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 2016 final guidance, Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, and with the FDA’s 2018 restriction on the sale and distribution of the device. The current and original labeling is listed below.
Current labeling from Bayer’s website:
Original labeling when Essure was first approved: