New Clinical Study and Added Warning on Essure Birth Control Label FDA MandatedMar 11, 2016
The U.S. Food and Drug Administration (FDA) announced on February 29, 2016 that there would be renewed examination of risks and concerns connected with the permanent birth control device, Essure.
Bayer, the manufacturer of Essure, has been ordered by the FDA to conduct a clinical study to investigate complications and real-world side effects of the controversial birth control device. The FDA also plans to require a boxed warning, the strongest type of FDA warning, on Essure's label. The black box would list reported adverse events, including insertion and removal procedures, told a news release on the agency's website.
A "Patient Decision Checklist" has also been proposed by the FDA enumerating benefits and risks of Essure empowering the user with a more complete understanding when examining their options. The checklist will include a "confirmation" test to be conducted three months after implantation of the Essure device to confirm that the device has been properly placed.
The FDA notes that some women may experience serious complication with Essure. These include persistent pain, migration of the device causing perforation of the uterus or fallopian tubes, abnormal bleeding, and allergy or hypersensitivity reactions.
Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health said, "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." Dr. Maisel added the agency's recognition that "more rigorous research is needed to better understand if certain women are at heightened risk of complications."