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

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h5162 (Published 13 October 2015) Cite this as: BMJ 2015;351:h5162
  1. Jialin Mao, research associate1,
  2. Samantha Pfeifer, associate professor2,
  3. Peter Schlegel, professor3,
  4. Art Sedrakyan, professor and director1
  1. 1Department of Health Policy and Research, Weill Medical College of Cornell University, New York, NY 10065, USA
  2. 2Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, New York-Presbyterian Hospital, New York, NY, USA
  3. 3Department of Urology, Weill Medical College of Cornell University, New York-Presbyterian Hospital, New York, NY, USA
  1. Correspondence to: A Sedrakyan ars2013@med.cornell.edu
  • Accepted 23 September 2015

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.

Footnotes

  • We thank Madris Tomes, developer of a post-market surveillance MAUDE analytics tool for providing up to date information about safety reports related to Essure.

  • Contributors: JM and AS were responsible for the study concept and design. AS acquired the data. JM and AS analyzed and all authors interpreted the data. All authors drafted the manuscript and critically revised it for important intellectual content. JM and AS were responsible for the statistical analysis. AS supervised the study and is the guarantor.

  • Funding: The study was funded in part through UO1 grant (NIH-1U01FD004494-01) from the National Institutes of Health and US Food and Drug Administration. AS received the funding for establishing the MDEpiNet Science and Infrastructure Centre. JM is an analyst within the Weill Cornell Medical College (WCMC) Patient Centered Comparative Effectiveness Program and the Medical Device Epidemiology Network’s (MDEpiNet) Science and Infrastructure Center: AS is the director of the Center).

  • 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.

  • Ethical approval: The study was approved by the Weill Cornell Medical College institutional review board (protocol no 1209013064).

  • Transparency: The lead authors (study guarantors) affirm that this manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained

  • Data sharing: The technical appendix and statistical code available from the corresponding author at ars2013{at}med.cornell.edu. The dataset is available from New York State Department of Health Statewide Planning and Research Cooperative System (SPARCS) at https://www.health.ny.gov/statistics/sparcs/access/.

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