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History of a Device: Essure

<ѻý class="mpt-content-deck">— This timeline summarizes steps taken by FDA and other agencies
MedpageToday

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.