Medical device manufacturer, Biomet, like their competitors DePuy Orthopaedics, Inc. (a subsidiary of Johnson & Johnson) and Stryker Corp., have come under scrutiny, in recent years, for their all-metal hip implant the Magnum M2a. Just like DePuy and Stryker, Biomet has had enough lawsuits filed against them (over 1,000) to form a multidistrict litigation (MDL), and in February the company conceded to pay $56 million to settle hundreds of these cases.
But unlike DePuy’s ASR implant, and Stryker’s Rejuvenate and the ABG II implants, the Magnum M2a has, up to this point, not been recalled. In fact, Biomet’s website still touts the advantages of this highly dangerous metal-on-metal (MoM) device. In this case, just because there hasn’t been a recall doesn’t mean the product is safe.
METAL-ON-METAL IMPLANTS AND THE FDA
The Magnum M2a was originally approved by the U.S. Food and Drug Administration (FDA) in 2004 via a loophole called the 510(k) process which waived clinical testing if the manufacturer could show that the device in question was similar to one already on the market.
By 2011, the FDA changed its tune, reporting that metal-on-metal devices were far more likely to be linked with adverse medical events than other types of implants, with nearly 17,000 such instances reported between 2000 and 2011.
In June of 2012 the FDA put together an advisory board to discuss the dangers of all-metal hip implants. One panel expert, Dr. Diane Zuckerman, president of the National Research Center for Women & Families, had this to say, “Keeping these implants on the market for the next 5 years while research is being done is not an ethical decision…I believe a tragic mistake was made by allowing these products on the market without good data.”
THE DANGERS OF THE MAGNUM M2A HIP REPLACEMENT SYSTEM
As with other all-metal implants, the Magnum M2a consists of a metal ball and metal socket. The primary concern is that when these parts rub against each other the friction causes toxic metal ions (cobalt and chromium) to flake off into the recipient’s bloodstream and surrounding tissue. This can lead to multiple symptoms and complications including:
Hip pain, tissue damage, inflammation.
Difficulty walking and standing.
Metallosis (the build up of metal debris in the tissue).
Premature hip implant failure.
The FDA is currently working to establish more stringent pre-market criteria for these types of medical devices. Meanwhile, anyone requiring a hip implant, who has not undergone surgery already, should talk to their physician about alternatives to MoM.
If you’ve received a Magnum M2a or other MoM implant, the FDA recommends blood testing for elevated metallic levels. Recall or not, there is no doubt about the lack of safety and efficacy of Biomet’s Magnum M2a.
Do you have questions about your legal rights concerning metal-on-metal hip replacement failure? Our personal injury attorneys at Meshbesher & Spence are here to help get you the compensation you deserve. Please contact our office at 888-728-9866 in order to protect your legal rights.