Transvaginal Mesh Case Record Review

Recommendations

1. We recommend that if deemed necessary by the Scottish Government, any bespoke Data Sharing Agreements should be put in place with the remaining Boards prior to the commencement of any larger case review.

2. We recommend that it is critical to have a process whereby what is requested is what the individual wishes to see, and provides relevance and context to what they would like to know. We therefore recommend, that, in conjunction with other initiatives, the short form retrieval method is adopted.

3. We recommend additional support mechanisms being put in place for GPs and practice teams to aid understanding and address concerns women may raise with them following a transvaginal mesh surgery.

4. We recommend that Scotland maintains a Mesh Register which records surgery in Scotland, as well as surgery which has occurred in other parts of the UK and overseas.

5. We were supportive of the practical and integrated response proposed by the New Zealand review and suggest that Scotland should reflect with a view to adopting similar initiatives.

6. We recommend that there needs to be a clear understanding and precision regarding the language used to describe the procedure being proposed. If there is discussion regarding a potential procedure to remove mesh, it has to be made explicit what type of surgery is to be undertaken and the proposed extent of what is going to be removed.

7. We recommend that, if requested by the patient, the organisation provides an explanation to the patient (or person authorised by the patient to request it on their behalf), why certain information has been redacted.

8. We recommend keeping a detailed set of medical notes of the dialogue, including what leaflets were given (and including a copy of these in the records), what counselling and advice was given about the procedure, and which risks and potential complications were discussed that led to an informed decision being made. This should then be replicated in a letter to the patient and copied to the patient’s GP.

9. We recommend that surgical units should keep a version control of their patient information Leaflets and that this should be noted in the case records so that when looking back, it can be seen precisely what information was given to a patient at any point in time.

10. We recommend that the use of patient decision-aids, checklists and information leaflets should be provided in advance of the consultation, so that the time available in the consultation can be optimised. This helps to ensure that patients are empowered with the information they need to decide and have shared responsibility for their care.

11. We recommend the creation of a national specific consent form, for use across the country, to reduce variation, and improve consistency of information covered during the counselling process.

12. We recommend to create the conditions in the NHS to enable an informed consent process, namely adequate training, and adequate time, supported by high quality decision aids and consent forms.

13. We recommend that all information should be drawn together into a single website. This website should be clear about where the responsibility lies for patient care at each stage through the referral pathway.

14. We recommend that dedicated funding should be made available so that work may be undertaken to make this website accessible, connected and regularly updated and maintained with up-to-date information.

15. We recommend that information around referral and treatment pathways is clarified and published on the website. This needs to be specific to the processes of the Complex Mesh Surgical Service, Scotland and designed from the patient perspective. Where responsibility lies at each stage should be identified and signposted effectively. This should be regularly updated and maintained.

16. We recommend the process of training and credentialing of surgeons in Scotland is a critical element and its process has to be clearly articulated, and made available, not only for clinicians, but also for women using the service.

17. We believe that patients should be clearly informed of the options available during their appointment prior to attending the Complex Mesh Surgical Service Scotland, for example, to be accompanied by a trusted person and to record discussions that take place during the appointment. Such options will help to enable the patient to retain and reflect on the information and treatment options discussed. It is recommended that this information is included on the single website.

18. We believe that it is crucial that there is an agreed system of NHS follow-up and ongoing support in place for patients who are returning from a mesh revision surgery which has taken place outside Scotland and that this data is captured, collated and forms part of a comprehensive evaluation mechanism.

19. We recommend the implementation of the Health Improvement Scotland Guidelines on data capture to also include national learning from significant adverse events.

20. We recommend the requirement for all Complex Mesh Surgical Services’ across the UK to collaborate on agreed consistent data gathering, including on longer term outcomes from treatment

21. We recommend that agreement be reached on how 'success' should be defined and measured, from both a clinician and patient perspective.