Bayer stopped all sales and production of Essure in the U.S. in December 2018, claiming it was a business and financial decision rather than issues with safety.
In a third quarter investor report, Bayer indicated that approximately 18,000 users of Essure have filed lawsuits as of October 30, 2018.
“Plaintiffs allege personal injuries from the use of Essure™, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, depression and unwanted pregnancy, and seek compensatory and punitive damages. Additional lawsuits are anticipated.”
Lawyers allege that Bayer knew or should have known that Essure posed unreasonable safety risks, but failed to warn women and doctors about those risks. Bayer continued to sell Essure in the U.S. for more than a year after pulling it off the market worldwide in 2017.
Last year, FDA officials received approximately 12,000 adverse event reports related to Essure. The agency also ordered Bayer to complete a 5-year follow-up study to investigate the long-term risks of Essure.
In April, FDA officials required doctors and patients to sign off on a lengthy checklist of potential complications linked to Essure. The FDA also required a “Black Box” warning label on Essure, which is the strongest warning label that the FDA can place on a medical device.