FDA Activities Related to Essure

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. As of December 31, 2019, all unused Essure units should have been returned to Bayer and are no longer available for implantation.

Even though Essure is no longer sold or distributed in the United States, the FDA remains committed to collecting long-term safety information in women who have received the device. A timeline and summary of our most significant activities related to Essure is provided below.

Date	Event
April 9, 2024	The FDA updated the Essure Information for Patients and Health Care Providers web page with the latest postmarket study information about device removals in the Information about Essure Device Removal section. In addition, the FDA updated the Problems Reported with Essure web page to include information about the medical device reports received in 2023.
October 30, 2023	The FDA provided interim results from a third planned interim analysis after all patients completed three years of follow up in the postmarket surveillance ("522") study. Because the patients in the study are at different points in their follow up, the results presented are the overall interim study results from all patients thus far. Five-year follow-up of patients in the study is ongoing. At the request of FDA in 2022, Bayer developed and implemented additional strategies to improve follow up in the study. The current study status is "ongoing" because the progress of the study is consistent with the study plan. The FDA will continue to monitor lost to follow-up rates in the study and work with Bayer to take additional measures as needed. Final analyses of endpoints will be performed when the study concludes, after all patients have completed 5 years of follow-up and final adjudication of the data is completed. In addition, the FDA updated the Essure Information for Patients and Health Care Providers web page with the most current postmarket study information about device removal in the Information about Essure Device Removal section.
March 31, 2023	The FDA updated the Problems Reported with Essure web page to include information about the medical device reports received in 2022.
October 6, 2022	The FDA updated the Essure Information for Patients and Health Care Providers web page with the most current postmarket study information about device removal in the Information about Essure Device Removal section. In addition, the FDA changed the postmarket surveillance ("522") study status to "Progress Inadequate" due to the increase in interim lost to follow-up rates in both the Essure and laparoscopic tubal sterilization groups from the previous database lock. Per the study protocol, if a patient misses a follow up visit but returns later and wishes to continue participation in the study, they will no longer be considered lost to follow-up. The FDA requested Bayer develop and implement additional strategies to improve follow-up rates in the study. Five-year follow-up of patients in the study is ongoing, and patients are still completing 3-year, 4-year, and 5-year follow-up visits. The next interim analysis of study results will be performed after all patients in the study have completed 3 years of follow-up.
March 14, 2022	The FDA updated the Problems Reported with Essure web page to include information about the medical device reports received in 2021.
February 14, 2022	The FDA updated the Essure Information for Patients and Health Care Providers web page with the most current results from the postmarket studies about device removal. In addition, the FDA provided interim results from a second planned interim analysis after all patients completed one year of follow up in the postmarket surveillance ("522") study. Because the patients in the study are at different points in their follow up, the results presented are the overall interim study results from all patients thus far. Five-year follow-up of patients in the study is ongoing. The next interim analysis of study results is planned after all patients complete three years of follow-up. Final analyses of endpoints will not be completed until the study concludes and final adjudication of the data is performed.
September 29, 2021	The FDA provided an update related to its review of reportable adverse events from social media information related to litigation that Bayer submitted as outlined in the April 24, 2020 variance from MDR reporting requirements. Additionally, Bayer posted the final analysis report of the adverse event information included in the variance reporting spreadsheets for the reporting time period of June 2020 through March 2021. Bayer completed the variance reporting and met the requirements of the variance. On June 14, 2021, the FDA posted the tenth spreadsheet.
May 17, 2021	The FDA posted the ninth spreadsheet 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 third quarterly analysis report of the adverse event information included in the seventh, eighth, and ninth variance reporting spreadsheets for the reporting time period of December 2020 through February 2021. The FDA will continue to make the adverse event information publicly available on the Problems Reported with Essure web page after spreadsheets are reviewed by the FDA. Bayer will provide a final analysis report of the adverse event information submitted under the variance, which Bayer will make publicly available after it is reviewed by the FDA. On April 12, 2021, the FDA posted the eighth spreadsheet.
March 15, 2021	The FDA provided an update related to the ongoing postmarket review of Essure, including information about the medical device reports in 2020. The FDA posted the seventh spreadsheet 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 second quarterly analysis report of the adverse event information included in the fourth, fifth, and sixth variance reporting spreadsheets for the reporting time period of September 2020 through November 2020. On January 11, 2021, the FDA posted the sixth spreadsheet.
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. 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 web page 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.
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.
July 8, 2020	The FDA provided interim results from the postmarket surveillance ("522") study on the Essure 522 web page. 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 laparoscopic 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 web page 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 web pages to include: the most up-to-date information from the ongoing postmarket review of medical device reports and postmarket study information about removal of the device from women who received it. an update on the status of the 522 study.
May 2019	The FDA updated the Essure web pages to include information about the medical device reports received in 2018.
December 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 web pages 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: 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.
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: discuss currently available scientific data pertaining to Essure's safety and effectiveness, hear expert scientific and clinical opinions on the risks and benefits of the device, and hear concerns and experiences of women implanted with Essure.

Additional Information on Essure

• Bayer News Release: Bayer to voluntarily discontinue U.S. sales of Essure at end of 2018 for business reasons (7/20/2018)

FDA Communications on Essure

• FDA Brief: FDA Provides Updates on Adverse Event Reports Associated with Essure Permanent Birth Control (3/15/2021)
• FDA Brief: FDA Posts Additional Postmarket Information for Essure (8/11/2020)
• FDA Brief: FDA Posts Interim Results from Required Essure Postmarket Surveillance Study (7/8/2020)
• 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)