An Essure lawsuit, demanding a trial by jury, was recently filed in Missouri over severe adverse side effects and complications suffered from the Essure permanent birth control device.

Plaintiffs Kristina B., Shawuana B., Stephanie B., and a number of others filed the Essure lawsuit claiming negligence, among other allegations related to the Class III medical device manufactured and sold by Bayer.

The women state that soon after being implanted with the Essure device they began to suffer severe complications. They state that what led them to become implanted with the device was their belief from the company’s claims that the birth control device was safe and effective.

Some of the side effects plaintiffs suffered included but are not limited to: “debilitating pain, heavy bleeding necessitating medication and/or additional surgical intervention, allergic reactions (including but not limited to rashes, itching, bloating, swelling, headaches, tooth-loss and hair loss), autoimmune disorders, dyspareunia, hysterectomy, and other complications,” the lawsuit states.

The women and their physicians relied on the company’s representations of the device stating that it was safe and effective. However, the plaintiffs’ Essure allegations state that the company in fact knew of the safety risks involved. They state that Conceptus, the original manufacturer,  “knew that if the true safety risk and consequences were known to the physicians and patients, sales of the device would plummet.”

“As a result, Conceptus made a decision to hide these safety risks and consequences from the FDA, physicians, patients, and the public at large.”

Overview: Filing an Essure Lawsuit

Essure is a permanent, non-surgical birth control device, approved by the U.S. Food and Drug Administration (FDA) and manufactured by Bayer Healthcare. The permanent birth control device was created by Conceptus and approved by the FDA in 2002. On April 29, 2013, Bayer acquired Conceptus and took over manufacture of Essure.

When first introduced, Essure was believed to be a contraceptive breakthrough, allowing women to have an option for permanent sterilization without undergoing a tubal ligation procedure. However, prior to its approval by the FDA, the device was passed through a fast-track approval system provided by the federal agency.

The device was the first to offer an alternative to surgical sterilization and promised patients a quick recovery time. Since then, however, the device has caused a number of severe adverse side effects, and even death.

Over the past several years, the FDA has been examining the extensive number of adverse event reports that it has received. Some complications include excessive bleeding, organ perforation, pelvic pain, miscarriage, ectopic pregnancy, allergic reactions, bloating, and rashes.

Women who file complaints against the company and suffer these adverse side effects claim neither they nor their physicians were warned about the severe side effects linked to the device. Complaints made against the company over the manufacturing of Essure claim that they device was approved too soon, before adequate testing and sufficient studies pertaining to the device could be done.

The Essure Lawsuit is Case No. 4:18-cv-02035-JAR, in the Circuit Court of the City of St. Louis, State of Missouri.