An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland

Executive Summary

A petition on polypropylene mesh medical devices was lodged in April 2014 to the Public Petitions Committee of the Scottish Parliament by Elaine Holmes and Olive McIIroy on behalf of the Scottish Mesh Survivors ‘Hear Our Voice’ campaign.

The Petition was lodged to draw attention to a number of women who had experienced serious complications following procedures to treat pelvic organ prolapse and stress urinary incontinence. This was linked with under-reporting of adverse events and a poor understanding as to why these complications had occurred. It received in excess of 1,700 signatures and 212 comments.

Following further evidence provided by the petitioners, Elaine Holmes and Olive McIlroy, on 17 June 2014, Alex Neil – then the Cabinet Secretary for Health and Wellbeing – informed the Committee that he intended to commission an Independent Review. The Review would not only explore the evidence that the petitioners had provided, but also consider complication rates and under-reporting of adverse events as well as looking at the overall evidence base for mesh devices.

The Scottish Independent Review Group held its first meeting on 25 August 2014.

On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report, entitled 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.^[1] This was preceded by an Interim Report which was published on 2 October 2015.

Prior to the publication of the Final Report, the first chair resigned and a second chair was appointed. Three further members of the Mesh Review Group resigned. The publication of the Final Report generated widespread criticism. Concerns ranged from the evaluation and exclusion of certain evidence, to the independence of the review process, and in particular to the inclusion of the petitioners’ input to the Final Report, despite their resignation and request for their contribution to be removed.

In response to these concerns, on 18 May 2017, the then Cabinet Secretary for Health and Sport, Shona Robison, advised the Public Petitions Committee of the Scottish Parliament that the process by which the Mesh Review Group came to its conclusions would in itself, be examined. An Investigative Review would be commissioned to undertake this task.

This report presents the findings of that Investigative Review. The task of this investigation has not been to reconsider the merits of the Mesh Review’s substantive conclusions on the safety and efficacy of transvaginal mesh implants, nor have we sought to apportion individual blame for any failing or omissions. That was not our remit. We have however, attempted to discover what caused the Mesh Review to be received in the way that it was.

Our Report comprises 10 chapters. It takes a chronological approach, from the commissioning of the Mesh Review until its publication. The balance of this chapter introduces key information about the composition of this Investigative Review Group and our methodology. Each subsequent chapter discusses key areas in which we have identified failures or mistakes as well as lessons which can usefully be learned from the Mesh Review for the establishment, management and support of future independent reviews.

Chapter 2 considers the importance of clarity and shared understandings in formulating the title, remit and terms of reference of any review and finds that the Mesh Review lacked many of these essential characteristics. This lack of clarity about the aims, object and purpose of the Mesh Review, continued to follow the review process through the long and increasingly dysfunctional months of its operation.

Chapter 3 examines the issues of independence, and conflicts and declarations of interest in the independent Review process. We identify a series of inadequacies in the approach adopted by, and record-keeping of, the Mesh Review. Chapter 4 considers the selection and responsibilities of the Chair, while Chapter 5 looks at important considerations in the selection and composition of members of a review.

Chapter 6 examines the role and responsibilities of the chair and members in an independent review. Chapter 7 considers the management and evaluation of the evidence in the course of the Mesh Review process.

Chapter 8 focuses on the composition and production of a review report, highlighting a number of limitations in the Mesh Review’s approach. Chapter 9 considers the timeframe, administration and budget of a review, and the problems characterising the Mesh Review on all three elements.

Chapter 10 considers the management of external influences on independent Review processes, and the impact which the publication and subsequent public and media scrutiny had on many of its members.

Having reviewed the evidence, we have concluded that the Mesh Review and the process leading up to the publication of its Final Report were characterised by systematic failures. We found that the Mesh Review was ill-conceived, thoughtlessly structured and poorly executed. Negative factors including irreconcilable differences of opinion of Review members, lack of agreement on the interpretation of evidence, unhelpful political and media influences and pressure to complete the report only served to magnify the failures in the process.

Whether the Mesh Review was independent was a recurring concern. The independence of any investigation is the spine which gives it credibility and legitimacy. Our investigation identified a number of problems with how the Mesh review solicited, monitored and reported relevant declarations and conflicts of interests by members of the Review Group.

We record a number of criticisms on how the Mesh Review was conducted. Some of these criticisms have informed our recommendations. However, we were satisfied that no one involved in the Mesh Review was acting in bad faith. On the contrary, public citizenship and sense of duty were the main factors in volunteering to be part of the Mesh Review. The same can be said of those who contributed and supported the process as Scottish Government officials.

The nature of any review, often commissioned by the Minister, whose departments have responsibility for the subject matter in question, usually arise from unanswered questions, controversy or public interest and can vary in terms of gravity and urgency.^[2] The fact that the review should be answerable to these elements gives rise to recurring concerns which usually involve the competence of the Chair, the independence of its members, the scope of its terms of reference, and its timescales and budget.^[3]

Although the use of independent reviews as an instrument of public policy is not without its critics,^[4] they appear to be here to stay.^[5] To give us an indication on the nature and frequency of reviews commissioned in Scotland, we asked the Scottish Government to provide data on how many reviews had been commissioned over the last 5 years. We were surprised to discover that this data is not available and we recommend that such data is collected.

There are no established procedures for guidance on how to establish, progress and publish outputs of a commissioned review. Guidance tends to be piecemeal, often relying on goodwill from those who may have had some previous involvement in the review process or whoever happens to have some time to spare. We recommend that a dedicated unit be established which would bring together experience and expertise that can be drawn upon when a review or other investigation is commissioned.

Finally, it is difficult for us to adequately describe the spectrum of emotions that we encountered from those that we met. The majority of members expressed strong, negative reactions towards their involvement in the Mesh Review. This was a combination of factors revolving around interpersonal conflicts within the group, politicisation of the review process, and treatment by the media. They felt totally unprepared for the levels of public and political scrutiny that they received. Some felt traumatized in the aftermath of the publication of the Final Report. One member noted:

“It was terrible, terrible, terrible.”

We hope that this Report and its recommendations are seen as a useful contribution which may reduce the risk of repeating the mistakes and failures which characterised the Scottish Mesh Review process.