Recall Sheds Light on FDA Medical Device Approval Process

The Senate Special Committee on Aging held a hearing on April 13th regarding how medical devices are approved for sale by the FDA. The hip replacement recall of the DePuy ASR was also discussed at the hearing, placing emphasis on the importance of the testing and better post-market surveillance of medical devices.

The government agency has two processes to approve medical devices: the Premarket Approval Process requires clinical trials, while the fast-track process, the 501(k), only requires that a product is similar to other approved products already on the market. The DePuy ASR hip replacement was approved through the 501(k) process, which required minimal testing of the device. The FDA’s fast-track process has come under scrutiny because hip implants, which are considered a high-risk device, are cleared through the non-rigorous 501(k) process.

The hearing included testimony from patient-safety advocates, industry representatives, and a ASR hip implant recipient. The patient disclosed that her doctor had received $600,000 in consulting fees from DePuy Orthopaedics. The amount, unfortunately, is consistent with the bribery complaint Johnson & Johnson, DePuy’s parent company, recently settled for $70 million. The company admitted to bribing European doctors and health-care providers in order to sell their products, including the DePuy hip replacement device.

Mass Device website, which published an article regarding the hearing, quoted DePuy’s Director of Communications as stating that the company supports efforts to improve patient safety, the establishment of a national joint registry in the U.S., and that DePuy would work “…with the FDA to strengthen an already-robust process that has worked well for three decades and evolved, when appropriate, to better serve patients.” Considering the amount of recalls of 501(k) approved products, it is troubling that DePuy would call the process ‘robust,’ especially because the company had its own product recalled. Although there is pressure from the medical device industry to lighten the approval burden, patient safety should not be neglected in order to make money, only to have the device recalled later. DePuy not only designed a faulty device, but also failed to timely warn surgeons and patients of the health risks of the device. The hip replacement recall of the ASR, which was implanted in over 30,000 patients in the U.S., helped shed a light on the importance of clinical trials and tougher FDA approval process to ensure patient safety.