Much Anticipated FDA Meeting on Metal-on-Metal Hip Implant Safety Kicks Off TomorrowJun 26, 2012 | Parker Waichman LLP
A panel being convened tomorrow by the U.S. Food & Drug Administration (FDA) will spend the two days examining the safety of metal-on-metal hip implants. The meeting comes as the agency reveals that metal-on-metal hip replacement systems have been associated with a stunning 16,800 adverse event reports over the last decade.
According to a report from Bloomberg News, most of those reports came after the 2010 worldwide recall of DePuy Orthopaedics' ASR hip implant systems. To put into perspective how badly metal-on-metal hip implant devices are performing, a total of 12,137 complaints related to all-metal hip systems were made to the FDA in 2011, compared with only 6,332 associated with other types of hip replacement products. Between 2000 and 2011, the vast majority of metal-on-metal hip implant complaints - over 14,000 - involved revision surgeries to remove a failing hip implant.
According to a report issued in advance of this week’s Orthopaedic and Rehabilitation Devices meeting, FDA staff acknowledged that data from orthopedic implant registries as well as peer-reviewed journal publications and presentations at scientific meetings have suggested increases in potential safety issues associated with metal-on-metal hips, including:
• Local complications such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions
• Early device failure and the need for revision surgery
• Systemic complications from metal ion exposure
The FDA will ask the advisory panel to consider whether blood tests, medical imaging and laboratory tests should be considered for metal-on-metal hip implant patients. Regulators in other countries, including the U.K. and Canada, have already issued such guidance to patients and doctors, but the FDA is lagging behind. Many patient advocates are hoping that the recommendations issued by the agency's advisors will finally prompt the FDA to take definitive action.
Some experts, however, aren't waiting on the FDA, and have reached their own conclusions about metal-on-metal hip implants.
"In my personal opinion there is very little room, if any, for metal-on-metal implants because the alternatives we have on the market are likely safer and as effective," Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York, recently told the Associated Press.