PE1517 - Polypropylene Mesh Medical Devices Published in Scotland by the Scottish Parliamentary Corporate Body

Published 21 August 2018 SP Paper 370 4th report (Session 5) Public Petitions Committee Comataidh nan Athchuingean Poblach PE1517 - Polypropylene Mesh Medical Devices Published in Scotland by the Scottish Parliamentary Corporate Body. All documents are available on the Scottish For information on the Scottish Parliament contact Parliament website at: Public Information on: http://www.parliament.scot/abouttheparliament/ Telephone: 0131 348 5000 91279.aspx Textphone: 0800 092 7100 Email: [email protected] © Parliamentary copyright. Scottish Parliament Corporate Body The Scottish Parliament's copyright policy can be found on the website — www.parliament.scot Public Petitions Committee PE1517 - Polypropylene Mesh Medical Devices, 4th report (Session 5) Contents Membership changes ____________________________________________________1 Introduction ____________________________________________________________2 Context of mesh issues __________________________________________________5 Role of the MHRA ______________________________________________________5 Litigation and global concerns _____________________________________________7 Publication of the interim report __________________________________________ 11 Evidence from chair of the Independent Review ______________________________ 11 Minority report ________________________________________________________14 Scottish Government position on interim report recommendations ________________15 Clinical studies completed after publication of the interim report _______________18 Publication of the final report_____________________________________________19 Recommendations of the final report _______________________________________19 Resignations from the independent review __________________________________19 Evidence from the Chair of the review and the Scottish Government ______________21 Process for agreeing and publishing the final report ___________________________23 Chapter 6 __________________________________________________________23 Mandatory reporting of mesh adverse events ______________________________24 Inclusion of petitioners' contributions in the final report _______________________25 Classification of mesh devices __________________________________________26 Expert clinician evidence - Dr Wael Agur __________________________________26 Petitioners' evidence _________________________________________________28 Professor Britton's review _______________________________________________33 Conclusions and recommendations _______________________________________34 Annexe A - Extracts from Minutes and links to oral evidence __________________37 Annexe B - Written evidence submitted to the Committee _____________________41 Annexe C - Conclusions and recommendations of the Independent Review’s interim report _________________________________________________________45 Annexe D - Conclusions and recommendations of the Independent Review’s final report ____________________________________________________________47 Public Petitions Committee PE1517 - Polypropylene Mesh Medical Devices, 4th report (Session 5) Public Petitions Committee The remit of the Public Petitions Committee is to consider and report on - whether a public petition is admissible; and what action is to be taken upon the petition. http://www.scottish.parliament.uk/parliamentarybusiness/CurrentCommittees/ petitions-committee.aspx [email protected] 0131 348 5254 Public Petitions Committee PE1517 - Polypropylene Mesh Medical Devices, 4th report (Session 5) Committee Membership Convener Deputy Convener Johann Lamont Angus MacDonald Scottish Labour Scottish National Party Rachael Hamilton Rona Mackay Scottish Conservative Scottish National Party and Unionist Party Brian Whittle Scottish Conservative and Unionist Party Public Petitions Committee PE1517 - Polypropylene Mesh Medical Devices, 4th report (Session 5) Membership changes 1. There have been two occasions where the membership of the Committee has changed during the consideration of this petition during Session 5 (from 12 May 2016 - to date): • Michelle Ballantyne MSP replaced Maurice Corry MSP on 28 June 2017 and; • Rachael Hamilton MSP replaced Michelle Ballantyne MSP on 17 May 2018. 1 Public Petitions Committee PE1517 - Polypropylene Mesh Medical Devices, 4th report (Session 5) Introduction 2. Petition PE1517 was lodged in April 2014, when transvaginal mesh was being used in procedures to treat pelvic organ prolapse, and transvaginal tapes were being used in the treatment of stress urinary incontinence. 3. For both conditions there are non-surgical interventions, though it may be necessary to consider surgery in certain cases. Mesh procedures have also been used for treating hernias in men. 4. PE1517 was lodged in April 2014 by Elaine Holmes and Olive McIlroy, on behalf of the Scottish Mesh Survivors “Hear Our Voice” campaign. The petition was brought forward in light of a number of women experiencing severe and debilitating complications from having undergone the procedure. The petition called on the Scottish Government to— • suspend the use of polypropylene transvaginal Mesh (TVM) procedures • initiate a public inquiry and/or comprehensive independent research to evaluate the safety of mesh devices using all evidence available, including that from across the world • introduce mandatory reporting of all adverse incidents by health professionals • set up a Scottish Transvaginal Mesh implant register with a view to linking this up with national and international registers • introduce fully informed consent with uniformity throughout Scotland's Health Boards • write to the MHRA and ask that they reclassify TVM devices to heightened alert status to reflect ongoing concerns worldwide. 5. The petition stated that the “wholesale use of polypropylene mesh medical implants to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) has been described as one of the biggest medical disasters of all time”. 6. On 3 June 2014, the Session 4 Committee took evidence from the petitioners. At that meeting, the petitioners expanded on their experiences and concerns which had led to their petition. 7. The petitioners summarised their concerns around informed consent. For example, Elaine Holmes stated: "We were not told that as many as one in five mesh implants can go wrong. When you consider that 11,000 women in Scotland have had the procedure, one in five suddenly becomes an alarming statistic. Further, as complications often take years to develop, we fear that we may just be the tip of the iceberg."i i Public Petitions Committee (Session 4), Official Report, 3 June 2014, col 2325. 2 Public Petitions Committee PE1517 - Polypropylene Mesh Medical Devices, 4th report (Session 5) 8. The petitioners explained their understanding that no action had been taken on the issue because it was considered that the benefits of a mesh procedure outweighed the risks, and argued that the system in place had failed because it was voluntary. They referred to official figures which showed that 328 women had "endured multiple surgeries", but that "only 12 doctor-reported incidents have been received from Scotland by the MHRA". They asked: "Why did those doctors not report the complications in 328 women? Because they did not have to."ii 9. The petitioners highlighted significant concerns about the role of the MHRA as the regulatory body, numbers, missing or non-existent data and under-reporting. These issues are discussed further below. 10. Following the petitioners' evidence, the then Cabinet Secretary, Alex Neil appeared before the Committee. In his opening statement he set out the steps that the Scottish Government had taken to address the issues. This included the development of 'patient guidance booklets' and correspondence to all general practitioners "to alert them to the possibility that women may suffer complications following insertion of the mesh implants, and that all adverse events must be reported to the MHRA".iii 11. The Cabinet Secretary outlined other steps that he had taken, including holding discussions with the chief executive of the MHRA and writing to the European Commission. Despite these steps, he was "convinced that more needs to be done by us in Scotland".iv 12. The Cabinet Secretary announced that he would set up an independent review "to report on all the issues that have been raised, including complication rates and under-reporting of adverse events". He went on: "In addition, I have asked the acting chief medical officer this week to write to all health boards to request them to suspend immediately the POP and transvaginal tape procedures until further evidence becomes available..."v 13. The Committee noted that some health boards, including Dumfries and Galloway had already suspended the use of mesh for POP procedures, and sought the Cabinet Secretary's response to this. The Cabinet Secretary said: "By rolling out the suspension throughout Scotland, we can ensure that every health board takes exactly the same position."vi 14. The Cabinet Secretary acknowledged that the regulatory regime was not straightforward, given that in Scotland health boards make the decisions but expressed his confidence that boards would act on his request. ii Public Petitions Committee (Session 4), Official Report, 3 June 2014, col 2326. iii Public Petitions Committee (Session 4), Official Report, 17 June 2014, col 2363. iv Public Petitions Committee (Session 4), Official Report, 17 June 2014, col 2364. v Public Petitions Committee (Session 4), Official Report,

Load more