For over a decade, transcervical sterilization revolutionized gynecology by offering an office-based procedure for sterilization under local anesthesia. Essure® was the most successful hysteroscopic sterilization device on the market, approved for almost 16 years in the United States and with an estimated 750,000 devices sold worldwide.1 While Essure proved to be very effective in preventing pregnancy, recent years have seen a dramatic rise in the number of adverse events (AEs) associated with it reported to the US Food and Drug Administration (FDA).2 Several countries have withdrawn the product from the market and Bayer AG recently announced it will discontinue sales in the United States by the end of 2018.3
A growing number of women are now seeking surgical removal of Essure due to suspected AEs such as pelvic pain, heavy bleeding, allergic reaction, and a multitude of other symptoms that may be related to the device.4,5 Essure removal is typically performed laparoscopically by removing both fallopian tubes as well as the interstitial portion of the microinsert. Many women also choose to undergo a cornual wedge resection or hysterectomy to ensure that the device and any fragments are completely excised.
Less commonly discussed is the issue of sterilization regret, a condition that affects up to 20% of sterilized women and likely some women with Essure.6 Traditionally, Essure sterilization is considered irreversible due to extensive scarring along a large portion of the fallopian tube. Most patients desiring pregnancy after Essure are advised to undergo in vitro fertilization (IVF), a readily-available alternative that has shown some success with Essure in situ.7,8 But what about women who desire removal of the device and restoration of fertility? For them, a procedure that removes the device and offers even a small chance of spontaneous pregnancy might be worthwhile.
Essure reversal is uniquely challenging. The device’s polyethylene terephthalate fibers induce permanent fibrosis along almost half of the fallopian tube, including the interstitial segment. This leaves only a short segment of the distal fallopian tube available for direct attachment to the uterus. This type of procedure is termed a tubouterine anastomosis; a technique that dates back to the late 19th century (Figure 1).
Tubouterine anastomosis was first described for treating women with proximal tubal occlusion unrelated to sterilization.9 Proximal tubal occlusion can be caused by conditions such as chronic salpingitis, salpingitis isthmica nodosa, cornual fibroids, adhesive disease, and endometritis.10 Long before IVF, tubal cannulation and tubouterine anastomosis were attempted to restore tubal patency in women with proximal tubal occlusion. Tubouterine anastomosis was classically an open procedure in which fundal hysterotomy or cornual wedge resection was performed for excision of the affected fallopian tube and reimplantation of the distal fallopian tube to the uterine cornua. Conception rates following the procedure were variable, ranging from 14% to 42% in the literature.11-14
The authors report no potential conflicts of interest with regard to this article.
- Bayer. Essure permanent birth control. http://www.essure.com/what-is-essure. Accessed August 15, 2018.
- Walter JR, Ghobadi CW, Hayman E, Xu S. Hysteroscopic Sterilization With Essure: Summary of the U.S. Food and Drug Administration Actions and Policy Implications for Postmarketing Surveillance. Obstet Gynecol. 2017;129(1):10-19.
- Mohan N. Bayer to stop selling Essure in the U.S. Wall Street Journal. July 20th, 2018.
- Kamencic H, Thiel L, Karreman E, Thiel J. Does Essure cause significant de novo pain? a retrospective review of indications for second surgeries after Essure placement. J Minim Invasive Gynecol. 2016;23(7):1158-1162.
- 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.
- Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93(6):889-895.
- Arora P, Arora RS, Cahill D. Essure® for management of hydrosalpinx prior to in vitro fertilization—a systematic review and pooled analysis. BJOG. 2014;121:527–536.
- Kerin JF, Cattanach S. Successful pregnancy outcome with the use of the in vitro fertilization after Essure hysteroscopic sterilization. Fertil Steril. 2007;87:1212.e1-4.
- Reis E. Plastic operation on the fallopian tubes. Am J Surg Gynecol. 1899;11:180.
- De Silva PM, Chu JJ, Gallos ID, Vidyasagar AT, Robinson L, Coomarasamy A. Fallopian tube catheterization in the treatment of proximal tubal occlusion: a systematic review and meta-analysis. Hum Reprod. 2017;32(4):836-852.
- Turck RC. Hysterosalpingostomy. NY Med J. 1909;89:1193-1196.
- Williams GF. Tubo-uterine implantation with special reference to reversal of sterilization. Lancet. 1969;1(7599):825-827.
- Green-Armytage VG. Tubo-uterine implantation. J Obstet Gynaecol Br Emp. 1957;64:47.
- Diamond E. A comparison of gross and microsurgical techniques for repair of cornual occlusion in infertility: a retrospective study, 1968–1978. Fertil Steril. 1979;32:370-376.
- Montieth CW, Berger GS, Zerden ML. pregnancy success after hysteroscopic sterilization reversal. Obstet Gynecol. 2014;124(6):1183-1189.
- Tubal Reversal A Personal Choice. https://www.tubal-reversal.net/. Accessed August 15, 2018.
- Trussel J, Guilbert E, Hedley A. Sterilization failure, sterilization reversal, and pregnancy after sterilization reversal in Quebec. Obstet Gynecol. 2003;101(4):677.
- Boeckxstaens A, Devroey P, Collins J, Tournaye H. Getting pregnant after tubal sterilization: surgical reversal or IVF? Hum Reprod. 2007;22(10):2660.
- Messinger LB, Alford CE, Csokmay JM, Henne MB, Mumford SL, Segars JH, Armstrong AY. Cost and efficacy comparison of in vitro fertilization and tubal anastomosis for women after tubal ligation. Fertil Steril. 2015;104(10):32-38.