Essure long-term side effects have prompted FDA action and several product liability lawsuits.

Essure is manufactured by Bayer HealthCare and is marketed as a permanent, non-surgical form of birth control. Essure is a soft, flexible inset made of metal and polyester that is placed in each of the fallopian tubes. The inserts are placed through the cervix in a similar procedure to IUD placement.

Over the span of three months, a scar tissue barrier forms around the inserts, resulting in permanent occlusion of the fallopian tubes. This stops eggs from reaching the uterus, thus preventing pregnancy.

When Essure was released, it was considered a breakthrough contraceptive device for women who wished to be permanently sterile but did not want to undergo a surgical procedure like tubal ligation (having your “tubes tied”). Essure also provides women with a hormone-free birth control option.

Since its initial approval by the FDA in 2002, over 4,500 adverse events reports have been filed regarding Essure long-term side effects. Complications have included persistent pain, perforation of the uterus and/or fallopian tubes, device migration into the abdominal cavity or pelvis, abnormal bleeding, weight changes, muscle pain or weakness, hair loss, and allergy reactions.

According to the FDA, some women have had surgical procedures to remove the device because of the severity of the symptoms.

The effectiveness of Essure has also been called into question, with reports of women getting pregnant after Essure placement. Both successful pregnancies and pregnancy complications have been reported. “If a woman becomes pregnant with Essure, there may be a risk for the pregnancy to occur outside of the uterus (ectopic pregnancy), which may result in serious complications,” the FDA states.

In 2015, in response to patient experiences, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss Essure long-term side effects. During this meeting, expert opinions and patient experiences were considered and taken into consideration.

In 2016, the FDA issued a new, mandatory clinical study for Essure to determine heightened risks. Their statement also included new requirements for a boxed warning regarding Essure long-term side effects. The FDA ordered Bayer to conduct a post-market study, hoping that the information gathered will determine what further actions are needed to protect public health.

“While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications.”

Essure lawsuits have been filed against Bayer due to Essure long-term side effects, accusing the drug manufacturer of misleading consumers about the permanent birth control. Plaintiffs are challenging the premarket approval of Essure which is currently shielding Bayer from product liability.

According to the Essure birth control lawsuits, Essure’s approval was based on unreliable studies, and the birth control should not have been put on the market without further study of Essure long-term side effects.