A South Carolina woman has filed a lawsuit alleging that the Biomet M2a Magnum metal-on-metal hip replacement system implanted in both her hips is defective and that it caused pain and other injuries, requiring revision surgery to remove and replace the left hip device.
According to the complaint, the patient received bilateral hip implants using Biomet’s M2a Magnum Hip System, which has an all-metal ball-and-socket design. The complaint describes a variety of symptoms she suffered including severe groin pain, discomfort, soft tissue reactions, and elevated metal ion levels in her blood. She underwent revision surgery to remove and replace the failed left hip.
By the time the patient received the Biomet devices, the lawsuit alleges, the defendants were aware of more than 100 adverse event reports associated with the device filed with the U.S. Food and Drug Administration (FDA), but they did not share this information with the her. Instead, the manufacturers misrepresented the implant as being safe and effective.
The complaint explains that revision surgery is often more expensive, more painful, and riskier than the original surgery because of bone loss and tissue damage. Revision surgeries typically require longer recovery time and can result in increased complications and possibly greater need for ongoing medical care.
The FDA has placed the entire class of metal-on-metal medical devices under increased scrutiny because of reports of high failure rates and reports that the devices can cause elevated levels of metallic debris to be released into patients’ bloodstreams. Earlier this year the agency released new monitoring guidelines for patients with all-metal devices, advising symptomatic patients to undergo regular physical examinations, diagnostic imaging, and metal ion testing.
The Canadian Institute for Health Information (CIHC) said that people implanted with certain types of metal-on-metal hip devices (like the Biomet M2a) have a 5.9 percent chance of requiring revision surgery within the first five years of implantation, compared with a 2.7 percent chance for patients receiving the most common type of metal-on-plastic implant, according to a June report on CBC News.
This case is part of a multidistrict litigation (MDL), In re: Biomet M2a Magnum Hip Implants Products Liability Litigation (MDL No. 3:12-md-2391). National law firm Parker Waichman LLP filed the lawsuit on November 6, 2013 in the U.S. District Court for the Northern District of Indiana, South Bend Division (Case No. 3:13-cv-011665). Biomet, Inc. and Biomet Orthopedics, LLC are named as defendants.