The following is taken without editing from the FDA
The FDA continues to monitor the safety of Essure. Women considering permanent birth control should make fully informed decisions by getting information from their health care provider about the risks and benefits of all options. The FDA continues to believe that the benefits of the device outweigh its risks, and that Essure’s updated labeling and the sales restriction help to assure that women are appropriately informed of the risks. The following is an overview of some of the FDA’s efforts to monitor the safety of Essure.
The FDA wants to ensure that each and every woman who receives Essure has been informed of the risks and benefits before getting the device implanted. The FDA has taken steps, including labeling changes in 2016 adding a boxed warning and patient decision checklist, to better inform health care providers and patients about the risks.
The FDA is aware that some women have received the Essure device without being adequately informed of Essure’s risks. In order for this device to meet reasonable assurance of safety and effectiveness, all women considering Essure should receive this important information.
On April 9, 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.
The FDA also approved Bayer’s new labeling that includes:
Also from the FDA:
Long-term risks to patients reported in clinical trials include:
Vasectomy continues to be a safe and effective method of permanent birth control for men.