FDA Convenes Expert Panel to Discuss Metal-on-Metal Hip Replacement Systems
Metal-on-metal hip replacement systems have come under close scrutiny in the last couple of years, as new studies have shown increased risks and failure rates for patients who receive these systems. And as those hip implants fail or cause serious complications for patients, the FDA has taken its fair share of criticism for insufficient regulatory oversight. But finally, at the end of June, the agency held a two-day expert panel session to discuss these medical devices and their continued use.
According to background information provided in anticipation of the meeting, metal-on-metal hip replacement devices have been marketed in the United States for several decades, but really gained popularity in around 2006 and 2007, when they peaked at about 30% of the market. But with that widespread use, there was also a spike in adverse events being reported on the device. Nearly 16,800 adverse events reports were made to the FDA between 2000 and 2011. And of the 12, 137 incident reports filed with the FDA in 2011, 74% were related to one specific hip replacement system: the DePuy implant.
These reports, combined with multiple research studies showing high failure rates and complications such as metallosis or cobalt poisoning, led to two voluntary recalls in the United States by DePuy and Zimmer. But other products made by Biomet, Encore Medical and Wright Medical Technology remain on the market. The expert panel that was convened in June was asked to will be asked to discuss: Device mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical follow-up considerations for patients with Metal-on-metal hip systems.
The outcome of the expert panel could prove to be a crucial step for patient safety, helping to ensure greater patient awareness of the risks and benefits of metal-on-metal devices, while also providing clearer guidelines for monitoring and treatment of complications.