An Oregon woman claiming her Biomet Orthopedics M2a Magnum Hip Implant System is defective has become the latest to file a lawsuit against the maker of a metal-on-metal hip implant.
The woman is being represented by the national law firm of Parker Waichman LLP. The firm represents numerous victims of defective metal-on-metal hip implants. This lawsuit has been filed by the fir in U.S. District Court for the Northern District of California.
According to a release from the firm announcing the filing of the lawsuit on July 2 in federal court, the Portland, Ore., woman received the Biomet M2a Magnum Hip system during a procedure in April 2008. Just more than two years later, the woman found herself back on the surgeon’s table to have it removed after it had failed. She, like more than 100 others across the country, believes the M2a Magnum hip implant has a defective design which causes it to fail much sooner than traditional hip implants and long before it was promoted to have lasted.
All-metal hip implants were introduced as an alternative to the traditional hip implants which rely on plastic or ceramic components at the site of the joint. The metal components, manufacturers touted, were supposed to last longer and be a more suitable fit for younger recipients because they would require less revision or replacement surgeries. More than 100 adverse event reports have been filed with the Food and Drug Administration centering around the Biomet M2a Magnum hip implant and they join tens of thousands more from recipients of other all-metal hip implants.
The Oregon woman claims she suffered from severe pain during her two years with the hip implant, eventually leading to her revision and replacement surgery. And while those procedures will remove the defective hip implants, they leave no guarantees that a person will regain full mobility afterward. Additionally, the surgery and subsequent physical therapy needed to recover come at a great and unexpected cost to the patient.
The lawsuit claims the Biomet M2a Magnum hip implant system also put the Oregon woman at risk of a toxic build-up of the metals cobalt and chromium, a hallmark of all metal-on-metal hip implants. Through normal wear-and-tear of the implant, small metallic fragments are dispersed into the body, either into the bloodstream or to nearby tissues and organs. If this goes unnoticed, it could cause metallosis and lead to tissue death and possibly organ failure. It also claims that Biomet has continued to market the hip implant is safe even after receiving hundreds of reports countering that claim.
Biomet also allegedly did not do thorough pre-market safety testing on the M2a Magnum hip implants. Metal hip implants were generally approved for use in the U.S. based on the fact that their design mirrored that of previously-approved devices, a condition which grants it access to the FDA’s 510(k) “fast-track” approval system.
Tens of thousands of people around the world have received an all-metal hip implant in recent years and many face these same risks. The FDA recently concluded a two-day conference trying to determine the best course of action for those who’ve not yet suffered complications due to these devices and has also ordered 33 manufacturers of these devices to conduct full post-market safety studies that could determine the fate of all these implants on the U.S .market in the future.