Discontinuation of Essure female birth control device
The Essure device is a birth control device that's implanted in the fallopian tubes. It has been on the market since 2002, but recently the FDA announced the Essure device will be discontinued on Dec. 31, 2018.
Key points from the FDA publication
Bayer will stop selling the device in December of 2018
Bayer has announced that they will stop selling and distributing the Essure device in the United States after Dec. 31, 2018 due to declining sales of the product. Bayer will continue to implement the restriction on sale and distribution placed by the FDA on the device in April l, 2018, to ensure women are fully informed of the risks associated with the device.
The FDA requires informed consent of the risks and benefits
On April 9, 2018, the FDA restricted sales of the Essure device to only doctors and health care facilities who use the FDA-approved "Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement." Sale and distribution of Essure is limited to health care providers who agree to review this checklist with patients, and give them the opportunity to sign it, before Essure implantation. The FDA has approved this new safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness.
You can follow the progress of this issue
The FDA ordered Bayer, the company that makes Essure, to conduct a post-market surveillance study to gather more data about Essure's benefits and risks. The FDA approved the study plan on Sept. 2, 2016 and will make interim study results and updates available on the Essure Postmarket Surveillance Study page. The FDA believes clinical data will help to better understand certain patient complications that may be experienced by women who have Essure permanent birth control when compared to women who undergo tubal ligation.