- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government how the recommendations of the Independent Review of Transvaginal Mesh Implants will protect women who could be invited to participate in research involving the use of medical mesh products.
Answer
Until the Independent Review’s recommendations are published it is not possible to comment on them. In general terms, clinical research in Scotland is governed by the Scottish Executive Health Department Research Governance Framework for Health and Community Care, published in 2006. The RGF sets exacting and well established standards around the ethics, science, patient care, information, health and safety, finance and quality research culture for clinical research studies. It also details the responsibilities and accountabilities of key people and organisations involved in research studies to ensure robust governance arrangements are in place to assure these standards are maintained. The full document is available from the Scottish Government website.
http://www.gov.scot/Topics/Research/by-topic/health-community-care/chief-scientist-office/6864/6933.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government what alternative, non-mesh treatments are available to patients being treated for hernias.
Answer
Non-mesh treatments include both surgical and non-surgical interventions. Surgical interventions include the use of simple suture repairs or the use of host native tissue.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government, in light of its interim report being published in October 2015, for what reason the report of the Independent Review of Transvaginal Mesh Implants has yet to publish.
Answer
The Independent Review has awaited the publication of several key studies that it wished to consider as part of its deliberations. These were published at the very end of last year, and the Review aims to issue its final report this spring.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government how many meetings of the Independent Review of Transvaginal Mesh Implants have taken place since its interim report was published in October 2015.
Answer
The Independent Review has met three times since the publication of the interim report: March 2016, January 2017 and March 2017.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government when it has (a) met and (b) been in contact with any medical mesh device manufacturer since the publication of the interim report from the Independent Review of Transvaginal Mesh Implants in October 2015.
Answer
Neither Scottish Government Ministers nor officials have met with, or contacted, manufacturers in relation to mesh devices.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government how many meeting of the Independent Review of Transvaginal Mesh Implants sub-group there (a) were before and (b) have been since October 2015, also broken down by location, and whether the minutes have been or will be circulated to the the review group's members.
Answer
The Chair of the Independent Review has confirmed that the clinician members of the review met twice; firstly in October 2016 (Edinburgh), and subsequently in January 2017 (Glasgow). In addition, the clinician members held a teleconference in January 2017. The nature of these meetings was to agree the content of the chapter of the final report for which the clinicians were responsible, and separate minutes were not therefore taken.
The Chair of the Review also held teleconferences with both the Scottish Mesh Survivors members and with the other patient representative in January 2017. These were informal discussions and were not minuted.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government whether the report of the Independent Review of Transvaginal Mesh Implants will publish all of the evidence and findings regarding patient choice in a manner that will be understandable to non-experts.
Answer
I understand that attempts have been made to make the Review’s final report as accessible as possible. However, as with any report of this kind, it will contain necessarily detailed, in-depth analysis of medical evidence that is, by its very nature, complex. An Expert Group is tasked with taking forward the recommendations of the Review. In response to previous recommendations it produced a patient-centred information and consent leaflet, and it will be expected to continue to take a patient-friendly approach in relation to the Review’s final recommendations.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government whether there are any situations in which standard non-mesh procedures cannot be provided by the NHS, and whether it expects the final report of the Independent review of Transvaginal Mesh Implants to identify and describe these situations.
Answer
I refer the member to the answer to question S5W-07740 on 17 March 2017. All answers to written Parliamentary Questions are available on the Parliament's website, the search facility for which can be found at http://www.parliament.scot/parliamentarybusiness/28877.aspx
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government whether informed consent is always required from patients being treated for hernias with medical mesh devices.
Answer
Informed consent and shared decision making are expected prior to any procedure being carried out. The Chief Medical Officer goes into this in more detail in her Realistic Medicine report.
http://www.gov.scot/Resource/0051/00514513.pdf.
- Asked by: Neil Findlay, MSP for Lothian, Scottish Labour
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Date lodged: Monday, 06 March 2017
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Current Status:
Answered by Shona Robison on 17 March 2017
To ask the Scottish Government whether it considers that the Independent Review of Transvaginal Mesh Implants has conducted itself in an impartial manner, and what its reasons are for its position on this.
Answer
Ministers and government officials have taken great care to allow the Review to take an independent view on the matter, and the members’ range of experiences and expertise was intended to ensure that a comprehensive examination of the situation was possible. This is a complex, technical area and the Scottish Government has given the Review wide latitude to prepare the report without interference from Government.