Medical Devices

Essure Labeling Information for Patients and Health Care Providers

The original Essure labeling has changed several times since approval in 2002 based on PMA supplements submitted to the FDA and to align with recommendations in the final guidance, Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization. In November 2016, the FDA approved Bayer's labeling which is consistent with the recommendations in the final guidance. The current and original labeling is listed below.

Current labeling from Bayer’s website:
Original labeling when Essure was first approved:


Page Last Updated: 12/28/2017
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