- The FDA has mandated Bayer add a black box warning to Essure, a permanent form of birth control that involves the insertion of flexible coils into the fallopian tubes. Bayer acquired Essure in 2013.
- Essure was promoted as an alternative to tubal ligation, but has been associated with numerous problems, ranging from pain, to uterine perforation and device migration.
- Since Essure was approved in 2002, critics have been calling for its removal from the market. During that time, the FDA examined a significant amount of information related to Essure's use and safety.
The new black box warning must warn about the adverse events associated with Essure, including the heightened risk when the device is first implanted, as well as the risks of taking it out.
The FDA also ordered Bayer to conduct post-marketing surveillance to evaluate the safety of Essure versus tubal ligation, in addition to tracking the rates of complications including unplanned pregnancy and surgery to remove the device. The study will also include a a quality of life component.
Despite widespread criticism over Essure, the FDA has not yet taken it off the market. Currently, the agency is seeking comment from the public, industry, and other stakeholders on this draft guidance. The docket will be open for 60 days.