Transvaginal mesh short-life working group minutes: December 2020

Attendees and apologies

Present

• Terry O’Kelly (T O’K), Scottish Government (chair)
• Ans Khan, NHS Lanarkshire
• Alan Mathers, NHS Greater Glasgow and Clyde
• Jennifer Allen, NHS National Services Scotland
• Paul Hornby, National Procurement
• David Bryce, National Procurement
• Christine Hemming (CH), NHS Grampian
• Carolyn McKinlay, NHS Fife
• Roseanne McDonald (RM), NHS National Services Scotland
• Lucie Buck, NHS Ayrshire and Arran
• Ibrahim Alsharaydeh, NHS Highland
• Irene Oldfather, The Health and Social Care Alliance
• Erin Fyfe, Scottish Government
• Kerry Chalmers, Scottish Government
• David Bishop, Scottish Government
• Alana Dickson, Scottish Government (note)

Apologies

• Karen Ritchie, NHS Healthcare Improvement Scotland
• Margaret McKeith, The Health and Social Care Alliance
• Klara Ekevall, NHS Forth Valley
• Peter Fowlie, NHS Tayside
• Jackie Montgomery, NHS Greater Glasgow and Clyde
• Cliff Sharp, NHS Borders
• Corinne Love, Scottish Government
• Craig Wheelans, NHS National Services Scotland
• Wael Agur, Independent
• Susanna Mendes, NHS National Services Scotland
• Brian Chittick, NHS Shetland
• Marthinus Roos, NHS Orkney
• Colin Fischbacher, NHS Public Health Scotland
• Michelle Watts, Scottish Government
• Alexandra Rice, NHS Lothian
• Heather Currie, NHS Dumfries and Galloway
• Simon Nicholson, NHS Lothian
• Kate Darlow, NHS Borders
• Sara Davies, Scottish Government
• Safia Qureshi, NHS Healthcare Improvement Scotland

Items and actions

Welcome and apologies (T O’K)

The Chair welcomed everyone and noted apologies.

Declarations of interest (T O’K)

The Chair reminded Group members of the importance of maintaining accurate, thorough and up-to-date declarations of interest. The Chair asked if anyone had not completed a declaration or had any new interests to declare and stressed that any interests, not only conflicts, be included.

Action point: Alana to forward declaration of interest forms to Paul Hornby, David Bryce, Jennifer Allen, and Lucie Buck. (Alana Dickson)

Minutes of meeting on 31 July 2020 (T O’K)

The Chair went through the minutes of the meeting on the 31 July and asked the group to comment on any inaccuracies. One change was suggested. Once changed, the minutes will be accepted as an accurate record.

Action point: amend minutes of 31 July meeting as above (Alana Dickson)

Chairman’s update (T O’K)

The Chair commented that the management of mesh complications and how treatment will go forward in Scotland and the UK remains under intense parliamentary and media scrutiny.

Three key recent events are the Parliamentary debate on the Independent Medicines and Medical Devices Safety Review (IMMDS) in September, a ruling by the medical regulator in Quebec, and Dr Veronikis’ evidence session at the Pubic Petitions Committee.

Parliamentary Debate on the IMMDS Review

• Scotland has embraced all of the recommendations made by Baroness Cumberlege that are within Scotland’s power, including the establishment of a Patient Safety Commissioner
• two amendments were accepted to the Government’s motion during the debate. Jackson Carlaw’s amendment, which was accepted, advocated that mesh injured women should have the prospect of mesh removal by a surgeon who enjoys their full confidence, fully funded by the NHS
• Neil Findlay also tabled an amendment but this was rejected. This asked for the development of and surgery in the mesh centre in Glasgow to stop, and the training and skills of surgeons to be reviewed. This amendment was rejected by only one vote which was cast by the Presiding Officer
• there is clear parliamentary momentum and scrutiny over how and where mesh injured women are managed and the choices they are given

International links

• the Chair noted that there had been a decision made by the medical regulator in Quebec, which ruled that because coherent care was not available in Quebec for women with mesh complications, the Quebecoise Government should reimburse and pay for women to go elsewhere for treatment
• a Specialist Centre for mesh complications is being established in Quebec. They are also undertaking to credential their surgeons in mesh removal surgery

Public petitions committee evidence session with Dr Veronikis

• Dr Veronikis was invited to the Public Petitions Committee to give his views on why his trip to Scotland could not come to fruition
• this has reinforced the desire among mesh injured women that they would like to be treated by him

In light of the events over the last few months, we need to look at how women can be provided with more choice and what can be done to build trust in the services available in Scotland and the UK.

In discussion, several suggestions were made on how we focus on moving forward. It was agreed that a communications package would help to show the steps being taken to improve treatment for mesh injured women in Scotland. At some point in the future, it may also be helpful for the Glasgow clinicians to host parliamentarians to showcase their work.

In an effort to move forward, we have elected to pursue the three avenues below:

1. Continued development of the complex mesh removal centre in Glasgow, with a focus on how we can restore and build trust and confidence. If we can better understand the issues then this may help women feel comfortable to pursue treatment in Scotland.
2. For those that do not wish to move forward with treatment in Scotland, we have been working with NHS England to develop a clinical network across the UK, tying all mesh removal centres together. This will enable women to have a choice of centres.
3. For those that do not wish to receive treatment from any clinician in the UK, we have been considering what can be done to help these women receive treatment, outside of the NHS.

 UK consensus building

• the commissioning process for the specialist centres in NHS England is ongoing
• the first in a series of UK meetings took place on 20 November, chaired by the NHS England lead commissioner. This brought together leads from the various potential centres in England, NI, and Scotland, with patient representatives and others, to look at various issues including; the care pathway, patient information and decision aids, and approach to surgery. The aim was to build consensus and a way forward for the UK as a whole

Credentialing

• colleagues from the Royal Colleges and specialist associations have been in contact with the GMC about establishing a GMC regulated and accredited credential for mesh removal surgery
• the credential will define what skills clinicians need to develop, how the skills will be measured, and how we can benchmark the acquisition of the skills. The accreditation will be registered in the GMC register of specialists, indicating that surgeons are credentialed to undertake mesh surgery
• the aim is that this will recognise the skills of our surgeons, it will provide support for the Service and it will increase public confidence. There was consensus that credentialing is a positive development to move forward and build trust. The length of time that the credential may take to come in to force was raised in discussion

Out of NHS referrals

• the Chair and Roseanne McDonald gave an overview of the work being undertaken by NHS National Services Scotland (NSS) to consider an out of NHS option for women who cannot be treated within the NHS, for a variety of reasons
• patient safety and quality of care are paramount, and a process of due diligence must be in place
• treatment must be integrated with pre- and post-operative care as ongoing care will be provided in this country
• NSS will follow their commissioning guidance, working closely with colleagues in their procurement department. A Clinical Advisory Panel will need to be established to move this work forward and assess applications. NSS are presenting this proposal at a meeting with SAMD on 17th January

Case record review

• the contracts are currently being finalised and it is expected that the Cabinet Secretary will make an announcement in the not too distant future
• the Terms of Reference will be made available to the Group
• this has been designed to help women move forward and hopefully this will be a process they can engage with and benefit from
• there will be an expectation that Accountable Officers assist with finding evidence and they will be contacted regarding this

Patient engagement led by the health and social care alliance (‘the alliance’)

The Chair invited Roseanne to provide more information on the work being done by NSS, the Alliance and NHS GG&C to restore trust in the new Glasgow centre:

• in order to build the confidence of women, GG&C are working with the Alliance to analyse recent patient experience data. The Alliance will then carry out a focus group with women to better understand their recent experiences of the service
• it is hoped that the Case Record Review will help reconcile some women, where there has been concerns about the accuracy of case records, regarding full and partial removal of mesh
• GG&C also intends to hold a stakeholder event in the Spring

The Chair invited Irene Oldfather from the Alliance to give more information on the work planned with the focus groups:

• the Alliance will be holding a first focus group with women who have recent experience of the GG&C Service, as well as a second focus group in January with a wider audience
• in addition, the Alliance will be holding an online survey to gather as wide a range of views as possible
• the aim of these sessions is to capture women’s experiences in more detail, understand what a good service looks like to these women and reassure people that that is what we want to deliver, as well as understanding any concerns or apprehensions women have about using the service here

Action point: Irene Oldfather to share the questions for the online survey with the SLWG for any feedback.

Action point: further discussion and thought required on how to integrate the Glasgow service into the Scottish pathway as a whole and improve networking (Terence O’Kelly, Roseanne McDonald).

Update on the specialist centre (RM)

The Chair invited Roseanne McDonald to give more information about the new mesh centre:

• GG&C have concluded two internal workshops looking at the pathway and the next step will be further engagement with multi-professional local teams and with patients. There is a need to better understand women’s experiences from the start of their journey, as well as after discharge from the National Centre. This is not just about the surgery, but about the whole pathway
• recruitment is underway, the service will have four uro-gynaecology consultants, and colorectal sessions have been secured too
• the intention to work on the patient pathways to clarify and improve the current pathways was noted. In discussion, the length of time it takes women to go through the pathway (i.e. getting MRI scans etc) was also noted. The establishment of a ‘task and finish’ group was suggested, to reduce variation across Scotland and also to build capacity at local centres

Action point: further discussion and thought required on how to integrate the Glasgow service into the Scottish pathway as a whole and improve networking (Terence O’Kelly, Roseanne McDonald).

Mesh database pilot (CH)

The Chair invited Christine Hemming to give an update on the Mesh Database:

• Scotland and all 4 nations will be participating in the database
• Scotland has decided that they are going to use the database to input data for patients that are undergoing surgery for uro-genital prolapse and incontinence in general (i.e. a wider group of procedures than only mesh complications and removals)
• the database is being provided by NHS Digital (out with Scotland) so a key concern is that we require appropriate information governance agreements
• the three pilot sites are NHS Fife, Greater Glasgow and Clyde, and Grampian
• the group have had discussions on how the key pieces of information can be retrieved locally and have identified that there are great differences between health boards (in IT systems, governance etc.)
• the database group require information from each Accountable Officer on what the pathway is for pelvic floor repair, mesh procedures, and urinary incontinence procedures so they can devise a more coordinated approach that makes it easier when the database is rolled out to all Health Boards
• Caroline, Veenu, and Christine will contact each Accountable Officer to get more information on their pathways

The Chair invited questions and comments. In discussion the following points were made:

• there was a suggestion that a diagram would help to illustrate this piece of work, what it is and what is needed from each Health Board to achieve the end goal
• Christine commented that it would be useful if another Health Board that used a different IT system to the three existing sites volunteered to act as the 4th pilot site. NHS Ayrshire and Arran or Lothian were suggested

Action point: Christine to contact each Accountable Officer to understand their pathways.

Action point: Christine to consider adding a further Health Board to the pilot (Christine Hemming).

AOCB (T O’K)

None

Next meeting

Date of next meeting to be confirmed.