ABSTRACT: The U.S. Food and Drug Administration has approved two devices for hysteroscopic tubal sterilization. To minimize the failure rates of these effective methods, it is important for health care providers to understand the important role hysterosalpingography (HSG) plays in any hysteroscopic tubal sterilization procedure. The purpose of this Committee Opinion is to emphasize the necessity of performing HSG 3 months after hysteroscopic tubal sterilization and to identify factors that may interfere with performance of an adequate HSG assessment.
The U.S. Food and Drug Administration (FDA) has approved two devices for hysteroscopic tubal sterilization, and in the future, more devices may be approved. These methods are a welcome expansion of the contraceptive options available to women. As minimally invasive methods, they can be performed without general anesthesia in many cases and offer an in-office sterilization procedure for selected patients. To minimize the failure rates of these effective methods, it is important for health care providers to understand the important role hysterosalpingography (HSG) plays in any hysteroscopic tubal sterilization procedure. According to the U.S. device labeling, HSG is the only method to be used for confirmation of tubal occlusion. The purpose of this Committee Opinion is to emphasize the necessity of performing HSG 3 months after hysteroscopic tubal sterilization and to identify factors that may interfere with performance of an adequate HSG assessment.
The Essure (intrauterine [intratubal] microinsert) system (1) was approved by the FDA in 2002. In this procedure, a microinsert made of a nickel titanium outer coil and a stainless steel inner coil wrapped in polyethylene terephthalate fibers is placed in the proximal portion of the fallopian tube under hysteroscopic guidance. Chronic inflammation induced by the polyethylene terephthalate fibers leads to fibrotic ingrowth in and around the microinserts culminating in tubal occlusion. According to the manufacturer, an estimated 310,000 devices have been placed to date (2). More recently, the Adiana (bipolar radiofrequency and silicone) system (3) was approved in July 2009. In this procedure, the delivery catheter is placed in the tubal ostia. Bipolar radiofrequency energy is delivered to create a superficial lesion within the fallopian tube. A silicone matrix is then deployed into the proximal tube in the area of the lesion. The tissue ingrowth causes tubal occlusion along the length of the implanted matrix. Both procedures have a number of important differences from other sterilization procedures that must be considered when selecting and counseling patients.
The most important difference from other sterilization procedures is that patients undergoing hysteroscopic sterilization must rely on another method of contraception for at least 3 months after the microinsert placement (interim contraception). They also must undergo HSG to confirm bilateral occlusion before relying on hysteroscopic sterilization because the tissue ingrowth necessary for occlusion typically takes 3 months after placement of the microinsert or deployment of the silicone matrix. In some patients, occlusion may take even longer. In the original phase III trial for the nickel titanium and polyethylene terephthalate system, 8% of women undergoing HSG 3 months after hysteroscopic sterilization had persistent tubal patency (4). Similar rates were noted in the first large trial of the bipolar radiofrequency and silicone system (5). If bilateral tubal occlusion is not confirmed on the HSG performed at 3 months, patients must be counseled to use interim contraception and have a repeat HSG 3 months later. If bilateral occlusion is still not confirmed on the repeat study, patients must be counseled not to rely on the hysteroscopic tubal sterilization and to use alternative contraception.
The manufacturers have specific protocols for the confirmatory HSG, which differ from the standard HSG required for infertility evaluation (6). These protocols are notable for requiring lower filling pressure, potentially making the procedure less uncomfortable for the patient, but requiring six specific separate images. Health care providers performing confirmatory HSG should follow these protocols.
Patients considering hysteroscopic sterilization need careful counseling regarding the need for interim contraception and the need to return for postoperative HSG. Interim contraceptive plans should be finalized before the placement procedure. Logistic difficulties potentially preventing return for HSG such as scheduling and verification of coverage by insurance should be dealt with before the procedure whenever possible. Patient insurance coverage may change in the interim, posing a substantial barrier. In clinical practice, patient adherence with HSG varies. In three studies specifically examining rates of adherence with HSG, rates varied from as high as 86.4% to as low as 12.7% (7–9). Out of the 64 pregnancies that occurred after the nickel titanium and polyethylene terephthalate procedure, which were reported to the manufacturer between 1997 and 2005, 47% appeared to result from nonadherence to use of interim contraception or return for HSG (10). Failure to return for confirmatory HSG was the most frequent risk factor. Out of the six pregnancies that occurred in the first 12 months of use in the Evaluation of the Adiana System for Sterilization Using Electrothermal Energy trial, three were attributed by the manufacturer to improper interpretation of the HSG (11).
Some health care providers have combined placement of the nickel titanium and polyethylene terephthalate system with same-day endometrial ablation procedures. A single published study conducted outside of the United States evaluated tubal occlusion in 23 participants undergoing placement of the nickel titanium and polyethylene terephthalate system and endometrial ablation by a variety of techniques (12). Out of these 23 participants, 20 returned for confirmation of occlusion, and all 20 had occlusion confirmed. However, in this study, tubal occlusion was documented by three-dimensional ultrasonogram and pelvic X-ray, not the HSG required in the device labeling. In the Hopkins et al study (13) sterilization was performed with the nickel titanium and polyethylene terephthalate system after endometrial ablation with an automated radiofrequency procedure in 25 patients. Out of the 23 patients who eventually returned for HSG, 21 had confirmed occlusion. Two of the patients were unable to have adequate HSG assessments, one because of cervical stenosis and one because of intrauterine synechiae. In a study presented to the FDA by the manufacturer, 10 out of 30 women undergoing thermal balloon endometrial ablation followed by sterilization with the nickel titanium and polyethylene terephthalate system had intrauterine synechiae on the day of HSG. Out of these 10 patients, five cases of synechiae were so severe that confirmatory HSG could not be performed (14). Based on this finding, the nickel titanium and polyethylene terephthalate device labeling was specifically changed to state "DO NOT perform the Essure procedure concomitantly with endometrial ablation. Ablation causes intrauterine synechiae, which can compromise (ie, prevent) the 3-month Essure confirmation test (HSG). Women who have inadequate 3-month confirmation tests cannot rely on Essure for contraception" (1). Labeling for the bipolar radiofrequency and silicone system contains similar warnings. Health care providers should follow the manufacturers' instructions and not perform same-day endometrial ablation and hysteroscopic sterilization.
- Conceptus, Inc. Essure: instructions for use. Mountain View (CA): Conceptus; 2009. Available at: http://www.essuremd.com/portals/essuremd/PDFs/TopDownloads/L3002%2009_09_09%20smaller.pdf. Retrieved January 28, 2010.
- Conceptus, Inc. What is Essure? Mountain View (CA): Conceptus; 2010. Available at: http://www.essuremd.com/Home/AboutEssure/WhatisEssure/tabid/219/Default.aspx. Retrieved January 28, 2010.
- Hologic, Inc. Hysterosalpingography (HSG) for Adianapermanent contraception. Marlborough (MA): Hologic; 2009.Available at: http://training.adiana.com/Content/AdianaHSGIFU.pdf. Retrieved January 28, 2010.
- Cooper JM, Carignan CS, Cher D, Kerin JF. Microinsert nonincisional hysteroscopic sterilization. Selective Tubal Occlusion Procedure 2000 Investigators Group. Obstet Gynecol 2003;102:59–67.
- Vancaillie TG, Anderson TL, Johns DA. A 12-month prospective evaluation of transcervical sterilization usingimplantable polymer matrices. Obstet Gynecol 2008;112: 1270–7.
- Conceptus, Inc. Essure: the alternative to incision. HSG protocol. Mountain View (CA): Conceptus; 2003. Available at: http://www.essuremd.com/Portals/0/Skins/Conceptus_Skin/PDFs/TR-0671-101-HSG-Protocol.pdf. Retrieved January 28, 2010.
- Glazerman LR. Hysterosalpingogram after Essure sterilization in a private practice: patient compliance and results [abstract]. J Minim Invasive Gynecol 2008;15:S76.
- Guiahi M, Goldman KN, Olson CG. Retrospective analysis of hysterosalpingogram confirmatory test follow-up after Essure hysteroscopic sterilization; 4-year experience in a community setting [abstract]. J Minim Invasive Gynecol 2008;15:S78–9.
- Shavell VI, Abdallah ME, Diamond MP, Kmak DC, Berman JM.Post-Essure hysterosalpingography compliance in a clinic population. J Minim Invasive Gynecol 2008;15:431–4.
- Levy B, Levie MD, Childers ME. A summary of reportedpregnancies after hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:271–4.
- Hologic, Inc. Adiana permanent contraception: instructions for use and radiofrequency (RF) generator operator's manual. Marlborough (MA): Hologic; 2009. Available at: http://www.adiana.com/pdf/hcp/adiana-instructions-for-use.pdf. Retrieved January 28, 2010.
- Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R,Fernandez H. Essure sterilization associated with endometrial ablation. Int J Gynaecol Obstet 2007;97:139–42.
- Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE,Famuyide AO. Radiofrequency global endometrial ablation followed by hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:494–501.
- Conceptus, Inc. Important information for physicians on modifications to the Essure permanent birth control system labeling related to concomitant use with Gynecare Thermachoice uterine balloon therapy system. Mountain View (CA): Conceptus; 2006. Available at: http://www.essuremd.com/portals/essuremd/PDFs/TopDownloads/CC-1411%2031Octo6F_on_lthd.pdf. Retrieved February 29,2010.
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Use of Hysterosalpingography After Tubal Sterilization. Committee Opinion No. 458. American College of Obstetricians and Gynecologists. Obstet Gynecol 2010;115:1343–5.