Mere weeks ago, a medical advisory organization that operates under the U.S. National Academy of Science’s charter, the Institute of Medicine, published a report stridently criticizing the U.S. Food and Drug Administration’s (FDA) medical device approval process. The process, called the “510(k) premarket approval process,” or “510k process” for short, requires artificial device manufacturers to show that their new products are merely “substantially equivalent” to devices already on the market without subjecting theirs to clinical trials. Unfortunately, the 510(k) process allows manufacturers to claim substantial equivalency to devices that also received FDA approval through the same process. In some instances, the chain of approvals can stretch back decades to products that bear only a passing resemblance to existing ones. DePuy Orthopaedics’ ASR XL Acetabular Hip System and ASR Hip Resurfacing System received FDA approval through this process. The result is hip replacements that fail in nearly half of all recipients after only six years and a worldwide hip replacement recall that affects tens of thousands of people.
Feel free to also download our free brochure on the DePuy hip replacement recall.
A New DePuy Product Receives 510(k) Approval
Despite the intense pressure placed on the FDA to fix the 510(k) process, artificial joint manufacturers continue using it. On August 19, 2011, DePuy Orthopaedics published a press release to investors touting its latest product, “TRUMATCH Personalized Solutions” (TRUMATCH). The newest product, thankfully, is not an untested artificial implant, but is instead a set of surgical instrumentation and software designed to improve the efficiency of its SIGMA knee replacement device. Curiously absent from the press release is what preexisting product DePuy claims TRUMATCH is substantially equivalent to. If TRUMATCH has not been subjected to clinical trials, were previous similar products? What about those? These are questions consumer groups should be asking of DePuy and the FDA.
RLG Represents Those Injured by Products That Went Through the 510(k) Process
What the outcome of DePuy’s new product will be we cannot say, but we can tell you that DePuy’s negligence has already damaged thousands of lives. If you have received either of DePuy’s recalled ASR hip replacements, you may be eligible for compensation by filing a DePuy hip replacement lawsuit. The Rottenstein Law Group is offering free, confidential legal consultations to those injured by DePuy’s products. One of our attorneys will contact you as soon as possible if you click on this link or complete our contact form to the right.