FDA Panel Meets Today to Address Mounting Problems with Metal-on-Metal Hip ReplacementsJun 27, 2012 | Parker Waichman LLP
A growing body of evidence from around the world indicates that metal-on-metal hip implants are more likely to fail than hip replacement devices made from plastic or ceramic, according to a new report from the U.S. Food & Drug Administration (FDA). Metal-on-metal hip devices have been implanted in an estimated 500,000 Americans, largely due to the belief that they would last longer than those made from other materials.
As we've reported previously, concerns about all-metal hip implants started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip devices after it was found that they were failing in about 12 percent of patients within just five years of implantation. The FDA began studying all-metal hip implants shortly after the DePuy ASR hip implant recall to determine if the devices are shedding dangerous levels of metal ions into patients’ surrounding tissue and blood streams.
Today marks the beginning of a two-day meeting of the FDA's Orthopaedic and Rehabilitation Devices Panel, which has been asked by the agency to make recommendations for follow-up of patients with metal-on-metal hip implants. According to a Reuters report, the advisors won't address the possibility of imposing more rigorous testing standards on companies who already make the devices, nor will they be asked for guidance on changing review requirements for bringing all-metal hip implants to market. As we've reported previously, metal-on-metal hip implants were cleared under the FDA's 510(k) process, which doesn't require human testing. Critics of the agency contend that the lack of human tests allowed dangerous all-metal hip implants to harm thousands of people.
Last week, the FDA revealed that it had received 16,800 negative event reports involving metal hips between 2000 and 2011. Of those, more than 14,000 involved revision surgeries, in which a defective implant was removed. Regulators in the U.K. and Canada have already issued guidance to help doctors and patients deal with complications from metal-on-metal hip implants, but the FDA has not issued any firm recommendations of its own for monitoring patients with the devices. While this week's advisory panel meeting will likely lead to new guidance, the FDA has already made it clear that there are no plans to ban the use of metal-on-metal hip replacements, according to a report from USA Today.