After FDA Committee Meeting, DePuy Stands up for Metal-on-Metal Hip Replacements
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The U.S. Food and Drug Administration (FDA) has been paying attention to reports sent by consumers and their physicians that metal-on-metal hip replacements fail at high rates. Those reports, coupled with the DePuy hip replacement recall and numerous hip replacement lawsuits manufacturers face, pressured the agency to convene an 18-person advisory committee to guide it on how to proceed regarding the devices. The committee’s two-day meeting led to some important findings, such as orthopedists claiming that they would not use all-metal implants at all, but on the whole, the FDA committee meeting’s results were modest. Nevertheless, DePuy Orthopaedics responded to the committee by publicly defending the devices.
Metal-on-Metal Hips Differ, Allegedly Have Merits
Although the FDA committee members all held metal-on-metal hips in low regard, a DePuy representative and one orthopedic expert felt otherwise. According to medicalxpress.com, a DePuy spokesperson, Mindy Tinsley, said, “DePuy believes that no single bearing surface meets the needs of all patients, and metal-on-metal implants provide the potential benefit of greater function and a lower risk of dislocation for some patients.” She added, “[A]ll metal-on-metal implants are not alike and they should not be grouped together if problems arise.”
Of course some people benefit from all-metal hip devices without the kinds of adverse consequences that prompted the DePuy recall. However, generally they do no better than implants made with other materials, according to findings published in the British Medical Journal. Furthermore, the National Joint Registry of England and Wales determined that 29 percent of the recalled ASR devices fail after six years in recipients—a finding that calls DePuy’s credibility into question.
Surprisingly, even an orthopedic expert made comments that differed from the FDA committee’s views. Dr. Joshua Jacobs, the former vice president of the American Academy of Orthopaedic Surgeons, remarked, “[M]etal-on-metal devices are not all the same. You have to go down to the individual product to fully understand the result. When you lump metal-on-metal together you miss a lot of important differences.” Hopefully the FDA’s 2011 request to manufacturers for postmarket information on their products will provide regulators and experts like Dr. Jacobs with the evidence they need one way or another. That said, if some materials tend to do no better than others as the British Medical Journal determined, then they should at least be tested rigorously before they are sent to the market, something that did not happen with most all-metal hips.
RLG Advocates for DePuy ASR Recipients
One orthopedist’s and a DePuy representative’s comments should be taken with some skepticism by recipients of DePuy’s ASR XL Acetabular System and ASR Hip Resurfacing System, which fail at higher-than-normal rates. Thousands of people who received these devices are suing DePuy and its parent, Johnson & Johnson, in federal and state courts. If you have one of these implants it’s not a good idea to negotiate with DePuy alone because the amount of compensation from a DePuy lawsuit might be greater than what the manufacturer will offer you. The Rottenstein Law Group offers free, confidential consultations, and to speak with a lawyer either click on this link or call 1-877-312-3274.