The FDA has restricted the sale and distribution of the Essure Permanent Birth Control System to only physicians and health care facilities that agree to use the FDA-approved “Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgement.”
Health care professionals must review this checklist with patients and give them the opportunity to sign it before Essure implantation.
This new safety measure has been enacted to ensure that women who receive Essure have been informed of the risks and benefits of the device.
