As of December 31, 2019, all unused Essure units should have been returned to Bayer so that they are no longer available for implantation.
Women who have been using Essure successfully to prevent pregnancy can and should continue to do so.
Patient Labeling Information
The original Essure labeling has changed several times since approval in 2002 based on PMA supplements submitted to the FDA and to align with recommendations in the 2016 final guidance, Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, and with the FDA's 2018 restriction on the sale and distribution of the device.
The current and original labeling is listed below.
Current labeling from Bayer's website:
Original labeling when Essure was first approved:
Required Patient-Doctor Discussion Checklist for Essure
In 2016, the FDA approved important labeling changes for Essure to provide important information about the risks of using Essure and to help women and their health care providers be better informed of the potential complications associated with implantable forms of sterilization. This included a boxed warning and a patient decision checklist to help ensure that women are informed about the device's benefits and risks. In April 2018, the FDA required that Essure only be sold to health care providers who share with patients and sign Bayer's Patient-Doctor Discussion Checklist in the Patient Information booklet. The FDA approved this safety measure to ensure that the device meets our standards for a reasonable assurance of safety and effectiveness. As noted above, all unused Essure units should have been returned to Bayer by the end of 2019 so that they would no longer be available for implantation.
Can Essure Be Removed?
Health care providers and patients should know that Essure devices may need to be removed after placement. Women who have been using Essure successfully to prevent pregnancy can and should continue to do so. Women with Essure who suspect they may be having symptoms related to the device, such as persistent pain, should consult with their health care providers on what steps may be appropriate for them to take.
The currently-approved labeling for health care providers provides recommendations on device removal that providers should be aware of. This includes patient counseling, device removal techniques, and other general considerations.
If Essure needs to be removed, a surgical procedure may require use of general anesthesia. Device removal has its own risks. Patients should discuss the benefits and risks of any operation or procedure with their health care provider before deciding on the best option.
Information about Essure Device Removal
In 2016, the FDA approved a change to an Essure post-approval study to gather more information about device removals. Since that time, the rate of device removal for all subjects for any reason in the post approval study has been reported as 13.4 percent after 6 years. The rate of device removal for US subjects and Outside of United States (OUS) subjects is 11.4 percent and 16.2 percent, respectively. Learn more about this post-approval study.
In February 2016, the FDA ordered Bayer, the company that makes Essure, to conduct a postmarket surveillance ("522") study to gather more data about Essure's benefits and risks. As of December 31, 2019, enrollment for this study has ended. The FDA will post the interim study results, including information about device removal, once the enrollment data are analyzed and the next report is reviewed. Follow-up of patients in the study is ongoing. The FDA believes clinical data from this postmarket study will help patients, health care providers, and the agency better understand certain patient complications that women who have Essure permanent birth control may experience when compared to women who undergo tubal ligation. To learn more about this study, please visit the Essure 522 webpage or find information provided by Bayer at ClinicalTrials.gov (NCT number): NCT03127722.
The FDA continues to monitor other sources of postmarket data, including adverse event reports related to device removal. Learn more about the FDA's latest review of reports about device removal.
Report Problems with Essure to the FDA
If you have been using Essure successfully to prevent pregnancy you can and should continue to do so. If you suspect that you may have problems related to Essure, such as persistent pain, you should consult with your health care provider right away.
Patients and health care providers are encouraged to submit a voluntary report about any problems experienced with Essure to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Additional Information on Essure
- Problems Reported with Essure to the FDA
- Bayer Women's Healthcare Letter to Essure Providers - Voluntary Discontinuation of Essure Sales. July 20, 2018
- Bayer Healthcare's Dear Healthcare Provider Letter. Update - Bayer Receives FDA Approval on Essure Labeling. November 15, 2016
- CDRH FOIA: How to Get Records from CDRH
- Essure Postmarket Surveillance Study Page