The controversial DePuy hip replacement device made it to the market without undergoing the strict protocol of testing reserved for medical devices. How did this happen? It made it to the market by the federal Food and Drug Administration’s (FDA’s) 510(k) program, which uses similar devices already on the market as a benchmark for the effectiveness of a new device. In the case of the DePuy hip implant, components broke down inside patients’ bodies, requiring pain and additional surgeries.
The prestigious New England Journal of Medicine (NEJM) wants the FDA to get rid of the 510(k) program for certain medical devices. The NEJM said that newer devices are more complex and that regulators cannot assume their safety and effectiveness. The NEJM article used the DePuy implant to demonstrate what happens when devices go through the 510(k) program without clinical trials.
The FDA policy behind the 510(k) program is to promote innovation and get devices to the market faster in order to help patients. Critics of the program have pointed out that manufacturing dangerous devices serves neither the medical industry nor the patients. The NEJM article said that federal regulators are essentially creating jobs that manufacture harmful medical devices.
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Colson Hicks Eidson – Florida attorneys