FDA Orders Follow-Up Studies, Boxed Warning for Essure
In a new draft guidance, the Food and Drug Administration (FDA) announced that they have ordered Bayer to conduct follow-up studies for their permanent form of birth control, Essure. In addition, the FDA will require a boxed warning explaining the adverse events associated with the device and a “patient decision checklist” to help with informed decision-making.
Essure was first approved in 2002. The procedure involves the insertion of flexible coils through the cervix and vagina into the fallopian tubes. Over a period of about three months, scar tissue forms around the inserts and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception.
While the FDA believes Essure to be an appropriate option for the majority of women, they reiterated how some may be at risk for serious complications, including persistent pain, perforation of the uterus or fallopian tubes, abnormal bleeding, allergy or hypersensitivity reactions. The draft guidance issued today by the FDA regarding permanent hysteroscopically-placed sterilization devices aims to increase patient and physician understanding of the potential risks associated with this type of device.
The draft guidance also includes a “patient decision checklist” for use by doctors when discussing the risks associated with Essure treatment. It is recommended that the checklist be completed and signed by the patient and physician prior to proceeding with the Essure procedure, or any permanent hysteroscopic sterilization procedure.
The FDA has also ordered Bayer to conduct a post-market study investigating risks tied to Essure and how they compare with laparoscopic tubal ligation. Metrics will include rates of complications such as unplanned pregnancy, pelvic pain, among other symptoms, and surgery to remove the Essure device.
The FDA is seeking comment from the public, industry, and other stakeholders on this draft guidance. The docket will be open for 60 days.
For more information visit FDA.gov.