Essure, marketed as the only available nonsurgical form of permanent birth control, is manufactured by Bayer HealthCare and has been available in the U.S. since 2002.

However, the Essure birth control system has been linked to serious complications and side effects. Although the product, Bayer maintains, has a long history of safety and effectiveness, women have alleged that Essure has seriously damaged their health.

According to adverse event reports filed with the FDA, Essure can in some cases allow pregnancy and lead to bleeding, vaginal infection, abdominal pain, and at times, death.

What is the Essure Birth Control System?

Essure is a flexible, small coil made of titanium alloy and nickel. During the nonsurgical procedure, the tiny inserts are placed through the vagina and uterus inside each fallopian tube. Over a three-month period, scar tissue begins to form around the inserts. This then creates a barrier preventing contraception.

After the three month period, the patient is evaluated by a radiologist to ensure that the Essure birth control system is properly in place and that contraception is no longer possible.

To confirm that a woman’s fallopian tubes are completely blocked by the inserts, the radiologist injects dye into the woman’s cervix. An X-ray is then taken to confirm that no dye has leaked passed the Essure inserts.

The Essure birth control system may not be indicated for women who have already had their tubes tied, have had a recent pelvic infection, have allergy to contrast dye or have allergy to nickel.

Essure Birth Control System Side Effects

The U.S. Food and Drug Administration (FDA) approved the use of Essure in 2002. However, according to the Daily Hornet, since the system’s approval, there have been over 10,000 Essure injuries and 30 deaths reported to the FDA.

The FDA received 5,016 medical device reports in 2016, and another 6,176 reports in 2015. The 30 deaths included 18 pregnancy losses, four adult women, a possible stillborn infant, and two infant deaths after birth.

The most common problems listed with Essure included:

• Pain, specifically abdominal pain
• Menstrual irregularities/ Heavier menses
• Headache
• Fatigue
• Device incompatibility
• Weight fluctuation
• Device breakage or migration
• Unintended pregnancies, including ectopic pregnancies
• Malposition of the device
• Fallopian tube, uterus, and colon perforation

In November 2016, the FDA also added a black box warning to the Essure birth control system, a warning reserved for the most severe potential side effects of medical devices and drugs.

The black box warning advises consumers that Essure has been linked to serious adverse side effects in women, including severe pain, uterine perforation, and the requirement for surgical removal of the Essure system.

According to the Daily Hornet, the FDA is also detailing a new ongoing Essure safety study. The clinical study will compare 1,400 women who have undergone a traditional “tube tying” sterilization to 1,400 women implanted with the Essure birth control system.

The researchers are looking to compare side effects such as abnormal uterine bleeding, hypersensitivity to nickel in Essure, allergic reactions, pregnancy, follow-up surgery, autoimmune diseases, and effectiveness of the device.