On August 2, 2016, Judge Winifred Smith in the Superior Court of California, Alomeda County, issued a decision that allowed the claims of 14 women injured by Essure to proceed against the manufacturer, Bayer. Bayer argued that it was immune from liability and that the women were barred from bringing their claims under a doctrine...
FDA Orders Bayer to Conduct Postmarket Surveillance Study of Risks of Essure
The U.S. Food and Drug Administration (FDA) has ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study for the permanent birth control device. The purpose of the study is “to provide important information about the risks of the device in a real-world environment.” Essure is a permanent birth control method...
FDA Announces Actions to Warn of Serious Essure Risks
The U.S. Food and Drug Administration (FDA) just announced actions to provide important information about the risks of using Essure, an implantable permanent contraceptive device. According to the FDA, the purpose of these actions is “to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.” As...