FDA - Metallic Hip Implants Require Premarket Approval

93,000 of these devices have been recalled, reports plaintiffs lawyer Mark Cornwall in this advertisement.

One of the most grievous loopholes in the system for regulating medical devices is the minimal pre-market review requirements for devices that are "substantial equivalents" of devices available before the 1976 Medical Device Amendments.  Dramatically new devices - such as metal on metal hip implants escaped significant scrutiny.  That is about to change: such devices will now be subjected to rigorous premarket review according to a new proposed rule.  In a new safety alert the FDA has encouraged practitioners to report adverse events and has ordered device manufacturers to conduct post-market surveillance studies.

The move is in response to thousands of patient reports of complications from metal on metal implants, the FDA reports:

 In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can be released from other parts of the implant where two implant components connect.  Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. Soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause symptoms or illnesses elsewhere in the body. 

Postmarket Surveillance studies are part of what I have called the duty of product stewardship, and the Institute of Medicine in its 2006 report The Future of Drug Safety called a "life-cycle approach" to drug safety.  The heart of the approach is that a product manufacturer has an affirmative duty to monitor how its product actually performs after marketing permission is granted by the FDA.