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Safety and Efficacy of Hysteroscopic Sterilization Compared BMJ: First Published As 10.1136/Bmj.H5162 on 13 October 2015

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Safety and Efficacy of Hysteroscopic Sterilization Compared BMJ: First Published As 10.1136/Bmj.H5162 on 13 October 2015 RESEARCH OPEN ACCESS Safety and efficacy of hysteroscopic sterilization compared BMJ: first published as 10.1136/bmj.h5162 on 13 October 2015. Downloaded from with laparoscopic sterilization: an observational cohort study Jialin Mao,1 Samantha Pfeifer,2 Peter Schlegel,3 Art Sedrakyan1 1Department of Health Policy ABSTRACT higher risk of unintended pregnancy (odds ratio 0.84 and Research, Weill Medical OBJECTIVE (95% CI 0.63 to 1.12)) but was associated with a College of Cornell University, To compare the safety and efficacy of hysteroscopic substantially increased risk of reoperation (odds ratio New York, NY 10065, USA sterilization with the “Essure” device with laparoscopic 10.16 (7.47 to 13.81)) compared with laparoscopic 2Department of Obstetrics and Gynecology, Weill Medical sterilization in a large, all-inclusive, state cohort. sterilization. College of Cornell University, DESIGN CONCLUSIONS New York-Presbyterian Hospital, New York, NY, USA Population based cohort study. Patients undergoing hysteroscopic sterilization have a 3Department of Urology, Weill SETTINGS similar risk of unintended pregnancy but a more than Medical College of Cornell Outpatient interventional setting in New York State. 10-fold higher risk of undergoing reoperation University, New York- compared with patients undergoing laparoscopic Presbyterian Hospital, PARTICIPANTS sterilization. Benefits and risks of both procedures New York, NY, USA Women undergoing interval sterilization procedure, should be discussed with patients for informed Correspondence to: including hysteroscopic sterilization with Essure A Sedrakyan decisions making. [email protected] device and laparoscopic surgery, between 2005 and 2013. Additional material is published Introduction online only. To view please visit MAIN OUTCOMES MEASURES Female sterilization is one of the most commonly used the journal online (http://dx.doi. Safety events within 30 days of procedures; unintended org/10.1136/bmj.h5162) methods of contraception worldwide and is adopted by pregnancies and reoperations within one year of Cite this as: BMJ 2015;351:h5162 over 10 million women of reproductive age in the procedures. Mixed model accounting for hospital doi: 10.1136/bmj.h5162 United States.1 Bilateral tubal ligation via laparoscopic clustering was used to compare 30 day and 1 year Accepted: 23 September 2015 approach or mini-laparotomy has been the primary outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated technique for decades; and implant based sterilization using frailty model for time to event analysis. by means of a hysteroscopic approach was developed as a less invasive alternative. The “Essure” device http://www.bmj.com/ RESULTS received approval in Europe (Conformité Européenne We identified 8048 patients undergoing hysteroscopic (CE) mark) in 2001 and was approved by the US Food sterilization and 44 278 undergoing laparoscopic and Drug Administration (FDA) in 2002.2 It is used in sterilization between 2005 and 2013 in New York State. North America, Europe, Australia, New Zealand, Cen- There was a significant increase in the use of tral and South America, and the Middle East.3 hysteroscopic procedures during this period, while use The hysteroscopic procedure with Essure device does of laparoscopic sterilization decreased. Patients not require general anesthesia, and its safety has been undergoing hysteroscopic sterilization were older than on 27 September 2021 by guest. Protected copyright. those undergoing laparoscopic sterilization and were considered to be similar or superior to that of laparo- 4 more likely to have a history of pelvic inflammatory scopic sterilization. However, the hysteroscopic disease (10.3% v 7.2%, P<0.01), major abdominal approach was reported to be associated with a higher surgery (9.4% v 7.9%, P<0.01), and cesarean section risk of unintended pregnancy and has a three month (23.2% v 15.4%, P<0.01). At one year after surgery, post-procedure waiting period before sterilization 4 hysteroscopic sterilization was not associated with a becomes effective. Unintended pregnancies can be con- sidered as a failure of the procedure and can lead to a higher risk of potentially lethal ectopic pregnancies.5 WHat IS ALREADY KNOWN ON THIS TOPIC Other reported complications related to device include pelvic pain, hemorrhage, and device migration or incom- Laparoscopic bilateral tubal ligation has been the primary method of female patibility6 that can lead to reoperation. Since the Essure permanent birth control for decades, and hysteroscopic microinsert device was device’s approval, thousands of reports of adverse events developed as a less invasive alternative method related to the device have been received by the FDA, and Since the procedure’s approval, there has been thousands of reports of adverse device failure became a subject of litigation in 2014.6-8 events related to the use of hysteroscopic sterilization, but there is little The only prospective data regarding safety and effi- information regarding its safety and efficacy compared with tubal ligation cacy of hysteroscopic sterilization was reported by WHat THIS stUDY ADDS phase II and phase III studies sponsored by the manu- facturer.9-11 No randomized controlled trial or large This population based cohort study found that patients who underwent comparative cohort study has been conducted to hysteroscopic sterilization did not have a higher risk of unintended pregnancy than compare the efficacy and safety of the implant based those who underwent laparoscopic tubal ligation hysteroscopic procedure with the traditional laparo- However hysteroscopic sterilization was associated with over 10-fold higher risk of scopic procedure. The purpose of our study was to eval- reoperation, and the higher risk of reoperation persisted in various age groups and uate the performance, safety, and other outcomes of patients with history of pelvic inflammatory disease hysteroscopic sterilization compared with laparoscopic the bmj | BMJ 2015;101h101 | doi1 10.00;1/bmj.h5162 1 RESEARCH sterilization using statewide and all-inclusive popula- inflammatory disease, traditionally were not consid- BMJ: first published as 10.1136/bmj.h5162 on 13 October 2015. Downloaded from tion data. Our secondary objective was to conduct sub- ered good candidates for laparoscopic sterilization14 group analyses by age and important risk factors. and have been shown to have higher risks of complica- tions after surgery.15 16 Therefore, we included prior Methods history of pelvic inflammatory disease, major abdomi- Data source nal surgery, and cesarean section (from hospitaliza- We used data from New York State Department of tion and outpatient records) before their index surgery Health Statewide Planning and Research Cooperative date since 1995 (the first year SPARCS data were avail- System (SPARCS) to conduct an observational cohort able for our use). ICD-9 and CPT codes were used to study. Established in 1979, SPARCS is an all age group, identify history of pelvic inflammatory disease, major all payer database that collects patient and treatment abdominal surgery, and cesarean section. History of information for every hospital discharge, outpatient pelvic inflammatory disease was determined based on service, ambulatory surgery, and emergency depart- any records identified from the database, including ment record in New York State.12 The data contains inpatient, outpatient, and emergency room settings. patient characteristics, primary and secondary diagno- Outcomes included procedure time and total charges; ses and procedures, length of stay, and charges. 30 day surgical safety; and one year follow-up for unin- A unique personal identifier is assigned to every patient tended pregnancy, ectopic pregnancy, and reoperation and encrypted to allow longitudinal analyses without after the initial procedure. The 30 day surgical safety compromising the confidentiality of the records. events included iatrogenic complications (hemorrhage or hematoma complicating a procedure and accidental Study population puncture or laceration) and major medical complica- Using CPT-4 (Current Procedural Terminology coding sys- tions (acute myocardial infarction, stroke, pulmonary tem, fourth edition) and ICD-9-CM (international classifi- embolism, perioperative shock, and respiratory compli- cation of diseases, ninth revision, clinical modification) cations). Pregnancy was identified from inpatient, emer- codes, we identified women undergoing hysteroscopic gency room and outpatient admission specifically for sterilization (CPT-4 58565) or laparoscopic sterilization pregnancy related care, including prenatal tests and (CPT-4 58670, 58671; ICD-9-CM 66.2x, 66.3x) with the exams and care of ectopic or abortive pregnancy or other encounter of sterilization (ICD-9-CM V25.2) between 2005 abnormal pregnancy after the index procedure. Patients and 2013 in New York State. The CPT code for hystero- who had a tubal reversal surgery or in vitro fertilization scopic sterilization was released at the end of 2004 and and became pregnant were not defined as unintended http://www.bmj.com/ became available in SPARCS in 2005. We only included pregnancy. Reoperation was determined based on patients who underwent the procedure in an outpatient repeated sterilization procedures and identified using setting for interval sterilization for the purpose of valid ICD-9 and CPT codes in subsequent records during fol- comparison. Patients who underwent sterilization
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