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Hysteroscopic Tubal Sterilization

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Hysteroscopic Tubal Sterilization Alberta STE Report Hysteroscopic tubal sterilization September 2014 INSTITUTE OF HEALTH ECONOMICS The Institute of Health Economics (IHE) is an independent, not-for-profit organization that performs research in health economics and synthesizes evidence in health technology assessment to assist health policy making and best medical practices. IHE BOARD OF DIRECTORS Chair Dr. Lorne Tyrrell – Professor & CIHR/GSK Chair in Virology, University of Alberta Government and Public Authorities Ms. Janet Davidson – Deputy Minister, Alberta Health Ms. Marcia Nelson – Deputy Minister, Alberta Innovation & Advanced Education Dr. Cy Frank – CEO, Alberta Innovates – Health Solutions Ms. Vickie Kaminski – President & CEO, Alberta Health Services Academia Dr. Walter Dixon – Associate VP Research, University of Alberta Dr. Jon Meddings – Dean of Medicine, University of Calgary Dr. Douglas Miller – Dean of Medicine & Dentistry, University of Alberta Dr. Ed McAuley – VP Research, University of Calgary Dr. James Kehrer – Dean of Pharmacy & Pharmaceutical Sciences, University of Alberta Dr. Braden Manns – Svare Chair in Health Economics and Associate Professor, Departments of Medicine and Community Health Sciences, University of Calgary Dr. Doug West – Chair, Department of Economics, University of Alberta Industry Ms. Lisa Marsden –VP, Cornerstone & Market Access, AstraZeneca Ms. Lauren Fischer – VP, Corporate Affairs, Eli Lilly Canada Inc. Ms. Jennifer Chan – VP, Policy & Communications, Merck Canada Dr. Ghislain Boudreau – VP, Public Affairs, Pfizer Canada Inc. Vice President, Public Affairs and Reimbursement, GlaxoSmithKline Inc. IHE Mr. Doug Gilpin – Chair, Audit & Finance Committee Dr. Egon Jonsson – Executive Director & CEO, Institute of Health Economics Ms. Allison Hagen – Director of Finance, Operations & Administration, Institute of Health Economics Alberta STE Report Hysteroscopic tubal sterilization Alberta STE Report: Policy-driven Health Technology Assessment reports that include an analysis of the social and system demographics, technological effectiveness and economic implications of a health technology. The reports are written under contract with the Alberta Health Technologies Decision Process and contextualized for use in Alberta. Acknowledgements The Institute of Health Economics is grateful to the Expert Advisory Committee for the provision of information and comments on the draft report. The authors would like to thank Wendy McIndoo (IHE) for her support with checking references and formatting/editing the document. We would also like to thank the following individuals for their assistance and provision of contextual information for the Background and Context section of the report: • Albert Rosengarten, Rockyview General Hospital, Department of Obstetrics & Gynecology, Calgary, Alberta • Sheila Watson, Rockyview General Hospital, Department of Obstetrics & Gynecology, Calgary, Alberta • Amber Burridge, Rockyview General Hospital, Department of Obstetrics & Gynecology, Calgary, Alberta • John Thiel, Women's Health Clinic, Regina General Hospital, Regina, Saskatchewan We also thank Sebastiaan Veersema, St. Antonius Hospital, Department of Obstetrics & Gynecology, Nieuwegein, the Netherlands for providing clarification on populations included in two published studies for the Technology Effectiveness/Efficacy section of the report. We also thank the CRM and Data Access group at Alberta Health for providing administrative data and the Health Technology Assessment and Innovation group at Alberta Health Services for providing operational, financial and contextual data. The views expressed in the final report are those of the Institute of Health Economics. Corresponding Author Please direct any inquiries about this report to: Dr. Anderson Chuck Director of Economic Evaluation and Analytics, Institute of Health Economics [email protected] 780-448-4881 Funding This report was supported by a financial contribution from Alberta Health (AH) through the Alberta Health Technologies Decision Process, The Alberta model for health technology assessment and policy analysis. The completed report was submitted to AH in April, 2014. The views expressed herein do not necessarily represent the official policy of Alberta Health. Hysteroscopic tubal sterilization i Declared Competing Interest of Authors Competing interest is considered to be financial interest of non-financial interest, either direct or indirect, that would affect the research contained in this report or create a situation in which a person’s judgement could be unduly influenced by a secondary interest such as personal advancement. The authors of this publication claim no competing interest. Suggested Citation (ICMJE or Vancouver Style) Institute of Health Economics. Hysteroscopic tubal sterilization. Edmonton AB: Institute of Health Economics. 2014. Web Address This publication is available for free download from the IHE website at http://www.ihe.ca. Reproduction, redistribution, or modification of the information for any purposes is prohibited without the express written permission of the Institute of Health Economics Institute of Health Economics, 2014 www.ihe.ca Hysteroscopic tubal sterilization ii Executive Summary Technology Effects and Effectiveness Background and context Permanent fertility control by bilateral occlusion of the fallopian tubes is achieved by various methods. The choice of the most appropriate method of sterilization depends upon a mix of factors such as an individual’s or couple’s preferences, provider’s training, the woman’s medical history, anatomy and medical assessment of risk, access to services, and timing of intervention (interval, postpartum, or post-abortion). The fallopian tubes are reached for occlusion either by the abdominal (laparoscopic or laparotomic) or transcervical (hysteroscopic) routes. Hysteroscopic tubal sterilization (HTS) using the Essure® system was investigated and found to be a less invasive, potentially safe, and effective method of permanent sterilization. Technology The Essure® system is manufactured by Conceptus Inc., Mountain View, California (CA), United States of America (USA), and in Canada, was granted a Medical Device License Class III by Health Canada in November 2001. The System is comprised of the Essure® micro-insert, a disposable delivery device, and a disposable split introducer. The mode of action is a combination of mechanical insertion of the implant, and tissue in-growth for device retention and obstruction of the fallopian tubes. After the HTS procedure, women need to use alternative methods of birth control for a three month period until the occlusion of the fallopian tubes becomes effective. Hysterosalpingography (HSG) at three months after HTS is a minimally invasive procedure recommended by the manufacturer of the Essure® system for the determination of tubal occlusion and device location. Other follow-up procedures such as pelvic radiography and transabdominal or transvaginal ultrasound have been used as alternative tests to HSG to check the position and alignment of the micro-inserts. The Essure® method is completely irreversible. Physicians need special training in the handling and insertion techniques of the Essure® micro-inserts under supervision of a Conceptus Inc.-designated preceptor or trainer until achieving competency in performing the HTS. The duration of professional training for gynecologists is about two days. The learning curve for those who are comfortable with hysteroscopy is between five and seven cases. Project context A local feasibility pilot study on HTS was conducted in Calgary at the Rockyview General Hospital between 2007 and 2010. In Alberta, a total of 72 HTS procedures (range 14 to 24 each year) were performed between 31 March 2008 and 31 March 2012, with the majority of the procedures done in the pilot study. Presently, in Alberta, there is much interest and increased demand by the public and by private providers in offering HTS using the Essure® system as an alternative to laparoscopic tubal sterilization (LTS). Although the demand for HTS grows, only a handful of clinicians have been involved in conducting this procedure, in Calgary. Presently, gynecologists at Rockyview Hospital are offering HTS using the Essure® system to women who have a contraindication for LTS and who meet certain medical criteria. Alberta Health Services (AHS) covers the costs of HTS for medically indicated cases. If the HTS is merely an option and not medically required, AHS pays for the procedure while women pay for the device. The cost of the device is presently considered a limitation in implementing the HTS procedure. Hysteroscopic tubal sterilization iii Technology Efficacy and Safety Objective The objective of the Technology Effects and Effectiveness section of this report was to perform a structured review and critical appraisal of the published research on the safety and efficacy/effectiveness of hysteroscopic tubal sterilization for permanent birth control. Results A search of electronic databases for articles published between 2006 and February 2012 identified eight case series studies, with a combined sample size of 2566 women. The studies were conducted in the USA, the UK, Spain, the Netherlands, and Sweden, and the majority of studies had a prospective design. The reporting of characteristics of women and risk of bias varied across studies. The studies included women ranging in age from 22 to 49 years (mean ages between 35 and 39.6 years in six studies). Two studies included women with comorbidities
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