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The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Interim Report

Description
ISBN9781785447051
Official Print Publication Date
Website Publication DateOctober 02, 2015

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ISBN 978 1 78544 705 1 (Web only publication)
PPDAS 57465

This document is also available in pdf format (2.1MB)

Contents

Preface

Executive Summary

Chapter 1 Introduction
Background
Remit of the Independent Review
Remit of the Expert Group
What are medical devices?
Approach to the Review: evidence, its limits and interpretation

Chapter 2 The clinical use of mesh for stress urinary incontinence and pelvic organ prolapse
Clinical indications
Guidance for surgery
Mesh products

Chapter 3 Womens' experiences
Telling the story
Evidence availability
Methods
Results
Interpretation

Chapter 4 Assessing the safety and effectiveness of vaginal mesh surgery for stress urinary incontinence and pelvic organ prolapse in Scotland
Operations provided in Scotland for stress urinary incontinence and pelvic organ prolapse
Problems after surgery for stress urinary incontinence and pelvic organ prolapse
Problems following operations for stress urinary incontinence
Summary of findings for stress urinary incontinence
Problems following operations for pelvic organ prolapse
Summary of findings for pelvic organ prolapse
What does all this mean for women and doctors?
Key messages

Chapter 5 Review of the evidence from safety reviews and systematic reviews
Evidence availability
Methods
Safety reviews of mesh implants
Systematic reviews of effectiveness of mesh in stress urinary incontinenece and pelvic organ prolapse
Systematic reviews of adverse outcomes in stress urinary incontinenece and pelvic organ prolapse
Conclusions

Chapter 6 The choice of surgical approach of mesh device implantation for the treatment of stress urinary incontinence in women: Clinicians' view
Clinicians' views
Conclusions

Chapter 7 Legal Judgements
Evidence availability
Methods
Results
Interpretation

Chapter 8 Adverse event reporting
Situation
Background
Assessment
Feedback to clinicians and patients
Resources to report mesh adverse events - staff and follow-up
Legislation
Summary

Chapter 9 The Conclusions and recommendations of the Independent Review

Chapter 10 Chairman's concluding remarks

Appendix A Remit of the Independent Review of transvaginal mesh implants

Appendix B Independent Review group members

Abbreviations

References

Annex A* Using routinely available health data to examine the provision of, and outcomes following, surgery for SUI and POP in Scotland: Technical Report

Annex B* Evidence review tables

*These documents have been provided separately due to their size and are available online