Transvaginal mesh implants independent review: final report

Preface

This Scottish Independent Review ( IR) of the use, safety and efficacy of transvaginal mesh implants in the treatment of stress urinary incontinence ( SUI) and pelvic organ prolapse ( POP) in women came about because of growing public concern about the number of women experiencing serious complications. This was linked with under-reporting of adverse events and a poor understanding as to why these complications had occurred.

Women felt that their voice had not been heard as they raised concerns about the side effects a number of them had suffered. Many of them eventually felt that the only way to bring this to the attention of the "powers that be" was to lodge a petition bringing the issue to the attention of the Petitions Committee of the Scottish Parliament. At that Committee the then Cabinet Secretary for Health and Wellbeing, Alex Neil MSP, promised an independent review and asked NHSScotland to consider suspension of transvaginal mesh procedures pending the outcome of this review. A link to the Interim Report is included here:
http://www.gov.scot/About/Review/Transvaginal-Mesh-Implants

The table from Chapter 6 of the Interim Report can be found at Appendix D.

From the outset, we were charged with listening to and valuing the views of patients, both those with a good result and those with a poor result, including those living with significant impacts on their day to day life. We were asked to review the best available research evidence, statistics and both patient and expert opinion to find out the nature and scope of the problem.

We have tried to do this by involving women who have undergone such surgery; the local clinical experts in this surgery; clinical experts from around the UK; the Scottish Public Health Network for an objective review of the research literature; the Information Services Division of National Services Scotland, for an objective epidemiological review of the information from routine data; MHRA, the statutory regulatory body; the professional bodies, including the Royal College of Obstetricians and Gynaecologists ( RCOG), the standard setting body for the profession; and input from the Chief Medical Officer's office and the Division of the Scottish Government Health and Social Care Directorate which deals with medical devices. We have been very ably supported throughout by a member of that latter Division.

During this IR we heard evidence from women who are disabled as a result of the surgery they had undergone. They also felt that they had not been listened to, or even believed which only increased their distress. We also heard of lives transformed and improved by the same surgery with statistical and research evidence showing poor outcomes to be in the minority of procedures done. We also acknowledged that adverse events could not be totally excluded from any surgery, as any surgery carries a risk. What we have tried to do is to take an objective view of both the results of the research and of the information review but also what they did not tell us, what was missing, what the patient stories can tell us and what the experience of clinicians in practice can tell us.

We found some concerning features about how new techniques are introduced into routine practice, how and for how long they are followed up, how women are informed of the risks and benefits so that they can give true informed consent and also how adverse events are reported and to what extent.

Our conclusions focus on the need for improved governance around both the introduction of new procedures or techniques and also of how women are assessed and treated, both initially and in the event of any side effects following surgery. Reporting of adverse events is another area where we feel that a tighter, more explicit practice is required and we make suggestions that the government should consider to ensure this area is improved. We differentiate between the use of mesh in the treatment of SUI and when it is used in the repair of POP. We see the need for an Expert Group to oversee the implementation of an improved way of working, and of organising services. We are aware that some of our conclusions have wider implications and see the need to embed this in the Patient Safety and Clinical Governance strands of the NHS.

As Chairman, I hope that this report goes some way towards ensuring above all that patient voices continue to be heard, believed and valued and that women with these conditions can be assured that the treatment which they receive within the NHS is evidence based, audited and likely to produce a good result while keeping to a minimum the possibility of an adverse effect.

The following report sets out what we did, how we did it, what we concluded and why and what we consider should be done as a result.

This report was the work of many people and disciplines. I am extremely grateful for all their contributions. Readers of this report may notice differences in styles in the chapters arising from this collaborative process.

Lesley Wilkie

As the Chair of this important Review from November 2016 to March 2017, I am delighted to add my agreement to the words of the previous Chair. I have found the work to be detailed, professional and personal, and I commend this final report to all.

Around a year and a half has elapsed since the IR published its Interim Report. This has, however, been for very good reason, the group having awaited the publication of several key studies, including PROSPECT, published at the end of last year. All evidence, including the important new studies, is considered in detail in chapters 4, 5 and 6. Whilst the new evidence has seen those chapters revised considerably since the Interim Report, the remaining chapters remain broadly as before, brought up to date wherever necessary.

I wish to thank the previous Chair, Lesley Wilkie for her caring and thoughtful work from 2014, the previous secretary, Gillian McCallum, of the Scottish Government, for her exacting work bringing in the interim report to publication and the rest of the Review team for the joint effort.

The final stages of completion of the review have been marred by suggestions that evidence has been destroyed or is missing, I am confident that is not so and have written to the Cabinet Secretary for Health and Sport setting out the approach taken. The material presented by one group member and not included in the final report is available on the website with the Declarations of Interest from group members.
http://www.gov.scot/About/Review/Transvaginal-Mesh-Implants

Although three members of the group resigned prior to the completion of the final report, I am grateful to them for their contribution to the development of the report and for their final comments which have been considered in detail prior to the completion of the report.

Developing consensus is never easy and particularly in this area where the underlying clinical conditions cause reductions in their quality of life and misery for many individuals and there is no intervention which is as effective as we would wish, or without risk of complications.

Tracey Gillies