FORT WORTH, Texas, June 28, 2012 – Yesterday, the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration began a two-day public hearing to discuss the current issues surrounding the safety and effectiveness of metal-on-metal hip implant systems. According to the meeting announcement on the FDA’s website, the committee will “seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.”
Among the topics of discussion are “…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 MoM hip systems (total and resurfacing).”
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 over another one of its devices, the metal-on-metal Pinnacle Acetabular Cup System.
In May of last year, in response to the recent concerns surrounding MoM hip implants, the FDA issued 145 orders for postmarket surveillance studies to 21 manufacturers of metal-on-metal hip systems. According to a recent New York Times article, “one of the biggest problems with metal hips is detecting whether the metallic debris generated by an implant is damaging a patient’s tissue or muscle or how to best monitor for such problems.”
In the same New York Times article Dr. Malchau of Massachusetts General said, “…future patients need to better protect themselves by demanding their surgeon provide data showing that the implant they are recommending has a long, proven track record.”
Parker McDonald currently represents over 400 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.
About Parker McDonald
Parker McDonald, P.C. offers comprehensive legal services for clients whose personal, business or property rights have been adversely affected. Built on years of trial experience, Parker McDonald lawyers are dedicated to a tradition of personal service and timely delivery of outstanding results. Parker McDonald has offices in Bedford, Fort Worth, Houston, Austin, and San Antonio.