Essure began as an exciting new contraceptive option for women, but when adverse event reports began piling up, it became a focus of controversy and litigation. It has now been removed from the market everywhere in the world except the United States. Following is a timeline from its approval in 2002 to 2023, when a major post-marketing study is supposed to conclude.
Nov. 4, 2002: FDA approved Essure, marketed by Conceptus, and mandated that the company conduct two post-approval studies, one to gather and another to . Summaries of both studies .
Sometime in 2011: Angie Firmalino, a patient who had the Essure system implanted and removed, starts the "Essure Problems" Facebook group
June 5, 2013: Bayer acquires Conceptus.
Feb. 20, 2015: Citizen petition filed with FDA by Koch Parafinczuk and Wolf, P.A., claiming the expedited premarket approval process was of trial participants."
April 24, 2015: required under the FDA’s 2002 approval publishes.
Sept. 25, 2015: FDA advisory committee discusses post-market data and peer-reviewed research, listens to dozens of women citing injuries related to Essure; concludes the device should clearly state that it's a surgical device, include more comprehensive instructions for insertion and follow-up monitoring.
Oct. 13, 2015: Study of Essure in The BMJ finds women who received implantable Essure inserts had 10 times the risk of repeat operations compared with those undergoing tubal ligation.
Feb. 29, 2016: FDA orders Bayer to conduct another Agency's "" from the original clinical trials (in response to the Citizen Petition) finds "less than 1 percent" of case report data related to pain, bleeding, device placement or migration and pregnancy were altered.
June 8, 2016: Rep. Mike Fitzpatrick (R-Pa.) and Rep. Louise Slaughter (D-N.Y.) which would amend the Federal Food, Drug, and Cosmetic Act to allow patients to collect damages despite "the federal prohibition on state or local requirements regarding medical devices."
August 2017: Patient-Centered Outcomes Research Institute board approves " of Essure vs. laparoscopic sterilization.
Aug. 3, 2017: The decides against renewing Essure's commercial license, which had the effect of suspending Essure everywhere in the European Union for 3 months.
Aug. 30, 2017: Australasian Medical and Science Ltd. (AMSL), in coordination with Australia's Therapeutic Goods Administration, issues a "hazard alert" for Essure and AMSL recalled unused stock while
Sept. 2, 2016: FDA of Essure.
Dec. 31, 2016: FDA notes receipt of 14,919 medical device reports related to Essure (prior to 2016 most reports volunteered by patients; in 2016, 56% from manufacturer).
Oct. 31, 2016: FDA issues to include a boxed warning and incorporate a patient decision checklist.
Feb. 17, 2017: Brazil's health agency announces sales of Essure . Bayer said the device was discontinued only “temporarily†because of paperwork issues.
Sept. 18, 2017: Bayer announced plans to .
Oct. 30, 2017: Rep. Rosa DeLauro (D-Conn.) , Rep. Jan Schakowsky (D-Ill.) and Rep. Louise Slaughter (D-N.Y.) send letter to Commissioner Scott Gottlieb, MD, requesting information and meeting.
July, 2020: Patient-Centered Outcomes Research Institute's expected to complete.
Sept. 1, 2023: Essure final report due.