Hysteroscopic sterilization was linked with an increased risk of gynecological complications over 1 year and 3 years compared with laparoscopic sterilization, French researchers reported.
The non-surgical procedure involves placing small implants in the fallopian tubes to make a woman infertile. Among more than 105,00 women undergoing first sterilization, hysteroscopic sterilization was associated with a higher risk of sterilization failure than those who underwent laparoscopic sterilization after the first year (4.83% versus 0.69%, adjusted HR 7.11, 95% CI 5.92-8.54) and third year (5.75% versus 1.29%, adjusted HR 4.66, 95% CI 4.06- 5.34), according to Kim Bouillon, MD, PhD, of the French National Agency for Medicines and Health Products Safety in Saint-Denis, France, and colleagues.
Additionally, hysteroscopic sterilization was linked to a higher need for gynecological reoperation compared with women who underwent laparoscopic sterilization (5.65% versus 1.76%, adjusted HR 3.26, 95% CI 2.90-3.67), they wrote in the Journal of the American Medical Association.
“Risk of medical outcomes was not significantly increased over 1 year or over 3 years. These findings do not support increased medical risks associated with hysteroscopic sterilization,” the authors stated.
In an accompanying editorial, Eve Espey, MD, MPH, and Lisa G. Hofler, MD, MPH, MBA, both of University of New Mexico in Albuquerque, commented that the study “both reinforces and augments the body of literature examining the outcomes of hysteroscopic sterilization. The authors report a 3-year pregnancy risk similar to previous large cohorts … similarly the 3-year risk of repeat sterilization found in other large cohorts was consistent with risk found in phase 2 and 3 studies.”
They noted that the report contributes important data regarding the procedural, gynecological, and medical outcomes associated with the two types of sterilization.
“Physicians and other individuals who provide contraceptive care may find this evidence useful in communicating the risks and benefits of these procedures as part of shared decision-making discussions with patients requesting permanent sterilization,” Espey and Hofler wrote.
The authors used a French national hospital discharge and health insurance claims database to study the outcomes of 105,357 women who received hysteroscopic sterilization (n=71,303) or laparoscopic sterilization (n=34,054) from 2010 to 2014, and were followed-up through December 2015.
Women were included in the study if they had undergone a first hysteroscopic or laparoscopic sterilization between 2010 and 2014, were ages 30-54, and registered in the general insurance coverage program. Those in the hysteroscopic sterilization group were slightly older (mean age 41.5 versus 40.8), had a higher socioeconomic status, and a healthier lifestyle, and were also less likely to have a history of allergy, suicide attempts, and prior pregnancy.
The authors analyzed risks of procedural complications (surgical and medical), gynecological complications, and medical outcomes — allergies, autoimmune diseases, thyroid disorder, antidepressants, outpatient visits — that occurred within 1 and 3 years after sterilization.
They found that patients who received hysteroscopic sterilization compared with laparoscopic sterilization had a lower risk of both surgical complications (0.13% versus 0.78%, adjusted RD −0.64, 95% CI −0.67 to −0.60) and medical complications (0.06% versus 0.11%, adjusted RD −0.05, 95% CI −0.08 to −0.01) during hospitalization for sterilization.
Hysteroscopic sterilization was associated with a lower risk of pregnancy within the first year of the procedure but there was no significant difference in risk of pregnancy by the third year (adjusted HR 1.04, 95% CI 0.83-1.30).
Overall, risk of medical outcomes was not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization. The one exception was that women with a prior allergy history had a slightly higher risk of allergic outcome 1 and 3 years after hysteroscopic sterilization (43.20% versus 40.0%, adjusted HR 1.10, 95% CI 1.03-1.17 at 3 years). This elevated risk was not identified in women without a prior history of allergy, added the researchers.
Study limitations included its observational nature, the use of administrative databases to investigate a possible role of hysteroscopic sterilization in notified complaints, and the fact that not all individual disorders reported by patients or physicians could be examined.
Bouillon disclosed no relevant relationships with industry. One co-author disclosed relevant relationships with Boston Scientific.
Espey disclosed no relevant relationships with industry. Hofler disclosed support from the American College of Obstetricians and Gynecologists.
Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner