Several women have filed a lawsuit against Bayer, alleging that Essure sterilization can cause a variety of detrimental side effects.

Twenty-one women are named plaintiffs in this Essure lawsuit against Bayer Corp. and a variety of other subsidiaries. The women in the lawsuit say they have each experienced complications as a result of Essure sterilization.

Complications reported by the plaintiffs include: inconsistent menstrual cycles, abnormal bleeding, pelvic pain, migraine headaches, rashes, tooth decay, weight gain, hair loss, loss of libido, pain during intercourse, formation of cysts, and more. These complications were allegedly a direct result of implantation with Essure.

What is Essure?

Essure is a birth control device consisting of two metal coils. The coils are placed into the fallopian tubes and are designed to trigger the formation of scar tissue which in turn blocks eggs from the fallopian tubes, similarly to tubal ligation. A few months after the Essure sterilization procedure, patients are supposed to be tested to make sure that sufficient scar tissue has formed.

Essure sterilization was initially hyped as a non-surgical alternative to permanent sterilization methods such as tubal ligation. The device was approved by the U.S. Food and Drug Administration (FDA) in 2002 and was met with high hopes. However, these hopes were soon dashed by an influx of adverse event complaints.

According to the Essure lawsuit, thousands of adverse events were reported to Conceptus, the company which initially released the device and was later acquired by Bayer. However, Conceptus allegedly chose to conceal these reports in order to protect the reputation of their product.

“Conceptus knew that if those complaints made it to the FDA and became public knowledge, it would inevitably result in changes to the Essure label, its risk/benefit profile, related physician advice, and patient’s decisions,” the Essure complaint claims.

Bayer allegedly continued hiding the problems associated with Essure when they acquired Conceptus. However, the FDA reportedly caught onto the fact that countless patients were experiencing adverse side effects after Essure sterilization.

FDA and Essure

Part of what drew the FDA’s attention was the consistent lobbying of affected consumers. Over 40,000 women joined the “Essure Problems” group on Facebook. Women in the group were able to voice their concerns and experiences and make efforts to educate others.

In October 2016, the agency announced that it was requiring a new black box warning on Essure to warn of “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.” This new warning was implemented along with a mandatory checklist which would require each patient to acknowledge the risks associated with the device.

In July 2018, Bayer announced that it would no longer sell Essure in the United States after Dec. 31, 2018. Although this protects US consumers from future complications associated with Essure sterilization, this does not benefit consumers like the plaintiffs which were harmed.

The Essure Sterilization Lawsuit is Case No. 4:18-cv-02033 in the Circuit Court of the City of St. Louis in the State of Missouri.