“In light of the recent attention focused on metal-on-metal hip implants and the U.S. Food & Drug Administration’s (FDA) newly released safety communication, it’s not suprising that lawsuits concerning these products are growing,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm is currently offering free confidential legal reviews to individuals allegedly injured by the Biomet M2a Magnum Hip device.
Metal-on-Metal Hip Implant Lawsuits
Biomet M2a Magnum Hip Replacements are metal-on-metal hip implants, a class of device that is currently the subject of an FDA safety review. Plaintiffs in Biomet hip replacement lawsuits allege the all-metal design of the M2a Magnum can generate high levels of metal ions, leading to metallosis in the surrounding tissue and early failure of the device.
Metal-on-metal hip implants were approved under the FDA’s 510(k) approval process, which does not require a device to undergo human clinical trials. On January 17th, the FDA proposed an order requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval (PMA) applications, which would make them ineligible for 510(k) clearance. The agency has also recommended that doctors consider metal ion testing for all-metal hip replacement patients who are experiencing symptoms of a failing implant, including pain, swelling, loosening of the implant, or change in the ability to walk.