FDA Restricts Sale of Permanent Contraceptive

The US Food and Drug Administration (FDA) has restricted the sale and distribution of the Essure permanent contraception device to ensure that all women who are considering use of the device are provided with adequate risk information.

The agency issued the order after learning that some women are not adequately informed of risks associated with use of the device before having it implanted, despite previous significant efforts geared towards educating patients and doctors about Essure’s risks.

“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” said FDA Commissioner Scott Gottlieb, MD.

Now, the device’s manufacturer, Bayer, must perform a post-market study and add a boxed warning and a patient decision checklist to the device’s labeling.

Essure is implanted by a health care provider via insertion of flexible coils through the vagina and cervix and into the fallopian tubes. Over the course of 3 months after insertion, tissue forms around the inserts and prevents contraception. It is currently the only permanently implanted birth control device for women on the market that does not require a surgical incision.

—Christina Vogt

Reference:

FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information [press release]. US Food and Drug Administration. April 9, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm604098.htm Accessed on April 10, 2018.