June FDA Meeting Will Review Safety Of Metal Hip Implants
The U.S. Food and Drug Administration (“FDA”) announced that a two-day expert review panel will convene in response to increasing concerns over metal hip implants. According to a March 29, 2012 Reuters article, the FDA meeting is set to take place on June 27-28. Scientists, researchers, patients and doctors will all weigh in on whether metal hip implants need new testing standards and review requirements before they receive market approval. “We are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations,” Dr. William Maisel, deputy director of science at FDA’s Center for Devices and Radiological Health stated.
The FDA meeting is set to convene in light of mounting evidence of metal hip implants’ high failure rates and dangerous side effects. In August 2010, Johnson & Johnson issued a recall of its ASR hip systems. However, other models of metal hip implants, such as DePuy’s Pinnacle metal-on-metal hip system, and the Wright Conserve hip replacement, have received similar adverse event reports, yet continue to remain on the market.
FDA Meeting Will Evaluate Problems Associated With Metal Hip Implants
The FDA meeting will focus on “failure rates, metal ion testing, imaging methods, patient risk factors, follow-up surgery and complications associated with metal-on-metal hip replacement and resurfacing systems,” according to Reuters. The announcement for the upcoming FDA meeting follows a series of events escalating the concern over the safety of metal hip implants, including:
- In August 2010, DePuy issued a worldwide voluntary recall of all variations of its ASR metal hip implants after receiving data from the National Joint Registry of England and Wales that showed that 1 out of every 8 patients (12%-13%) who received a DePuy metal-on-metal ASR hip implant had to undergo revision surgery within five years of implant. Approximately 93,000 patients worldwide were affected.
- In May 2011, the FDA ordered all medical device manufacturers of metal-on-metal hip implants to collect safety data.
- In January 2012, Johnson & Johnson announced it would take a $3 billion charge to cover the costs associated with the ASR recall.
Problems With Metal Hip Implants Lead To Hip Replacement Lawsuits
Patients who are suffering from hip replacement failure or other serious side effects are now filing lawsuits to seek compensation for their injuries. If you received a metal hip implant from DePuy or Wright, you may be entitled to compensation for your lost wages, medical expenses, and pain and suffering. Contact a Bernstein Liebhard LLP lawyer today to learn about your legal rights and options.