The Food and Drug Administration (FDA) has responded to the continued concern of Metal-on-Metal hip implants by announcing a public meeting to discuss the safety and effectiveness of Metal-on-Metal hip implant devices.
On June 27 and 28, 2012, the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee, which is part of the FDA, will meet to discuss Metal-on-Metal hip implants and consider whether more rigorous testing standards are needed. According to the meeting announcement on the FDA’s website, the committee “will discuss current knowledge about the safety and effectiveness of Metal-on-Metal hip arthroplasty systems. The FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.” The FDA will allow public comments on the issues to be submitted by May 9, 2012.
The FDA’s meeting will revolve around “…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 (total and resurfacing)” as noted in the announcement.
The decision to hold a committee meeting comes nearly a year after the FDA issued approximately 150 orders for post market surveillance studies to 21 manufacturers of metal-on-metal hip systems, including Zimmer Holdings, DePuy, Wright Medical, Biomet, and Smith & Nephew.
Metal-on-Metal hip replacement systems have been under scrutiny due to numerous reports of pain and swelling that have all too often required revision surgery. In 2010, Johnson & Johnson recalled roughly 93,000 implants. The FDA has already asked device companies to conduct additional follow-up studies to monitor problems with the implants. The FDA stated that they are concerned about potential problems with the device, including loosening, adverse local tissue reactions, and increased metal ion concentrations in the blood.
If you or a loved one have a hip 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.