Biomet Issues Addressed at FDA Meeting

Two representatives for Biomet’s metal-on-metal hip replacement products may have avoided talking about some serious issues at an FDA meeting earlier this summer. While they claimed that Biomet is safer than other metal-on-metal hip implants because they contain less cobalt-chrome, research has found high titanium levels in Biomet hip implant patients. Biomet’s presentation also focused on their M2a-Magnum device when registry data shows a significantly higher revision rate with a different Biomet device.

Dave Schroeder of the Research Department at Biomet explained how the M2a-Magnum design minimizes “edge loading,” or the chisel-like effect that occurs when the ball grinds against the socket and sheds metal debris into a person’s bloodstream. Instead, he blamed edge loading on patients’ individual bodies and doctors’ placement of the device. Dr. Jing Xie, in charge of Biomet’s Global Clinical Research, followed up with praise for the device because of its lower cobalt-chrome levels in patients’ blood samples. She explained that the Biomet “M2a-Magnum has the lowest cobalt level” in follow-up research, most likely due to its “unique design of adapter sleeve, which is made of titanium.” However, Dr. Xie did not mention the high levels of titanium found in patients’ bodies which can also lead to hip replacement failure.

To find out more about the Biomet presentation, read the full article at PA Law Blogs.