On March 29, 2012, the FDA announced that it will convene the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to discuss the risks and benefits of Metal-on-Metal (MoM) hip systems. The FDA asked outside scientific and medical experts to discuss recent information on these metal-on-metal hip devices so that the Agency can continue to make reliable safety recommendations to patients and their health care providers.
On Wednesday and Thursday of this week, the committee will discuss current knowledge about the safety and effectiveness of MoM hip arthroplasty systems. The FDA will ask a panel of experts to recommend the best practices for monitoring patients with the devices. Panelists will consider blood tests, medical imaging and laboratory tests. Some orthopedic specialists say they have already reached their own conclusions about metal hips: “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,” said Dr. Art Sedrakyan, professor of public health at Weill Cornell Medical College in New York.
According to the FDA’s website, a recent scientific publication raised serious concerns about the failure rates of MoM hip systems for the UK population. This peer-reviewed journal article presented the following findings regarding primary MoM total hip arthroplasty: (1) increased failure rate at 5 years for MoM total hip arthroplasty related to larger head sizes; (2) significantly higher risk for revision in female patients (in the United States, labeling discourages use of MoM hips in females of child bearing age with warnings in MoM total hip arthroplasty labeling and contraindications in MoM hip resurfacing labeling); and (3) revisions for dislocation in men with MoM replacements were slightly lower, showing some benefit to larger head sizes.
Attorneys at Pope, McGlamry will be watching the FDA’s meeting closely and will provide updates on any findings following the hearing.
Attorneys at Pope, McGlamry are currently filing lawsuits on behalf of Plaintiffs injured by defective metal-on-metal hip implants. If you or a loved one have a DePuy ASR, DePuy Pinnacle, Biomet or Wright Conserve metal-on-metal hip implant, or any other metal-on-metal implant, and have suffered complications, or experienced a hip replacement failure requiring revision surgery, you may be entitled to recover significant damages from the defective product manufacturer. The lawyers at Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C., are actively handling claims for you injury and loss.