Global InformationEssure information
| Essure | |
|---|---|
 | |
| Background | |
| Type | Sterilization |
| First use | 2002 |
| Failure rates (first year, after occlusion; data disputed) | |
| Perfect use | 0.26% |
| Typical use | ? |
| Usage | |
| Duration effect | Permanent |
| Reversibility | irreversible |
| User reminders | Additional methods until 3 month check by hysterosalpingogram |
| Clinic review | None |
| Advantages and disadvantages | |
| STI protection | No |
| Benefits | Permanent contraception |
Essure was a device for female sterilization. It is a metal coil which when placed into each fallopian tube induces fibrosis and blockage.[1] Essure was designed as an alternative to tubal ligation. However, it was recalled by Bayer in 2018, and the device is no longer sold due to complications secondary to its implantation. The company has reported that several patients implanted with the Essure System for Permanent Birth Control have experienced and/or reported adverse effects, including: perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reaction. Although designed to remain in place for a lifetime, it was approved based on short-term safety studies. Of the 745 women with implants in the original premarket studies, 92% were followed up at one year, and 25% for two years, for safety outcomes. A 2009 review concluded that Essure appeared safe and effective based on short-term studies, that it was less invasive and could be cheaper than laparoscopic bilateral tubal ligation.[2] About 750,000 women have received the device worldwide.[3]
Initial trials found about 4% of women had tubal perforation, expulsion, or misplacement of the device at the time of the procedure.[3] Since 2013, the product has been controversial, with thousands of women reporting severe side effects leading to surgical extraction.[4] Rates of repeat surgery in the first year were ten times greater with Essure than with tubal ligation.[3] Campaigner Erin Brockovich has been hosting a website where women can share their stories after having the procedure.[4][5][6] As of 2015 many adverse events, including tubal perforations, intractable pain and bleeding leading to hysterectomies, possible device-related deaths, and hundreds of unintended pregnancies occurred, according to the US FDA adverse events database and other studies.[1][7]
It was developed by Conceptus Inc. and approved for use in the United States in 2002.[8] Conceptus was acquired by Bayer AG of Germany in June 2013.[citation needed][9] In 2017, the CE marking in the European Union, and thus the commercial license for Essure was suspended for at least three months. Authorities in France and Ukraine recalled the implants, and the manufacturer withdrew the product voluntarily in Canada, the UK, Finland, and the Netherlands.[10][11][12][13] In April 2018, the FDA restricted sale and use of Essure which resulted in a 70% decrease in sales.[14][15] In July 2018 Bayer announced the halt of sales in the U.S. by the end of 2018.[16][17] The device is featured in the 2018 Netflix documentary The Bleeding Edge.
- ^ a b Dhruva SS, Ross JS, Gariepy AM (October 2015). "Revisiting Essure--Toward Safe and Effective Sterilization". The New England Journal of Medicine. 373 (15): e17. doi:10.1056/NEJMp1510514. PMID 26397951.Free full text
- ^ Cite error: The named reference
Hurskainenwas invoked but never defined (see the help page). - ^ a b c Clark NV, Endicott SP, Jorgensen EM, Hur HC, Lockrow EG, Kern ME, et al. (November 2018). "Review of Sterilization Techniques and Clinical Updates". Journal of Minimally Invasive Gynecology. 25 (7): 1157–1164. doi:10.1016/j.jmig.2017.09.012. PMID 28939482. S2CID 24849899.
- ^ a b Cite error: The named reference
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BBC27871265was invoked but never defined (see the help page). - ^ Stein R (21 September 2015). "FDA Revisits Safety Of Essure Contraceptive Device". NPR. Retrieved 21 September 2015.
- ^ Cite error: The named reference
BMJwas invoked but never defined (see the help page). - ^ Cite error: The named reference
FDAwas invoked but never defined (see the help page). - ^ "Essure Permanent Birth Control". U.S. Food and Drug Administration. Retrieved June 24, 2014.
- ^ Isle JW (17 August 2017). "Essure Loses Commercial License in European Union - Legal Reader". Legalreader.com. Retrieved 16 May 2018.
- ^ "Essure Sales Halted In European Union, Implants Recalled". Birthcontrolproblems.com. 7 August 2017. Retrieved 16 May 2018.
- ^ "EU suspends sale of contraceptive implant". Medicalspress.com. Retrieved 16 May 2018.
- ^ "Satojen naisten sterilisaatiot menneet pieleen Suomessa – vaeltamaan lähteneitä implantteja löydetty muualta elimistöstä". Yle Uutiset. 17 August 2017. Retrieved 16 May 2018.
- ^ US FDA Medical Devices--FDA Activities: Essure Page Last updated 04/09/2018, accessed 16 May 2018
- ^ Office of the Commissioner (18 March 2019). "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". FDA. Retrieved 6 September 2019.
- ^ Bellon T. "Bayer to phase out Essure birth control device in U.S." U.S. Retrieved 2018-07-26.
- ^ "Sales of Essure birth control implant to be halted by Bayer; U.S. last to sell controversial device". Washington Post. Retrieved 6 September 2019.