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Scottish Government Declines Help of Mesh Expert

That the Parliament notes with much disappointment reports that the Scottish Government has declined an invitation from the St Louis-based obstetrician-gynaecologist, Dr Dionysios Veronikis, to travel to Scotland to help safely remove transvaginal and other mesh implants from people in Lothian and across the country who are experiencing life-changing pain and disability and to train other surgeons how to do this safely; understands that Dr Veronikis has developed specialist skills and instruments that allow entire mesh implants to be removed with positive results; believes that full mesh removal is currently unavailable in Scotland, and notes the calls for the Scottish Government to reconsider this invitation and to do all that it can to help facilitate the offer that Dr Veronikis has made.

Supported by: Elaine Smith


Current Status: Eligible for Members’ Business, Pending Cross Party Support

To ask the Scottish Government what its response is to reports that the St Louis-based obstetrician-gynaecologist, Dr Dionysios Veronikis, has offered to come to Scotland to remove surgical mesh from patients and train other surgeons on how to do this.


Current Status: Expected Answer date 30/01/2019

To ask the Scottish Government, what its response is to the offer that was made by Dr Dionysios Veronikis, who is a St Louis-based specialist in carrying out mesh removal procedure, which was published in The Sunday Post on 13 January 2019, to treat mesh-injured women in Scotland and assist with training physicians in performing full mesh removal surgery; whether it has been in contact with Dr Veronikis regarding this, and what estimate it has made of how much this would cost.


Current Status: Expected Answer date 30/01/2019

To ask the Scottish Government what work it has undertaken, since its announcement on 12 September 2018 that mesh surgery would be halted, to ensure that all NHS boards comply with this instruction and not use mesh as happened previously following the suspension announced in 2014 when some boards continued to carry out mesh procedures.


Answered by Jeane Freeman (21/12/2018):

Following the 12 September announcement of the halt, the Chief Medical Officer wrote to all Health Board Chief Executives and Medical Directors in order to instruct them that no further procedures were to be carried out. An exception was permitted in the case of those women who were already on the waiting list. In those circumstances surgery was allowed to go ahead, providing clinicians firstly explained the situation to the patient and sought fresh consent, and Scottish Government officials required Health Boards to confirm that those discussions had taken place.

Health Boards confirm they have complied with the instruction to halt procedures, and surgery has gone ahead only in the exceptional circumstances noted above.


Current Status: Answered by Jeane Freeman on 21/12/2018

To ask the Scottish Government what further work it has undertaken with the Department of Health and Social Care, and the other devolved administrations, regarding the establishment of a mesh database.


Answered by Jeane Freeman (12/12/2018):

Officials have continued to meet with colleagues in the Department of Health and Social Care as well as the other devolved administrations, the British Society of Urogynaecology, and the British Association of Urologiccal Surgeons in order to progress development of a registry.

An outline of an interim registry has been agreed upon and is expected to become operational in the spring of next year, and officials will be considering information governance aspects in order to ensure that NHSScotland can fully participate. A bespoke registry will continue to be developed after implemetation of the interim solution, with delivery expected in around two years.

Both the interim and bespoke registries will record all stress urinary incontinence and pelvic organ prolapse procedures, not just those that involve mesh repair. Further, they will record patient reported outcomes in addition to clinician reports.


Current Status: Answered by Jeane Freeman on 12/12/2018

To ask the Scottish Government what progress has been made with the development and implementation of the high vigilance restricted use protocol for mesh procedures.


Answered by Jeane Freeman (12/12/2018):

Health Boards have nominated 'Accountable Officers' who, in each Health Board that carries out mesh procedures in the future, will be responsible for ensuring that the necessary high vigilance measures have been followed in every case.

In February Accountable Officers will meet with Scottish Government and NHS ISD officials, as well as members of Healthcare Improvement Scotland's Mesh Oversight Group, in order to progress the development of the protocol. In doing so, Accountable Officers will take account of NICE guidelines, Royal College of Surgeons training guidelines, the Mesh Oversight Group's newly developed Self-Assessment Tool, and the views of regional clinical groups, the latter having been asked to give careful consideration to the issue following the announcement of the halt in September 2018.


Current Status: Answered by Jeane Freeman on 12/12/2018

To ask the Scottish Government what its position is on withdrawing the use of hernia mesh in the NHS, and what action it can take in this regard in Scotland.


Answered by Jeane Freeman (21/12/2018):

I refer the member to the answer to question S5W-20179 on 21 December 2018. 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 .


Current Status: Answered by Jeane Freeman on 21/12/2018

To ask the Scottish Government what recent discussions it has had with the UK Government and Medicines and Healthcare products Regulatory Agency regarding problems cause by medical implants.


Answered by Jeane Freeman (21/12/2018):

As set out in answer to S5W-20173 on 21 December 2018, both the Chief Medical Officer and I have written to the MHRA expressing concerns about the regulation of medical devices. In addition, Scottish Government officials participate in teleconferences with the Department of Health, the MHRA and other devolved administrations. Recently these discussions have focused mainly on EU withdrawal and transvaginal mesh. 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 .


Current Status: Answered by Jeane Freeman on 21/12/2018

To ask the Scottish Government what its response is to the report by the International Consortium of Investigative Journalists on the use of medical implants, and what implications it has for Scotland.


Answered by Jeane Freeman (21/12/2018):

On 31 October, both the Chief Medical Officer and I wrote to the MHRA to express concerns about how medical devices are regulated in the UK. We questioned the degree to which the present system of regulation is fit for purpose, and the level of scrutiny given to evidence prior to the approval of a medical device.

Although some assurances were received in the agency’s response, the Chief Medical Officer has written again to the MHRA. Aside from asking the MHRA to set out the actions it has taken specifically in relation to transvaginal mesh, the Chief Medical Officer also outlined a number of more general concerns, including in relation to the governance of notified bodies, the MHRA’s relationship with industry, and public confidence in the agency and the regulatory system.

Details are provided in a Scottish Government news release of 27 November: www.gov.scot/news/regulation-of-mesh-devices .


Current Status: Answered by Jeane Freeman on 21/12/2018

To ask the Scottish Government what recent discussions it has had with regulators regarding problems associated with hernia mesh.


Answered by Jeane Freeman (07/01/2019):

I refer the member to the answer to question S5W-20173 on 21 December 2018. 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


Current Status: Answered by Jeane Freeman on 07/01/2019
 
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