Essure update: FDA recommends new warnings

The FDA is recommending words of caution for the label of this permanent birth control method.

Over 5,000 people who use Essure, and health care providers, have shared their concerns about this permanent birth control method with the U.S. Food and Drug Administration (FDA). And the FDA is listening. Last year, they had a public meeting where people could talk about their experiences with Essure. In March 2016, the FDA announced that they would ask the maker of Essure, Bayer, to add new warnings to the patient information pamphlet.

Now, the FDA has released their final recommendations. Here’s what they recommend that Bayer add to their pamphlet:

1) A black box stating that it’s possible for Essure to perforate the uterus or fallopian tubes, be found in the belly outside the fallopian tubes, or cause pain or allergic reactions, including a warning that removal may require surgery.

2) A patient checklist going over some of the possible long-term effects of using Essure, including a warning that removal may not be covered by insurance.

Although much of this information is in the current pamphlet about Essure, the black box and checklist are designed to highlight possible risks and make sure health care providers go over each of them with anyone considering this method.

It’s not clear yet when or if Bayer will take the FDA’s recommendations. (They’re not required to.) The good news is that there’s a big study of the safety of Essure in progress that will give us answers about how often pain, bleeding, allergic reactions, surgeries, and accidental pregnancies occur. The bad news is that these answers may be a long time coming—Bayer has until 2023 to share the final results.

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