Transvaginal mesh short-life working group minutes: June 2019

Attendees and apologies

Attendees

• Terry O’Kelly, Scottish Government (Chair) 
• Heather Currie, NHS Dumfries and Galloway 
• Klara Ekevall, NHS Forth Valley
• Wael Agur, Scottish Mesh Survivors Representative
• Christine Hemming, NHS Grampian 
• Carolyn McKinley, NHS Fife
• Alan Mathers, NHS Greater Glasgow and Clyde
• Simon Nicholson, NHS Lothian
• Lorna McKee, Chair, TVMO Group 
• Kelly Macdonald, TVMO Programme Manager
• Karen Ritchie, Healthcare Improvement Scotland 
• Alexandra Rice, Scottish Government 
• Corinne Love, Scottish Government 
• Michelle Watts, Scottish Government, Primary Care Clinical Advisor (by phone)
• Craig Wheelans, National Medical Advisor, National Services Division 
• Margaret McKeith, The Health and Social Care Alliance
• Anne Lillico (Secretariat)

Apologies 

• Ibrahim Alsharaydeh, NHS Highland 
• Sham Konamme, NHS Ayrshire and Arran
• Brian Chittick, NHS Shetland 
• Martin Roos, NHS Orkney 
• Angus McKellar, NHS Western
• Isles Peter Fowlie, NHS Tayside 
• Alex Stirling, NHS NSS ISD
• Jackie Montgomery, NHS GGC, Physiotherapy Lead
• Sara Davies, Scottish Government 
• David Bishop, Scottish Government
• Ans Khan, NHS Lanarkshire Welcome and Apologies  
   
  1. Terry O’Kelly welcomed everyone to the meeting, noted apologies and introductions took place round the table. 

Items and actions

Welcome and Apologies 

1. Terry O’Kelly welcomed everyone to the meeting, noted apologies and introductions took place round the table. 

Re-confirmation of Declaration of Interests 

2. Wael Agur reported that he has recently commenced medico-legal work on behalf of women taking action against mesh manufacturers. He noted that he would need to submit an updated declaration form with relevant details but did not think the new activity amounted to a conflict of interest.   

Craig Wheelans and Alan Mathers expressed some concerns regarding a possible conflict of interest. This was noted by the Chair and it was agreed that this would need to be assessed and reviewed regularly as the work of the Group progresses. There were no other changes to declarations of Interest. 

Action: Wa Action: Wael Agur to update and re-submit his Declarations of Interest for review by the next meeting in August.el Agur to update and re-submit his Declarations of Interest for review by the next meeting in August.

Minutes of Previous Meeting  

3. Subject to some minor changes to spelling and grammar, the minutes of the meeting held on 10 May 2019 were approved. 

Capturing Patient experience 

4. Terry explained the relevance and importance of capturing a broad perspective of experience from women who have suffered complications and who have received remedial treatment following vaginal mesh surgery in Scotland. He acknowledged the very significant contribution made by Scottish Mesh Survivors (SMS) but recognised that other voices must also be heard, as highlighted in the Britton report. To achieve this the Health and Social Care Alliance (supported by a Reference Group of the Transvaginal Mesh Oversight Group) are leading a further piece of work, using a range of methods including patient interviews to capture women’s experiences of complications. Updates will be given at subsequent meetings of the Group.  

5. Following an invitation from the Chair, Wael Agur introduced papers submitted on behalf of SMS.  The first (Management of Pelvic Mesh Complications in Scotland: Preliminary Results of a Service Evaluation Co-designed by Patients and Clinicians) described the results of a questionnaire investigating patient views on the management of vaginal mesh complications in Scotland. This was completed by a relatively small cohort of women who either attended the Independent Medicines and Medical Devices Safety Review (Cumberlege Review) meeting in Glasgow or accessed the questionnaire online via the SMS website.  The limitations of this study were accepted.   The second document had been prepared by Dr Agur for SMS (Views of the Scottish Mesh Survivors Group on the Service provided to the Meshinjured Women in Scotland). It contains opinion and recommendations reflecting the views of SMS and Wael Agur for improving the complication service in Scotland. These include bringing Dr Veronikis to Scotland to remove mesh, introducing translabial ultrasound scanning (TLUS), improving social support for mesh-injured women, introducing care pathways, photographing surgical specimens following mesh removal, ensuring patient follow up and mandating data collection.  It was noted that many of the issues highlighted in the report are being, or have already been addressed by the Group, as is documented in previous minutes.  Craig Wheelans and Alan Mathers raised concerns that the use of the word “recommendation” implied a robust evidence base. They suggested use of the term “suggestions” and this was accepted by the wider group. 

6. Inclusion of Dr Veronikis into proposed bench-marking visits by clinicians to centres of excellence in the USA was discussed. This had been agreed at the previous meeting of the Group and the plan was accepted by Wael Agur. Details and timing of these visits are still to be finalised. 

7. There was also discussion regarding the use of TLUS and it was agreed that this is only one of the imaging techniques available to clinicians.  NICE recognise that TLUS might have a role, but indicate that the clinical utility of TLUS is still to be defined and, as noted at the previous meeting, neither NICE nor NIHR advocate routine use on the basis that the outcome for the patient is not affected. The Group agreed that there is no objective evidence to support offering translabial 3D scanning at present.

 8. Margaret McKeith confirmed that she had met with TVMO to look at undertaking a consultation to capture as wide a range of patient experience as possible.  By using a variety of methods including social media, focus groups and one to one interviews, the intention was to reach as many women as possible from across Scotland.  She highlighted that this is a hard to reach group, but a key part of the process would be to be open and transparent, and to make patients feel safe and secure. 

9. Other issues discussed included social support, involvement of radiology and rheumatology as core members of the MDT, development of patient decision aid, awareness in primary care and management of surgical specimens after mesh removal. 

10. Terry O’Kelly noted that learning material had been developed by NHS England and it was thought it had been circulated to GPs in Scotland. Michelle Watts commented on the volume of such initiatives and that it might be difficult for GPs to keep abreast of the evolving landscape specifically around treatment of this group of patients.  Craig Wheelans confirmed that in his experience as a GP this was the case and that it was likely that referral pathways would be unique in each Health Board at present.  Michelle Watts highlighted the importance of signposting with appropriate support and direction about where to look for further information such as NHS Inform which is hosted by NHS24. 

Action: Michelle Watts to review the clinical pathway for patients in Primary Care and how this can be improved.

11. With regard to the management and recording of explanted mesh material, it was agreed that further information is needed from the specialist centres so that current practice can be established and a common protocol agreed.  

Action: Alan Mathers and Simon Nicholson to review current practice regarding handling of removed mesh with particular reference to recording by photography and pathology.    

12. The need for better co-ordination of the care pathway and increased availability of support with “navigation” was discussed and was agreed. In addition, it was recognised that aspects of the current pathway can appear ad hoc and this is particularly the case with patient follow-up. A better understanding of current practice and greater standardisation are required. 

Action: Craig Wheelans to work with Alan Mathers to develop care pathway for National Service with a view to improving equity of access to specialist care. 

Action: Christine Hemming to review current practice regarding patient follow up and make recommendations for a more standardised process

13. Following a discussion on the nature of their submissions, it was agreed that SMS should be asked to acknowledge Wael Agur as the author of the document. In addition they will be asked to review use of the term “Recommendations” as the heading on page 10. 

Action: Wael Agur to liaise Scottish Mesh Survivors Group regarding acknowledgement of authorship and use of the term “recommendations”.

Health Board Care Pathway for managing complications  

14.  The pathways received prior to the meeting had been circulated.  The outstanding ones will be followed-up for the next meeting. 

Action: Secretariat to follow-up the outstanding returns.   

NICE (123) April 2019 and comparison with current care available in each Health Board in Scotland.   

15. The pathways received prior to the meeting had been circulated.  The outstanding ones will be followed-up for the next meeting. 

Action: Secretariat to follow-up the outstanding returns.  

Tertiary Centres

16. Craig Wheelans set out the National Specialist Services 3 stage process and anticipated timetable for establishing a recognised National Service for managing mesh complications. He explained that he and Alan Mathers had been working together with a view to NHS Greater Glasgow and Clyde hosting such a service however this would require the agreement of the Health Board following the development of a robust and credible business case by the National Specialist Services Committee on behalf of the 14 territorial boards and the agreement of the Board Chief Executives.  The Group agreed that it was important to establish a National Service and recognised the need for greater patient support and coordination. This will be detailed in the service plan.    Michelle Watts commented on the importance of connecting the pathway to the community to ensure involvement of GPs. Craig Wheelans added that NSS plan to progress this as quickly as possible and the Group offered to provide support and assistance as required.  It is anticipated that the submission is likely to be considered in August. 

Action: Michelle Watts to provide a note on GPs perspective of a National Service. 

 Configuration of workforce and training needs

17. A paper mapping out the current medical urogynaecology workforce in Scotland was circulated prior to the meeting.   The exercise had shown there is good service provision across Scotland and that there is enthusiasm amongst current consultants to enhance surgical skills.  There was a discussion on how this might be achieved and agreed that further work should be undertaken. 

 Action: Alex Rice and Carolyn McKinley to investigate specific requirements for additional training and development.

AOCB

18.Terry O’Kelly advised the Group that the Scottish Government had received a substantial volume of correspondence from patients seeking a second opinion and asking the Cabinet Secretary for Health and Sport for assistance. He advised that where appropriate, enquiries would be allocated to the relevant Accountable Officer for action.   The Group commented that individual Health Boards were also receiving similar requests.  The Group was advised that Boards should follow their established policy regarding requests for and assistance with, second opinions.  

Dates of next meeting:

• 16 August 2019
• 27 September 2019