FDA to Review Essure Contraceptive Device Amid Complaints

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The Food and Drug Administration will convene a panel Thursday to review the Essure contraceptive device amid complaints that it causes harmful side effects.

Essure is a permanent contraceptive device for women that is marketed as an alternative to tying the fallopian tubes, NBC reports. But of the roughly 750,000 women who have had Essure implanted, some 17,000 women say it harmed them, including by inducing chronic pain, bleeding, fatigue and skin allergies.

An FDA website page about Essure said women had “[described] symptoms that are not included in the labeling, and were not observed in post-approval studies, or described in the clinical literature.”

Angela Lynch had Essure implanted when she was 28, and told NBC, “After two years I started losing hair. Then I started losing teeth, and over time it got to where my whole body was hurting.”

Once she had the device removed, “After three days it was like I woke up from a five-year flu.”

Dr. Patricia Carney, Bayer AG’s medical director for Essure, said ,”We want to understand as a company what is going on. We want to know whether there is a link to the product.”

Thursday’s panel will discuss potential changes to Essure’s label or whether more clinical studies should be conducted on the product, but the panel will not formally vote on any measures. The FDA approved Essure in 2002.

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Write to Tessa Berenson at tessa.Rogers@time.com