By Rebecca H. Allen, MD, MPH
Assistant Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants’ Hospital, Providence, RI
Dr. Allen reports she is a Nexplanon trainer for Merck, a Liletta trainer for Actavis, and on the advisory board for Bayer, Actavis, and Vermillion.
SYNOPSIS: In this retrospective cohort study, women who underwent concomitant hysteroscopic sterilization and endometrial ablation procedures were more likely to have inadequate 3-month hysterosalpingram testing to confirm tubal occlusion.
SOURCE: Hopkins MR, et al. Hysterosalpingography after radiofrequency endometrial ablation and hysteroscopic sterilization as a concomitant procedure. Obstet Gynecol 2015;126:628-634.
This single-center, retrospective, cohort study compared women who underwent concomitant radiofrequency endometrial ablation (Novasure) and hysteroscopic tubal occlusion (Essure) to women who underwent hysteroscopic tubal occlusion alone. The primary outcome of the study was the frequency of the inability to rely on the microinserts for contraception based on hysterosalpingogram (HSG) interpretation using manufacturers’ guidelines. Secondary outcomes included the degree of intrauterine synechiae present on HSG. Included women were seeking treatment for heavy menstrual bleeding and sterilization. Exclusion criteria included pregnancy, postmenopausal bleeding, undiagnosed uterine bleeding, large submucal leiomyoma, and known tubal anomaly. Women underwent HSG testing at 3 months and again at 6 months if the first exam was unsatisfactory. The HSGs were interpreted by two blinded reviewers, a radiologist, and a gynecologist. Clinical data abstracted from the medical record included basic demographic information, prior cesarean delivery, need for subsequent hysterectomy, and postprocedure pregnancy.
A total of 94 women underwent combined procedures between January 2003 and June 2011. These women were compared to 92 randomly selected subjects who underwent sterilization only during that time period. HSGs were not completed in 14 of 92 (15.2%) women in the sterilization-only group compared with 20 of 94 (21.3%) women in the combined group (P = 0.03). This was mostly due to patient non-adherence to the protocol; however, two women in the combined group had failed HSG attempts (one due to cervical stenosis and one due to pain). This resulted in a final study cohort of 76 patients in the sterilization-only group and 71 in the combined group. The combined group had 13 of 71 (18.3%; 95% confidence interval [CI], 10.1%-29.3%) HSGs interpreted as inadequate for the patient to rely on the device for sterilization compared with 5 of 76 (6.6%; 95% CI, 2.2%-14.7%) in the sterilization-only group. Of the seven women who returned for indicated 6-month HSGs, the two women from the sterilization-only group achieved adequacy and tubal occlusion, while the five women in the combined group did not achieve adequacy, three because of persistently patent tubes and two because of intrauterine synechiae. Including all completed HSGs, women in the combined group were five times more likely to have an unsatisfactory HSG compared to women in the sterilization-only group (odds ratio, 5.45; 95% CI, 1.48-20). Overall, the rate of intrauterine synechaie was higher in the combined group (80%) compared to the sterilization-only group (P = 0.001).
Commentary
The FDA requires HSG testing 3 months after hysteroscopic sterilization to document device location and tubal occlusion before relying on the microinserts for contraception. The concern regarding concomitant hysteroscopic sterilization and endometrial ablation procedures stems from the possibility that the HSG confirmation test performed to document tubal occlusion will be suboptimal due to intrauterine scarring. In other words, the dye used in the HSG may not be able to fill the entire uterine cavity and reach the cornua and fallopian tubes. This concern has led the FDA and the American College of Obstetricians and Gynecologists (ACOG) to warn against combined procedures.1,2 Nevertheless, there may be some circumstances where a joint procedure would benefit the patient.3
This group of authors reports on their experience interpreting the HSGs of patients who have had combined procedures with an appropriate control group of women who underwent sterilization only. Their technique for combined procedures involved a suction curettage to clean out the uterine cavity, the radiofrequency endometrial ablation, and finally the microinsert placement. They found that almost 20% of women in the combined procedure group did not have an adequate HSG test compared with 7% in the sterilization-only group. Most of the inadequate tests were due to lack of fill of the uterine cavity due to synechaie. The strengths of the study include a blinded assessment of the HSG and a large number of procedures to evaluate. Weaknesses include utilizing stored rather than real-time HSG images for evaluation.
So what is the problem with inadequate HSG tests after hysteroscopic sterilization, especially if an endometrial ablation was performed as well? The chance of pregnancy after endometrial ablation exists, but is low (0.7-1.6%). Nevertheless, these pregnancies tend to be high risk and complicated by placental abnormalities.4 Therefore, contraception is still recommended after endometrial ablation. Performing the hysteroscopic sterilization with the endometrial ablation should provide that contraception, but in some cases the confirmation test cannot be performed. Therefore, the patient may have to be told that she is likely protected against pregnancy, but the certainty is not 100% and that combining the procedures is off-label. This type of counseling should be performed before doing the procedures together so that the woman understands the potential issues with HSG interpretation afterward.
But will this point be moot shortly? The company that manufactures Essure has just received approval from the FDA to remove the HSG requirement and replace it with pelvic ultrasound for straightforward Essure procedures.5 This is what is commonly done in Europe, where tubal occlusion is presumed if the microinserts are seen in the appropriate location in the cornua. Given that non-compliance with the 3 month HSG approaches 20% in some populations, as in this study, the option of a more convenient and less painful pelvic ultrasound might improve this rate of follow-up.6 Let’s not forget, however, that the levonorgestrel IUD provides both excellent treatment of heavy menstrual bleeding and contraception and is a viable and simple alternative to sterilization + ablation. In addition, stay tuned for the outcome of the FDA expert panel review on the safety of Essure in response to patient complaints of chronic pain, fatigue, depression, and headaches after device placement. Although Essure will not be removed from the market, Bayer may be required to conduct further studies on the device.
REFERENCES
- Essure Labeling Information for patients and health care providers. Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452280.htm. Accessed Aug. 29, 2015.
- ACOG Committee Opinion No. 458: Hysterosalpingography after tubal sterilization. American College of Obstetricians and Gynecologists. Obstet Gynecol 2010;115:1343-1345.
- Levy-Zauberman Y, et al. Concomitant hysteroscopic endometrial ablation and Essure procedure: Feasibility, efficacy and satisfaction. Eur J Obstet Gynecol Reprod Biol 2014;178:51-55.
- Hare AA, Olah KS. Pregnancy following endometrial ablation: A review article. J Obstet Gynaecol 2005;25:108-114.
- U.S. FDA Approves Alternate Confirmation Test for Essure® Permanent Birth Control. Available at: http://www.prnewswire.com/news-releases/us-fda-approves-alternate-confirmation-test-for-essure-permanent-birth-control-300107554.html. July 1, 2015.
- Leyser-Whalen O, Berenson AB. Adherence to hysterosalpingogram appointments following hysteroscopic sterilization among low-income women. Contraception 2013;88:697-699.
In this retrospective cohort study, women who underwent concomitant hysteroscopic sterilization and endometrial ablation procedures were more likely to have inadequate 3-month hysterosalpingram testing to confirm tubal occlusion.
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