FDA Panel on Metal-on-Metal Hip Implant Safety Could Boost Lawsuit ClaimsApr 10, 2012 | Parker Waichman LLP
A meeting of outside experts scheduled for June by the U.S. Food & Drug Administration (FDA) on the safety of metal-on-metal hip implants could lead to tighter controls on the devices. Depending on the panel's findings, plaintiffs who have filed personal injury lawsuits against the makers of metal-on-metal hip implants, including DePuy Orthopaedics, Biomet and Wright Medical, could get a boost to their cases.
According to an announcement posted last month on the FDA website, the agency's Orthopaedic and Rehabilitation Devices Panel will meet over June 27 and 28 to discuss the risks and benefits of metal-on-metal hip replacement devices used in total hip replacement surgeries, as well as hip resurfacing. Failure rates and modes; metal ion testing; imaging methods; local and systemic complications; patient risk factors; and considerations for follow-up after surgery.
Metal-on-metal hip implants have sparked concerns that they could be leaching dangerous amounts of metal ions into this tissue and blood streams of recipients. This can lead to early failure of the implant, as well as damage to tissue and organs. In February, a report in the British Medical Journal raised fears that hundreds of thousands of people around the world may have been exposed to dangerously high levels of toxic metals from failing metal-on-metal hip implants. Last month, authors of a study published in The Lancet said all-metal hip implants should no longer be used because of their high failure rates.
The FDA had already directed 21 companies that market all-metal hip replacement to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. The recommendations made by its advisory panel in June could lead to new testing standards and review requirements to be met before an all-metal hip implant device can be approved by the FDA.
It’s likely that alleged victims of metal-on-metal hip implants, as well as their lawyers, will be watching the FDA proceedings closely. If the panel finds that metal-on-metal hip implants are more dangerous than other varieties, people suing the makers of all-metal hip replacement could find they have stronger cases.