From the Journals

Greater gynecological but not medical risks with hysteroscopic sterilization

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Uncertainty still hangs over future of hysteroscopic sterilization

In 2016, in response to safety concerns about the hysteroscopic sterilization implant Essure, the Food and Drug Administration placed a “black box” warning on the device to highlight potential risks, and a global patient advocacy movement called for a ban on the product. In this environment, there is therefore a need for strong scientific evidence to inform objective decision making.

This study provides reassuring evidence that adverse outcomes are not significantly higher after hysteroscopic sterilization compared with laparoscopic sterilization, at least up to 3 years after the procedure. However, given the powerful and very public grassroots effort to ban the hysteroscopic implant and the possibility of class action litigation, the future of hysteroscopic sterilization is uncertain.

Dr. Eve Espey

Hysteroscopic sterilization is an important contraceptive option and could benefit many women. While the results of the FDA-mandated trial are awaited, this study provides physicians and others who provide contraceptive care with information on the risks and benefits of these procedures to use as part of shared decision-making discussions with patients who are seeking permanent sterilization.

Eve Espey, MD, MPH, and Lisa G. Hofler, MD, MPH, are in the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. The comments are taken from an editorial (JAMA. 2018 Jan 23;319[4]:347-50). Dr. Hofler declared personal fees and nonfinancial support from the American College of Obstetricians and Gynecologists.


 

FROM JAMA

Hysteroscopic sterilization is associated with a significantly greater risk of gynecological complications but not medical or surgical complications, compared with laparoscopic sterilization, according to data from a French nationwide cohort study.

Women who had the hysteroscopic procedure had a nearly threefold higher risk of tubal disorder or surgery, a sevenfold higher risk of sterilization failure, and a 25-fold higher risk of undergoing a second sterilization procedure at 1 year compared with those who had the laparoscopic procedure (P less than .001 for each). These risk increases persisted even at 3 years after the procedure (hazard ratios of 1.79, 4.66, and 16.63, respectively; 95% confidence interval for each).

“A second sterilization procedure following hysteroscopic sterilization is a well-identified risk already described in phase 2 and 3 studies, in which the risk varied between 4.0% and 4.5%,” wrote Kim Bouillon, MD, PhD, of the French National Agency for Medicines and Health Products Safety, and her coauthors.

“In the present study, this risk was 4.1% at the 1-year follow-up, comparable with that reported in previous studies conducted in real-life conditions in patients who received care in public or private hospitals, and much higher than after laparoscopic sterilization.”

However, hysteroscopic sterilization was associated with a significantly reduced risk of surgical complications, compared with laparoscopic sterilization (adjusted odds ratio, 0.18; 95% CI, 0.14-0.23). The overall rate of in-hospital surgical complications was 0.13% with the hysteroscopic procedure and 0.78% with the laparoscopic procedure. Medical complications occurred in 0.06% of hysteroscopic procedures and 0.11% of laparoscopic procedures.

Women who underwent hysteroscopic procedures also had a significantly lower risk of uterine disorders (adjusted HR, 0.85; 95% CI, 0.74-0.98), uterine bleeding, and hysterectomies at 1 year, after adjustment for known hysterectomy risk factors.

The researchers noted that in absolute terms, the differences in the risk of procedural complications were very small, compared with the differences in the risk of gynecological complications.

The risk of pregnancy was significantly lower in the hysteroscopic group, compared with the laparoscopic group at 1 year after the procedure, but by 3 years’ follow-up, the difference was no longer significant.

There were no significant differences seen in the risk of medical complications such as autoimmune disease and thyroid disorders, attempted suicide, or death between the two procedures. Women who underwent hysteroscopic sterilization had a slightly lower use of analgesics, antidepressants, and benzodiazepines at 1 year that was more pronounced by 3 years.

There was a significantly higher risk of allergic reaction seen with hysteroscopic sterilization among women with prior allergies, but the authors suggested that a null overall effect and large number of tested interactions made the finding “hypothesis-generating” only.

The study was prompted by safety concerns about hysteroscopic sterilization, with the Food and Drug Administration in 2015 receiving a large number of reports of adverse events including bleeding, pelvic pain, fallopian tube perforation, unwanted pregnancy, hysterectomies, depression, and allergic reactions.

The FDA has since ordered the device manufacturer to undertake an open-label, nonrandomized study comparing outcomes between hysteroscopic and laparoscopic sterilization, which is expected to deliver results in 2023.

“To our knowledge, this is the first study aiming at comparing medical outcomes in addition to gynecological outcomes between hysteroscopic and laparoscopic sterilization,” the authors wrote, referring to their own work. They concluded, “these findings do not support increased medical risks associated with hysteroscopic sterilization.”

One author declared personal fees from Boston Scientific but no other conflicts of interest were declared.

SOURCE: Bouillon K et al. JAMA. 2018 Jan 23;319:375-87.

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