Photo courtesy of: Petr Kovář
On the heels of an historic, nearly $11 billion settlement over Roundup lawsuits, Bayer AG will dole out more than an additional $1 billion for Essure female contraception lawsuits.
In 2018, Bayer announced it was discontinuing sales of Essure, an implanted birth control device designed to permanently block the fallopian tubes. At the time, Bayer said it was pulling the product from the marketplace not because of safety, but rather declining sales.
Despite Bayer’s insistence that Essure is safe, 39,000 women have filed claims against the German multinational company. To resolve the lawsuits, both resolved and those outstanding, Bayer recently announced it is setting aside $1.6 billion.
Users of the birth control device allege that the device (which is shaped like a coil) causes a hole in the fallopian tubes or uterus; constant pain; menstrual cycle complications; and/or the migration of the device into the abdomen or pelvis. Moreover, some women cite the failure of the product to perform its intended task: to prevent pregnancy.
Despite the 2016 FDA decision to issue their strongest caution on a product—a “black-box warning”—Bayer announced in a statement related to the settlement, that while the company sympathizes with all women who have experienced side effects, the product’s efficacy and safety is supported by science.
Bayer is not the manufacturer of Essure. That dubious distinction belongs to Conceptus, a Silicon Valley company founded in 1992. Bayer acquired Conceptus in 2013.
Essure was created as an alternative to tubal ligation, the female sterilization procedure commonly referred to as “getting your tubes tied.”
In September 2019, the FDA announced that Bayer informed their customers that all Essure units that had not been implanted should be returned to Bayer by the end of 2019.