The company faces more than 2,000 lawsuits alleging it sold defective knee and hip implants.
Category: Medical Devices
From Dr. Oz to Heart Valves: A Tiny Device Charted a Contentious Path Through the FDA
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.
KFF Health News’ ‘What the Health?’: Abortion Access Changing Again in Florida and Arizona
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 KFF Health News join KFF 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.
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
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.
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
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.
Ten Doctors on FDA Panel Reviewing Abbott Heart Device Had Financial Ties With Company
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.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
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.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
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.
Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records
Thousands of medical devices are sold, and even implanted, with no safety tests.
Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?
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.
