Thursday, October 4, 2012

FDA Meeting Addressed Biomet Issues





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.

In response to the presentation, panel member Dr. Stephen Li pointed out that Schroeder and Xie discussed the M2a-38 implant in length without talking much about the higher revision rates of Biomet’s 32 mm metal-on-metal device.

In terms of the devices that Xie did mention, researchers “…do not see a higher failure rate in Biomet metal-on-metal hip system compared to other bearing surfaces.” However, if Biomet is yielding average statistics when compared to similar products – including those that have been recalled due to failure rates – Li explained that the device is still “mediocre,” because there are many devices that perform much better than average.

The Biomet reps’ presentation did not fully describe the potential problems with their metal-on-metal hip implants. Patients who require hip replacement surgery should not rely on medical device companies alone for information. When corrosion, metal poisoning, bone loss and other problems lead to hip implant failure, Biomet patients should speak with a hip recall lawyer to protect their legal rights.

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