July 1, 2015 - Are There Design Defects Associated With the Biomet M2A Magnum Hip Implant?
Metal hip implants have been front and center in the news over the past few years—and not in a good way. There have been recalls, injured patients, and lawsuits associated with more than one metal hip manufacturer. The Biomet M2A Magnum hip implant is no exception. The M2A Magnum is manufactured by Biomet, an Indiana-based company. (Biomet was subsequently sold to Zimmer in mid-2014). The design of the M2A utilizes a metal femoral head and a metal cup, both made out of chromium and cobalt.
Just like other all-metal hip implants, the M2A Magnum has experienced extremely high failure rates and may bring serious health risks to patients. The M2A Magnum gained FDA approval in 2004. The Biomet M2A Magnum is designed with a larger-diameter head which has been found to increase the amount of wear on the surface, as the metal parts rub against one another on the inside of the cup. What this means for patients, is more chromium and cobalt ions finding their way into the hip tissues and the blood. The risks for Biomet M2A hip failure are high, causing many patients to be forced into undergoing risky revision surgery.
What are the Biomet M2A Magnum Hip Dangers?
As with other all-metal hip implants, when the metal parts rub against one another, tiny cobalt and chromium particles shear away from the device, leading to Biomet M2A Magnum hip metallosis or metal toxicity. When metal particles land in the surrounding hip tissues, metallosis symptoms such as inflammation, chronic pain, deterioration of bone and tissue and total hip failure can occur. When the metal shards reach the bloodstream, the patient may experience symptoms of metal poisoning or metal toxicity such as hearing and vision loss, gastrointestinal disorders, renal, neurological and cardiovascular problems, reproductive disorders, skin rashes, headaches, alterations in DNA, the development of Biomet M2A Magnum hip pseudotumors, anxiety, depression and irritability as well as the development of certain types of cancers.
Have Patients Experienced Biomet M2A Magnum Hip Failure?
The Biomet M2A Magnum hip implant has not been recalled like some other all-metal hip implants, however some patients received the device under an FDA clinical investigation known as the “investigational device exemption.” This is a regulatory investigation which is exempt from many of the regulatory requirements for medical devices. Other patients received the M2A Magnum under the controversial 501(k) FDA fast-track program. While the M2A Magnum hip implant offered greater range of motion than some other all-metal hip implants, more than 450 adverse event reports were filed with the FDA concerning the device, and more than 1,000 Biomet M2A Magnum hip lawsuits have been filed to date against Biomet.
Do I Need a Biomet M2A Magnum Hip Lawyer?
Due to Biomet M2A Magnum hip failure and Biomet M2A Magnum hip metallosis, potentially thousands of implant recipients have suffered harm. In September, 2013, a federal judge declined to dismiss a lawsuit against Biomet due to the fact the plaintiff received a M2A Magnum which had been approved through the IDE program—although the plaintiff was not part of the study. In January, 2014, Biomet agreed to a $56 million settlement which would resolve lawsuits for all those who received a hip implant and later suffered Biomet M2A Magnum hip failure, requiring revisions surgery. Each qualified plaintiff was set to receive a base payment of $200,000, although individual plaintiffs would see deductions and additions to that amount, depending on their circumstances. If you received a Biomet M2A Magnum device, it could be very beneficial to speak to a Biomet M2A Magnum hip lawyer about your implant to determine your options.