Concerned with the growing number of reports and studies linking metal-on-metal hip implants with serious health problems, including cobalt poisoning and metallosis, the U.S. Food & Drug Administration (FDA) announced yesterday that it would convene an advisory panel meeting in June to discuss the safety of all-metal hip replacement devices. The FDA’s Orthopaedic and Rehabilitation Devices Panel will meet over June 27 and 28 to discuss the risks and benefits of metal-on-metal hip systems, as well as potential patient and practitioner recommendations for their use.
“We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations to patients and their health care providers,” William Maisel, M.D., M.P.H., deputy director of science at FDA’s Center for Devices and Radiological Health (CDRH), said in a statement from the agency.
Concerns about metal-on-metal hip implants started to mount in 2010, when DePuy Orthopaedics issued a recall of its ASR hip implants, following findings that they were failing in about 12 percent of patients within five years. Last May, the FDA directed 21 companies that market all-metal hip replacement to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. Earlier this month, authors of a study published in The Lancet said all-metal hip implants should no longer be used because of their high failure rates. In February, a report in the British Medical Journal raised fears that hundreds of thousands of people around the world may have been exposed to dangerously high levels of toxic metals from failing metal-on-metal hip implants,
According to the FDA, June’s advisory panel meeting will look at metal-on-metal hip implants used in total hip replacement surgeries, as well as hip resurfacing. The panel will discuss:
• Failure rates and modes
• Metal ion testing
• Imaging methods
• Local and systemic complications
• Patient risk factors
• Considerations for follow-up after surgery.
The panel could vote to recommend that the FDA impose new testing standards and review requirements to be met before an all-metal hip implant device can be sold in the United States. The FDA is not legally obligated to follow the recommendations of its advisory panels, but usually does so.
Since the DePuy ASR hip implant recall, DePuy and other manufacturers have been named in lawsuits over their metal-on-metal hip replacement devices. Thousands of DePuy ASR hip implant lawsuits have been consolidated in federal court in Ohio. In February, a multidistrict litigation was established in the U.S. District Court for the Northern District of Georgia for lawsuits involving the all-metal Wright Conserve Hip Replacement System. Claims involving a metal-on-metal version of DePuy’s Pinnacle hip implant have been consolidated in a multidistrict litigation in Texas. Several lawsuits are also pending in the U.S. over Biomet metal-on-metal hip implants.