Transvaginal Mesh Case Record Review

Footnotes

1 Motamedi, M., Carter, S.M. & Degeling, C. (2022) Women’s Experiences of and Perspectives on Transvaginal Mesh Surgery for Stress Urine Incontinency and Pelvic Organ Prolapse: A Qualitative Systematic Review. Patient 15, 157–169. Available from: https://doi.org/10.1007/s40271-021-00547-7 [Accessed January 13 2022]

2 Karmakar D, Hayward L. (2019) What can we learn from the vaginal mesh story? Climacteric. 22(3):277–82, in Motamedi, M., Carter, S.M. & Degeling, C. Women’s Experiences of and Perspectives on Transvaginal Mesh Surgery for Stress Urine Incontinency and Pelvic Organ Prolapse: A Qualitative Systematic Review. Patient 15, 157–169 (2022). Available from: https://doi.org/10.1007/s40271-021-00547-7 [Accessed January 13 2022]

3 Angelova, N et al (2021) User testing a patient information resource about potential complications of inserted synthetic mesh , BMC Womens Health. 2021; 21: 35. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7831188/#CR3 [Accessed February 5 2023]

4 Muller P, Gurol-Urganci I, Thakar R, Ehrenstein MR, Van Der Meulen J, Jha S.(2022) Impact of a mid-urethral synthetic mesh sling on long-term risk of systemic conditions in women with stress urinary incontinence: a national cohort study. BJOG An Int J Obstet Gynaecol. 129(4):664–670.

5 Keltie K, Elneil S, Monga A, et al. (2017) Complications following vaginal mesh procedures for stress urinary incontinence: an 8-year study of 92,246 women. Sci Rep. 7(1):12015. 10

6 Morling JR, McAllister DA, Agur W, et al. (2017) Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population-based cohort study. Lancet (London, England).389(10069):629–640.

7 Thompson C, Faunce TA. (2018) Australian senate committee report on transvaginal mesh devices. Thompson C Faunce TA Aust Senate Comm Rep Transvaginal Mesh Implants J Law Med. 8;25(4):934–943.

8 PE1517.

9 PE1517 was lodged on 30^th April 2014 and closed on Sept 9^th 2021. For a full chronology, see https://archive2021.parliament.scot/GettingInvolved/Petitions/scottishmeshsurvivors

10 Scottish Government Publications (2017) The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Final Report. Available from: http://www.gov.scot/Resource/0051/00515856.pdf.

11 Britton A. (2018) An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland, with particular reference to the Independent Review of Transvaginal Mesh Available from: https://www.gov.scot/publications/investigative-review-process-establishing-managing-supporting-independent-reviews-scotland/

12 Scottish Parliament Official Report 18 December 2018, at columns 29-36, The Justice Secretary (now Cabinet Secretary for Health noted that ; ‘I absolutely accept the vast majority of the recommendations, but I am giving further consideration to a few others’…Many of the review recommendations, certainly the central ones, make a lot of sense to me, especially those on impartiality of members and there being more transparency about remits and terms of reference….’ At column 35. Available from: https://www.parliament.scot/api/sitecore/CustomMedia/OfficialReport?meetingId=11854 [Accessed January 23 2023]

13 Scottish Government, ‘Support for mesh victims.’ (23/2/2020) Available from: https://www.gov.scot/news/support-for-mesh-victims/ [Accessed September 29 2021]

14 The case Record Review and its membership was announced by the Cabinet Secretary in the Scottish Parliament February 12 2021. Available from: https://www.parliament.scot/chamber-and-committees/questions-and-answers/question?ref=s5w-35181 [Accessed April 28 2023]

15 All six participants received their surgery out with Scotland.

16 Montgomery v Lanarkshire Health Board [2015] UKSC 11 is a Scottish case that outlines the rule on the disclosure of risks to satisfy the criteria of an informed consent. Chapter 8 considers the implications of this case.

17 The Scottish Government announced its establishment in June 2020 and it opened in August 2020. Available from: https://www.gov.scot/news/national-mesh-removal-service/ [Accessed January 24 2023]

18 Surgery to remove all, or part of, the mesh (subsequently referred to in the report as 'mesh revision surgery').

19 PE1517.

20 PE 1517 was lodged on 30^th April 2014 and closed on Sept 9^th 2021. For a full chronology, see https://archive2021.parliament.scot/GettingInvolved/Petitions/scottishmeshsurvivors

21 Scottish Government Publications (2017) The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women: Final Report. Available from: http://www.gov.scot/Resource/0051/00515856.pdf

22 Britton A. (2018) An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland, with particular reference to the Independent Review of Transvaginal Mesh. Available from: https://www.gov.scot/publications/investigative-review-process-establishing-managing-supporting-independent-reviews-scotland/

23 Scottish Parliament Official Report 18 December 2018, at columns 29-36, The Justice Secretary (now Cabinet Secretary for Health noted that; ‘ I absolutely accept the vast majority of the recommendations, but I am giving further consideration to a few others’…Many of the review recommendations, certainly the central ones, make a lot of sense to me, especially those on impartiality of members and there being more transparency about remits and terms of reference….’ At column 35. Available from: https://www.parliament.scot/api/sitecore/CustomMedia/OfficialReport?meetingId=11854 [Accessed January 23 2023]

24 Scottish Government, ‘Support for mesh victims’ (23/2/2020). Available from: https://www.gov.scot/news/support-for-mesh-victims/ [Accessed September 29 2021]

25 Scottish Government (2020), ‘Support for mesh victims: Case Note Review to take place in Spring’ (23/2/2020). Available from: https://www.gov.scot/news/support-for-mesh-victims/ [Accessed September 29 2021]

26 The remit of this Scottish Government Group established in March 2019,‘considers the care provided for women who experience complications following vaginal mesh surgery in Scotland.’ Available from: https://www.gov.scot/groups/transvaginal-mesh-short-life-working-group/#:~:text=Overview,complications%20following%20vaginal%20mesh%20surgery [Accessed January 8 2023]

27 Available from: https://www.alliance-scotland.org.uk/ [Accessed January 8 2023]

28 Available from: https://www.gmc-uk.org/ [Accessed January 8 2023]

29 Available from: https://www.spso.org.uk/ [Accessed January 8 2023]

30 Available from: https://clo.scot.nhs.uk/ [Accessed January 8 2023]

31 Available from: https://www.rcog.org.uk/ [Accessed January 8 2023]

32 Which was published on the Transvaginal Case Record Review website. Available from: https://tmcrr.scot/ [Accessed January 8 2023]

33 Scottish mesh Survivors Group website can be accessed on: http://scottishmeshsurvivors.com/ [Accessed June 15 2022]

34 MSP 1999-2021

35 MSP 2011-2021

36 Dr. Wael Agur is a lead urogynaecologist with NHS Ayrshire and Arran. He is also an honorary senior clinical lecturer at the University of Glasgow.

37 Transvaginal Case Record Review website. Available from https://tmcrr.scot/terms-of-reference/ [Accessed June 15 2022]

38 Transvaginal Mesh Case Record Review website available from: https://tmcrr.scot/terms-of-reference/ [Accessed June 15 2022]

39 Transvaginal Mesh Case Record Review website available from: https://tmcrr.scot/terms-of-reference/ [Accessed June 15 2022]

40 Participants were invited to have someone accompany them for any meetings that were held.

41 Although there has been a number of studies into what was noted in case records. The primary purpose was not with a view to feeding back this information to the patients themselves. One such example was a study of case records of documentation of older people’s end-of-life care in the context of specialised palliative care. What problems, wishes, aspects of wellbeing, assessment tools, and interventions are documented in patient records and to what extent? Sjöberg et al. (2021) Documentation of older people’s end-of-life care in the context of specialised palliative care: a retrospective review of patient records BMC Palliative Care (2021) Available from: https://link.springer.com/content/pdf/10.1186/s12904-021-00771-w.pdf?pdf=button [Accessed January 8 2023]

42 There are plenty models which helped us refine this task. Of particular note was information from the Association of Project Management, What is the difference between a Pilot and a Trial? Available from: What is the difference between a trial and a pilot? | APM [Accessed July 27 2022]

43 Brennan, N., Barnes, R., Calnan M., et al (20) Trust in the health-care provider–patient relationship: a systematic mapping review of the evidence base International Journal for Quality in Health Care vol. 25 no. 6 pp682-688 at. p 682. Available from: untitled (silverchair.com) [Accessed August 1 2022]

44 Rolfe A, Cash-Gibson L, Car J, Sheikh A, McKinstry B (2014) Interventions for improving patients' trust in doctors and groups of doctors (Review). Available from: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004134.pub3/pdf/full [Accessed January 13 2022]

45 Rolfe A, Cash-Gibson L, Car J, Sheikh A, McKinstry B (2014) Interventions for improving patients' trust in doctors and groups of doctors (Review). Available from: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD004134.pub3/pdf/full [Accessed January 13 2022]

46 Brennan, N., Barnes, R., Calnan M., et al (20) Trust in the health-care provider–patient relationship: a systematic mapping review of the evidence base International Journal for Quality in Health Care vol. 25 no. 6 pp682-688 at. p 682. Available from: untitled (silverchair.com) [Accessed August 1 2022]

47 Coulter, A., (1999) Paternalism or Partnership BMJ 319:719. Available from: https://www.bmj.com/content/319/7212/719/article-info [Accessed August 1st 2022]

48 Kraetschmer N, Sharpe N, Urowitz S, Deber RB. (2004) How does trust affect patient preferences for participation in decision‐making? Health Expect. 7(4):317–26

49 The Scottish landmark case of Montgomery v Lanarkshire Health Board in 2015 changed the legal landscape in terms of what a patient would expect in terms of the quality and quantity information disclosure prior to them making any decision about whether they would consent to a proposed treatment or therapy.

50 Hall MA, Dugan E, Zheng B, et al, (2001) Trust in physicians and medical institutions: what is it, can it be measured, and does it matter? Milbank Q. 2001;79(4):613–39 at p.613. Available from: BL047-05.txt (nih.gov) [Accessed August 2 2022]

51 Pokhilenko I, van Esch TEM, Brabers AEM, de Jong JD (2021) Relationship between trust and patient involvement in medical decisionmaking: A cross-sectional study. PLoS ONE 16(8) pp1-14 at p.2 Available from: Relationship between trust and patient involvement in medical decision-making: A cross-sectional study (nih.gov) [Accessed August 2 2022]

52 This aspect had been made clear by the women who attended meetings with the First Minister in November 2020.

53 Cleghorn, E., (2021) Unwell Women. London: Weidenfeld & Nicolson

54 The Independent Medicines and Medical Devices Safety Review was announced in February 2018. It was asked to focus on how the health system responds when patients and their families raise concerns about the safety of treatments. Baroness Cumberlege was asked to chair the review and to look at the cases of vaginal mesh, sodium valproate, hormone pregnancy tests (HPTs), in this case Primodos. The Review published its report on 8 July 2020 and made 9 recommendations. Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023]

55 Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023] at p. 153

56 Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023] at p. 151

57Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023] at p. 140

58 Schwab, A,P (2006) Formal and effective autonomy in healthcare. J Med Ethics. 2006 Oct; 32(10): 575–579. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2563308/ [Accessed January 13 2023]

59 A full discussion on this point can be found in, Dodds, S., (2000) Choice and control in feminist bioethics. In: Mackenzie, C et al, eds, Relational Autonomy: Feminist Perspective on Autonomy, Agency and the Social Self. New York:Oxford University Press at pp 213-220)35

60 D’Agincourt-Canning, Ells, C., Women’s healthcare through a feminist ethics lens in: D’Agincourt-Canning, Ells, C., (2019) Ethical Issues in Women’s Healthcare at p.3

61 Meier, B. (1998). Restorative Justice - A New Paradigm in Criminal Law?, European Journal of Crime, Criminal Law and Criminal Justice, 6(2), 125-139. Available from: https://doi.org/10.1163/157181798X00148 [Accessed January 13 2023]

62 Boyes-Watson, C. (2014). Suffolk University, College of Arts & Sciences, Center for Restorative Justice

63 Restorative Justice Council, ‘Restorative Practice in Mental Health’ (2021) Available from: https://restorativejustice.org.uk/restorative-practice-mental-health [Accessed 16 June 2022]

64 Wailling J, Marshall C, Wilkinson, J., (2019) ‘Hearing and Responding to the Stories of Survivors of Surgical Mesh’. Available from: Hearing and Responding to the Stories of Survivors of Surgical Mesh (health.govt.nz) [Accessed June 16 2022]

65 Wailing j, Marshall,C, Wilkinson J, (2020) ‘Healing after harm: An evaluation of a restorative approach for addressing harm from surgical mesh. Kia ora te tangata: He arotakenga i te whakahaumanu,’ (2020), The Diana Unwin Chair in Restorative Justice, Victoria University of Wellington, Available at: <https://www.wgtn.ac.nz/restorative-justice/our-work/research-evaluation/restorative-practice-and-surgical-mesh/healing-after-harm-evaluation-report-moh-pdf> [accessed - 16 December 2022] at p.5

66 Opdenakker, R (2006) Advantages and Disadvantages of Four Interview Techniques in Qualitative Research. Qualitative Research Forum. Available from: https://www.qualitative-research.net/index.php/fqs/article/view/175/392 [Accessed January 13 2023]

67 Microsoft Teams is a proprietary business communication platform developed by Microsoft, as part of the Microsoft 365 family of products. What is Microsoft teams? Available from: https://support.microsoft.com/en-us/topic/what-is-microsoft-teams-3de4d369-0167-8def-b93b-0eb5286d7a29

68 Chouffani, R., (2021) 12 advantages and disadvantages of video conferencing. Available from: https://www.techtarget.com/searchcontentmanagement/tip/8-business-benefits-and-challenges-of-video-conferencing [Accessed 25 August2022]

69 The administrator and myself are based in Glasgow, Dr Lunan, our GP, in Edinburgh and our consultant Panel members, Mr Ian Currie and Prof Anthony Smith were based in England.

70 Gagnon, M, Chérif, L, Roy-Charland, A (2022) Contextual cues about reciprocity impact ratings of smile sincerity, Cognition and Emotion. Available from: Contextual cues about reciprocity impact ratings of smile sincerity (tandfonline.com) [Accessed August 25 2022]

71 See for example, SCHMID MAST, M. (2007) On the importance of nonverbal communication in the physician–patient interaction. Patient Education and Counseling, 2007, vol. 67, no. 3, pp. 315-318

72 Saarijärvi, M, Bratt E., (2021), When face-to-face interviews are not possible: tips and tricks for video, telephone, online chat, and email interviews in qualitative research, European Journal of Cardiovascular Nursing, Volume 20, Issue 4, April 2021, Pages 392–396. Available from: https://doi.org/10.1093/eurjcn/zvab038 [Accessed January 13 2023]

73 We understand that some women also met with the then Cabinet Secretary for Health & Sport, Jeane Freeman.

74 For a good discussion on the challenges of this task please see Torrisi, A, Bevan, R, Atkinson, K et al., Combining Textual and Visual Information for Typed and Handwritten Text Separation in Legal Documents, (2019) in Legal Knowledge & Information Systems. Araszkiewiez, M & Rodrigues-Doncel V (eds at p. 223. Available from: https://books.google.co.uk/books?hl=en&lr=&id=4GTIDwAAQBAJ&oi=fnd&pg=PA223&dq=collation+of+medical+records,+pagination+indexing&ots=LHrncQb9R-&sig=PblK8mIR_3uSu8jJakeJHMJoY4w#v=onepage&q&f=false [Accessed 22 September 2022]

75Available from: https://clinco.co.uk/ [Accessed February 28 2021]

76 They are UK certified to the stringent international data protection standards of ISO27001. Clinco’s information security management system (ISMS) which meets the requirements of ISO 27001:2013 and their approach to management and storage of data can be found here: data protection security confidentiality of medical records (clinco.co.uk) [Accessed 22 September 2022]

77 I remain personally indebted to Sarah Wallace and her team at Clinco for going above and beyond in their assistance with this Review.

78 This can be found in Appendix 1.

79 This was emailed on the 22 February 2021, to all 47 names on the list we received from the Scottish Government.

80 An explanation of what the Plain English Campaign do can be found here. Available from: http://plainenglish.co.uk/about-us.html [Accessed July 25 2022]

81 Scottish Government (2021) Transvaginal Case Record Review website. Available from: https://tmcrr.scot/ [Accessed June 15 2022]

82 We have discussed this more fully in Chapter 2.

83 This can be found in Appendix 1 of this Report.

84 More commonly abbreviated to CHI number. This is a unique 10-character numeric identifier, allocated to each patient on first registration with the system.

85 An explanation of what the Plain English Campaign do can be found here. Available from: http://plainenglish.co.uk/about-us.html [Accessed July 25 2022]

86 This will be discussed further in Chapter 5.

87 Current boundaries of NHS Health Boards in Scotland are defined by National Health Service (Variation of Areas of Health Boards) (Scotland) Order 2013 (SSI 2013/347), which came into force on April 1st 2014, and replaces the previous definition based upon the former Regions and Districts of the Local Government (Scotland) Act 1973. For further information, see Scottish Government (2021) NHS Health Boards – Scotland. Available from: https://www.data.gov.uk/dataset/27d0fe5f-79bb-4116-aec9-a8e565ff756a/nhs-health-boards-scotland [Accessed October 26 2022]

88 Some participants required us to retrieve records from more than one Health Board.

89 NHS inform sets this process out clearly. Available from: https://www.nhsinform.scot/care-support-and-rights/health-rights/confidentiality-and-data-protection/health-records#accessing-your-health-records [Accessed June 8 2023]

90 The two-stage consent process is described in Chapter 3.

91 The first participant’s consent form was received by Clinco on 18 August 2021.

92 …with a further two ready by the end of the following week.

93 We were advised by the Scottish Government that Fife and Greater Glasgow and Clyde Health Board signed September 10 2021, Highland Health Board 14^th September 2021, Lothian Health Board, 17 September 2021, NHS Borders 21 September 2021, Forth Valley NHS 6 October 2021, Tayside NHS Board 14 October 2021, Lanarkshire NHS 25 October 2021. Ayrshire and Arran HB 27 October 2021.

94 I kept in regular contact with the Scottish Government at this time who understood that the delays were impacting on our timescales and I acknowledge the work that they undertook to expedite this process.

95 First requests for the records of 3 participants from Clinco to GP surgeries and overseas treatment centres were made on September 8^th 2021. First records received back from a GP on 29 September 2021.

96 The Scottish Government notes that: ‘This group, established in March 2019, considers the care provided for women who experience complications following vaginal mesh surgery in Scotland.’ Available from: https://www.gov.scot/groups/transvaginal-mesh-short-life-working-group/#:~:text=This%20group%2C%20established%20in%20March,complications%20following%20vaginal%20mesh%20surgery [Accessed January 14 2023]

97 There is also a sub Group of the above for Accountable Officers whose membership is confined to only Accountable Officers but chaired by the same person as the short life working Group. Established in September 2018 by the Chief medical Officer, - The accountable officer’s group has been convened to consider aspects of the service and care available to women suffering from stress urinary incontinence and pelvic organ prolapse. The membership of this appears to be the same as above but without patient representatives. Available from: https://www.gov.scot/groups/transvaginal-mesh-accountable-officers-group/ [Accessed January 14 2023]. At this date, there is only one set of minutes on the website from this group published in February 2019.

98 Scottish Government (2020) Transvaginal mesh short-life working group minutes: December 4 2020(published October 2021). Available from https://www.gov.scot/publications/transvaginal-mesh-short-life-working-group-minutes-december-2020/ [Accessed October 28 2022]

99 Scottish Government (2021) Transvaginal mesh short-life working group minutes: February 26 2021(published October 2021). Available from: https://www.gov.scot/publications/transvaginal-mesh-short-life-working-group-minutes-february-2021/ [Accessed 27 October 2022]

100 It was attempted to retrieve published minutes from meetings held post February 2021 but we were unable to locate any.

101 Clinco received a telephone call from a Senior Medical Officer on behalf of the Scottish Government providing assurance that they would assist in establishing primary contacts and their emails.

102 Template is available in Appendix 1 of this Report.

103 Described in Chapter 2.

104 The Community Health Index (CHI) is a population register, which is used in Scotland for health care purposes. The CHI number uniquely identifies a person on the index.

105 Egress is a software system which assists with secure file sharing and handling.

106 For further information please see Cole, B (2014) EDRM (electronic discovery reference model). Available from: https://www.techtarget.com/searchcio/definition/EDRM-electronic-discovery-reference-model [Accessed December 13 2022] See also, What is EDRM? (Electronic Discovery Reference Model) And How it Has Evolved (2022) Available from: https://ipro.com/resources/articles/what-is-edrm-electronic-discovery-reference-model-and-how-it-has-evolved/ [Accessed December 13 2022]

107 The Data Protection Act 1998 implemented the European Directive on the protection of individuals with regard to the processing of personal data and on the free movement of such data (Council Directive (EC) 95/46 1995).

108 For example, please see Greater Glasgow Health Board information at https://www.nhsggc.org.uk/media/264232/medical-records-gdpr-new-application-form-2020-12.pdf and NHS Lothian can be found at https://www.nhslothian.scot/YourRights/DataProtection/Pages/Subject-Access-Requests.aspx [Accessed February 15 2023]

109 This would be subject to relevant permissions /consent being obtained.

110 The GDPR and Data Protection Act 2018 provides for a number of exemptions in respect of information falling within the scope of a SAR.

111 Chapters 6, 8 and 9 discuss these initiatives.

112 * My sincere thanks to Dionne Revie, LLB, for the research and first draft of this chapter.

113 Queensland Government, ‘About pelvic mesh and complications,’ (22 September 2021) Available from: <https://www.qld.gov.au/health/services/specialists/pelvic-mesh-service/about-pelvic-mesh-and-complications> [Accessed September 15 2022]

114 Parliament of Australia, ‘Number of women in Australia who have had transvaginal mesh implants and related matters’. Available from: <https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants> [Accessed September 15 2022]

115 Ibid.

116 Ibid - Chapter 5, Paragraph 5.152.

117 Ibid - Paragraph 5.45.

118 Ibid - Paragraph 5.46.

119 Queensland Government – Recent Patient Contact (2021) Available from: https://www.qld.gov.au/health/services/specialists/pelvic-mesh-service/about-pelvic-mesh-and-complications/recent-patient-contact [Accessed June 6 2023]

120 Ibid.

121 Ibid - Paragraph 5.55.

122 Ibid - Paragraph 5.66.

123 Ibid - Paragraph 5.67.

124 This is explored further in chapter 8 of this Report.

125 Parliament of Australia, ‘Number of women in Australia who have had transvaginal mesh implants and related matters’. Available from: <https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants> [Accessed September 15 2022]

126 The Senate Report uses the word ‘counselling’ to mean advice, guidance, support and the disclosure of information.

127 Ibid - Paragraph 5.79.

128 Ibid.

129 Alliance, ‘My Life, My Experience - Capturing Lived Experiences of Complication Following Transvaginal Mesh Surgery,’ (2019, Alliance Scotland), 14, Available from: <https://www.alliance-scotland.org.uk/wp-content/uploads/2019/11/ALLIANCE-Mesh-Report-2019.pdf> [Accessed October 3 2022]

130 Please see Chapters, 1, 2 and 7 of this Report.

131 Parliament of Australia, ‘Number of women in Australia who have had transvaginal mesh implants and related matters,’ Paragraph 5.87. Available from: <https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants> [Accessed September 15 2022]

132 Ibid - 5.92.

133 Ibid - 5.89.

134 Ibid.

135 Ibid - 5.137.

136 Ibid - 5.151.

137 Victoria Government, Australia & Dept of Health (Aus) (2022) Better Health Channel - Transvaginal Mesh. Available from: https://www.betterhealth.vic.gov.au/health/conditionsandtreatments/transvaginal-mesh [Accessed June 9 2023]

138 Safer Care, Victoria(Aus) (2018), Transvaginal mesh: the Victorian response. Available from: https://www.safercare.vic.gov.au/sites/default/files/2018-08/Transvaginal%20mesh_FINAL.pdf [Accessed June 9 2023]

139 New South Wales Government, (2023) Safety Notice 002/23 UPDATED: Transvaginal mesh implants for Pelvic Organ (Vaginal) Prolapse Available from: https://www.health.nsw.gov.au/sabs/Documents/2023-sn-002.pdf [Accessed June 9 2023]

140 Australian Capital Territory Government Health (2022) (updated) Transvaginal Mesh. Available from: https://www.health.act.gov.au/services-and-programs/womens-health/transvaginal-mesh [Accessed June 9 2023]

141 Department of Health and Aged Care, ‘Progress report: Australian Government response to the Senate Community Affairs References Committee report,’ (Australian Government, 2 December 2019) Available from: <https://www.tga.gov.au/resources/publication/publications/progress-report-australian-government-response-senate-community-affairs-references-committee-report> [Accessed October 7 2022]

142 Patient Safety Commissioner (England) (2022)Mesh Patients Resource for GP’s. Available from: https://www.patientsafetycommissioner.org.uk/wp-content/uploads/2023/05/Mesh-Patients-Resource-for-GPs.docx [Accessed June 8 2023]

143 Queensland Pelvic Mesh Service https://www.qld.gov.au/health/services/specialists/pelvic-mesh-service

144 Queensland Government, ‘About Pelvic Mesh and Complications,’ (2021) Queensland Government, Available from: <https://www.qld.gov.au/health/services/specialists/pelvic-mesh-service/about-pelvic-mesh-and-complications> [Accessed December 16 2022]

145 Available from: https://www.qld.gov.au/health/services/specialists/pelvic-mesh-service [Accessed June 9 2023]

146 Steven Miles, ‘Gold Coat to host service dedicated to women affected by pelvic mesh,’ (19 December 2018, The Queensland Cabinet and Ministerial Directory) Available from: <https://statements.qld.gov.au/statements/86342> [Accessed December 16 2022]

147 Placing this figure into a broader context, Queensland Health’s full annual budget for 2022-23 is $23.6 billion.

148 Scottish Parliament (29 Sept 2022) Mesh Treatment Clarity. Available from: https://www.theyworkforyou.com/sp/?id=2022-09-29.20.0&s=job+Johnson [Accessed April 25 2023]

149 SPICe(2023) Health, Social Care and Sport Committee Complex Mesh Surgical Service – Summary of evidence . Available from: https://www.parliament.scot/-/media/files/committees/health-social-care-and-sport-committee/complex-mesh-surgical-service-call-for-views.pdf [Accessed 24 April 2023]

150 Wise, J (2022) Specialist surgical mesh centres are not working, MPs are told BMJ 376:o314 Available from: https://www.bmj.com/content/376/bmj.o314 [Accessed January 29 2023]

151 Yu Hwee Tan, Malcom I. Frazer, ‘Establishing the Queensland Pelvic Mesh Service: Preliminary experience,’ (2022) Aust N Z J Obstet Gynaecol, Vol. 62 (2), p.294-299.

152 Ibid.

153 Ibid.

154 Ibid - p.298.

155 Ibid.

156 New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) (2018) Regulatory action on surgical mesh products. Available from: www.medsafe.govt.nz/hot/alerts/UrogynaecologicaSurgicalMeshImplants.asp [Accessed February 5 2023]

157 Wallis K, A (2017) No-fault, no difference: no-fault compensation for medical injury and healthcare ethics and practice. Br J Gen Pract. 2017 Jan; 67(654): 38–39 Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5198606/#:~:text=NEW%20ZEALAND'S%20NO%2DFAULT%20ALTERNATIVE&text=The%20scheme%20provides%20assistance%20with,been%20covered%20under%20the%20scheme. [Accessed February 3 2023]

158 Jane Akre, ‘New Zealand Surgical Mesh Restorative Justice Report Released,’ (13 December 2019, MeshNewsDesk) Available from: <https://www.meshmedicaldevicenewsdesk.com/articles/new-zealand-surgical-mesh-restorative-justice-report-released> [Accessed December 16 2022]

159 Ibid.

160 The Accident Compensation Corporation, ‘Pelvic Surgical Mesh Treatment Injury - A guide to ACC cover - Information for Health Professionals,’ (October 2020, ACC) Available from: <https://www.acc.co.nz/assets/provider/pelvic-surgical-mesh-ti-cover-acc8210.pdf> [Accessed December 16 2022]

161 Please refer to Chapter 1 of this Report for a discussion on how we applied principles of restoring trust in our engagement with those women who participated in the Review.

162 This is also discussed in Chapter 2 of this Report.

163 Available from: https://www.health.govt.nz/system/files/documents/publications/responding-to-harm-from-surgical-mesh-dec19.pdf [Accessed June 7 2023] pg 11

164 Available from: https://www.health.govt.nz/system/files/documents/publications/responding-to-harm-from-surgical-mesh-dec19.pdf [Accessed June 7 2023] pg 11

165 Jo Wailing, Chris Marshall, Jill Wilkinson, ‘Hearing and Responding to the Stories of Survivors of Surgical Mesh,’ (Ministry of Health, 12 December 2019) Available at: <https://www.health.govt.nz/publication/hearing-and-responding-stories-survivors-surgical-mesh> [Accessed December 16 2022]

166 For a history of the development of this organisation please see, Berry , C (2019) Women together: A history of women’s organisations in New Zealand. Available from: https://nzhistory.govt.nz/women-together/mesh-down-under [Accessed February 5 2023]

167 Jo Wailing, Chris Marshall, Jill Wilkinson, ‘Hearing and Responding to the Stories of Survivors of Surgical Mesh,’ (Ministry of Health, 12 December 2019) Available from: <https://www.health.govt.nz/publication/hearing-and-responding-stories-survivors-surgical-mesh> [Accessed December 16 2022]

168Jo Wailing, Chris Marshall, Jill Wilkinson, ‘Healing after harm: An evaluation of a restorative approach for addressing harm from surgical mesh. Kia ora te tangata: He arotakenga i te whakahaumanu,’ (2020), The Diana Unwin Chair in Restorative Justice, Victoria University of Wellington, Available from: <https://www.wgtn.ac.nz/restorative-justice/our-work/research-evaluation/restorative-practice-and-surgical-mesh/healing-after-harm-evaluation-report-moh-pdf> [Accessed December 16 2022]

169 Assessing an individual’s skill knowledge or performance level.

170 Jo Wailing, Chris Marshall, Jill Wilkinson, ‘Hearing and Responding to the Stories of Survivors of Surgical Mesh,’ (Ministry of Health, 12 December 2019) Available from: <https://www.health.govt.nz/publication/hearing-and-responding-stories-survivors-surgical-mesh> [Accessed December 16 2022]

171 Ibid - p.14.

172 Ibid - p.23.

173 Jo Wailing, Chris Marshall, Jill Wilkinson, ‘Hearing and Responding to the Stories of Survivors of Surgical Mesh,’ (Ministry of Health, 12 December 2019), p.44 - 45, Available from: <https://www.health.govt.nz/publication/hearing-and-responding-stories-survivors-surgical-mesh> [Accessed December 16 2022]

174 Empowered Women’s Health (2021) Why Women Aren't Reporting Loss of Bladder Control and How to Help, Available from: https://www.volusonclub.net/empowered-womens-health/why-women-arent-reporting-loss-of-bladder-control-and-how-to-help/ [Accessed April 5 2023]

175 Coyne KS, Kvasz M, Ireland AM, Milsom I, Kopp ZS, Chapple CR. (2012) Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States. Eur Urol. 61(1):88–95. https://doi.org/10.1016/j.eururo.2011.07.049 Epub Jul 26.

176 The Cumberlege Report recognised this point and more recently in a 2023 study by Toyne,F, Izett-Kay, Barker, KL and McNiven, A (2023). The experience of women reporting damage from vaginal mesh: a reflexive thematic analysis. The Lancet Available from: https://www.thelancet.com/action/showPdf?pii=S2589-5370%2823%2900095-0 [Accessed April 4 2023]

177 For example, in this article, it was shown that 25-35% women delayed reporting their urinary incontinence for 5 years or more before seeking medical advice. Please see, Norton PA, MacDonald LD, Sedgwick PM, Stanton SL. (1988) Distress and delay associated with urinary incontinence, frequency and urgency in women BMJ 297: 1187-9. See also Brocklehurst, J.C (1993) Urinary incontinence in the community--analysis of a MORI poll. BMJ 1993; 306 Available from: https://doi.org/10.1136/bmj.306.6881.832 [Accessed 7 June 2023]

178 For example, a thoughtful overview is broken down into themes by Charmaz, K., (1983) Loss of self: a fundamental form of suffering in the chronically ill. Sociology of Health and Illness Vol. 5 No. 2 PP168-195

179 Cumberledge Report at p.4.

180 Toyne,F, Izett-Kay, Barker, KL and McNiven, A (2023) The experience of women reporting damage from vaginal mesh: a reflexive thematic analysis. The Lancet Available from: https://www.thelancet.com/action/showPdf?pii=S2589-5370%2823%2900095-0 [Accessed April 4 2023]

181 See for example, Toyne,F, Izett-Kay, Barker, KL and McNiven, A (2023) The experience of women reporting damage from vaginal mesh: a reflexive thematic analysis. The Lancet Available from: https://www.thelancet.com/action/showPdf?pii=S2589-5370%2823%2900095-0 [Accessed April 4 2023] at p.4

182 Siapakidou, S., Campani – Nygaard, C Pape J, et al (2021) Evaluation of guidelines on the use of vaginal mesh implants for pelvic organ prolapse using the AGREE II instrument. Int J Gynecol Obstet. 154:400–411

183 These were The Association of the Scientific Medical Societies in Germany and European Association of Urology.

184 For example, risks associated with anaesthesia or more generally associated surgical risks.

185 Shi C, Zhao Y, Hu Q, Gong R, Yin Y, Xia Z. (2021) Clinical analysis of pain after transvaginal mesh surgery in patients with pelvic organ prolapse. BMC Women’s Health. Jan 30;21(1):46. Available from: doi: 10.1186/s12905-021-01192-w. PMID: 33516228; PMCID: PMC7847570. [Accessed April 24 2023]

186 Reid, F.M., Aucott, L., Glazener, C.M.A. et al. (2023) PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse. Int Urogynecol J 34, 67–78. Available from: https://doi.org/10.1007/s00192-022-05308-0 [Accessed April 24 2023]

187 ‘Fibromyalgia is a condition that causes widespread pain and extreme tiredness. There is no cure and symptoms can vary from person to person. It's not clear what causes fibromyalgia. It can start after a stressful event like an injury, illness or the death of a loved one.’ NHS UK – Available from: https://www.nhs.uk/conditions/fibromyalgia/#overview [Accessed 6 April 2023]

188 Kings College News Centre (2021) New study shows Fibromyalgia likely the result of autoimmune problems Available from: https://www.kcl.ac.uk/news/new-study-shows-fibromyalgia-likely-the-result-of-autoimmune-problems [Accessed June 9 2023]

189 National Institute for Clinical Excellence (NICE), (2021) Treating complications from mesh used for stress urinary incontinence, Options for women referred to specialist centres, Patient decision aid. Available from: https://www.nice.org.uk/guidance/ng123/resources/treating-complications-from-mesh-used-for-stress-urinary-incontinence-options-for-women-referred-to-specialist-centres-patient-decision-aid-pdf-6725286117?fbclid=IwAR0aCXrorVkXTvzJttOtid2zNzBg7U4uGLWjymIXTgxkudQd1VKquW0Au4k [Accessed June 9 2023]

190 NHS Inform (2022) Chronic Pain. Available from: https://www.nhsinform.scot/illnesses-and-conditions/brain-nerves-and-spinal-cord/chronic-pain [Accessed April 24 2023]

191 Waybe G., (2023) Acute Pain Nursing care plan. Nurses Labs. Available from: https://nurseslabs.com/acute-pain/ [Accessed April 24 2023]

192 Sullivan M, Ferrell B. (2005) Ethical challenges in the management of chronic nonmalignant pain: Negotiating through the cloud of doubt. J Pain ;6(1):2–9. 10.1016 Available from: /j.jpain.2004.10.006 [Accessed April 24 2023]

193 Henry SG, Matthias MS. (2018) Patient-Clinician Communication About Pain: A Conceptual Model and Narrative Review. Pain Med. Nov 1;19(11):2154-2165. Available from: 10.1093/pm/pny003. PMID: 29401356; PMCID: PMC6454797 [Accessed April 24 2023]

194 P. Mistiaen, M. van Osch, L. van Vliet, J. Howick, et al (2015) The effect of patient–practitioner communication on pain: a systematic review. European Journal of Pain. Available from: https://onlinelibrary.wiley.com/doi/full/10.1002/ejp.797 [Accessed June 8 2023]

195 The Panel are aware that research is ongoing into issues such as the role of vaginal microbiomes and whether vaginal preparation at the time of surgery influences port-operative complications.

196 The most common association was with the Scottish Mesh Survivors. See: http://www.scottishmeshsurvivors.com/

197 This aspect has been addressed in Chapters 2-5 of Part l of this Report.

198 Atreja, A .,Bellham N., Levy S ., (2005) Strategies to Enhance Patient Adherence: Making it Simple MedGenMed. 7(1): 4. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1681370/ [Accessed April 11 2013]

199 The Health Literary place. Use Simple Language. Available from: https://www.healthliteracyplace.org.uk/toolkit/techniques/use-simple-language/ [Accessed April 11 2023]

200 NHS Scotland (2016) Making it Easier A Health Literacy Action Plan for Scotland. Available from: https://www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2017/11/making-easier-health-literacy-action-plan-scotland-2017-2025/documents/00528139-pdf/00528139-pdf/govscot%3Adocument/00528139.pdf [Accessed April 11 2023]

201 Atreja, A .,Bellham N., Levy S ., (2005) Strategies to Enhance Patient Adherence: Making it Simple MedGenMed. 7(1): 4. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1681370/ [Accessed April 11 2013]

202 Richard C., Glaser E., Lussier MT 2016) Communication and patient participation influencing patient recall of treatment discussion. Health Expectations 20 4 760-770. Available from: https://onlinelibrary.wiley.com/doi/full/10.1111/hex.12515 [Accessed April 11 2023]

203 Available from: Royal College of General Practitioners. Health literacy: report from an RCGP led health literacy workshop. June 2014.

204 The Royal College of GP’s undertook a study in 2014 noting that, ‘“Doctors can unintentionally use words that are unfamiliar to their patients, without realising that the meaning is not clear. Some concepts familiar and obvious to doctors may be alien to patients.” Available from: Royal College of General Practitioners. Health literacy: report from an RCGP led health literacy workshop. June 2014.

205 Rimmer A (2014). Doctors must avoid jargon when talking to patients, royal college says. BMJ available from: https://www.bmj.com/content/348/bmj.g4131 [Accessed April 11 2023] “Doctors may use familiar words in unfamiliar ways,” it said. “For example, when health practitioners use the term ‘chronic’ they frequently mean ‘persistent,’ whereas a common alternative understanding of the word is to mean ‘severe.’”

206 The obturator nerve is in the groin. It enables sensation and muscle movement in the inner thigh.

207 Rovner E, de Tayrac , R ., Kirschner‐Hermanns, R (2020) Is polypropylene mesh material fundamentally safe for use as are constructive material in vaginal surgery:ICI‐RS2019? Neurourology and Urodynamics. 2020;39:S132–S139. At p. 132 available from: https://onlinelibrary.wiley.com/doi/epdf/10.1002/nau.24312 [Accessed 6 April 2023]

208 Ross, S., Magali, R., Ducey, A ( 2015) The short life cycle of a surgical device – Literature analysis using McKinlay׳s 7-stage model. Health Policy and Technology. 4 168-188 Available from: https://reader.elsevier.com/reader/sd/pii/S2211883715000222?token=EA59CE6F15989E2F94CE9F9EC11876B6BA18708C0A450D6B6B546C2AFB91EEC7CD996D793EBE319D347851048E7E3CD2&originRegion=eu-west-1&originCreation=20230406133908 [Accessed April 6 2023]

209 This is considered further in the ‘gold standard’ section below

210 Although the length of the mesh to be used in surgery is standard, the length of the mesh inserted into the patient ultimately depends on the patient anatomy, as it will be 'cut to fit'.

211 This has been defined as the involuntary leakage of urine in an inappropriate place and time. Javanmardifard, S., Gheibizadeh M., Shirazi, F., Kourosh Z, Ghodsbin, F (2022) Experiences of Urinary Incontinence Management in Older Women: A Qualitative Study, Public Health Available from: https://doi.org/10.3389/fpubh.2021.738202 [Accessed April 5 2023

212 A Burch procedure suspends and stabilizes the urethra (the tube carrying urine from the bladder to the outside of the body). The urethra is stabilized by using permanent sutures to connect the tissues surrounding the urethra to a strong ligament attached to the pubic bone.

213 O'Neill, J. (2021) Lessons from the vaginal mesh scandal: enhancing the patient-centric approach to informed consent for medical device implantation. International Journal of Technology Assessment in Health Care, 37(1), at p. 2 Available from: https://www.cambridge.org/core/services/aop-cambridge-core/content/view/85C4A34DE54AB3476217FB524B0310C9/S0266462321000258a.pdf/lessons-from-the-vaginal-mesh-scandal-enhancing-the-patient-centric-approach-to-informed-consent-for-medical-device-implantation.pdf [Accessed April 11 2023]

214 For example, Marks, B Goldman H (2012) What is the gold standard for posterior vaginal wall prolapse repair: mesh or native tissue? Curr Urol Rep. 13(3):216-21. Available from: doi: 10.1007/s11934-012-0248-y. [Accessed April 6 2023] or, Webber-Brown, C (2015) England's 'gold standard' TVT device - how safe is it? Available from: https://www.lexology.com/library/detail.aspx?g=b8f28eff-0f32-46dc-a55b-ddd867d65389 [Accessed April 6 2023]

215 With the exception if the mesh was infected.

216 Data Protection Act 2018. Access can be limited or denied if it would be 'likely to cause serious harm to the physical or mental health of the data subject or another individual', unless it is information of which the patient is already aware.

217 Each case needs to be considered individually and the Information Commissioner’s Office (ICO) provides guidance on this. Available from: https://ico.org.uk/for-organisations/guide-to-data-protection/guide-to-the-general-data-protection-regulation-gdpr/right-of-access/information-about-other-individuals/ [Accessed April 20 2023]

218 Medical Defence Union (2022) Redacting Third Part Information from Notes. Available from: https://www.themdu.com/guidance-and-advice/guides/redacting-third-party-information-from-notes#:~:text=Redaction%20should%20be%20considered%20for,be%20removed%20can%20be%20difficult. [Accessed April 20 2023]

219 Hunter V Hanley 1955 SC 200 and Bolam v Friern Hospital Management Committee [1957] 1 WLR 582

220 Hunter V Hanley 1955 SC 200. In order to establish liability in circumstances where deviation from normal practice is alleged, three facts have to be established: It must be proved that there is a usual and normal practice; It must be proved that the defender has not adopted that practice; and Most importantly, it must be established that the course the professional had adopted is one which no professional person of ordinary skill would have taken if he/she had been acting with ordinary care. The onus rests on a pursuer to establish these three facts, and without all three his case will fail.

221 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582. The judge noted, "I myself would prefer to put it this way, that he is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.” McNair J.

222 Bolitho v. City and Hackney Health Authority [1996] 4 All ER 771 established that a court is not bound to hold that a doctor can escape liability for negligence simply by producing evidence from a number of experts that his opinion and actions accorded with accepted medical practice.

223 YF v Turkey ECHR 22 Jul 2003

224 Chester v Afshar [2004] 3 WLR 927

225 Montgomery v Lanarkshire Health Board [2015] UKSC 11. The test of ‘materiality’ was created.

226 A doctor was now “under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative treatments “. The test of materiality was described as “whether in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should be aware that the particular patient would be likely to attach significance to it “.

227 A subsequent case provided context as to the nature and duty if this test- Duce v Worcestershire Acute Hospitals NHS Trust [ 2018] EWCA Civ 1307 at para 33- 1. what risks associated with an operation were or should have been known to the medical professional in question. This is a matter falling within the expertise of the medical professionals; and 2, Whether the patient should have been told about such risks by reference to whether they were material. This is a matter for the Court to determine. The issue is not therefore the subject of the Bolam test and not something that can be determined by reference to expert evidence alone.

228 Wald, DS., Bestwick, JP, Kelly, P (2020) The effect of the Montgomery judgment on settled claims against the National Health Service due to failure to inform before giving consent to treatment. QJM: An International Journal of Medicine, Volume 113, Issue 10, October 2020, Pages 721–725, at p. 721 Available from: https://doi.org/10.1093/qjmed/hcaa082 [Accessed 8 June 2023]

229 Wald, DS., Bestwick, JP, Kelly, P (2020) The effect of the Montgomery judgment on settled claims against the National Health Service due to failure to inform before giving consent to treatment. QJM: An International Journal of Medicine, Volume 113, Issue 10, October 2020, Pages 721–725, at p. 721 https://doi.org/10.1093/qjmed/hcaa082 [Accessed 8 June 2023]

230 The body which handles clinical negligence claims against NHS trusts.

231 Royal College of Surgeons(England), (2016) Surgeons warn NHS failing to implement patient consent rules, risks facing increase in litigation pay-outs Available from: https://www.rcseng.ac.uk/news-and-events/media-centre/press-releases/surgeons-warn-nhs-failing-to-implement-patient-consent-rules/ [Accessed April 15 2023]

232 Choudry M, Latif A, Hamilton L et al (2016) (Documenting the process of patient decision making: a review of the development of the law on consent. Future Hosp J. Jun;3(2):109-113. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6465837/ [Accessed April 15 2023]

233 Godfrey, J (2020) The Odyssey of Informed Consent Post Montgomery – Have We Reached Ithaca? Medico Legal magazine. Available from: https://www.medicolegalmagazine.co.uk/all-medico-legal-magazine-articles/the-odyssey-of-informed-consent-post-montgomery-have-we-reached-ithaca [Accessed April 14 2023]

234 Malik v St George’s University Hospital NHS Foundation Trust [2021] EWHC 1913 (QB), the clinician concerned did not keep handwritten notes or typed notes of the consent consultation. HHJ Blair QC commented that: “this is a practice which it seems to me is fraught with risks of being unable confidently to answer important questions many years later without having the benefit of a contemporaneous set of detailed notes”.

235 The Royal College of Surgeons (England) note in addition to completing the consent form, surgeons should maintain a written decision making record that contains a contemporaneous documentation of the key points of the consent discussion – and the patient’s decision, even if the patient decided not to undergo a procedure or have any treatment. This could be in the form of a letter to the patient and their GP/referring doctor. The record should also contain documentation of any discussion around consent with the patient’s supporters and with colleagues. Any written information given to the patient should also be recorded and copies should be included in the patient’s notes. Royal College of Surgeons (England) Consent: Supported Decision-Making A GUIDE TO GOOD PRACTICE at p.18 Available from: Consent: Supported Decision-Making — Royal College of Surgeons (rcseng.ac.uk) [Accessed April 15 2023]

236 See for example, Medical Defence Union, (2023) Montgomery and Informed Consent. Available from: https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informed-consent#:~:text=In%20its%20guidance%20Decision%20making,option%20to%20take%20no%20action.; Medical Protection Society, (2017) An Essential Guide to Consent. Available from: https://www.medicalprotection.org/uk/articles/an-mps-essential-guide-to-consent [Accessed June 9 2023]

237 Royal College of Physicians and Surgeons of Glasgow, Medical Consent, More than a signature and more than a form. Available from: https://rcpsg.ac.uk/college/speaking-up-for-the-profession/policy-reports-and-publications/consent [Accessed April 15 2023]

238 Royal College of Physicians and Surgeons of Glasgow, Medical Consent, More than a signature and more than a form. Available from: https://rcpsg.ac.uk/college/speaking-up-for-the-profession/policy-reports-and-publications/consent [Accessed April 15 2023]

239 The Royal College of Surgeons (England) Consent: Supported Decision-Making A GUIDE TO GOOD PRACTICE at p.18 Available from: Consent: Supported Decision-Making — Royal College of Surgeons (rcseng.ac.uk) [Accessed April 15 2023]

240 There is a debate about whether the legal and professional duties are or should be the same. There is no doubt that they have a highly influential effect upon each other. See, Le Gallez I, SkopekJ, Liddell K et al, (2021) Montgomery’s Practical and Legal Impact: A Systematic Review at 6 Years. J Eval Clin Pract. 2022;28:690–702. At p.695. Available from: https://onlinelibrary.wiley.com/doi/epdf/10.1111/jep.13620 [Accessed April 15 2023]

241 The literature is extensive representing the range of healthcare specialities. Nicholas M. The surgical care practitioner seeking consent: an appropriate delegate? JPerioperPract. 2018;28(10):273-277; Edozien L. (2016) Special issue: patient consent after Montgomery. Clin Risk.22 (1-2) pp 1-3. A systematic review is available from: Le Gallez I, SkopekJ, Liddell K et al, (2021) Montgomery’s Practical and Legal Impact: A Systematic Review at 6 Years. J Eval Clin Pract. 2022;28:690–702. At p.695. Available from: https://onlinelibrary.wiley.com/doi/epdf/10.1111/jep.13620 [Accessed April 15 2023]

242 Choudry M, Latif A, Hamilton L et al (2016) (Documenting the process of patient decision making: a review of the development of the law on consent. Future Hosp J. Jun;3(2):109-113. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6465837/ [Accessed April 15 2023]

243GMC (2008) (now withdrawn) Consent; Patients and Doctors making decision together. Available from: https://www.gmc-uk.org/-/media/documents/consent-patients-and-doctors-making-decisions-together-2008---2020_pdf-84769495.pdf [Accessed April 15 2023]

244 General medical Council (2020) Decision making and consent: Guidance on professional standards and ethics for doctors. Available from: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---decision-making-and-consent-english_pdf-84191055.pdf. [Accessed April 15 2023]

245 GMC (2020) Decision making and consent: Guidance on professional standards and ethics for doctors. Section 50 -Recording Decisions. Available from: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent/recording-decisions [Accessed June 9 2023]

246 GMC (2020) Decision making and consent: Guidance on professional standards and ethics for doctors. Section 51 -Recording Decisions. Available from: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent/recording-decisions [Accessed June 9 2023]

247 GMC (2020) Decision making and consent: Guidance on professional standards and ethics for doctors. Section 51 -Recording Decisions. Available from: https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/decision-making-and-consent/recording-decisions [Accessed June 9 2023]

248 General Medical Council (2020) Decision making and consent: Guidance on professional standards and ethics for doctors. Available from: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---decision-making-and-consent-english_pdf-84191055.pdf. [Accessed April 15 2023]

249 Sustersic, M et al, (2017) How best to use and evaluate Patient Information Leaflets given during a consultation: a systematic review of literature reviews Health Expect.; 20(4): 531–542 at p 531. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5512995/ [Accessed February 5 2023]

250 Horwitz A, Reuther L, Andersen SE. [Patient information leaflets seen through the eyes of patients in a general practice]. Ugeskr Laeger. 2009 Feb;171(8):599–602.

251 Raynor DK, Blenkinsopp A, Knapp P, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007;11:1–160 Available from: https://pubmed.ncbi.nlm.nih.gov/17280623/ [Accessed 5 February 2023]

252 National Institute for Health and Care Excellence (NICE). Shared decision making: NICE Guideline. UK: NICE; 2021 17/06/2021.Available from: https://www.nice.org.uk/guidance/ng197/resources/shared-decision-making-pdf-66142087186885 [Accessed 5 February 2023]

253 Harris E, Conway D, Jimenez-Aranda A., (2022) Development and user-testing of a digital patient decision aid to facilitate shared decision-making for people with stable angina. BMC Med Inform Decis Mak 22, 143 (2022). Available from: https://doi.org/10.1186/s12911-022-01882-x [Accessed April 16 2023]

254 National Institute for Health and Care Excellence (NICE). Shared decision making: NICE Guideline. UK: NICE; 2021 17/06/2021.Available from: https://www.nice.org.uk/guidance/ng197/resources/shared-decision-making-pdf-66142087186885 [Accessed 5 February 2023]

255 Carmora C, Crutwell J, Burnham, M et al (2021) Shared decision-making: summary of NICE guidance BMJ 373:n1430 Available from: https://www.bmj.com/content/373/bmj.n1430 [Accessed April 16 2023]

256 Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023] at para. 2.22

257 National Institute for Clinical Excellence, (2019), Surgery for stress urinary incontinence – Patient decision aid, Available from: https://www.nice.org.uk/guidance/ng123/resources/surgery-for-stress-urinary-incontinence-patient-decision-aid-pdf-6725286110 [Accessed April 16 2023]

258 For example, see Dumfries and Galloway , Patient Information Policy Available from: https://www.nhsdg.co.uk/wp-content/uploads/2019/07/Patient_Information_Policy.pdf [Accessed February 15 2023]

259 For example, see those produced by EIDO Healthcare. Please note this reference is to serve merely as an example and not as any endorsement nor review. Available from: https://www.eidohealthcare.com/case-studies/improving-patient-understanding-using-effective-medical-animations/ [Accessed September 8 2022]

260 Scottish Government (2020) National Mesh Removal Service- Press announcement. Available from: https://www.gov.scot/news/national-mesh-removal-service/ [Accessed April 16 2023]

261 The Cumberlege Report was published 8^th July 2020. Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023]

262 Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023] at p.12.

263 Alliance Scotland (2021) My health, my path, my life. Available from: https://www.alliance-scotland.org.uk/wp-content/uploads/2021/03/MESH-Report-March-21.pdf [Accessed April 16 2023]

264 For example, the website contains a section on Lifestyle but its focus remains on providing ‘information is to help you know what you might be able to do in the days or weeks before any mesh related surgery. This will speed up your recovery and help you get the best outcome possible.’ Available from: https://www.nhsggc.scot/hospitals-services/services-a-to-z/national-complex-mesh-surgical-service/your-visit-to-the-mesh-service/ [Accessed April 28 2023]

265 Available from: https://www.nhsggc.scot/hospitals-services/services-a-to-z/national-complex-mesh-surgical-service/your-visit-to-the-mesh-service/ at Downloads/Specialist-Mesh-Removal-Referral-Process.pdf [Accessed April 28 2023

266 Wise J (2022) Specialist surgical mesh centres are not working, MPs are told BMJ BMJ 2022; 376: Available from: https://doi.org/10.1136/bmj.o314 (Published 04 February 2022) [Accessed April 18 2023]

267 Samson K, (2022) 10 Problems with England’s Specialist Mesh Centres. Patient Safety Learning, The Hub. Available from: https://www.pslhub.org/learn/patient-safety-in-health-and-care/womens-health/kath-sansom-10-problems-with-nhs-england%E2%80%99s-specialist-mesh-centres-r7742/ [Accessed April 20 2023]

268 SPICe (2023) Health, Social Care and Sport Committee Complex Mesh Surgical Service – Summary of evidence. Available from: https://www.parliament.scot/-/media/files/committees/health-social-care-and-sport-committee/complex-mesh-surgical-service-call-for-views.pdf [Accessed 24 April 2023]

269 BBC News (April 2023) Mesh survivors' trust 'completely depleted' Available from:

- https://www.bbc.co.uk/news/uk-scotland-65346616 [Accessed June 10 2023]

270 Scott M (2022) Minister under pressure over NHS failure to send a single mesh victim to US, Sunday Post. Available from: https://www.sundaypost.com/fp/minister-under-pressure-over-nhs-failure-to-send-a-single-mesh-victim-to-us/ [Accessed June 10 2023]

271 Dates received from the Complex Mesh Surgical Service- Scotland.

272 SPICe (2023) Health, Social Care and Sport Committee Complex Mesh Surgical Service – Summary of evidence. Available from: https://www.parliament.scot/-/media/files/committees/health-social-care-and-sport-committee/complex-mesh-surgical-service-call-for-views.pdf Accessed 24 April 2023

273 NHS Scotland (2022) Complex Mesh Surgical Service. Available from: https://www.nss.nhs.scot/specialist-healthcare/specialist-services/complex-mesh-surgical-service/ [Accessed December 16 2022]

274 NHS Scotland (2022) Complex Mesh Surgical Service. Available from: https://www.nss.nhs.scot/specialist-healthcare/specialist-services/complex-mesh-surgical-service/ [Accessed December 16 2022]

275 Health and Social Care Alliance Scotland (2021) My Path, My Health, My Life: Learning from the experiences of women to plan future mesh services. Available from: https://www.alliance-scotland.org.uk/wp-content/uploads/2021/03/MESH-Report-March-21.pdf [Accessed December 16 2022]

276 Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023]

277 Health and Social Care Alliance Scotland (2021) My Path, My Health, My Life: Learning from the experiences of women to plan future mesh services. Available from: https://www.alliance-scotland.org.uk/wp-content/uploads/2021/03/MESH-Report-March-21.pdf [Accessed December 16 2022] at pp 3 & 4

278 NHS Scotland(2022) Complex Mesh Surgical Service. Available from: https://www.nss.nhs.scot/specialist-healthcare/specialist-services/complex-mesh-surgical-service/ [Accessed December 16 2022]

279 See: https://www.nhsggc.scot/page_category/national-surgical-mesh-removal-service/ [Accessed April 27 2023]

280 See: https://www.nss.nhs.scot/specialist-healthcare/specialist-services/complex-mesh-surgical-service/ [Accessed April 27 2023]

281 See: https://www.nhsggc.scot/page_category/national-surgical-mesh-removal-service/ [Accessed April 27 2003]

282 See: The New Zealand Female Pelvic Mesh Service – Te Whatu Ora - Health New Zealand (newdunedinhospital.nz) [Accessed June 9 2023]

283 NHS Scotland (2022) Complex mesh surgical service. Webpage. Available from: https://www.nss.nhs.scot/specialist-healthcare/specialist-services/complex-mesh-surgical-service/ [Accessed April 18 2023]

284 NHS Scotland (2022) Complex mesh surgical service. Website. Available from: https://www.nss.nhs.scot/specialist-healthcare/specialist-services/complex-mesh-surgical-service/ [Accessed April 18 2023]

285 See: https://www.nhsggc.scot/downloads/national-mesh-removal-referral-pathway/ [Accessed April 18 2023]

286 Gov.uk (2020) First do no harm: Independent Medicines and Medical Devices Safety Review Report. Available from: https://www.gov.uk/government/publications/independent-medicines-and-medical-devices-safety-review-report [Accessed January 13 2023] Section 5.102.

287 Royal College of Obstetricians and Gynaecologists(2021) Mesh Complications Management Training Pathway Available from: https://www.rcog.org.uk/media/5uhpq4m1/mesh-complications-management-training-pathway.pdf [Accessed April 18 2023]

288 Royal College of Obstetricians and Gynaecologists(2021) Mesh Complications Management Training Pathway Available from: https://www.rcog.org.uk/careers-and-training/training/curriculum/mesh-complications-management-training-pathway-pilot/background-and-purpose/ [Accessed April 18 2023]

289 Royal College of Obstetricians and Gynaecologists(2021) Mesh Complications Management Training Pathway Available from: https://www.rcog.org.uk/media/5uhpq4m1/mesh-complications-management-training-pathway.pdf [Accessed April 18 2023]

290 Scottish Government (2020) Transvaginal Short Life Working Group Minutes December 2020. Available from: https://www.gov.scot/publications/transvaginal-mesh-short-life-working-group-minutes-december-2020/. [Accessed April 18 2023]

291 General Medical Council, (2020) Decision Making and Consent Guidelines at section 27. Available from: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---decision-making-and-consent-english_pdf-84191055.pdf [Accessed June 10 2023]

292 Please see Chapter 8 of this Report.

293 General Medical Council, (2020) Decision Making and Consent Guidelines at section 27. Available from: https://www.gmc-uk.org/-/media/documents/gmc-guidance-for-doctors---decision-making-and-consent-english_pdf-84191055.pdf [Accessed June 10 2023]

294 Healthcare Improvement Scotland (2020) Transvaginal Mesh Implants Oversight Group Final Report. Available from: Transvaginal Mesh Implants Oversight Group - Final Report: April 2020 (healthcareimprovementscotland.org) [Accessed April 24 2023]

295 This group disbanded in 2019 on conclusion of its work and with its major tasks absorbed by the Scottish Government Accountable Officers’ Group.

296 Healthcare Improvement Scotland (2020) Transvaginal Mesh Implants Oversight Group Final Report. Available from: Transvaginal Mesh Implants Oversight Group - Final Report: April 2020 (healthcareimprovementscotland.org) [Accessed April 24 2023] at p.9

297 Angelova, N et al (2021) User testing a patient information resource about potential complications of vaginally inserted synthetic mesh, BMC Womens Health. 2021; 21: 35. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7831188/#CR3 [Accessed February 5 2023]

298 NHS Scotland Information Services Division (2019) Transvaginal Services in Scotland. Available from: https://www.isdscotland.org/Health-Topics/Hospital-Care/Publications/2019-10-08/2019-10-08-Transvaginal-Mesh-Procedure-Summary.pdf [Accessed April 24 2023]

299 Healthcare Improvement Scotland (2020) Transvaginal Mesh Implants Oversight Group Final Report. Available from: Transvaginal Mesh Implants Oversight Group - Final Report: April 2020 (healthcareimprovementscotland.org) [Accessed April 24 2023] at p.9

300 SPICe Spolight (2022) Surgical mesh Complications. Available from: https://spice-spotlight.scot/2022/06/30/surgical-mesh-complications/ [Accessed April 24 2023]

301 Healthcare Improvement Scotland (2020) Transvaginal Mesh Implants Oversight Group Final Report. Available from: https://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/programme_resources/transvaginal_mesh_implants/tvmo_final_report.aspx [Accessed April 24 2023] at p.11

302 Scottish Government, News (12 July 2021) Mesh Removal Surgery. Available from: https://www.gov.scot/news/mesh-removal-surgery/#:~:text=Contracts%20awarded%20for%20option%20of,Dr%20Dionysios%20Veronikis%20performs%20surgery. [Accessed April 26 2023]

303 Healthcare Improvement Scotland (2020) Transvaginal Mesh Implants Oversight Group Final Report. Available from: https://www.healthcareimprovementscotland.org/our_work/technologies_and_medicines/programme_resources/transvaginal_mesh_implants/tvmo_final_report.aspx [Accessed April 24 2023] at p.15

304 Healthcare Improvement Scotland (2019) Learning from adverse events through reporting and review. A national framework for Scotland: December 2019. Available from: https://www.healthcareimprovementscotland.org/our_work/governance_and_assurance/learning_from_adverse_events/national_framework.aspx [Accessed April 24 2023]

305 Healthcare Improvement Scotland (2022) Adverse Events Notification System: Update Report. Inspection and Reviews. Available from: Adverse Events Notification System: Update Report: January 2022 (healthcareimprovementscotland.org) [Accessed April 24 2023]

306 The panel understand that some clinical units have questionnaires which may be specific to prolapse quality of life questionnaires and specific incontinence quality of life questionnaires.

307 Scottish Parliament (2023) Experiences of the Complex mesh surgical service. Available from https://yourviews.parliament.scot/health/experience-complex-mesh-surgical-service [Accessed April 18 2023] The questions ion the consultation covered: About you, Your symptoms, Referral and access, Mesh removal surgery, Support following your surgery, Issues and more information.

308 SPICe (2023) Health, Social Care and Sport Committee Complex Mesh Surgical Service – Summary of evidence . Available from: https://www.parliament.scot/-/media/files/committees/health-social-care-and-sport-committee/complex-mesh-surgical-service-call-for-views.pdf [Accessed April 24 2023]

309 NHSGGC Patient Experience Public Involvement Team. (2022) Complex Mesh Surgical Service Patient Experience Questionnaire Cycle 2 Report. Available from: https://www.nhsggc.scot/downloads/national-mesh-patient-feedback-report/ [Accessed June 13 2023]

310 See: The CARE Measure Website (stir.ac.uk) [Accessed April 24 2023]