Adding to the constantly increasing number of legal claims regarding metal-on-metal hip implant systems, a New York man recently filed a lawsuit against Biomet Orthopedics over their Biomet M2a Magnum metal-on-metal hip implant.
Similar to other metal-on-metal devices, the Biomet system involved a metal ball component that fits into a metal socket or cup. The metal components differ from traditional hip replacement systems that typically use ceramic or plastic components. At one time praised for offering a more durable and long-term medical device for hip replacement patients, there is now increasing controversy over the safety and effectiveness of these systems. A growing body of research suggests that instead of being more durable, metal-on-metal systems actually exhibit a higher failure rate compared to other types of implants. For metal-on-metal systems, the rate is 6% within the first five years, compared to just 1.7%-2.3% for plastic and ceramic versions. For these patients, this means a revision surgery to replace or repair the faulty implant.
On top of the higher failure rates, the metal-on-metal systems also pose some serious risks to patients that receive them. Research has shown that the friction from the two metal components rubbing against each other releases small amounts of metal into the blood stream, which can lead to serious conditions such as cobalt poisoning. And research also shows a higher than acceptable prevalence of adverse local tissue reaction.
The lawsuit that was recently filed in New York touches on a number of issues. The plaintiff alleges that he received a Biomet M2a Magnum hip replacement and that the device’s defective design led to implant failure. This led to the need for a revision surgery, and countless months of pain and suffering, followed by more recovery time. The complaint additionally alleges a lack of testing prior to the device entering the market.
The FDA, in fact, has come under criticism for not doing enough to ensure patient safety and health related to the metal-on-metal devices. In light of these growing concerns, the FDA finally held an expert panel at the end of June to discuss the safety and continued use of metal-on-metal systems. The outcome of that panel discussion is not yet known, but it could play a key role going forward.