Hysteroscopic sterilization is associated with a significantly higher risk for gynecological complications in the first 3 years after the procedure compared with laparoscopic sterilization, a nationwide study shows. However, the risk for medical complications is not significantly different between the two procedures. The new findings run counter to concerns expressed by regulatory agencies and others.
“To our knowledge, this is the first study aiming at comparing medical outcomes in addition to gynecological outcomes between hysteroscopic and laparoscopic sterilization,” write Kim Bouillon, MD, PhD, from the Department of Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety, Saint-Denis, France, and colleagues.
“These findings do not support increased medical risks associated with hysteroscopic sterilization,” they conclude in an article published online January 23 in JAMA.
The US Food and Drug Administration (FDA) approved hysteroscopic sterilization with fallopian tube inserts (Essure, Bayer) in 2002. Although the procedure has advantages such as the ability to perform it under minimal sedation, the FDA received more than 8000 reports of complications between 2002 and 2016. Medical complications associated with the device include chronic pelvic pain, menstrual irregularities, headache, fatigue, allergic reactions, and the development of autoimmune conditions. Gynecologic complications include pregnancy and need for resterilization.
In 2016, the FDA responded by requiring an additional postmarketing trial on safety and efficacy and included a “black box” warning on the device’s packaging describing potential risks. The data from that trial are not expected until 2023, Dr Bouillon and colleagues note.
“[O]ur study was able to timely respond to issues raised by the FDA and by others who have debated hysteroscopic sterilization,” they write.
The researchers conducted a nationwide cohort study in France, using the national hospital discharge database, which is linked to the health insurance database. The study included 105,357 women aged 30 to 54 years who received their first hysteroscopic or laparoscopic sterilization between 2010 and 2014; women were followed through December 2015. Of those, 71,303 (67.7%) underwent hysteroscopic sterilization and 34,054 (32.3%) underwent laparoscopic sterilization.
In-hospital complications during the procedure occurred in 0.13% of women who underwent hysteroscopic sterilization compared with 0.78% of women in the laparoscopic sterilization group (adjusted risk difference [aRD], −0.64). Medical complications at the time of the procedure were also lower among women who underwent hysteroscopic sterilization (0.06% vs 0.11%; aRD, −0.05).
The authors note, however, that the absolute risk difference between the two groups is very small for procedural complications.
Similarly, risks for a large range of medical outcomes were not significantly increased with hysteroscopic sterilization over the course of 3 years compared with laparoscopic sterilization. The outcomes analyzed included allergy, autoimmune disease, thyroid disorder, and suicide attempt, as well as use of a number of drug types (analgesics, antimigraine, antidepressant, and benzodiazepine).
When the analysis was restricted to women who had an allergy before sterilization, there was a 10% greater risk of developing a new allergy among women in the hysteroscopic sterilization group vs the laparoscopic group (43.20% vs 40.00%; adjusted hazard ratio [aHR], 1.10; aRD, 5.86 per 100 person-years; at 1 year). No difference was seen among women without preexisting allergies.
The team also found small differences in use of various drug classes, with some favoring hysteroscopic sterilization (analgesics, antidepressants, and benzodiazepines) and another favoring laparoscopic sterilization (antimigraine).
Hysteroscopic sterilization was associated with a reduced risk for suicide at 3 years (0.55% vs 0.79%; aHR, 0.80), but the difference was not statistically significant.
Conversely, the absolute differences for gynecologic complications were much larger. Specifically, during the first year after the procedure, 4.83% of the women in the hysteroscopic sterilization group experienced sterilization failure compared with 0.69% of those who had laparoscopic sterilization (aHR, 7.11 [95% confidence interval (CI), 5.92 – 8.54]; aRD, 4.23 per 100 person-years [95% CI, 3.40 – 5.22]).
In addition, among the women who underwent hysteroscopic sterilization, 5.65% needed gynecologic reoperation compared with 1.76% of the women in the laparoscopic group (aHR, 3.26; 95% CI, 2.90 – 3.67; aRD, 4.63 per 100 person-years; 95% CI, 3.38 – 4.75). These differences continued after 3 years, but waned.
“The history of hysteroscopic sterilization reads as a classic boom-and-bust cycle. The device received expedited FDA review because it offered advantages compared with laparoscopic sterilization, leading to rapid and widespread adoption with more than 750 000 implanted devices worldwide by 2016,” Eve Espey, MD, from the Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, and Lisa G. Hofler, MD, from the Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, write in an accompanying editorial.
They note that the FDA approved the device without evidence from randomized clinical trials, even though it is categorized as a class III (high-risk) device, and 30% of the original cohort was lost to follow-up for the 5-year outcomes in the phase 3 postmarketing study.
“The future of hysteroscopic sterilization is uncertain given the powerful and highly publicized grassroots effort to ban the device, the chilling effect of the FDA black box warning, and the specter of class action litigation,” Dr Espey and Dr Hofler explain. “Although the FDA review process for Essure was imperfect, the way forward should focus on the best scientific evidence. Hysteroscopic sterilization has added an important option for contraception and benefited numerous women with limited options for permanent contraception. Although the current controversy may only be resolved after completion of the FDA-mandated randomized trial, the report by Bouillon et al in this issue of JAMA contributes important information about the procedural, gynecological, and medical complications and outcomes associated with hysteroscopic vs laparoscopic sterilization.”
One coauthor has disclosed receiving personal fees from Boston Scientific. The remaining authors and editorialists have disclosed no relevant financial relationships.
JAMA. Published online January 23, 2018. Article abstract, Editorial extract
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