Transvaginal Mesh Case Record Review

Chapter 1 - Background and Process

1.1 In April 2014, Medical mesh devices were the subject of a petition to the Scottish Parliament’s Public Petitions Committee.^[19] 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. The Petition received over 1700 signatures and 212 comments.^[20] In 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.

1.2 On 27 March 2017, the Scottish Government published the Mesh Review’s Final Report.^[21] It received widespread criticism over a range of concerns including the evaluation and inclusion of certain evidence, the nature and quality of the independence of the review process, and the inclusion of the two petitioners’ input despite their resignation and subsequent request for their contribution to be removed.

1.3 In May 2017, Shona Robison, the then Cabinet Secretary for Health and Sport, commissioned me to investigate the process by which the Review came to its conclusions. The findings of the Investigative Review were published in October 2018.^[22] It highlighted a number of failings and made recommendations on how such reviews should be conducted in future. Despite being well received, to date,^[23] none of the 46 recommendations have been implemented by the Scottish Government.

Membership of the Transvaginal Mesh Case Record Review

1.4 In November 2019, the First Minister met a number of women who had experienced complications after having had surgery for mesh implants. Some expressed concerns about their clinical care, how it was documented in their case records and how it was reported to them. Following those meetings and to address such concerns, the First Minster confirmed that these women would be given an opportunity to set out their concerns about treatment and offered an independent review of their medical notes.^[24]

1.5 On the 12th February 2021, the then Cabinet Secretary for Health and Sport, Jeane Freeman, announced the start of the Transvaginal Mesh Case Record Review.^[25]

1.6 The Membership of our Panel was:

• Alison Britton – Moderator of the Case Record Review. Professor of Healthcare & Medical Law, Glasgow School for Business and Society, Glasgow Caledonian University;
• Mr Ian Currie – Consultant Obstetrician and Gynaecologist, Buckinghamshire Hospitals NHS Trust: 1997- Present;
• Dr Carey Lunan, GP principal, NHS Lothian. Immediate past-Chair of Royal College of General Practitioners in, Scotland )2017-2020;
• Professor Anthony Smith, Professor of Urogynaecology (Manchester Academic Health Services Centre) & Consultant Gynaecologist, Manchester (retired);
• Administration – Irene Brown, Directorate of School Professional Services, Glasgow Caledonian University (retired);
• Transcription - Irene Brown, Directorate of School Professional Services, Glasgow Caledonian University (retired); and
• Transcription - Alison Lockhart, Directorate of School Professional Services, Glasgow Caledonian University.

1.7 Each member sat in a personal capacity and did not represent the views of any particular organisation or body.

The Purpose of the Review - Remit & Terms of Reference

1.8 The Scottish Government commissioned and funded this Review. Its design, purpose and Terms of Reference are the product of a consultation process with interested parties, including, amongst others, the Short Life Working Group on Mesh Complications,^[26] the Health and Social Care Alliance Scotland^[27] and women’s representatives, the General Medical Council,^[28] the Scottish Public Services Ombudsman,^[29] Central Legal Office,^[30] Royal College of Obstetricians and Gynaecologists,^[31] and the Panel members of the Review.

1.9 Much of the engagement with these parties had been conducted prior to the appointment of the Panel but once appointed, we were given the opportunity to adapt and revise any of the provisions.

1.10 Following the initial publication^[32] of the Terms of Reference, a number of requests for clarity were received regarding some of its sections. As moderator, I attended a meeting with representatives from the Scottish Mesh Survivors Group,^[33] Jackson Carlaw MSP, Alex Neil,^[34] Neil Findlay^[35] and Dr Wael Agur^[36] following which, a revised version was agreed and published.^[37]

1.11 The purpose of the Review is set out in its Remit and Terms of Reference.

1.12 The remit of the Review was to:

‘Consider the serious concerns raised by some women at the meetings with the First Minister in November 2019. Specifically, if their case records accurately reflect whether they have undergone full or partial removal of transvaginal mesh. The Review aims to provide clarity on individual case records and the mesh removal procedure performed by providing an opportunity for women to set out their concerns and have their records reviewed by clinicians to allow for discussion, explanation and mutual understanding.’^[38]

1.13 As a Panel, we unanimously agreed that the remit supported the rationale for the Review.

1.14 The remit was met by following the provisions contained in the Terms of Reference.

Terms of Reference

This Review is intended for the women in Scotland who have had transvaginal mesh implants and who attended the meetings with the First Minister in November 2019. The purpose is to address the concerns they expressed about their clinical care and how this is documented in their case records and/or how this care has been communicated to them. In particular, the Review will address concerns about the clarity of documentation regarding full and partial removal of mesh.^[39]

1.15 The Review was not intended to provide an examination of a participant’s entire case history, nor was it to include any specific recommendations about further treatment. Instead, it was intended to examine case records relevant to the mesh care and treatment. Defining what constituted ‘relevant’ case notes was not as straightforward as was initially thought. This will be discussed further in this and the following chapter.

1.16 A bespoke report has been provided to each participant, summarising the findings of the Panel. This was accompanied by an invitation to meet to discuss our findings regarding the participant’s case records. These meetings were optional but if they were requested, they were attended by the participant, moderator, administrator and one of the clinical panel members. All participants were invited to have someone attend these and all meetings with them if that was their preference.^[40] There was a subsequent opportunity, after a period of reflection, for any follow-up comment and questions. Participants were encouraged to make their General Practitioner aware of their engagement in the Review. The Health Boards will add a note to a participant’s case record to advise that they have participated in this Review. The terms of reference note that consideration will be given to offering a Review of this nature to other women who have had transvaginal mesh implants and who may have similar or other concerns.

Structure of this Report

1.17 This Report presents our findings and comprises two parts. Part l provides a critical and reflective assessment of the review process that we adopted; its strengths, weaknesses and whether it achieved its aims. The terms of reference required that the Review was to be undertaken as a ‘pilot’ and that this Report should include a description and analysis, and make recommendations for some possible models that could be used to enable a larger number of women to engage in any future Case Record Review.

1.18 As such the concluding chapter of Part l contains practical recommendations for requesting, scoping and conducting any future larger review.

1.19 The second part of our Report considers some of the recurring themes which emerged as part of our discussions with the women who agreed to participate in the Review and also through our own engagement as a Panel with the case records.

1.20 The balance of this chapter outlines some of the challenges in relation to conducting a pilot review and what we did to address them. It concludes with key information about who this report was written for (our intended audience) and acknowledges our thanks to those who chose to participate in the Case Record Review.

What is a ‘pilot’ review?

1.21 A pilot process, or in this case, pilot review, will often bring with it a degree of uncertainty because it will be introducing untried or unique approaches. The purpose of the pilot is to ascertain the viability of the approaches taken using a smaller scale before committing resources for use on a larger scale.

1.22 This was true in this context, since a Review of this nature had not been undertaken before.^[41] Part of the purpose of our Review was to prove the viability of the approach(es) that we adopted. The smaller scale elements were satisfied by confining eligibility to a group of 47 women who had attended meetings, in November 2019 with the First Minister and Cabinet Secretary for Health and Sport.

1.23 A first task for us was to design and create processes which would underpin the Review. Once these were in place we continued to test and reflect upon them throughout the Review’s duration.^[42] In particular this included the use of various documents. These comprised not only the final Report but included explanatory materials, consent forms, forms to ingather information and a clinical proforma which detailed what aspects of their case records the participants would want the panel to review. These documents are considered in more detail in chapters 3, 4 and 5.

1.24 This Report also documents our perceptions and experiences throughout the duration of the Review. As befits a pilot, it includes consideration of whether the Panel believes that the Review was viable and beneficial – not only as a concept in itself, but also whether the underpinning processes that were used achieved the aims and outcomes of the Review and, if so, what may be done to enhance the viability of a larger future review. Whether a review of case records should stand in isolation or form part of a multi-faceted approach to address the participants’ needs and concerns, is a question that the Panel revisited a number of times throughout the review process, and is reflected in this Report.

Intended audience

1.25 Although the office of the Cabinet Secretary for Health and Sport commissioned this Report, we anticipate that it will have a wide and diverse reading audience. It has therefore been written with that diversity of interests in mind. Where technical terms have been used, an explanation or links to further explanation can be found in the footnotes. If we have referred to other literature, a reference to this can also be found in the footnotes. All the templates that we designed and used during the Review process are included in Appendix 1 of the Report.

1.26 We also wanted all participants to feel involved in the review process; that we would seek to work with them in whatever way they felt comfortable engaging with us. When speaking with the women who participated in this Review, it was not unusual that their own words conveyed their experiences much more succinctly and powerfully than we could in the retelling. As a result, we believed that their words should be actively included in the composition of our Report. Their own words are quoted throughout Part l and Part ll of the Report.

1.27 We would like to thank everyone who took the time to contribute to this work. A Case Record Review of this type has not been undertaken in Scotland before. Starting with a blank canvas, we drew upon a significant and diverse range of knowledge and expertise to design and effect a review of this nature. We are grateful to everyone who contributed.