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Observational Study
. 2015 Oct 13:351:h5162.
doi: 10.1136/bmj.h5162.

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

Jialin Mao  1 , Samantha Pfeifer  2 , Peter Schlegel  3 , Art Sedrakyan  1
Affiliations
Observational Study

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

Jialin Mao et al. BMJ. .

Erratum in

Abstract

Objective: To compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort.

Design: Population based cohort study.

Settings: Outpatient interventional setting in New York State.

Participants: Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013.

Main outcomes measures: Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis.

Results: We identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization.

Conclusions: Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work (other than the funding listed); no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Fig 1 Number of hysteroscopic sterilization and laparoscopic sterilization procedures between 2005 and 2013 in New York State
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Fig 2 Use of hysteroscopic sterilization by age group between 2005 and 2013 in New York State
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