The US Food and Drug Administration (FDA) has announced the actions it plans on taking to provide safety and risk information to Essure patients and prescribers. Essure is a permanent birth control involving the surgical placement of flexible coils into a woman’s reproductive system. After about three months, scar tissue forms around the coils and is supposed to prevent pregnancy. Women must use an alternative birth control during this period.
Essure was approved by the FDA in 2002, and continued monitoring of the product has led the FDA to its recent decisions. They will be requiring product labeling changes, such as a boxed warning and a Patient Decision Checklist, to help patients and doctors make informed decisions about using Essure. The FDA has ordered the product’s manufacturer, Bayer, to perform a new postmarket surveillance study to provide information about real-world risks when using the device. These risks include unplanned pregnancy, surgery to remove Essure, and pelvic pain and other side effects.
To help the FDA with the proposed warning language, they have issued draft guidance to allow the public to make comments for 60 days.