Meeting of the Parliament

Meeting date: Thursday, March 30, 2017

Official Report 892KB pdf

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Transvaginal Mesh Implants

The next item of business is a statement by Shona Robison on the independent review of transvaginal mesh implants. As the cabinet secretary will take questions at the end of her statement, there should be no interventions or interruptions.

15:09  

I am grateful for the opportunity today to make a statement about the independent review of transvaginal mesh implants. I thank all those who contributed to the review; I thank in particular Elaine Holmes and Olive McIlroy, whose efforts, along with those of other members of the Scottish mesh survivors campaign, helped to bring it about.

The review was established partly as a result of a petition that was lodged by the Scottish mesh survivors with the Public Petitions Committee in April 2014. The petition asked for several things, including suspension of mesh procedures, the establishment of an independent review, mandatory reporting of adverse events and the introduction of fully informed consent. Much of that has been, or will be, achieved as a result of that original petition. I will go into more detail shortly.

It cannot be denied that the independent review has been a very difficult and challenging process. In addition to the resignation of Elaine Holmes and Olive McIlroy, we also saw the resignation of a clinician member because of a disagreement with other clinicians about the clinical evidence. In any such review or inquiry there will be a wide range of views and experiences, and a myriad of evidence and other material to consider.

The review’s terms of reference specified that it would determine the safety of vaginal mesh implants for stress urinary incontinence and pelvic organ prolapse, and it would determine the relative efficacy of surgery for those conditions. In doing so, it was expected to consider a wide range of material—from patient experiences to scientific and statistical information—while always bearing it in mind that the patient should be put first. As a Government, we need to reflect further upon the difficulties and challenges of undertaking the independent review; that reflection will include formally examining how future reviews are undertaken and concluded. I will keep Parliament informed of details as that is taken forward.

The seriousness that the Government attaches to the issue is reflected in the fact that, back in 2014, my predecessor Alex Neil—as then Cabinet Secretary for Health and Wellbeing—established the independent review of transvaginal mesh implants. Furthermore, the then cabinet secretary asked that health boards consider suspending use of mesh implants until the independent review had reported; I have given my continued support to that request for suspension. However, it must be noted that when women have experienced very distressing symptoms and have wanted procedures, they have, in those difficult circumstances, gone ahead, provided that the women were fully informed of the risks. It is also important to remember that only the Medicines and Healthcare products Regulatory Agency—the United Kingdom regulatory body—has the power to ban the use of mesh implants, but has not done so.

My predecessor and I have been very mindful that the review should be independent, so to that end, all ministers and Government officials have taken great care to allow the review to develop a fully independent and comprehensive view on the matter, without interference from Government.

As we all know, and as I alluded to a moment ago, the review has been challenged in recent weeks through the resignation of three valuable members, amid concerns that evidence had been ignored, hidden or deleted. Those are very serious concerns, which I have raised directly with the chair. She has confirmed that all evidence that was considered by the review has been published, either in the final report or on the review’s website. In addition to that, I asked the chief medical officer to review carefully the evidence that is contained in the report, in order to ensure that she considers that the evidence is the best that is available. She has given me her assurances and professional judgment that the evidence in the report is the best that is available at this time. The chief medical officer also made herself available to MSPs this morning to answer detailed clinical questions about the report.

On hearing of their resignations, I arranged to meet Elaine Holmes and Olive McIlroy and took note of all their concerns. I then met the review’s chair to discuss those concerns in depth, and have sent a very detailed response to Elaine Holmes and Olive McIlroy based on those discussions.

I am sure that many members here today will now have had a chance to read the review’s final report and will have noted the conclusions that are outlined in it. It is clear from the report that, in the past, there have been serious issues with mesh procedures. Members will note the report’s two very clear recommendations on the circumstances in which such procedures can be offered in the future. The first recommendation is that when women are treated for stress urinary incontinence, all appropriate options—mesh and non-mesh—should be offered and, crucially, women must be given full information in order that they can make an informed choice. The second recommendation is that mesh procedures must not be routinely offered in cases of pelvic organ prolapse. Those recommendations are clear, unambiguous and incredibly important.

We also see that the final conclusion makes it clear that reporting of adverse events must be made mandatory, and be in line with the General Medical Council guidance. That, too, is a very important recommendation that will contribute to much-improved monitoring of mesh procedures in the future. When I met the chair she explained that the word “mandatory” had been used as a direct result of a request from Elaine Holmes and Olive McIlroy. Although it is deeply unfortunate that we got to the stage at which those two very committed women felt that they had no choice but to resign, we can, nonetheless, see that they have had a direct impact on the report.

Indeed, their efforts, along with those of many women who have been affected, have led to other key achievements outside the independent review. A helpline has been established, where any woman who is affected by the issue can seek expert advice. A patient information and consent leaflet has been developed that is designed to help women who are suffering from stress urinary incontinence to make a careful and properly informed decision about their treatment. Of course, it was through Elaine Holmes’s and Olive McIlroy’s campaign that the Scottish Government initially requested that use of the procedures be suspended.

Looking to the future, I can today confirm that the chief medical officer has written to health boards drawing their attention to the review’s report. Health boards will be expected to implement fully the conclusions that have been set out by the review, and the chief medical officer has highlighted in particular the conclusions around the circumstances in which mesh procedures can and cannot be offered, which I mentioned a few moments ago. It is vital that all health boards ensure that the most up-to-date, detailed and patient-friendly information is available to all women. The information must be provided so that they can make careful and fully informed decisions on the best treatment in their case. The CMO will meet medical directors to ensure that those further safeguards are in place prior to any procedures using mesh being reintroduced routinely in individual health boards.

An oversight group will also be formed to work with health boards to ensure that the national aspects of the independent review’s conclusions are taken forward. To that end, the Scottish Government is in discussion with Healthcare Improvement Scotland, with a view to that body assuming responsibility for the oversight group. Healthcare Improvement Scotland is well placed to develop and oversee the introduction of measures, in close partnership with health boards, to ensure that the independent review’s conclusions are implemented. I am also keen to ensure—I continue to stress this—that the patient must at all times be central to the oversight group’s work. I have asked Healthcare Improvement Scotland to build upon its existing processes to allow this to happen in a meaningful and purposeful way.

Finally, and in addition to the work that the oversight group will be expected to carry out, I also confirm that Scottish Government officials are exploring a pilot of a specific mesh registry, in collaboration with colleagues elsewhere in the UK. Again, that was requested by women who have been affected by mesh.

I hope that what I have said today helps to set out my position on the independent review of transvaginal mesh implants. The independent review’s report will play an important role in shaping the future approach that health boards will be expected to take.

The action that will be taken by the Scottish Government in response to the report’s publication gives a very clear message that all women must be offered high-quality options, information and support that will allow them to make informed decisions about the best treatment in their case. The safeguards that will be put in place will ensure that procedures that are undertaken by clinicians in Scotland are monitored with transparency, thereby assuring quality and safety.

Let me end by once again thanking all those who have been involved in the process for their efforts—especially the women who have been affected by mesh, who have worked incredibly hard in difficult circumstances to raise awareness of the issue and to bring about meaningful change.

I am happy to answer questions on my statement.

The cabinet secretary will now take questions on the issues that have been raised in her statement, for which I intend to allow around 20 minutes.

It was my privilege to sit on Parliament's Public Petitions Committee when Elaine Holmes and Olive McIlroy first presented their shocking, damning and harrowing evidence and testimony on behalf of the then dozens, and since then hundreds and indeed thousands, of women across the world regarding what so many people now openly regard as being one of the great health scandals—transvaginal mesh implants.

I can recall the women first being dismissed as delusional and as making connections and assertions that were not true. I recall the incredulity, tears and fury of women as the Medicines and Healthcare products Regulatory Agency sat in front of more than 100 Scottish survivors claiming that barely a handful had been affected across the whole United Kingdom. It is important to remember and understand how heroic those women have been. They have had to discuss the most intimate and personal details relating to their anatomy with men whom, I imagine, they never expected to need to have such conversations with. That, in itself, must have been traumatic for them.

I remember the small measure of pride that I felt when the Scottish Parliament and, heroically, the then Cabinet Secretary for Health and Wellbeing, Alex Neil, announced a temporary ban and the review, the conclusions of which we are discussing. That was not only a response to the women concerned in Scotland; it drew the eyes of the world to the lead that Scotland had taken.

I do not want to dismiss the review out of hand, and I will not do so, but it is a final publication that bears little, if any, resemblance to the interim review that was published last year. It is not just an evolution; it is an alleged miracle based on new evidence that suddenly recasts mesh as an appropriate procedure for women. I am sorry to say this—I do so reluctantly—but it is a whitewash of damning evidence now traduced and downgraded, and of international reclassification of mesh as a high-risk procedure, not least by the European Union.

You must come to your question.

That is not a basis for lifting the suspension. Will the cabinet secretary respond positively to my considered request that there be no lifting of the suspension on mesh procedures until either the Public Petitions Committee or the Health and Sport Committee, or both, have been able to consider the review and take more evidence from the most important people of all—the women who were affected and the expert clinician who together felt that they had no option but to resign from the review? There has been a whitewash; will the cabinet secretary confirm that it will not be followed by a betrayal?

I acknowledge Jackson Carlaw’s tenacity on the issue. He has pursued it for a long time with me and others, and the review and the suspension that was put in place are in no small part down to him and others.

Let me respond to some of Jackson Carlaw’s questions. I very much recognise his description of the physical challenges that have been involved in the women going about an enormous campaign and piece of work. I hope that I outlined in my statement some of their achievements over that period. I am not going to stand here and pretend that they are happy with the conclusions of the report, because I know that they are not, but I hope that they and Jackson Carlaw will recognise that the things that I outlined—the recommendations, conclusions and the mandatory reporting—have been achieved by their campaign.

Jackson Carlaw talked about the final publication and the interim report. The final publication built on the interim report, but it incorporates, of course, much of the evidence that was publicised between the interim report and it. There was such a gap in time because of the need to wait for reports including the Cochrane report, which has been built into the final report’s recommendations.

On lifting the suspension, I outlined in my statement that the chief medical officer will have to be satisfied that all the safeguards that are laid out in the report and, indeed, all the safeguards in the COM’s letter to boards that go beyond the report, are in place before any board starts routinely to offer the procedure, which can be done only with fully informed consent from the women concerned.

I hope that reassures Jackson Carlaw in some way.

The Scottish mesh survivors and their families are furious at the report, and it is a scandal that we have only a few minutes to discuss it, after a statement at the end of the parliamentary term. Will the Government bring forward a debate on the issue in Government time, when members have returned from the recess?

Despite assurances from the chair that their submission would be withdrawn because of their complete lack of confidence in the final report, why have Elaine Holmes and Olive McIlroy been betrayed? Why was their evidence included in the final report? Why was the draft report that was agreed by all members of the review group in 2015 changed beyond all recognition by the time of publication? Why was research that was published in the medical journal Nature that suggested that one in seven of the women will suffer serious mesh risks in their lifetime omitted from the final report? Why are avoidable and unnecessary procedures that too often cause irreversible problems being continued when there are safer alternatives?

I have many, many more questions on the report. Lack of time will not allow me to ask them now, but they will be asked. The world has been watching Scotland in relation to mesh implants. What people will see is a cover-up, omission and a medical establishment stitch-up, which is a tragedy and a disgrace. The Scottish mesh survivors group has been betrayed and misled. However, the cabinet secretary knows those women: they will not lie down and they most certainly will not accept this whitewash.

I begin by paying tribute to Neil Findlay and the work that he has done in pursuing the issue and in supporting the women in doing so. He talked about other parliamentary opportunities to discuss the issues in more detail; I am sure that there will be more parliamentary opportunities to do that.

As Jackson Carlaw did, Neil Findlay compared the interim report with the final report. As I said to Jackson Carlaw, the reason why there was such a time gap between the interim and final reports is, as Neil Findlay will be aware, that studies were being published that were then considered and incorporated in the final report.

Neil Findlay asked a number of specific questions, many of which are answered in the response that I sent to Elaine Holmes and Olive McIlroy on the detail of changes to the chapters. I raised those issues with the chair and have given details on that in my response to them.

Given the expectations of many women who have written to me over the past few months, they would, understandably, have been disappointed with anything short of a complete ban on mesh implants resulting from of the report. However, I have to point out that the Scottish Government and the independent review have never had the power to introduce a ban. As I said in my statement, that power lies only with the MHRA, which is the UK regulatory body, and it has decided not to introduce a ban. We have to be guided by that body. If its decision changes, clearly, the situation will be different. However, that is the MHRA’s position. The independent review considered clinical evidence on circumstances in which the procedure should and should not go ahead. That is the evidence that has been brought forward and the chief medical officer has said that it is the best available evidence at this time.

If Neil Findlay wants it, I will be happy to send him a copy of the letter that I sent to the women outlining in great detail some of the chapter changes that he referred to.

We had long questions and answers for the openers, in order to allow important information to be given. I ask other members to recognise that. Can we please now have short questions and answers so that we can get through everyone?

The report says that mesh must not be used in the case of pelvic organ prolapse. Does the Scottish Government support that recommendation and is it the cabinet secretary’s expectation that it should be followed by all boards?

Yes, that is absolutely the case. The report is clear that, with pelvic organ prolapse, mesh must not be used, and it goes into some detail on why the group came to that conclusion. As I said in my statement, it is really important that not just that conclusion but all the conclusions are now implemented by health boards, including the additional safeguards and the reporting. Boards need to ensure that all those measures are in place before they routinely reintroduce mesh procedures. The chief medical officer and I are very clear that that has to be the case, and the chief medical officer will keep me closely informed as we take that forward.

The eyes of women from across the world are on Scotland. Mesh-injured women, not just in Scotland or the rest of the United Kingdom but across the western world, were eagerly awaiting the independent review report and they will be rightly disappointed with its contents. Does the cabinet secretary share my disappointment with the removal from the final report of an entire chapter and its accompanying evidence that highlighted the dangers of transvaginal mesh surgery? Can the cabinet secretary explain why the report does not recommend that transvaginal mesh procedures be reclassified to the highest-possible risk category, as has happened in the United States and in accordance with the recently issued European Union guidelines?

The chair has assured me that all the evidence that was received is either in the final report or on the website. Indeed, the clinician who resigned from the group provided an alternative commentary and chapter, based on his clinical view, and that has also been provided on the website for everyone to see.

Alison Harris talked about reclassification. The MHRA is the body that would reclassify mesh, and we would of course await any reclassification from the MHRA. It is the responsibility of the MHRA, not the Scottish Government, to determine the classification of mesh. Our responsibility is to give clear guidance to clinicians on the circumstances in which they should or should not undertake the procedure. That is what the independent review was set up to do, and it has made its recommendations.

I understand that many women wanted the review to ban mesh. I think and hope that I have explained that that was not within the gift of either the independent review or the Scottish Government. Only the MHRA could do that, and it has not done so. I am happy to write to the member with more detail, if she wants me to do so.

I thank the chief medical officer for the informative meeting today.

I and other members have been contacted by many women who underwent the procedure and are still suffering greatly from its consequences. When women have been left in such pain, why are mesh implant procedures resuming? Surely women should have the choice.

Sandra White’s point about choice is critical. The report says clearly that there should be a fully informed choice.

Many women—I think that it is 43 per cent—will suffer from urinary incontinence problems at some point in their lives, and for some women the symptoms are devastating. It is very important that women have a full choice and that the clinical expertise and guidance are as good as they can be. That is why the independent review’s recommendations are so important. The report lays out clearly in what circumstances the procedure should be used. For women who suffer from stress urinary incontinence, mesh and non-mesh procedures and their benefits, disbenefits and risks should be fully explained, so that the women can make a fully informed decision.

The report’s recommendations will strengthen that approach and we will ensure that the guidance, particularly the guidance in patient information, is as good as it can be, so that women can make that informed choice.

The most important individuals in the entire situation are the survivors of the mesh scandal. It is a fact to say that they feel angry, let down and betrayed. Individuals who served on the review group asked for their submissions to be withdrawn and are asking why they were not withdrawn. Today, at First Minister’s question time—

May we have a question, please?

I am coming to my question.

The First Minister rightly apologised for the consequences of the treatment. Will the health secretary apologise for the botched process that has let down so many individuals?

Right at the beginning of the process, when the chief medical officer and I were in front of the Public Petitions Committee, I apologised to women for the hurt, damage and injury that they had suffered, and I undertook to ensure that, going forward, there would be clear, clinical guidance, that there would have to be fully informed consent for procedures and that the suspension that Alex Neil had put in place would continue until all that work had been done.

Anas Sarwar referred to information that the women had asked to be removed. When I met the women, they asked me to remove the minority report that they had written, and I passed on that information to the chair of the independent review group, who agreed to do so. The women subsequently asked for further information to be removed and that again was passed on to the chair, but, at that point, the report had already been published. There was also a request to remove information from the interim report, which was published 18 months ago.

That information is still there but nobody is under any illusion on the women’s views of the report, and I understand that. As I have said to other members, I say to Anas Sarwar that one of the issues was that the expectation for what the independent review group could achieve was expressed in the expectations of many of the women who wrote to me to say that there should be nothing less than a ban on mesh procedures. That was not something that the independent review or the Scottish Government could deliver. That responsibility and power lies only with the MHRA, and it has chosen not to ban the procedures in light of the evidence that it has seen. That is the fact.

Ninety-eight per cent of the women in the report said that their consent to mesh surgery was not informed, and 70 per cent said that their surgeon was not open to the idea that mesh was the cause of their symptoms. Those symptoms have resulted in active women losing their livelihoods and incomes. It has impacted on their relationships. They have experienced—

Can you come to a question please, Ms Johnstone?

Yes. Women are unable to lift up their own children. I would like to understand what on-going support the Government is giving to the survivors, their partners and their families.

Alison Johnstone makes an important point about fully informed consent. Many women have horrendous stress urinary incontinence symptoms. If they come forward for treatment, it is important that the clinician informs them fully of all the risks of any procedure. The report’s recommendation is very clear that women should be taken through all the options, including non-mesh and mesh options, and all the risks associated with all that should be explained fully. Also, patient information leaflets should ensure that all that information is clearly set out for those women so that they can make a fully informed decision.

We expect our services, whether it be the health service or other services, to support women who need on-going support. If Alison Johnstone wants more detail, I am happy to write to her.

I thank the minister for advance sight of her statement. My question focuses on the precautionary principle. How many health boards ignored the request by the previous health secretary, Alex Neil, and the current health secretary for a suspension of this procedure until the independent review reported? Does the cabinet secretary know how many of these procedures have taken place across the country since the request was first made and ignored?

As I have said a number of times, and as Alex Neil said previously, because the procedure is not banned, if, in light of all the risks having been explained to her, a woman wanted to go ahead with the procedure, nothing would stop that.

On the specific question about how many mesh procedures have been carried out, I can tell the member that, between June 2014 and September 2016, 148 transobturator tape procedures, 38 transvaginal mesh procedures for pelvic organ prolapse, and 327 transabdominal procedures for pelvic organ prolapse were carried out. On the transobturator tape procedures, the report now recommends retropubic tape and not transobturator tape procedures.

As I have said in answer to a number of questions, when it comes to pelvic organ prolapse, the report is extremely clear—it recommends that transvaginal mesh procedures and transabdominal procedures must not be routinely offered. We would not expect health boards to routinely offer those procedures in the light of that clinical guidance. The chief medical officer will take forward the detail of that with every health board, and we expect them to implement that before the suspension is lifted.

We have used up the allocated time, but I am willing to allow two more questions.

Thank you very much for extending the time slightly, Presiding Officer.

I set up the inquiry when I was the Cabinet Secretary for Health and Wellbeing, and I am disturbed and disappointed that we have ended up where we have ended up. I say to the cabinet secretary that we cannot just leave things as they are. Therefore, I welcome the part of her statement in which she said that she was minded to carry out a formal review of the process, because we need to look at how we got from a unanimous decision of the review group on the interim report to the position that we arrived at on the final report. Given all the unanswered questions of the women and the allegations of the consultant, who believed that this was a “betrayal”, I do not think that we can leave it there, for the sake of the credibility of the report and its recommendations and for the sake of future reviews of this kind. If we do not carry the confidence and trust of our patients, these reports will not be worth the paper that they are written on.

I absolutely recognise the role that Alex Neil played as cabinet secretary in establishing much of the work on the issue.

As I said in my statement, I think that there is an issue with the process of the independent review that we must learn lessons from. However, I must make it absolutely clear that it will not be a case of opening up and reviewing the clinical evidence or the conclusions and recommendations of the report; we will look to learn lessons about the process.

When patients are involved in independent reviews, there can often be a power imbalance in the dynamics of the process. I think that it is really important that we learn lessons from the review of transvaginal mesh implants and that recommendations are made to ministers that inform not only the guidance that is provided to the chairs and members of future independent reviews, but the terms of reference of those reviews.

I am happy to keep Parliament informed of the detail of that process. I expect someone independent to take forward that work, and I will keep Alex Neil informed of progress.

I apologise for missing the very beginning of the cabinet secretary’s statement.

The cabinet secretary will be aware that the report discusses the use of a stand-alone database system. Given that the current British Society of Urogynaecology database can be used by only a relatively small proportion of surgeons and that it

“is not available to general practice”,

as the report notes, will the cabinet secretary consider using a comprehensive and independent database so that a much wider range of medical professionals can use it to report adverse incidents and concerns, and to track patient progress?

As I said in my statement, data gathering and the monitoring of adverse incidents are extremely important and form a key element of the recommendations. The oversight group that is being established will take forward much of the detail, and I am clear that we must ensure that there is transparency on all the data so that people can see the information for themselves.

I will be happy to keep Donald Cameron involved in the detail of that process as we proceed with it.