Essure was pulled off the market in the U.S. after over 16,000 women filed lawsuits for severe side effects like chronic pain, allergic reactions, uterine perforation, heavy bleeding, and more.
UPDATE: Essure Class Action Lawsuit Goes Forward in Philadelphia
April 2019 — Lawsuits by 9 women who were injured by Bayer’s Essure sterilization implant were allowed to proceed by a federal judge in Philadelphia. Click here to read more.
Bayer Stops Selling Essure in United States
July 2018 — Bayer will stop all sales of Essure implants at the end of the year, making the U.S. the last country where the controversial device was still sold. Bayer stands by the safety and effectiveness of Essure, and claims it was a “business decision” based on a 40% drop in sales.
What is Essure?
Essure is a permanent sterilization device made by Bayer that has been sold in the United States since 2002. It consists of a nickel-titanium metal coil coated in polyester fibers. After it is inserted into a woman’s fallopian tubes, Essure causes a low-level inflammatory reaction. Over time, tissues grow into the coil and block off the fallopian tubes.
Essure Linked to 10X Risk of Surgery and Thousands of Injuries
Bayer markets Essure as a non-surgical outpatient procedure — an alternative to minimally-invasive “tube tying” procedures. However, studies have shown that Essure is actually more risky. Women who get Essure were 10X more likely to need follow-up surgery compared to women who get their tube tied (2.9% vs. 0.2%), according to a study published in the British Medical Journal.
FDA Orders “Black Box” Warning for Essure
In February 2016, Bayer was ordered to conduct new clinical trials and update the label on Essure to include a “Black Box” warning about severe, debilitating side effects. The FDA also required a new clinical trial to determine the risks for particular women. Click here to read more.
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