Surgical mesh for inguinal hernia repair March 2019 Acknowledgements This report is authored by Elena Tumasz-Jordan, Liza Mastikhina, Brenlea Farkas, Diane Lorenzetti, Joyce Li, and Fiona Clement on behalf of the HTA Unit at the University of Calgary. The authors declare no conflict of interests. This research was supported by the Health Technology Assessment Office, Province of BC. The views expressed herein do not necessarily represent those of the Government of British Columbia. Table of Contents Abbreviations .................................................................................................................................. 9 Executive Summary ...................................................................................................................... 10 Purpose of this Health Technology Assessment ................................................................... 13 Research Question and Research Objectives ........................................................................ 13 Overview of Approach .......................................................................................................... 13 Background ........................................................................................................................... 14 4.1 Surgical Mesh ................................................................................................................. 14 4.1.1 Description of Mesh ................................................................................................ 14 4.1.2 Mesh Characteristics ............................................................................................... 14 4.2 Inguinal Hernia ............................................................................................................... 15 4.2.1 Treatment of Inguinal Hernia .................................................................................. 17 Environmental Scan of Advisories and Licenses .................................................................. 20 5.1 Purpose ........................................................................................................................... 20 5.2 Methods .......................................................................................................................... 20 5.3 Findings .......................................................................................................................... 20 5.3.1 Meshes Available in Canada ................................................................................... 20 5.3.2 Advisories and Withdrawals from the Market ........................................................ 22 5.3.3 Class-action Lawsuits in Canada and the United States ......................................... 24 5.4 Conclusions .................................................................................................................... 24 Review of Guidelines and Best Practice Recommendations ................................................ 25 6.1 Purpose ........................................................................................................................... 25 6.1 Methods .......................................................................................................................... 25 6.2 Results ............................................................................................................................ 25 6.3 Conclusions .................................................................................................................... 27 Review of Health Technology Assessments ......................................................................... 34 7.1 Purpose ........................................................................................................................... 34 7.2 Methods .......................................................................................................................... 34 7.2.1 Search Strategy ....................................................................................................... 34 7.2.2 Study Selection ....................................................................................................... 34 7.2.3 Data Extraction ....................................................................................................... 35 7.3 Results ............................................................................................................................ 35 7.3.1 Study Characteristics .............................................................................................. 35 7.3.2 Clinical Effectiveness Findings .............................................................................. 35 7.3.3 Cost-Effectiveness Findings ................................................................................... 36 7.4 Conclusion ...................................................................................................................... 36 Systematic Review of Safety and Efficacy of Surgical Mesh for Inguinal Hernia Repair ... 46 8.1 Purpose ........................................................................................................................... 46 8.2 Methods .......................................................................................................................... 46 8.2.1 Search Strategy ....................................................................................................... 46 8.2.2 Study Selection ....................................................................................................... 47 8.2.3 Data Extraction ....................................................................................................... 47 8.2.4 Quality Assessment ................................................................................................. 47 8.2.5 Meta-Analysis ......................................................................................................... 47 8.3 Results ............................................................................................................................ 49 8.3.2 Synthetic Mesh vs Suture repair ............................................................................. 51 8.3.3 Synthetic Mesh vs Porcine ...................................................................................... 60 8.4 Conclusion ...................................................................................................................... 66 Conclusion ............................................................................................................................ 68 References ............................................................................................................................. 70 Appendices ............................................................................................................................ 73 Appendix 1: Search Strategies for Systematic Review of Safety and Efficacy of Surgical Mesh for Inguinal Hernia Repair ........................................................................................................ 73 Appendix 2: Characteristics of Included Studies ...................................................................... 76 Appendix 3: Meta-Analysis Forest Plots .................................................................................. 82 Table of Figures Figure 1: Mesh Materials .............................................................................................................. 15 Figure 2: EHS Classification by Laparoscopic Approach ............................................................ 17 Figure 3: EHS Classification by Open Approach ......................................................................... 17 Figure 4: PRISMA Flow-chart for Inguinal Hernia Review ........................................................ 50 Figure 5: Follow-up Times in Synthetic Mesh vs. Suture repair Studies, n=19 ........................... 51 Figure 6: Forest Plot of Recurrence Rates in Patients with Inguinal Hernia Receiving Synthetic Mesh vs. Suture repair .................................................................................................................. 55 Figure 7: Risk Differences for Complications in Inguinal Hernia Patients Receiving Synthetic Mesh vs. Suture repair .................................................................................................................. 56 Figure 8: Patient-reported Outcome Measures across the Synthetic Mesh vs. Suture Repair Studies, n=19 ................................................................................................................................ 60 Figure 9: Follow-up Times in Synthetic Mesh vs. Porcine Mesh Studies, n=4............................ 61 Figure 10: Forest Plot of Recurrence Rates in Patients with Inguinal Hernia Receiving Synthetic Mesh vs. Porcine Mesh ................................................................................................................. 63 Figure 11: Risk Differences for Complications in Inguinal Hernia Patients Receiving Synthetic Mesh vs. Porcine Mesh ................................................................................................................. 64 Figure 12: Patient-reported Outcome Measures across the Synthetic Mesh vs. Porcine Mesh Studies, n=4 .................................................................................................................................. 66 Figure A1: Forest Plot