Fort Worth, Texas, March 30, 2012 –The Food and Drug Administration has responded to the continued concern of metal-on-metal hip implants by announcing a public meeting to discuss the safety and effectiveness of these 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. 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 (MoM) hip arthroplasty systems. 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 followup considerations for patients with MoM hip systems (total and resurfacing)” as noted in the announcement see on the FDA’s website.
The decision to hold a committee meeting comes almost a year after the FDA issued 145 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.
The FDA’s heightened scrutiny over metal-on-metal devices arose after DePuy Orthopaedics, Inc., subsidiary of healthcare giant Johnson & Johnson, recalled its metal-on-metal ASR XL Acetabular Hip System in the United States. The recall came after data from the National Joint Registry of England and Wales indicated that the five-year failure rate of these products is approximately 13 percent, or 1 in 8 patients. Symptoms include loss of vision, severe pain, implant loosening, implant dislocation, and toxic heavy metal poisoning. Since the recall in August of 2010, there has been heightened scrutiny over the materials used in replacement hips. DePuy has also faced scrutiny overanother one of its devices, the metal-on-metal Pinnacle Acetabular Cup System.
Parker McDonald currently represents over 250 clients who have received a DePuy ASR or Pinnacle metal-on-metal hip implant. The firm has established a website, www.hipimplantrecovery.com, to provide the latest information for concerned defective hip implant patients and their families.
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