Essure, a form of permanent birth control made by Bayer Healthcare Inc., would seem to be the perfect solution for the busy professional woman. The device, consisting of two small coils about an inch and one-half in length, could be inserted bilaterally into the fallopian tubes at a local doctor’s office and in under ten minutes. Essure would also seem to be the perfect solution for a woman that might fear the more invasive surgical tubal ligation procedure.

Essure Installation and Reported Injuries

Essure coils are put in place through the vagina and cervical opening. There is no need for a surgical incision or anesthesia during installation. The idea behind Essure is that the fallopian tubes would essentially become blocked by the coils and prevent monthly migration of the matured ova in its journey to the uterus.

This blockage would gradually develop over a few months as scar tissue built around and adhered the coils in place. It is theoretically a great concept for the female desiring to become permanently sterile. Unfortunately, there are reports of Essure injuries and death that call this birth control method into question.

Since it was first fast-tracked through the Food and Drug Administration’s (FDA) approval process in 2002, there have been several negative medical events reported by users of this method of non-surgical sterilization.

Essure injuries reported to the FDA in 2015 and 2016 total approximately 12,000 and include ectopic pregnancy, heavy menstrual cramps, coil migration within the pelvic cavity, pain, fatigue, and allergic reaction to the nickel which makes up part of the device. There have also been 30 deaths reported in association with use of Essure coils, but these have been largely embryonic or fetal through unplanned pregnancy (regular or ectopic) leading to abortion, miscarriage, or stillbirth.

FDA’s Black Box Warning

Because Essure injuries have been significant, the FDA has added what is known as a ‘black box’ warning to the Essure label as of November 2016. This is the most critical type of FDA warning and advises medical personnel to clearly review the risks involved with choosing this method of permanent birth control. The warning is surrounded by a black box-like outline and reads as follows:

“WARNING: Some patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse events, including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions. If the device needs to be removed to address such an adverse event, a surgical procedure will be required. This information should be shared with patients considering sterilization with the Essure System for Permanent Birth Control during discussion of the benefits and risks of the device.”  
Tubal Ligation and Reversibility 

Tubal ligation is potentially reversible if a patient changes her mind about her desire to have a child.

Essure coils, which were marketed as an alternative to tubal ligation because the procedure was quick and non-invasive, do not provide for this type of reversibility. The coils can be removed, but the scar tissue which was encouraged to develop around them has been shown to increase the risk of uterine rupture in the final trimester of pregnancy. Often, a partial or full hysterectomy is needed to deal with Essure injuries.