Since Essure's approval in 2002, the agency has continued to monitor the product's safety and effectiveness by reviewing the medical literature, clinical trial information, postmarket study data and medical device reports submitted to the agency.
A timeline and summary of our most significant activities related to Essure is provided below.
|December 7, 2020||The FDA posted the fourth and fifth spreadsheets of reportable adverse events that Bayer is required to submit as outlined in the April 24, 2020 variance from MDR reporting requirements. Additionally, Bayer posted the first quarterly analysis report of the adverse event information included in the first three variance reporting spreadsheets for the reporting time period of June 2020 through August 2020. The FDA will continue to make the adverse event information publicly available on the Problems Reported with Essure webpage after spreadsheets are received from Bayer and reviewed by FDA. On October 15, 2020, the FDA posted the third spreadsheet.|
|September 15, 2020||The FDA updated the Essure Information for Patients and Health Care Providers webpage to include the most current postmarket study information about device removal, and approval of Bayer’s revised 522 study protocol to include an additional interim analysis for the 522 study after all patients have completed one year of follow-up. The FDA posted the second spreadsheet of reportable adverse events that Bayer submitted under the variance. The FDA will continue to make the adverse event information publicly available on the Problems Reported with Essure webpage after spreadsheets are received from Bayer and reviewed by FDA.|
|August 11, 2020||The FDA provided an update on the adverse event information from the first monthly spreadsheet that Bayer is required to submit as outlined in the April 24, 2020 variance from the MDR reporting requirements. The FDA will continue to make the adverse event information publicly available on the Problems Reported with Essure webpage after spreadsheets are received from Bayer and reviewed by FDA.|
|July 8, 2020||The FDA provided interim results from the postmarket surveillance (“522”) study on the Essure 522 webpage. Early results show that Essure patients tend to have higher rates of chronic lower abdominal and/or pelvic pain and abnormal uterine bleeding as compared to women who had laproscopic tubal ligation. The rate of additional gynecologic surgical procedures, which includes device removal, was higher for Essure patients than tubal ligation patients. The pregnancy rates are similar for patients with Essure and laparoscopic tubal ligation. Follow-up of patients in the study is ongoing.|
|April 24, 2020||
The FDA provided an update related to the ongoing postmarket review of Essure, including information about the medical device reports in 2019. Bayer reports that all unused Essure devices of which Bayer is aware have been returned to the company and there should be no devices available for implantation in the U.S.
The FDA was notified by Bayer that it became aware of adverse event information about Essure in social media information related to litigation, which they began to receive in November 2016 and will continue to receive through November 2020. The FDA granted Bayer’s request for a variance from the MDR reporting requirements, under which Bayer must process all reportable adverse events within one year of the date of the variance, unless an extension is granted. The FDA will make the events publicly available on the Problems Reported with Essure webpage at the pre-specified timepoints over the next year, starting in July 2020. Summary information about the events will be accessible in the FDA’s MAUDE database. Bayer will provide quarterly and final analysis reports of the events, which Bayer will make publicly available.
|January 10, 2020||The FDA provided an update on the end of enrollment for the 522 study.|
|December 31, 2019||All unused Essure units should have been returned to Bayer so they are no longer available for implantation.|
|November 2019||The FDA updated the Essure webpages to include:
|May 2019||The FDA updated the Essure webpages to include information about the medical device reports received in 2018.|
Following Bayer's 2018 announcement that it planned to remove Essure from the market, the FDA worked with Bayer to determine the best way to move forward to answer the critical questions we posed concerning certain patient complications that may be experienced by women who have Essure since the company would not meet its expected enrollment numbers. The FDA approved a revised postmarket surveillance ("522 study") plan that extended Bayer's mandatory follow up of women enrolled in the study from three years to five years. The FDA also provided an update on the Essure webpages related to the ongoing postmarket review of Essure, including the status of the 522 study and information about device removal from medical device reports and an ongoing post-approval study.
|July 2018||The FDA was notified by Bayer that the Essure permanent birth control device would no longer be sold or distributed after December 31, 2018|
|April 2018||The FDA restricted the sale and distribution of Essure to health care providers who agreed to review Bayer's Patient-Doctor Discussion Checklist with patients, and gave them the opportunity to sign it, before Essure implantation. The FDA approved this new safety measure to ensure that the device meets our standards for providing a reasonable assurance of safety and effectiveness.
The FDA also approved Bayer's new labeling that includes:
|March 2017||The FDA announced active evaluation of a significant collection of new medical device reports submitted to FDA involving potential device removal of Essure|
|October 2016||The FDA issued the final guidance, "Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization" after carefully considering public comments. To view the comments received, go to the Public Docket and search Docket # FDA-2016-D-0435. Updated Essure Labeling Information for Patients and Health Care Providers is available online.|
|February 2016||The FDA ordered Bayer, the company that makes Essure, to conduct a post-market surveillance ("522") study to gather more data about Essure's benefits and risks. Specifically, the post-market study will provide data to help the FDA to better understand the risks associated with Essure and compare them to laparoscopic tubal ligation. This includes the rates of complications including unplanned pregnancy, pelvic pain and other symptoms, and surgery to remove the Essure device. The study will also evaluate quality of life measures after sterilization.|
|September 2015||As part of examining safety concerns about Essure raised by patients and cited in Medical Device Reports (MDRs), the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015 to:
Additional Information on Essure
- 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
FDA Communications on Essure
- FDA Brief: FDA Posts Additional Postmarket Information for Essure
- FDA Brief: FDA Posts Interim Results from Required Essure Postmarket Surveillance Study
- FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure (04/24/2020)
- FDA provides updates on discontinuation of Essure and ongoing postmarket activities (01/10/2020)
- FDA provides updates on our ongoing postmarket activities for Essure (11/04/2019)
- FDA provides updates on the agency's continued commitment to evaluating postmarket safety of Essure device (05/15/2019)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen the long-term safety oversight of the Essure device following discontinuation of its U.S. sales (12/20/2018)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S.; agency's continued commitment to postmarket review of Essure and keeping women informed (07/20/2018)
- FDA restricts sale and distribution of Essure to protect women and to require that patients receive risk information (04/09/2018)
- Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA activities related to the ongoing post-market review of Essure and FDA's commitment to keep women informed (03/07/2018)
- FDA takes additional action to better understand safety of Essure, inform patients of potential risks (02/29/2016)