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BBC's Victoria Derbyshire Programme

That the Parliament congratulates the BBC's Victoria Derbyshire programme on its work exposing the medical problems and life-changing injuries and pain that can be caused by surgical mesh; notes that the programme featured Scottish women who experienced such injuries and pain from transvaginal mesh and male and female hernia patients who have severe pain and complications following the use of mesh for their conditions, and calls on the Scottish Government to conduct a review of the use of mesh in hernia operations in Scotland.

Supported by: David Stewart, Jeremy Balfour, Alexander Burnett, Alison Johnstone, Iain Gray, Alex Neil, Gordon Lindhurst, Jackie Baillie, Alex Cole-Hamilton, Alex Rowley, Brian Whittle, Jackson Carlaw


To ask the Scottish Government how many women in Scotland have been implanted with transvaginal mesh since 2007.


Current Status: Taken in the Chamber on 27/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), what its response is to concerns that evidence regarding the risks arising from the commonest continence procedures was removed from the final mesh report.


Answered by Shona Robison (28/04/2017):

Chapter 5 reviews evidence relating to risk. The evidence on risk was considered together with the patient survey (chapter 3), the evidence from the routine data sources (chapter 4) and the clinicians views (chapter 6), in order that the Independent Review could reach its final conclusions. All the evidence considered is included in the Final Report.


Current Status: Answered by Shona Robison on 28/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), whether it provided assurances to Elaine Holmes and Olive McIlroy that their chapter would be withdrawn from the final mesh report and, if so, for what reason it was included.


Answered by Shona Robison (28/04/2017):

When I met with Ms McIlroy and Ms Holmes they requested that their minority report be removed from the Independent Review's Final Report. I relayed this to the Chair of the Review and she acceded to this request. Subsequently, Ms McIlroy and Ms Holmes asked that further material be removed and this request was, again, relayed to the Chair. However, the Chair confirmed that, by that point, the Final Report had been submitted to the Chief Medical Officer, and no further changes could therefore be made. Any changes to the Report were a matter for the Chair to decide upon, not Scottish Government Ministers or officials.


Current Status: Answered by Shona Robison on 28/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), for what reason the final mesh report does not mention the US Food and Drug Administration's (FDA) warning regarding counterfeit mesh, including from Boston Scientific, or that three US states have launched legal action on this issue.


Answered by Shona Robison (28/04/2017):

The Independent Review was established due to wider concerns around mesh usage. It is the job of the MHRA to regulate medical devices across the UK, and it has not issued a Medical Device Alert regarding the implants concerned. The MHRA has found no evidence to indicate that polypropylene mesh implants are unsafe, and has not been required to initiate any enforcement action against Boston Scientific, or any other manufacturer in the UK. Under current arrangements, regulation is a reserved matter, and the MHRA will therefore continue to monitor and evaluate the safety and performance of these devices, and will inform the Scottish Government if circumstances change.


Current Status: Answered by Shona Robison on 28/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), for what reason mesh procedures for prolapse continue to be offered despite concerns that there is a lack of evidence regarding their effectiveness and reports of both Scottish and international studies regarding possible high risks.


Answered by Shona Robison (28/04/2017):

The Independent Review's Final Report concludes that mesh procedures should not be offered routinely in the case of prolapse, and the Chief Medical Officer has accepted this conclusion. However, in each individual patient's case it is necessary to apply individually focused clinical care, and there will be exceptions where this type of operation is considered suitable, subject to agreement by the patient and her clinicians. The Oversight Group that is being established will be expected to continue to be provided with - and review - the routine data on number of cases and complications.


Current Status: Answered by Shona Robison on 28/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), what its response is to concerns that the final mesh report does not make clear that the EU classifies mesh as "high-risk".


Answered by Shona Robison (28/04/2017):

The Independent Review’s Final Report made clear that, at the time of writing, it was anticipated that the new EU Medical Device Regulations would include a change to the classification of surgical mesh devices intended for long-term or permanent use.

It is now confirmed that the new EU Regulations, subject to their formal adoption, will up-classify surgical meshes to Class III. The new Regulations can be viewed here: http://data.consilium.europa.eu/doc/document/ST-10728-2016-REV-4/EN/pdf.


Current Status: Answered by Shona Robison on 28/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), in light of the patients' survey suggesting that over 70% continue to experience pain, including after the implant has been removed, for what reason the final mesh report recommends that such surgery can take place.


Answered by Shona Robison (28/04/2017):

In coming to the conclusions noted in its Final Report, the Independent Review considered a range of evidence, including the patient survey, all of which is summarised within the Report. The conclusions are based upon the totality of that evidence.


Current Status: Answered by Shona Robison on 28/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), for what reason chapter six of the final report suggests that mesh procedures are better than non-mesh ones.


Answered by Shona Robison (28/04/2017):

Chapter 6 is a clinicians' review of the evidence and experiences noted elsewhere in the Report. Based on that evidence, it concludes that:

  • retropubic mesh tape is a valid option to be offered routinely to women considering surgical treatment for SUI;

  • colposuspension and autologous fascial pubo-vaginal sling are both appropriate alternatives for women who wish to avoid the use of a permanent implant, provided they accept the increased associated short-term morbidities and longer recovery, and increased long-term risk of prolapse following colposuspension;

  • women may wish to consider urethral injection therapy; they should be made aware that the efficacy is less than with other interventions, and decreases over time; hence the risk of re-admission for complications or re-operation for SUI is very much higher; and

  • in the case of pelvic organ prolapse, vaginal wall repair using native tissue (anterior and posterior colporrhaphy) should be the procedure of choice for women seeking surgery for POP; the use of polypropylene mesh or biological graft should not be offered routinely but may be considered in complex conditions – only after discussion at an appropriately constituted multi-disciplinary team.


Current Status: Answered by Shona Robison on 28/04/2017

To ask the Scottish Government, further to the statement by the Cabinet Secretary for Health and Sport on 30 March 2017 (Official Report, c. 57), for what reason the evidence suggesting that (a) non-mesh procedures are safer than mesh procedures for incontinence, (b) transobturator mesh tape can be too risky a treatment to treat incontinence and (c) prolapse mesh has no benefit and can be risky is in the annexe of the final report only.


Answered by Shona Robison (28/04/2017):

Appendix D of the Final Report contains the table from the Interim Report's Chapter 6, and Annex A contains the evidence tables referenced in the Interim Report's chapter 5. The evidence from the Interim Report was built upon by new evidence to provide the Independent Review with its final conclusions. For transparency, all the evidence has been published.


Current Status: Answered by Shona Robison on 28/04/2017