FDA Wants Review of All Metal-On-Metal Hips

The FDA has ordered a comprehensive review of all metal-on-metal artificial hips, irrespective of the model or the manufacturer. The order was communicated in an FDA letter sent this past Friday to all hip device manufacturers including Stryker, Johnson & Johnson’s Depuy Orthopaedics, Biomet and Wright Medical, according to the NY Times.
The broad study comes in the wake of mounting concern that the problems with metal-on-metal hip implants is not isolated to a particular design or a particular manufacturer. The FDA is concerned that the problem may be much wider spread than previously thought. In the FDA letter, hip device manufacturers were told the FDA was invoking a federal rule requiring postmarket studies of each metal-on-metal hip implant device. Some analysts believe that such a postmarket study reflects a failure on the part of the FDA for allowing such metal-on-metal hip implants move to market without rigorous premarket testing.
The FDA order compels manufacturers to test their hip device products as well as conduct an extensive study of patients who’ve received these metal-on-metal artificial hips. The manufacturers will have to submit failure rates for their hip devices as well.
The patient study will focus on whether patients have experienced hip failure as well as whether the artificial metal hips are shedding high levels of cobalt into the bloodstream which can lead to a condition known as metallosis. The FDA is requiring hip device companies to provide blood tests to hip implant patients in order to determine the level of metallic debris in their bloodstream.
The NY Times interviewed Dr. William H. Maisel, the deputy director for science at the FDA’s Center for Devices and Radiological Health. Maisel commented that “Our concern is the product, not about a manufacturer.” He acknowledged that the hip review is significant in that it marks the broadest review of any medical device after the device has already gone to market.
Until news of potential failure issues with the metal-on-metal hips began surfacing a few years ago, the metal hip devices had accounted for nearly one-third of the 250,000 hips implanted annually in the United States.
Unlike other countries, the United States has no medical device registry. This will make the FDA’s order more difficult for medical device manufacturers to track the hips and the patients who received them. The FDA has given the manufacturers 30 days in which to propose their review plan to the federal agency.
Some metal hips have been subject to scientific scrutiny as well as hip device lawsuits already. Johnson & Johnson’s subsidiary DePuy Orthopaedics is the subject of a class of lawsuits for which a multidistrict litigation has been formed in Ohio.
This past March, British Orthopaedic Association estimated that the DePuy ASR XL had a failure rate of 50% within the first six years of implantation. They also believe that other manufacturers of the metal-on-metal hip implants have a higher than expected and reported hip failure rate.
The metal-on-metal hip implants had been touted as an improvement over the older hip devices since they were purportedly able to offer more flexibility and resilience for those seeking to maintain an active lifestyle.