Essure Birth Control Injury News & Info

Black Box Warnings Now Required for Essure

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.

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The Law Offices of Richard J. Serpe, PC are currently investigating potential injury claims for anyone who has suffered from complications or has been seriously injured by an Essure permanent birth control device.

If you or a loved one has suffered from an injury related to an Essure permanent birth control device, you may want to contact an attorney. Our dangerous and defective products attorneys offer a free, no obligation, consultation. Additionally, our no fee promise means you don’t owe us any legal fees unless we settle or win your case. Contact us to discuss your situation today 877-544-5323.