Earlier this week, the FDA announced actions to provide important information about the risks of Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.
These actions also include ordering Bayer to conduct a postmarket surveillance study to obtain more data to better define and understand certain outcomes and events associated with Essure.
The FDA also issued a draft guidance to require manufacturers of all permanent hysteroscopically-placed tubal implants intended for sterilization to include key information inpatient and physician labeling.
"The actions we are taking today will encourage important conversations between women and their doctors to help patients make more informed decisions about whether or not Essure is right for them," said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health. "They also reflect our recognition that more rigorous research is needed to better understand if certain women are at heightened risk of complications."
Although Essure has been deemed as an appropriate option for most women seeking permanent birth control, the FDA recognizes the possibility of some women being at risk for serious complications such as persistent pain, perforation of the uterus or fallopian tubes from device migration, abnormal bleeding and allergy or hypersensitivity reactions.
Additional information about the Agency's actions can be found on the Essure Permanent Birth Control website.