The U.S. Food and Drug Administration expects to release new guidance by the end of February on a form of birth control that has been linked to more than 15,000 adverse events, including at least a dozen deaths.
Essure, a permanent contraception procedure, is a small, soft, flexible coil made of nickel that, when inserted into each fallopian tube, prevents eggs from getting into the uterus. In its announcement last week, the FDA called its review of the safety and efficacy of Essure a “high priority,” and said it is working expeditiously to conduct an evidencebased review of the available information. It plans to communicate its actions publicly within the next three months. Bayer has continued to firmly support the product, saying it is supported by more than a decade of research, the FDA and real-world experience.