Biomet hip replacements have run into more than one serious issue over the last several years. When the M2a metal-on-metal replacement system was birthed in 1996, it quickly became a popular. Second in line only to the DePuy ASR device (which has also seen rocky waters), the Biomet M2a-Magnum hit the ground running to the tune of million in profits.
Biomet advertises the M2a-Magnum extensively on its website claiming the metal-on-metal large head device provides enhanced stability and suffers from less wear than other devices. Many medical studies dispute the claims of Biomet instead suggesting instead that the large head is a danger. The studies suggest the can cause increased metal ion concentrations in the bloodstream. Further, it has been shown that metal-on-metal devices such as the M2a-Magnum and even the DePuy ASR are much higher fail rates than over replacement devices.
Biomet has a selection of seven metal-on-metal devices:
• Exceed ABT
There are some common side effects with Biomet products including pain and swelling. However, the serious side effects are called just that because they are not so common:
• Device dislocation
• Osteonecrosis – bones loose blood supply; leads to pain and collapse
• Ossification – new bone forms in tissues where they shouldn’t
• Debris buildup
• Device loosening
The Biomet Hip Replacement history on a timeline:
1996 – M2a metal-on-metal hip replacement comes to market
2001 – Zirconia Ceramic Femoral Head hip devices recalled by Biomet due to linked with fracture within 13 -27 months of implantation
2004 – M2a-Magnum comes to the United States
2009 – After 10 years on the market, more than 110,000 M2a hip replacement devices had been implanted.
2012 – Fail rate of metal-on-metal hip replacement devices revealed to be 14%. British Medical Journal published article with claims.
2012 – Biomet settled lawsuit filed against them by the Securities and Exchange Commission to the tune of $22.9 million. The lawsuit alleged Biomet bribed physicians in Argentina, Brazil, and China into using their products from 2000 – 2008.
2012 – A published medical study in the Journal of Bone and Joint Surgery reported that 39% of patients with large diameter head metal-to-metal implants, like Biomet’s M2a-Magnum, developed pseudo tumors.
2013 – FDA became the recipient of more than 500 adverse event reports on the Biomet M2a-Magnum
With the evidence and the progression of occurrences, it appears Biomet may be on the verge of further dismay. The company’s fate is not what is in question, however. Patients who have received implantation of the Biomet M2a-Magnum would be advised to discuss this evidence with a trained professional.