Metal On Metal Hip Implant FDA Order

New FDA Proposed Order Will Take Metal on Metal Hips Off the Market
The FDA released a proposed Order today that will likely remove most metal on metal hips from the marketplace. Metal on metal hips had been grandfathered in and allowed to be sold for a decade because they were similar to polymer hips and ceramic hips.
Today’s proposed FDA Order, if finally approved, will require that “anyone who wishes to continue to market the device” (metal on metal hip) will have to submit an application for Premarket Approval called a PMA. A PMA application requires very expensive clinical studies that the manufacturers are unlikely to spend the money to complete. The metal on metal hip manufacturers are unlikely to spend the money for the PMA studies because it is unlikely that a PMA for a metal hip implant would ever be approved. There is enough evidence out there already that these hips are failing at a high rate to indicate that they are not safe or effective.
The hip implant products affected by this proposed Order are: the Biomet Magnum, the DePuy Pinnacle, the Wright Profemur Conserve, the Wright Dynasty, the Wright Linaege, the Zimmer Trabeculer, and the Encore. These products are currently on the market.
The DePuy ASR and the Smith & Nephew R3 have already been recalled. The Smith and Nephew Birmingham hip, the BHR, which is a resurfacing device has already received a PMA approval and will likely stay on the market.
Today’s action by the FDA is a step forward in patient safety and an acknowledgement that these metal on metal hips should never have been placed on the market without an adequate study of the dangers of cobalt and chromium in the blood.