Biomet is facing a new lawsuit alleging that its metal-on-metal hip implant is to blame for a New York woman’s injuries. The plaintiff is a 61-year-old woman who was implanted with the Biomet M2a Magnum Hip Replacement System in her right hip six years ago. As the name implies, the implant is a metal-on-metal hip device where all contacting surfaces are made of metal. The suit alleges that the all-metal design caused the plaintiff to suffer injuries and ultimately implant failure, forcing her to undergo revision surgery to remove the implant.
The plaintiff alleges that she suffered severe and constant pain, swelling, tissue damage, synovial fluid buildup, lack of mobility and metal poisoning (metallosis). As a result of these complications, the lawsuit alleges, the plaintiff had to undergo revision surgery to remove the implant. The suit alleges that these injuries caused the plaintiff emotional distress and loss of enjoyment of her life.
According to the lawsuit, the Biomet M2a Magnum Hip Replacement System is composed of all metal surfaces that can make contact with one another during patient movement. Other types of hip implants also contain metal components, but they are sometimes separated by a liner of polyethylene. This liner stops the metal from touching other metal surfaces.
The issue with metal-on-metal hip implants is that they can shed metal debris into the body if the surfaces of the implant rub together. If the metal particles leech into the nearby tissues, it can lead to a number of health problems and cause tissue death. The implant may become loose as a result. Other complications include swelling, inflammation and elevated levels of metal ions in the blood. Metallosis linked to hip implants is most commonly seen with high levels of cobalt and chromium.
According to the lawsuit, the M2a Magnum did not undergo rigorous clinical testing because it was approved through 510(k), a route that circumvents the need for testing if the manufacturer can show that the device is “substantially equivalent” to a previously approved device.