Association of Hysteroscopic Vs Laparoscopic Sterilization with Procedural, Gynecological, and Medical Outcomes EDITORIAL COMMENT

The main types of female sterilization in developed countries are laparoscopic and hysteroscopic sterilization. Approximately 1 million women worldwide have undergone the hysteroscopic procedure. In 2015, the safety of hysteroscopic sterilization was questioned following complaints reported to the US Food and Drug Administration (FDA) by a large number of women who had received hysteroscopic sterilization. Complaints reported included adverse gynecological results such as pelvic pain, perforation of fallopian tubes or uterus, and unwanted pregnancy in addition to general symptoms such as allergy, tiredness, and depression. Similar adverse events were also reported in France-the country with the second largest number of women using this method after the United States-and other countries. As a consequence of these safety concerns, 4 recent studies compared procedural and gynecological outcomes between hysteroscopic and laparoscopic sterilization; however, none of these examined nongynecological outcomes. This cohort study compared the risk of reported adverse events between hysteroscopic and laparoscopic sterilization. Data were obtained from the French national hospital discharge database and health insurance claim database. Women included in the study had undergone a first hysteroscopic or laparoscopic sterilization between 2010 and 2014 and were between 30 and 54 years old. Adverse events were compared using inverse probability of treatment-weighted Cox models and included the following: risks of procedural complications (surgical and medical) and of gynecological (sterilization failure that includes salpingectomy, second sterilization procedure, or pregnancy; reoperation) and medical outcomes (allergic reactions; autoimmune diseases; thyroid disorders; use of analgesics, antimigraine medications, antidepressants, benzodiazepines; outpatient visits; sickness absence; suicide attempts; death) that occurred within 1 and 3 years after sterilization. To account for differences between the comparison groups, multivariate models were used, adjusting for baseline covariates including medical history and medication use, and weighted for inverse probability of treatment using a propensity score. Of 110,299 women who met inclusion criteria, 105,357 (95.5%) were included in the final analysis: 71,303 (67.7%) underwent hysteroscopic, and 34,054 (32.3%) underwent laparoscopic sterilization. Multivariable analysis showed that the risk of surgical complications was lower for hysteroscopic sterilization than laparoscopic sterilization (0.13% vs 0.78%; adjusted risk difference [aRD], -0.64; 95% confidence interval [CI], -0.67 to -0.60); the risk of medical complications was also lower (0.06% vs 0.11%; aRD, -0.05; 95% CI, -0.08 to -0.01). Hysteroscopic sterilization during the first year was associated with a significantly higher risk of sterilization failure (4.83% vs 0.69%; adjusted hazard ratio, 7.11; 95% CI, 5.92-8.54; aRD, 4.23 per 100 person-years; 95% CI, 3.40-5.22). In addition, the requirement for gynecological reoperation after 1 year was higher for hysteroscopic sterilization compared with laparoscopic sterilization (5.65% vs 1.7%; adjusted hazard ratio, 3.26; 95% CI, 2.90-3.67; aRD, 4.63 per 100 person-years; 95% CI, 3.38-4.75); although attenuated, these differences persisted after 3 years. The risk of pregnancy was lower for hysteroscopic sterilization within the first year, but was not by the third year (adjusted HR, 1.04; 95% CI, 0.83-1.30; aRD, 0.01 per 100 person-years; 95% CI, -0.04 to 0.07). Hysteroscopic sterilization was not associated with an increased risk of medical outcomes over 1 or 3 years, as compared with laparoscopic sterilization. These findings show, in a population of women undergoing first sterilization, a significantly higher risk of gynecological complications over 1 and 3 years with use of hysteroscopic sterilization compared with laparoscopic sterilization. The data do not support an increased risk of medical outcomes with use of hysteroscopic sterilization.