases hidden from public view.
The FDA said it might reclassify the widely used devices featured in a recent Kaiser Health News investigation.
The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, leaving doctors and medical sleuths in the dark.
High-profile failures of implantable medical devices 鈥 such as certain hip joints and pelvic mesh 鈥 have prompted the Food and Drug Administration to revise its assessment process.
Democratic governors and mayors are unveiling new ideas to control costs and expand coverage. The federal government shutdown has spared most health agencies, but not all. And learn the latest on that lawsuit out of Texas, which is threatening the Affordable Care Act once again. Margot Sanger-Katz of The New York Times, Anna Edney of Bloomberg News and Rebecca Adams of CQ Roll Call join KHN鈥檚 Julie Rovner to discuss these issues and, for 鈥渆xtra credit,鈥 provide their favorite health policy stories of the week. Rovner also interviews KHN鈥檚 Jordan Rau about the latest 鈥淏ill of the Month.鈥
Ski buff Sarah Witter will get $6,358.26 back from her hospital and insurer after a careful review of her bill following the KHN-NPR story on her case.
She took a bad fall on the slopes and her surgeon used a metal plate to put the splintered bones of her leg back together. When that device failed less than four months later, she and her insurer had to pay full price for the replacement plate.
Breast implants 鈥 used for both cancer and cosmetic surgeries 鈥 give a glimpse into how hospitals mark up prices of medical devices to increase their bottom lines.
Do sales reps in the operating room lend helpful expertise or inflate already bloated costs? Depends on whom you ask.
In this episode of KHN鈥檚 鈥淲hat the Health?鈥 Mary Agnes Carey of Kaiser Health News, Margot Sanger-Katz of The New York Times, Alice Ollstein of Politico and Anna Edney of Bloomberg News discuss the impact of House Democratic leadership elections and their impact on health policy; as well as efforts by the Trump administration to address high drug prices and ensure the safety of medical devices. Plus, Julie Rovner interviews KHN鈥檚 Jay Hancock about the latest 鈥淏ill of the Month.鈥
Medicare limits payments for valve replacement via a catheter to hospitals with large numbers of heart procedures. But smaller facilities are crying foul.
A new study in JAMA Surgery finds that a large sample of published medical research failed to disclose details on the financial relationships between medical device makers and physicians. Changes in the disclosure process could close this loop.
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