By Rebecca H. Allen, MD, MPH, Editor
SYNOPSIS: In this retrospective cohort study using Medicaid claims data from 2008-2014 in California, the rate of pregnancy was 4.74% after hysteroscopic sterilization among 5,906 women and 5.57% after laparoscopic sterilization among 23,965 women. These rates are higher than reported previously.
SOURCE: Gariepy AM, Lewis C, Zuckerman D, et al. Comparative effectiveness of hysteroscopic and laparoscopic sterilization for women: A retrospective cohort study. Fertil Steril 2022;117:1322-1331.
This is a retrospective cohort study evaluating Medicaid claims data for sterilization procedures performed in California on women ages 18 to 50 years from Jan. 1, 2008, to Aug. 31, 2014. Women with postpartum sterilization procedures and those with a history of cancer, hysterectomy, or any contraindication to hysteroscopic or laparoscopic surgery were excluded. Codes were used to identify sterilization procedures as well as any pregnancy-related claims after the sterilization, excluding luteal phase pregnancies. Pregnancy rates during follow-up were calculated by age and at six, 12, 24, 36, 48, and 60 months. Women in the hysteroscopic sterilization group also were evaluated to see if they had complied with the three-month hysterosalpingogram to confirm tubal occlusion. Other data collected included race, region of residence, year of index procedure, obesity, pregnancy history, and months of Medi-Cal enrollment.
The authors identified 4,906 women who had undergone hysteroscopic sterilization and 23,965 who had undergone laparoscopic sterilization procedures. The average age of the participants was 33 years. Laparoscopic sterilization was the most common method, although hysteroscopic sterilization increased from 9% in 2008 to 29% in 2013. Among women who had hysteroscopic sterilization, 47.9% did not have any claim for a hysterosalpingogram within one year of the procedure. Overall, pregnancy-related claims were identified for 4.74% of those who had hysteroscopic sterilization and 5.57% of those who had laparoscopic sterilization. There was no difference in claims for pregnancy at 12 months after the procedure among the two types of sterilization techniques (adjusted incidence rate ratio, 1.06; 95% confidence interval [CI], 0.85-1.26), after adjusting for women’s propensity to receive hysteroscopic sterilization compared with laparoscopic sterilization and other covariates. At five years, the adjusted rate of pregnancy actually was lower for hysteroscopic sterilization than laparoscopic sterilization (adjusted rate ratio, 0.76; 95% CI, 0.62-0.90). Younger women (ages 18-27 years) had higher cumulative rates of pregnancy at five years (6.38 pregnancies per 100 women receiving hysteroscopic sterilization and 12.54 pregnancies per 100 women receiving laparoscopic sterilization) compared to older women (ages 45-50 years; 3.92 pregnancies per 100 women receiving hysteroscopic sterilization and 3.15 pregnancies per 100 women receiving laparoscopic sterilization).
COMMENTARY
The authors performed this study to follow up on the effectiveness of hysteroscopic sterilization after the Essure system was voluntarily removed from the market by the manufacturer at the end of 2018.1 This study was surprising because the pregnancy failure rates reported were higher than expected for both sterilization procedures. In fact, with failure rates of roughly 5% in each group at five years, sterilization procedures become a much less effective option than intrauterine devices or implants.
There are limitations to this study, however. As with any claims database study, the data are only as good as how accurate the coding was by the providers, coders, and billers of the healthcare system. For example, pregnancy rates may have been undercounted if home pregnancy tests were used or patients sought abortions or had miscarriages that were not captured in the database. On the other hand, pregnancies might have been overcounted if some individuals relied on in vitro fertilization to achieve subsequent pregnancies. Nevertheless, the data represent a robust picture of a large sample of sterilization procedures in California.
Whether this study should change our counseling is uncertain given the limitations of the data. Typically, we counsel patients that the rate of failure with sterilization is about 1%.1 There is a known higher risk of failure in younger women compared to older women, as demonstrated in this study. Nevertheless, the study definitely highlights the need for additional prospective studies to accurately describe the risk of pregnancy after permanent contraception procedures. Now that many providers perform bilateral laparoscopic salpingectomies for sterilization, these data regarding laparoscopic sterilization may not be as relevant. The effectiveness of a complete bilateral salpingectomy in preventing future pregnancy likely is much higher than laparoscopic tubal occlusion techniques.
REFERENCE
- American College of Obstetricians and Gynecologists. Practice Bulletin Number 208: Benefits and risks of sterilization. Published March 2019. https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2019/03/benefits-and-risks-of-sterilization
