An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker Waichman LLP, comments made by the DePuy official were in conflict with the way most metal-on-metal hips have been cleared for sale by the U.S. Food & Drug Administration (FDA).
During a two-day meeting convened last week by the FDA to discuss the safety of metal-on-metal hip replacement devices, Paul Voorhorst, the director for biostatistics and data management for DePuy Orthopaedics, urged FDA advisors not to treat all metal-on-metal implants in the same fashion. Voorhorst asserted that the clinical performance of each device should be evaluated on its own merits.
“It is ironic that when they file with the FDA for a 510k, fast-track approval, the manufacturers claim their new metal-on-metal hip implant is substantially similar to others on the market,” Mr. Burke said in a statement issued by Parker Waichman LLP. “Now they say metal-on-metal hips should be individually evaluated when it comes to failures, without having subjected their own devices to more stringent analysis during the approval process.”
According to the law firm’s statement, the majority of metal-on-metal hip replacement devices used in total hip replacements were cleared for sale through the FDA’s 510(k) protocols, which allows manufacturers to forgo human testing if they can show a device is similar to a predicate product that has already been brought to market. Mr. Burke believes that had metal-on-metal hip implants been subjected to more stringent premarket scrutiny, their safety issues may have been detected and their sales prevented.
According to Parker Waichman LLP, the firm is representing scores of people who claim they were injured by defective all-metal hip replacement devices, including DePuy Orthopedics’ recalled ASR hip implants, as well as an all-metal version of the company’s Pinnacle hip implant. Parker Waichman also recently filed several lawsuits on behalf of people allegedly injured by metal-on-metal hip implants manufactured by Biomet Orthopedics.
In addition to Biomet and DePuy, metal-on-metal hip implants have also been brought to market by numerous other firms, including Zimmer Holdings Inc., Smith & Nephew PLC, and Encore Medical L.P.
During last week’s two-day meeting, FDA advisors on the agency’s Orthopaedic and Rehabilitation Devices Panel recommended that patients with metal-on-metal hip implants be monitored, including regular X-rays and blood testing for metal levels for patients complaining of pain and other symptoms. Annual X-rays were recommended for patients not experiencing symptoms. The advisors also recommended including label warnings about pseudotumors and high levels of metal ions in patients’ blood. Finally, they called for a warning stating that metal-on-metal hip implant recipients are more sensitive to the devices’ positioning than patients with other types.
During their two day meeting, some experts on the FDA panel questioned why all-metal implants would ever be used, considering their poor track record of safety.
As we’ve reported previously, it was thought that metal-on-metal hip implants would be superior to devices made from plastic or ceramic when they were first brought to market about a decade ago. But since the August 2012 worldwide recall of DePuy Orthopaedics ASR hip implant devices, it’s become increasingly clear that all-metal hip implant’s haven’t been living up to their promise. Patients have increasingly complained of pain and early implant failures, while a number of studies have pointed to significant problems with metal-on-metal hip implants. Last week, the FDA revealed that it had received 16,800 negative event reports involving metal hips between 2000 and 2011. Of those, more than 14,000 involved revision surgeries, in which a defective implant was removed.