Bayer Reports Spike in Essure Lawsuits and Congress Questions FDA

Decatur, ILLitigation involving Essure is taking its toll on Bayer. In less than a year, the permanent birth control device manufacturer has seen lawsuits more than double, and it has been removed from every global market, except in the U.S.

At the beginning of the year, the pharma giant in its financial statement reported it was facing 3,700 Essure lawsuits. By last month that number increased to 10,600 lawsuits filed by Essure victims in the U.S. alone, according to I-TEAM with Wand News. Bayer also racked up $413 million in litigation and impairment losses, said Modern Healthcare (February, 2017). But the company still maintains that Essure is safe and is providing an effective method of birth control for “hundreds of thousands” of women. 

But many young women who want the Essure coils removed face a hysterectomy. They are calling the product E-Hell. One Essure user told an I-TEAM reporter that she “would have to be locked in my bedroom, with the blinds closed, for two or three days at a time…When I went into the shower I passed a blood clot the size of a softball.” One Facebook page titled “Essure Awareness” has almost 5,000 members, and another, called “Essure Problems” has over 35,000 members. At the end of 2016, the FDA had received almost 15,000 adverse event reports about the device since it approved Essure in 2002.

But the FDA is still sitting on the fence: It has only made Bayer slap a black-box warning on Essure’s packaging listing side effects, some of which are severe.

With so many women demanding that Essure be removed, why is the U.S. the only market left, and why isn’t the FDA demanding it be withdrawn?

Three members of Congress may soon be dealing with the FDA’s inability to act on Essure. The FDA’s news, called the QMN weekly bulletin (Nov 3, 2017) reported it had received a letter from three members of Congress, requesting a meeting “to address the agency’s inaction on the numerous reports of adverse events associated with Bayer’s contraceptive device Essure.” Congress members have several questions they want to be answered and they also want “a broad discussion about post-market surveillance on Class III devices in general”. The Essure device was approved by the FDA’s fast-track process…