Black Box Warnings Now Required for Essure
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The Food and Drug Administration is taking a hard look at the effectiveness and safety of Essure, a medical device designed to permanently prevent pregnancy. The sterilization coils have come under fire following more than 5,000 adverse events reported to the FDA in the years following its approval for the market. Complaints range from abdominal pain to unintended pregnancy to organ perforation. Most complaints stem from one common problem: migration of the device.
The Essure coils are implanted in a woman’s Fallopian tubes, but many reports indicate they have broken apart inside the body. Even worse, the coils have reportedly migrated, requiring hospitalization, surgery and even hysterectomies. Undoubtedly, had women known about these risks, they would have opted for safer alternatives. Tubal ligations have been around for a long time, and present far fewer dangers than Essure does.
The FDA has mandated a new black box warning label for all Essure packages, but many feel this doesn’t go far enough to require Bayer, the pharmaceutical company behind Essure, to comply with safety standards. Until the product is redesigned or pulled from the market entirely, many advocates will not rest.
Side effects are an expected part of any medical treatment, but devices like Essure need to be better tested before reaching consumers. At the very least, informing consumers of the dangers is a good start. Still, it shouldn’t have taken an FDA mandate – more than a decade after the initial product release – for Bayer to keep their consumers informed.