FDA Orders Additional Clinical Studies and Considers Black Box Warning for Essure

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The birth control device Essure is a non-surgical alternative to sterilization surgery and involves a small pair of metal coils inserted into a woman’s fallopian tubes to prevent pregnancy. It has been available since 2002, but an increasing number of reported serious complications and risks have made it a controversial method of birth control.

On February 29, 2016, the U.S. Food and Drug Administration (FDA) ordered Bayer, the manufacturer of Essure, to perform a clinical study evaluating real-world side effects and complications linked to the birth control device. The FDA also plans to require a boxed warning on Essure’s label, itemizing reported adverse effects of the device. This is the strongest type of warning the FDA issues indicates the FDA news release on the agency’s website.

Thousands of women have experienced complications since Essure’s initial approval including persistent pain, perforation of the fallopian tubes or uterus due to device migration, abnormal bleeding, and allergy or hypersensitivity reactions.

The FDA also proposes a “Patient Decision Checklist” informing patients of the benefits as well as the risks of using Essure. The checklist would include a “confirmation” test to be conducted 90 days after implantation of the device to check that Essure has been properly placed. These additions would aid women’s understanding giving them more factual information when discussing their birth control options with their physicians.

The consumer activist Erin Brokovitch started a website for women who have had the Essure procedure to give them a platform to share their experiences and concerns. Some of these stories reported debilitating headaches, nausea, allergic response to the nickel the device is made of, and colon perforation due to migration of the device. These women all reported they were not warned of the serious side effects associated with Essure.