A recently filed lawsuit in a Nevada federal courtroom claims the Biomet M2a Magnum metal-on-metal Hip System is defective and has a high early failure rate and these causes led to serious and debilitating injuries for yet another recipient.
The national law firm of Parker Waichman LLP announced this week that they have filed a lawsuit in U.S. District Court for the District of Nevada against Biomet Inc., and other companies associated with the Biomet M2a Magnum metal-on-metal Hip System. The lawsuit claims Biomet and its subsidiaries did little to test the safety of this metal-on-metal implant device and continually marketed it as safe and effective.
The woman represented by Parker Waichman’s latest lawsuit against the makers of a metal-on-metal hip implant claims she has twice suffered failures of her Biomet M2a Magnum Hip System. This has resulted in two costly and more painful revision surgeries and the time associated with recovering from those procedures.
She originally received the Biomet M2a Magnum Hip System on her left hip during a December 2005 procedure to replace her failing natural hip. At some point soon after that surgery, the woman began experiencing complications common among metal-on-metal hip implants, like pain and inflammation at the site of the surgery, and was forced to endure the first of two revision surgeries. This procedure would replace the original device with a new M2a Magnum Hip System. Similar complications occurred and each revision surgery put her at greater risk of serious injuries and never regaining full mobility again.
At the time of the first surgery in 2005, the Food and Drug Administration had received more than 100 adverse event reports associated with the M2a Magnum Hip System. Despite that and the belief that Biomet hid safety data which showed these hip implants were likely to suffer from a high early failure rate, the woman and her surgeon were never properly warned of the dangers, leading them both to believe it was a safe option.
This lawsuit is just one of expected thousands of claims that metal-on-metal hip implants – this one specifically and numerous others using the same technology – are flawed in design and prone to early failures and a link to serious injuries and increased medical costs and unnecessary surgeries.
Metal-on-metal hip implants were designed for a younger recipient and touted as having a longer life than traditional implants. Many of the devices were passed through the FDA’s 510(k) “fast-track” approval system and could reach prospective recipients without undergoing any rigorous pre-market testing. These implants have been prone to early failures – close to 13 percent for some – and been linked to a dangerous accumulation of toxic metals cobalt and chromium caused by tiny metal particles being shed from implants during normal use of the hip.
Since they’ve been approved for use, the FDA has since backed off its full support of metal-on-metal hip implants and recently concluded a conference aimed at determining the best course of action for people who still rely on these devices but may not have experienced complications that, as a whole, the metal-on-metal hip implant does not provide a clear clinical benefit over previous technologies.
The agency has also asked several makers of metal-on-metal hip implants to conduct post-market safety testing and evaluations on their devices to help it determine the viability of them in the future.