The past few years have been marked by a shocking number of high-profile recalls of medical devices that were previously approved by the Food and Drug Administration’s abbreviated investigation process, dubbed 510(k). Last summer’s DePuy Orthopedics hip implant recall, for example, followed an abnormally high number of revision surgeries caused by thousands of artificial hips. Late last week, the journal Institute of Medicine released a report criticizing the FDA’s loopholes that allow medical devices to go to market if they are “substantially equivalent” to other models that have been approved in a complete FDA review.
The 510(k) process, the report notes, raises serious questions about an agency that has approved devices that require revision surgeries and are recalled much more frequently than normal. “The 510(k) process generally is not intended to evaluate the safety and effectiveness of medical devices and, furthermore, cannot be transformed into a premarket evaluation of safety and effectiveness,” the Institute of Medicine authors wrote in a letter to the FDA.
The report was particularly tough on dangerous medical devices that have already been recalled, like DePuy’s line of ASR metal-on-metal hip implants, which “appeared to work well when tested only on mechanical simulators but then failed disastrously when implanted in patients,” reports the New York Times. The relatively large number of revision surgeries has led to hundreds of DePuy hip implant lawsuits here in California and across the country. Since, the FDA’s abbreviated approval process has been in the line of fire thanks to journalists, doctors, and safety advocates.
But despite the growing consensus that DePuy’s metal-on-metal hip implant models were faulty and approved thanks to the shortened process the Institute of Medicine criticizes, the report was immediately met with opposition from the pharmaceutical industry and Washington lobbyists. A full month before the report was released, the pro-business Washington Legal Foundation petitioned the FDA to disregard the results due to the panel’s bias against the medical device industry. The American Academy of Orthopaedic Surgeons quickly congratulated the organization for “taking the bull by the horns” to discredit the Institute of Medicine study, reports the Times.
Others have come to the defense of the Institute of Medicine report and its authors. “I think it would be difficult to find a more reputable scientific organization than the Institute of Medicine,” said Dr. William Maisel, the FDA’s chief scientist overseeing medical devices. Although the FDA is not required to accept the report’s finding, Dr. Maisel’s faith in the Institute of Medicine suggests that the agency will at least take the claims seriously, which could potentially lead to stricter rules regulating the approval of medical devices here in the United States.
Contentious debate aside, the most important aspect of this discussion is the patients who may be suffering serious pain and metal poisoning due to DePuy’s faulty hip implants. If you or a loved one received a DePuy artificial hip, consider contacting your doctor to check if your model could require a revision surgery. We’ll keep you updated on FDA developments as they progress.