December 5, 2012 — A man from South Carolina has filed a federal lawsuit alleging that the Biomet M2A hip replacement is defective. Tony R. Bishop received the implant in October 2006, about 15 years after he fell off a horse and suffered hip injuries. Soon afterward, the metal-on-metal hip implant began shedding particles of chromium and cobalt into his body, causing severe side effects that eventually required a risky revision surgery.
In recent years, several types of metal-on-metal hip implants have been recalled, and hundreds of lawsuits have been filed against the manufacturers. The problem is that the metal parts grind together during normal use, shedding tiny particles of chromium and cobalt into nearby tissues. Acute complications include inflammation, pain, tissue damage, bone loss, dislocation of the hip, and the formation of soft-tissue pseudotumors. Long-term complications are unknown.
Bishop had the hip implant removed in a 4-hour revision surgery. This type of surgery is often very painful, debilitating, and traumatic for the hip. The femoral stem is usually removed, and another stem is re-driven into the bone. There is a risk of fracture and long-term complications.
Bishop alleges that he is unable to continue working as a janitor due to his injuries. The lawsuit also alleges that Biomet, the manufacturer of the M2A Magnum, concealed “bad data” and serious complications linked to the implant.
These complications might have been noticed if the manufacturer had conducted safety studies. The M2A Magnum, like most metal-on-metal hip implants, was approved by the U.S. Food and Drug Administration (FDA) under the 510(k) system. This allows new medical devices that are “substantially equivalent” to existing devices to enter the U.S. market without requiring new studies.
Unfortunately, since the M2A Magnum was approved, the FDA has received at least 350 complaints and many lawsuits have been filed. In October 2012, about 70 lawsuits were centralized in a Multi-District Litigation (MDL) located in the U.S. District Court for the Northern District of Indiana, near the headquarters of Biomet.