Desired Pregnancy after Essure Placement
8/1/2011 - Roger Smith, MD
Editor: Martin E. Olsen MD
While permanent methods of sterilization should be considered just that, permanent, patients and their partners can and do change their minds. Pregnancies after permanent sterilization procedures can occur spontaneously. In the clinical studies of the Essure device, approximately 1 out of every 7 women were not able to have the device placed in both fallopian tubes during the first placement procedure. Adherance to the recommended confirmatory hysterosalpingogram (HSG) at 3 months has been reported to vary widely, from as low as 13% to greater than 85%. At routine 3-month follow-up, 4% of the women who did receive placement in both tubes were found to have the inserts in an incorrect position, including having too much or too little of the device within the tube, expulsion from the tube, or perforation through the tube or uterine wall. In these cases, the device cannot and should not be trusted for contraception. Even with hysterosalpingography that confirms correct placement and apparent tubal occlusion, late pregnancies have been reported. The exact frequency of subsequent pregnancy is not known, though in clinical studies the device was shown to be 99.74% effective at 5 years of follow-up, if the recommended HSG confirmed tubal occlusion. Women who undergo sterilization by Essure or incisional tubal ligation are more likely to have an ectopic pregnancy if they spontaneously conceive.
Options for pregnancy are even more limited after Essure than after traditional methods of sterilization. With procedures performed on the mid-portions of the fallopian tube, tubal reanastomosis, bridging or excising the damaged portions were traditionally attempted. This approach has been generally abandoned because of poor conception rates, increased rates of ectopic implantation and improved successes with in vitro fertilization (IVF). IVF offers the ability to bypass the obstructed fallopian tube regardless of site of obstruction. There are no data on the safety or effectiveness of IVF after Essure. Because the procedure for introducing the conceptus following IVF may snag the portion of the device that is in the uterus or the devices could interfere with successful implantation of the fertilized egg, a slightly higher failure rate might be expected. The risks of the Essure devices to the fetus or mother are unknown if pregnancy is achieved, as is the rate of continuation of the pregnancy. There are reports of successful pregnancy following hysteroscopic extraction of the implants, but given the degree of tubal scarring caused by the device placement and damage caused by the removal, successful conception or an intrauterine pregnancy would not be assured. Interestingly, an off-label use of Essure in the management of hydrosalpinx has been described as an alternative to salpingectomy in patients with hydrosalpinx who desire in-vitro fertilization. In these descriptions, Essure replaces salpingectomy as a mechanism to treat hydrosalpinx and improve in vitro fertilization rates.
Cohen SB, Bouaziz J, Schiff E, Simon A3, Nadjary M, Goldenberg M, Orvieto R, Revel A. In Vitro Fertilization Outcomes After Placement of Essure Microinserts in Patients With Hydrosalpinges Who Previously Failed In Vitro Fertilization Treatment: A Multicenter Study. J Minim Invasive Gynecol. 2016 Sep-Oct;23(6):939-43. doi: 10.1016/j.jmig.2016.05.010. Epub 2016 May 30.
Initial Approval August 2011; Updated January 2017
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