Medical Devices

Essure Permanent Birth Control: Information for Patients

Bayer announced that they will no longer sell or distribute Essure in the U.S. after December 31, 2018, for business reasons.

This information does not change the FDA's understanding of the safety and effectiveness of the device; however, the FDA emphasizes that women with Essure should speak with their physician about any medical questions they may have.

Essure is a permanent form of birth control. Essure is not appropriate for all women of child-bearing age, but it may be appropriate for those women who:

  • do not want any more children
  • want a permanent form of birth control
  • seek a sterilization procedure that does not require an incision or general anesthesia. Some doctors may use a local (numbing) anesthetic to reduce potential discomfort during the procedure.
  • want a permanent birth control method that does not involve hormones

Anyone considering Essure should be aware that the procedure is not immediately effective in preventing pregnancy. If you are considering Essure as a permanent birth control method, you must use another form of birth control to prevent pregnancy until you undergo your confirmation test. At three months after Essure placement, it is important you see your doctor for a confirmation test to verify that the Essure inserts are placed correctly.

You are encouraged to discuss all available sterilization and birth control options with your health care provider before deciding on the method that is right for you. If you are considering sterilization implants (like Essure), you may find it helpful to use the FDA-approved Decision Checklist based on the Final Guidance to discuss sterilization benefits and risks with your physician.

In November 2016, the FDA approved Bayer’s labeling which is consistent with the recommendations in the final guidance. If you are considering Essure, use Bayer’s Patient-Doctor Discussion Checklist, which is available in the Patient Information Booklet.disclaimer icon

In April 2018, the FDA restricted sales of the Essure device to only doctors and healthcare 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 healthcare 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.

Page Last Updated: 07/20/2018
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