The FDA has been criticized for approving medical devices through the 510K (fast track) approval requiring no clinical trials. But there’s another way-read on.
Our mission: ask a large gathering of orthopedic surgeons how long hip and knee implants should be warrantied.
A report showing a heart pump, the HeartMate II, increases blood clots raises questions about whether clinical trials should go forward, possibly risking participants lives.
The publicly funded National Health Service bans metal-on-metal hips.
Johnson & Johnson Settlement Resolves Metal Hip Lawsuits But Weak Oversight Of Medical Device Industry Leaves Patients Vulnerable
Consumers Union Calls for Stricter Safety Testing & Warranties for Implants.
41 Action News found more than 838 adverse reactions reported to the FDA from both patients and doctors.
The Minneapolis Star Tribune reports on the trend of younger patients getting implantable medical devices. From 2000 to 2010, the percentage of medical devices – hips, knees, pacemakers and defibrillators – going into middle-age and younger patients has grown dramatically. Consumers Union’s Safe Patient Project Director Lisa McGiffert quoted.
“it is not uncommon for a newly-named pacemaker or defibrillator to add several thousand dollars to the health care system over last year’s device yet they may add only minor advances over the prior year’s model.”