RisksBy Mayo Clinic Staff
The Food and Drug Administration (FDA) issued updated guidelines in 2016 for women who choose the Essure system and their doctors to help them better understand the risks and know when to be evaluated for side effects. According to the FDA, the Essure system remains an appropriate treatment for the majority of women seeking permanent birth control, but some women may be at risk of serious complications.
Risks associated with the Essure system include:
- Tubal blockage occurring on only one side
- Perforation of the uterus or fallopian tubes from movement of the device
- Pelvic pain
- Needing to have the device removed, if serious complications occur
You may not be able to have further pelvic electrosurgical procedures, such as some types of endometrial ablation, after having the Essure system implanted.
The Essure system doesn't offer protection from sexually transmitted infections (STIs).
In the first year after implantation of the Essure system, fewer than 1 out of 100 women will get pregnant. The risk of unintended pregnancy is likely highest during the first three months after the placement of the Essure system.
Testing to confirm the Essure system has blocked the fallopian tubes can reduce the risk of unintended pregnancy.
If you do conceive after having the Essure system inserted, there's a higher chance that the pregnancy will be ectopic — when fertilization happens outside the uterus, usually in a fallopian tube.
Nov. 29, 2016
- Hatcher RA, et al. Contraceptive Technology. 20th ed. New York, N.Y.: Ardent Media; 2011:249.
- Greenberg J. Hysteroscopic sterilization. http://www.uptodate.com/home. Accessed Oct. 26, 2014.
- Essure (prescribing information). Milipitus, Calif.: Bayer Healthcare LLC; 2012. http://www.essuremd.com. Accessed Oct. 28, 2014.
- Adelman MR, et al. Management of complications encountered with Essure hysteroscopic sterilization: A systematic review. Journal of Minimally Invasive Gynecology. 2014;21:733.
- Jost S, et al. Essure permanent birth control effectiveness: A seven-year survey. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2013;168:134.
- FDA takes additional action to better understand safety of Essure, inform patients of potential risks. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm488313.htm. Accessed March 3, 2016.
- Laughlin-Tommaso SK (expert opinion). Mayo Clinic, Rochester, Minn. March 4, 2016.
- Essure permanent birth control system by Bayer Healthcare: FDA announcement — label changes. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm529241.htm. Accessed Nov. 16, 2016.