The FDA’s Center for Devices and Radiological Health (CDRH) has been incredibly busy lately. Earlier this week, the CDRH announced the completion of a project to analyze past medical device applications and their postmarket trials.
The CDRH reviewed every medical device subject to a premarket approval application (PMA) filed before 2010. The CDRH then looked at each postmarket clinical study the devices were required to conduct. The goal of the review was to determine whether or not to reduce the requirements for premarket approval and rely more heavily on postmarket trial data. Reducing the requirements for premarket approval would allow life-saving medical devices to more quickly enter the market, but it also heightens the risk of approving harmful devices.
The shift to requiring less data for premarket approval is frightening for many critics and patients who have already experienced the dangers of harmful devices firsthand.
The FDA is notoriously slow at issuing warnings and recalls. It took the FDA more than ten years and more than 5,000 adverse event reports to investigate the popular contraceptive Essure. After thousands of women experienced debilitating complications, the FDA’s review of the device led to a requirement that the manufacturer update the labeling to include a black box warning, the most severe warning issued for medical devices. Women who have been harmed by the device believe it should be recalled from the market and are angry the FDA only issued a warning.
But this isn’t the device the FDA has been delicate with. Reports that power morcellators used in laparoscopic hysterectomies and myomectomies were inadvertently spreading cancerous cells throughout the body rolled in for years before the FDA took action. After more than twenty years on the market, the FDA advised discontinuing use of the device. Not only did the FDA’s slow action in recommending against use of the device cost women their lives, the agency didn’t even recall it.
The FDA walks a fine line between protecting consumers from dangerous products and providing approval for life-saving medical treatments – but it doesn’t appear that the agency is handling the balance all that successfully.