Last month’s announcement by the U.S. Food & Drug Administration (FDA) that it would convene a panel of outside medical experts to evaluate the safety of metal-on-metal hip implants may signal that the agency is preparing to subject the controversial devices to stricter regulation. According to a report from Reuters, the FDA panel’s findings could also impact the thousands of product liability lawsuits currently filed against the makers of metal-on-metal hip replacement devices.
In May of last year, the FDA asked 21 makers of metal-on-metal hip implants to conduct safety studies of their devices. The FDA order followed the August 2010 recall of DePuy Orthopaedics’ ASR hip implants, after they were failing in about 12 percent of patients within five years. Since then, a number of studies have continued to raise frightening questions about the health consequences posed by metal-on-metal hip implants that may shed dangerous amounts of metal debris into surrounding tissue, and even a patient’s blood stream. This can result in a condition called metallosis, which causes the death of tissue around the implant, including bone and muscle. Metal ions can also cause irreversible damage to DNA in cells, and have been found in many organs following hip replacements, including marrow, blood, liver, kidneys and bladder.
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. 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.
The FDA announced late last month that its Orthopaedic and Rehabilitation Devices Panel will meet over June 27 and 28 to discuss the risks and benefits of metal-on-metal hip systems, as well as potential patient and practitioner recommendations for their use. According to the agency, the panel will discuss:
• Failure rates and modes of metal-on-metal hip implants
• Metal ion testing for metal-on-metal hip implant recipients
• Imaging methods
• Local and systemic complications
• Patient risk factors
• Considerations for follow-up after surgery
The panel’s recommendation 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.
The controversy surrounding metal-on-metal hip implants has sparked thousands of lawsuits against DePuy and other manufacturers. DePuy ASR hip implant lawsuits have been consolidated in federal court in Ohio. In February, a multidistrict litigation was established in the U.S. District Court for the Northern District of Georgia for lawsuits involving the all-metal Wright Conserve Hip Replacement System. Claims involving a metal-on-metal version of DePuy’s Pinnacle hip implant have been consolidated in a multidistrict litigation in Texas. Several lawsuits are also pending in the U.S. over Biomet metal-on-metal hip implants.
According to Reuters, the expert opinions of the FDA panel members and more data on metal-on-metal hip implant failures could go a long way to strengthen plaintiffs’ claims. Such individuals should stay updated on the FDA metal hip investigation and keep in touch with a products liability attorney, Reuters said.