On this site you will find information about the Transvaginal Mesh Case Record Review. This Review has been commissioned by the Scottish Government to address concerns raised by women about whether their case records accurately reflect the treatment they have received, specifically in relation to full and partial removal of mesh.
This website will be updated as the Review progresses and a final report will be published upon completion of the Review.
If you have any questions about the Review, please get in touch at: email@example.com
Welcome from the Moderator
Professor Alison Britton
Introduction and the setting up of the Review
This section provides some background and context on why a Transvaginal Mesh Case Record Review has been established.
For a number of years, matters relating to polypropylene pelvic mesh implants have been the subject of intense scrutiny and debate not only in Scotland but across the world.
These medical devices were the subject of a petition to the Scottish Parliament’s Public Petitions Committee in April 2014. This was followed by the Scottish Review into their use, safety and efficacy. The Review’s Final Report, published in March 2017, generated widespread criticism. In May 2017, I was commissioned by the then Cabinet Secretary for Health and Sport to investigate the process by which the Review came to its conclusions. My Report was published in October 2018.
In November 2019, the First Minister met a number of women who had experienced complications arising from their mesh implants. During these meetings, some women expressed concerns about their clinical care, how it was documented in their case records and how it was reported to them.
Finally, such background would not be complete without acknowledging the Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege. In July 2020, she published her Report which provided a comprehensive set of recommendations on how to improve the lives of people who have been harmed by use of medicines and medical devices such as pelvic mesh implants. Themes emerged from these recommendations that spoke of strengthening the patient voice and provided guidance on how to help build a healthcare system that ‘listens, hears and acts’.
On the 12th February 2021, the Cabinet Secretary for Health and Sport announced the start of the Transvaginal Mesh Case Record Review. This Case Record Review has been established in response to the serious concerns raised in both the media and in Parliament, as well as with the First Minister and the Cabinet Secretary for Health and Sport in November 2019.
The Cabinet Secretary for Health and Sport has commissioned me to act as the Moderator and has also commissioned 3 Panel members with a clinical background: Dr Carey Lunan MBE, Mr Ian Currie and Professor Anthony Smith. I welcome the individual qualities, and considerable expertise that each will bring to the Review. I am also grateful to Mrs Irene Brown, who will provide administrative support. See our biographies.
I will be writing to all of the women who attended those meetings with an invitation to participate in this Review. For the women who choose to come forward, I wish to express my thanks to you in advance and promise that I will listen and, along with the members of the Review Panel, we will aim to provide clarity and answers.
The Purpose of the Review
The purpose of the Review is set out in its Remit and its Terms of Reference.
A Remit involves the areas of activity that the review will undertake to meet the Terms of Reference. It should sit consistently with, and expand upon, the key words contained in the title. The remit for this Case Records Review is 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. The remit will be met by following the provisions contained in the Terms of Reference.
Terms of Reference define the purpose and structure of a review and provide the framework in which a thorough investigation of events can take place.
The Scottish Government has commissioned and funded this Review. Its design 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, the Health and Social Care Alliance and women’s representatives, the General Medical Council, the Scottish Public Services Ombudsman, Central Legal Office, Royal College of Obstetricians and Gynaecologists, and the Panel members of the Review.
The full Terms of Reference are available on the Review’s website. In summary:
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 (Those who responded with their intention to attend the meetings in November will also be eligible to participate). 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 reported to them. In particular, the Review will address concerns about the clarity of documentation regarding full and partial removal of mesh. It is not intended as a review of the women’s entire case history and the Review will not make any specific recommendations about further treatment. For those women who choose to participate, the Review will include an examination of the relevant case records and an open discussion with the reviewing team for the purposes of explanation and understanding. There will be a subsequent opportunity, after a period of reflection, for any follow-up comment and questions. A written report will be provided for each participant, summarising the findings, which will be added to their case records. Finally, and subject to the outcome of appropriate evaluation, consideration will be given to offering a review of this nature to the wider group of women who received transvaginal mesh implants and who may have similar or other concerns.
How the Review will be carried out
While Scottish Ministers will retain oversight of the Review, I must stress that the Review Panel will operate independently from the government or any other organisations.
It will be conducted with transparency and openness and in the spirit of the recommendations outlined in my 2018 Investigative Review. As well as operating independently, the Review is also entirely impartial. As the Moderator, I have the same responsibilities as a chair in terms of introductions, time keeping and maintaining respect between parties. A moderator’s role tends to be more participative in terms of ensuring that all parties have an opportunity to be heard fairly, fully and openly.
For further detail on the process, please see “What can I expect from the Case Record Review”.
How you can keep updated on its progress
Throughout the duration of the Review our website will provide updates on timescales and progress. If you have questions about the Review, or if you have any information which you think should be drawn to our attention, you can contact us at firstname.lastname@example.org Please note that we also have a Frequently Asked Questions section.
Moderator, Transvaginal Mesh Case Record Review