Hysteroscopic sterilization may not be associated with increased risks of non-gynecologic adverse outcomes in most women
EBM Focus - Volume 13, Issue 5
- Concerns exist that tubal sterilization performed via hysteroscopy may be associated with an increased risk of general health adverse outcomes.
- A recent retrospective cohort study used French national databases to assess adverse events in 105,357 women who had a first tubal sterilization via hysteroscopic or laparoscopic procedure between 2010 and 2014.
- Compared to laparoscopic sterilization, hysteroscopic sterilization was not associated with increased risks of non-gynecologic adverse outcomes in most women. A subgroup analysis suggests that hysteroscopic sterilization may be associated with an increased risk of allergic outcomes in women with a history of allergy.
Women seeking tubal sterilization may choose between hysteroscopic (use of fallopian tube implants) and laparoscopic (cautery, clipping, banding, or removal of fallopian tubes) procedures. Hysteroscopic sterilization does not require general anesthesia, but another form of contraception must be used for the first 3 months after the procedure to allow for fallopian tube fibrosis and women must return for a medical visit at that time to confirm correct location of the implant. Due to reports of gynecologic and non-gynecologic adverse events possibly associated with hysteroscopic sterilization, the Food and Drug Administration (FDA) issued a change in the labeling for the Essure implant (nitinol coil) to include a boxed warning and a Patient Decision Checklist to aid in patient counseling (FDA Nov 2016). To better evaluate the safety of hysteroscopic sterilization, a recent retrospective cohort study used French national databases to assess 105,357 women aged 30-54 years who had a first tubal sterilization via hysteroscopic or laparoscopic procedure between 2010 and 2014. The study population was restricted to women primarily seeking tubal sterilization (interval sterilization). Hysteroscopic sterilization was performed with the Essure implant in 71,303 (67.7%) women and laparoscopic sterilization was performed in 34,054 women.
Concerning some of the non-gynecological adverse events that motivated the FDA-issued label change, hysteroscopic sterilization at 3 years was not associated with an increased risk of multiple outcomes (autoimmune disease, thyroid disorders, attempted suicide, and use of analgesics, antidepressants, antimigraine agents, and benzodiazepines). In a subgroup analysis of 15,463 women with a history of allergy, hysteroscopic sterilization was associated with a slightly increased risk of allergic outcomes compared to laparoscopic sterilization (adjusted hazard ratio 1.1, 95% CI 1.03-1.17) (allergic outcome in 43.2% with hysteroscopic vs. 40% with laparoscopic sterilization). At 3 years, hysteroscopic sterilization was associated with a greater risk of a second sterilization procedure than laparoscopic sterilization (in 4.5% with hysteroscopic vs. 0.28% with laparoscopic sterilization, p < 0.001). Nevertheless, there was no significant difference in pregnancy rates (in 0.48% with hysteroscopic sterilization vs. 0.57% with laparoscopic sterilization). Risk of uterine complications was decreased with hysteroscopic sterilization (in 4.25% vs. 5.26% with laparoscopic sterilization, p < 0.001), but risk of fallopian tubal disorder (complications related to prosthesis or implant placement) or salpingectomy was slightly increased with hysteroscopic sterilization (in 1.17% vs. 0.68% with laparoscopic sterilization, p < 0.001).
The results from this study suggest that hysteroscopic sterilization compared to laparoscopic sterilization was not associated with an increased risk of many of the non-gynecologic adverse outcomes reported to the FDA. However, there may be a modest increased risk of allergic outcome in women with a history of allergy who undergo hysteroscopic sterilization. Hysteroscopic sterilization was also associated with an increased risk for a second sterilization procedure and risk of fallopian tube disorder, but not an increased risk of pregnancy, consistent with previous data (BMJ 2015). An ongoing prospective study planning to enroll 2,800 women allowed to choose between hysteroscopic and laparoscopic sterilization may provide additional information, but the results are not expected until 2023 (ClinicalTrials.gov). In the meantime, this retrospective cohort study may be the best currently available evidence to inform women who are considering tubal sterilization, and it suggests that in women without a history of allergy, hysteroscopic sterilization may not be associated with increased risks of non-gynecologic adverse outcomes. Shared decision-making will also need to include a discussion regarding risks of gynecologic adverse outcomes.