The recent removal of Essure from the US market has created concern among patients with the device about the reason for the manufacturer’s action. Many women also may have questions about whether to have the device removed. This article reviews the history, literature, and symptoms related to Essure as well as removal techniques to guide physicians through the counseling process.
Essure is a hysteroscopic sterilization technique involving placement of nickel-titanium microinserts in the fallopian tubes. Over the course of
12 weeks, the microinserts cause fibrosis and occlusion of the fallopian tubes. Essure was approved by the US Food and Drug Administration (FDA) in 2002.1 Benefits of the technique were that it was a minimally invasive procedure that could be conveniently performed in the office without requiring general anesthesia or abdominal incisions and hormone-free sterilization. It was a safe option for women who had contraindications to general anesthesia or hormonal contraception or who wanted to avoid abdominal surgery.
Concerns about Essure
Increasing patient reports about Essure-related symptoms led to a growing number of safety concerns about the device. Patient concerns have ranged widely from hair loss to physical and mental disabilities.2 One retrospective cohort study found that the most commonly reported symptoms following Essure placement were abdominal pain, back pain, fatigue, leg and hip pain, dysmenorrhea, and heavy menstrual bleeding.3 Another retrospective case series revealed that pelvic pain, abnormal uterine bleeding (AUB), and a reported allergic reaction were the symptoms most commonly reported by women prior to undergoing Essure removal.4 Patients who reported allergic reactions prior to sterilization were at higher risk of developing an allergic reaction with hysteroscopic sterilization when compared to laparoscopic sterilization.5
For more information on Essure removal - Laparoscopic Essure Tubal Reversal: How We Do It
Websites and Facebook groups run by women with Essure who had symptoms, led to a public outcry against the device, specifically in regards to the polyethylene terephthalate (PET) fibers in the microinserts.6,7 In response, in 2015, the FDA appointed a special panel to investigate these claims, added a “black box” warning, and created stricter guidelines for placement.1 Continued complaints and stricter guidelines caused a significant decrease in the number of devices placed.8 Bayer removed Essure from the European market in September 20173 and from the US market in December 2018 due to the decrease in sales.1 In its announcement, Bayer stated that preventative removal for those without symptoms was unnecessary.1
The authors report no potential conflicts of interest with regard to this article.
- Bayer. Frequently Asked Questions About Essure. http://www.essure.com/faq. Accessed April 29, 2019.
- Banks C, et al. Increasing patient engagement in pharmocovigilance through online community outreach and mobile reporting applications: an analysis of adverse event reporting for the Essure Device in the US. Pharm Med. 2015;29(6):331-340.
- Maassen LW, van Gastel DM, Haveman I, Bongers MY, Veersema S. Removal of Essure sterilization devices: a retrospective cohort study in the Netherlands. J Minim Invasive Gynecol. 2018 Oct 16. pii: S1553-4650(18)31302-5.
- Clark NV, Rademaker D, Mushinski AA, Ajao MO, Cohen SL, Einarsson JI. Essure removal for the treatment of device-attributed symptoms: an expanded case series and follow-up survey. J Minim Invasive Gynecol. 2017;24(6):971-976.
- Bouillon K, Bertrand M, Bader G, Lucot JP, Dray-Spira R, Zureik M. Association of hysteroscopic vs laparoscopic sterilization with procedural, gynecological, and medical outcomes. JAMA. 2018;319(4):375-387.
- Advocating Safety in Healthcare E-Sisters (ASHES). https://www.ashesnonprofit.com/. Accessed April 29, 2019.
- Essure Problems. https://essureproblems.webs.com/. Accessed April 29, 2019.
- Bayer. New Release: Bayer to voluntarily discontinue U.S. sales of Essure at end of 2018 for business reasons. http://www.essure.com/assets/pdf/PP-250-US-1923-FINAL-News-Release.pdf. Accessed April 29, 2019.
- Meister MR, Sutcliffe S, Ghetti C, et al. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019;220(3):255.e1-255.e9.
- Sills ES, Dalton MM. Referrals for complications following hysteroscopic sterilisation: characteristics associated with symptomatic patients after the Essure procedure. Eur J Contracept Reprod Health Care. 2016;21(3):227-233.
- Charavil A, Agostini A, Rambeaud C, Schmitt A, Tourette C, Crochet P. Vaginal hysterectomy with salpingectomy for Essure insert removal. J Minim Invasive Gynecol. 2019;26(4):695-701.
- Sills ES, Li X, Wood SH, Jones CA. Analysis of surgeries performed after hysteroscopic sterilization as tabulated from 3,803 Essure patient experiences. Obstet Gynecol Sci. 2017;60(3):296-302.
- Thiel L, Rattray D, Thiel J. Laparoscopic cornuectomy as a technique for removal of Essure microinserts. J Minim Invasive Gynecol. 2017;24(1):10.
- Albright CM, Frishman GN, Bhagavath B. Surgical aspects of removal of Essure microinsert. Contraception. 2013;88(3):334-336.
- Lazorwitz A, Tocce K. A case series of removal of nickel-titanium sterilization microinserts from the uterine cornua using laparoscopic electrocautery for salpingectomy. Contraception. 2017;96(2):96-98.
- Lane A, Tyson A, Thurston E. Providing Re-Essure-ance to the nickel-allergic patient considering hysteroscopic sterilization. J Minim Invasive Gynecol. 2016;23(1):126-129.