December 5, 2012 — About 15 years after Tony R. Bishop fell off a horse and suffered hip injuries, he was implanted with the Biomet M2A Magnum hip replacement.
Recently, the South Carolina man filed a lawsuit alleging that the hip implant is defective because the metal-on-metal parts can grind together, shed toxic nano-particles, and require risky revision surgery. He joins a growing federal litigation against the manufacturer that includes at least 70 other lawsuits.
Bishop, a 41 year-old former janitor, received the metal hip implant in October 2006. Soon afterward, the metal-on-metal implant shed particles of cobalt and chromium into his body. The metal debris has been linked to many complications, including tissue damage, bone loss, severe pain, dislocation of the hip implant, and unknown long-term risks.
Bishop underwent a 4-hour revision surgery to remove the defective hip implant and re-implant another hip implant. Revision surgery for defective hip implants often involves re-driving a femoral stem, which can be very traumatic, painful, and debilitating.
The lawsuit alleges that Bishop is unable to work due to the long-term complications linked to the Biomet hip implant. It also alleges that Biomet concealed the serious complications and “bad data” associated with the hip implant.
Like most metal-on-metal hip implants, the Biomet was approved under the U.S. Food and Drug Administration (FDA) 510(k) approval process, which allows new devices that are similar to existing devices to enter the U.S. market without conducting new safety studies.
Since the FDA approved the Biomet M2A, the lawsuit alleges that the FDA has received more than 350 reports of adverse events. The FDA has required manufacturers to conduct post-market surveillance studies, including reports of metal poisoning related to cobalt and chromium debris.
A federal judicial panel centralized lawsuits involving the Biomet M2A Magnum hip implant in October 2012 in the U.S. District Court for the Northern District of Indiana, where Biomet is headquartered.