Audience: OBGYN, Patient, Risk Manager
ISSUE: 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 standards for a reasonable assurance of safety and effectiveness.
The FDA also approved Bayer’s new labeling that includes:
- The following statement: “The sale and distribution of this device are restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Bayer.”
- Bayer’s Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement, which is part of the patient information booklet, and has key items about the device, its use, and safety and effectiveness outcomes, which the patient should be aware of as they consider permanent birth control options.
BACKGROUND: 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.
RECOMMENDATION: Health care providers should thoroughly discuss available sterilization and birth control methods with their patients, including their benefits and risks. The FDA-approved Decision Checklist based on the Final Guidance should be used to facilitate these discussions and ensure patients understand the benefits and risks.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178