On September 24, the Food and Drug Administration (FDA) convened a public advisory committee meeting to discuss safety concerns about the Essure -- a permanent birth control device that is implanted in the Fallopian tubes in order to create a tissue barrier and prevent pregnancy. The meeting of the Obstetrics and Gynecology Devices Panel was prompted by complaints submitted to the manufacturer (Bayer) and the FDA about unusual side effects -- including patient deaths -- and other health concerns that were not reflected in the labeling.
The ad hoc nature of such meetings, as a reaction to over 5,000 complaints, is a product of the U.S.’s current device surveillance system which itself is ad hoc in nature. Once a device is approved for market, the FDA relies heavily on these voluntarily submitted complaints in order to flag any potential adverse effects not identified during initial testing -- a system that, the agency acknowledges, may be "incomplete, inaccurate, untimely, unverified, or biased." In recent years, the FDA has renewed its efforts to actively strengthen or revamp this system.
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