New Lawsuit against Biomet for Faulty Metal on Metal Hip ImplantAug 26, 2016
A woman from New York had a Biomet M2a Magnum Hip Replacement System implanted six years ago. The 61-year-old has filed a lawsuit against the manufacturer alleging the device has caused her severe injury.
As a result of her hip surgery, the woman has experienced constant pain and suffering, swelling, tissue damage, synovial fluid buildup, lack of mobility, and metal poisoning (metallosis). Metallosis is caused by elevated levels of metal in the body, such as cobalt and chromium which can lead to systemic effects. These effects can cause endocrine disruption and organ damage. She had revision surgery to replace the allegedly defective medical device with a new hip implant.
Biomet's M2a Magnum Hip Replacement System is a class III medical device. Generally class III medical devices are required to pass rigorous testing before they can be released on the market. However, a manufacturer may bypass stringent premarket approval if the device is "substantially equivalent" to a similar device that has already been approved. As a result, , Biomet manufactured, marketed and sold its device with "virtually no clinical or non-clinical trials or U.S. Food and Drug Administration (FDA) review of the hip replacement System for safety and effectiveness," according to the lawsuit.
The Biomet System is made with metal parts that touch, unlike other hip implants that are separated by a liner that is usually made of polyethylene. The liner stops the metal pieces from actually touching during normal movement of the ball and socket, where small flakes of metal can shed from the device. The metal debris can then cause the side effects, as in the case of the aforementioned patient. If the metal gets into the surrounding tissue, it may cause necrosis, or death, of the tissue. This can cause the device to loosen, which can cause swelling and inflammation.
The patient who filed the suit against Biomet alleges negligence, product liability, fraudulent concealment, and false advertising, among other allegations.