 The next item of business is a statement by Shona Robison on transvaginal mesh implants. The cabinet secretary will take questions at the end of her statement and so there should be no interventions or interruptions. I call on Shona Robison up to 10 minutes, please, cabinet secretary. Thank you, Deputy Presiding Officer. I am grateful for the opportunity today to make a statement about the independent review of transvaginal mesh. I would like to begin by thanking all those who contributed to the review. I would particularly want to thank Elaine Holmes and Olive McElroy, whose efforts, along with other members of the Scottish Mesh Survivors, helped to bring about the review. Indeed, the review was established partly as a result of a petition lodged by the Scottish Mesh Survivors with the Public Petitions Committee back in April 2014. That petition asked for several things, including the suspension of mesh procedures, the establishment of an independent review, the 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, and I will go into more detail shortly. What cannot be denied, however, is that this independent review has been a very difficult and challenging process. Indeed, in addition to the resignation of Elaine Holmes and Olive McElroy, we saw the resignation of a clinician member due to a disagreement with other clinicians about the clinical evidence. In any review or inquiry of this nature, there will always 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 both stress urinary incontinence and pelvic organ prolapse and 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, whilst always bearing in mind that the patient should be put first. However, the difficulties and challenges in bringing this independent review is something that we do need to reflect further upon as a Government, including formally examining how future reviews are undertaken and concluded, and I will keep Parliament informed of the detail of this as it is taken forward. The seriousness that this Government attaches to this issue is reflected in the fact that back in 2014, my predecessor, Alex Neil, as Cabinet Secretary, established the independent review of transvaginal mesh. Further, the then Cabinet Secretary asked that health boards consider suspending the use of mesh until such times as the independent review reported. That request for suspension is something that I have given my continued support to, though it must be noted that if women were experiencing very distressing symptoms and wanted to proceed, then in those difficult circumstances, procedures did go ahead provided the women concerned were fully informed of the risks. Importantly, it must be remembered that only the Medicines and Healthcare Products Regulatory Agency, the UK regulatory body, has the power to ban the use of mesh and it has not done so. What both my predecessor and I were very mindful of was that this should be an independent review and, to that end, all ministers and Government officials have taken great care to allow the review to develop a fully independent 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 with the resignation of three valuable members amid concerns that evidence had been ignored, hidden or deleted. Those were very serious concerns and I raised them directly with the chair. She has confirmed that all evidence that is 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 carefully review the evidence that is contained within the report to ensure that she considered the evidence to be the best available. The chief medical officer has given me her assurances and professional judgment that the evidence in the report is the best available at this time. The chief medical officer also made herself available to MSPs this morning to answer any detailed clinical questions about the report. On hearing of the resignations that I arranged to meet with Elaine Holmes and Olive McElroy and took note of all their concerns, I met the chair, who discussed those concerns with me in-depth, and I have sent a very detailed response to Elaine Holmes and Olive McElroy 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 outlined in it. What is clear from the report is that, in the past, there have been serious issues around mesh procedures, and members will note that it makes two very clear recommendations in relation to the circumstances that can be offered in the future. One is that, when women are treated for stress, urinary incontinence, all appropriate options, both mesh and non-mesh can be offered, and crucially, women must be given full information to make an informed choice. The second is that mesh procedures must not be offered routinely in the case of pelvic organ prolapse. Those recommendations are clear, unambiguous and incredibly important. We can also see that the final conclusion makes clear that the reporting of adverse events must be mandatory and be in line with the general medical council guidance. That again is a very important recommendation that will help to contribute to much-improved monitoring of mesh procedures in the future. Indeed, when I met with the chair, she explained that the word mandatory is used as a direct result of the request from Elaine Holmes and Olive McElroy. While it is deeply unfortunate that we got to the stage where those two very committed women felt they had no choice but to resign, we can nonetheless see that they have had a direct impact upon the report. Indeed, their efforts, along with those of many women affected, have led to other key achievements outside of the independent review. A helpline has been established, where any women who are affected by the issue can seek expert advice. A patient information and consent leaflet has been developed that is designed to help those who are suffering from stress, urinary incontinence to make a careful, properly informed decision about their treatment. Of course, it was through their campaign that the Scottish Government initially requested that those procedures be suspended. Looking to the future, I can confirm today that the chief medical officer has written to health boards drawing their attention to the review's report. Health boards will be fully expected to implement the conclusions set out by the review, and the chief medical officer has in particular highlighted the conclusions around the circumstances in which mesh procedures can and cannot be offered, which I mentioned a few moments ago. It is vitally important that all health boards ensure that the most up-to-date, detailed yet patient-friendly information is available to all women. That information must be provided so that they can make careful, fully informed decisions on the best treatment in their case. The CMO will meet medical directors to ensure that further safeguards are in place prior to any procedures using mesh being reintroduced routinely in individual health boards. I can also say today that an oversight group will now 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 Health Improvement Scotland with a view to their assuming responsibility for the oversight group. Health Improvement Scotland will and indeed will be well placed to develop and oversee the implementation of measures in close partnership with health boards to ensure that the independent review's conclusions are implemented. I am keen to ensure, and indeed to continue to stress, that the patient must at all times be central to the oversight group's work. I have asked that Healthcare Improvement Scotland build upon its existing processes that would allow that in a meaningful and purposeful way. Finally, in addition to the work that the oversight group will be expected to carry out, I can also confirm that the Scottish Government officials are exploring a pilot of a specific mesh registry in collaboration with colleagues elsewhere in the UK. Again, that is something that is requested by women and affected by mesh. Presiding Officer, I hope that what I have said today helps to set out my position on the independent review of transvaginal mesh. The independent review's report has 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 an informed decision about the best possible treatment in their case. The safeguards put in place will ensure that procedures undertaken by clinicians in Scotland are monitored with transparency, so that assuring quality and safety. Let me end by once again thanking all involved in the process for their efforts, particularly the women who are 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 any questions on my statement. The cabinet secretary will now take questions on the issues that are raised in her statements, for which I intend to allow around 20 minutes. It would be helpful if members would press their buttons if they wished to ask questions, and I call on Jackson Carlaw. It was my privilege to sit in this Parliament's Public Petitions Committee when Elaine Holmes and Olive McElroy first presented their shocking, damming and harrowing evidence and testimony. On behalf of dozens of women and, since then, hundreds, indeed thousands across the world regarding what so many now openly regard as one of the great health scandals transvaginal mesh, I recall these women first being dismissed as delusional of making connections and assertions that were not true. I recall the incredulity, tears and fury of women as the MHRA sat in front of over 100 Scottish survivors while claiming that there were barely a handful affected across the whole of the UK. It is important to remember and understand how heroic these women have been. They have had to stand, sit and discuss the most intimate and personal details relating to their personal anatomy, with men with whom I imagine they never anticipated or expected they would have to have such conversations. That must have been traumatic for them. I can remember the small measure of pride that I felt when this Scottish Parliament and, heroically, the then health secretary, Alex Neil, announced a temporary ban and the review and the conclusions of which we are discussing today. Not only was this a response to the women concerned here in Scotland, it drew the eyes of the world to the lead Scotland had taken. I do not want to dismiss the review out of hand and I won't, but, Presiding Officer, this is a final publication that bears little of any resemblance to the interim review that was published last year. It is not just an evolution but an alleged miracle based on new evidence that suddenly recasts mesh as an appropriate procedure for women. I am sorry to say this and I do so reluctantly. A whitewash of damning evidence now reduced and downgraded an international reclassification of mesh as a high-risk procedure, not least by the European Union. It is not the basis for the lifting of the suspension. I am asking the cabinet secretary today will she respond positively now to my considered request that there will be no lifting of the suspension on mesh procedures until either or both the Public Petitions Committee or Health Committee of this Parliament have been able to consider the review and take further evidence from the most important with people of all the women affected together with the expert clinician who together with them felt they had no option but to resign from the review itself. A whitewash, yes, but will the cabinet secretary confirm that a whitewash will not be followed by a betrayal? Shona Robison Can I first of all recognise Jackson Carlaw's tenacity on this issue? He has for a long time pursued this issue with me and others. I think that no small part is why we are have got the review and the suspension that was put in place is down to Jackson Carlaw and others. Let me respond to some of the questions that Jackson Carlaw asked. Also, I should say, recognise very much his description of the physical challenges involved with the women going about an enormous campaign and piece of work. I hope that in my statement I was able to outline some of the achievements that they have gathered and have made over that period. I am not going to stand here and pretend that they are happy with the conclusions of this report, because I know that they are not. However, I hope that they will recognise them. What Jackson Carlaw will recognise is that the things that I outlined in terms of the recommendations of the conclusions and all of the other things, including the mandatory reporting, have been achieved by their campaign. Jackson Carlaw talked about the final publication and interim report. The final publication builds on the interim report, but incorporates much of the evidence that was since publicised between the interim report and the final report. The reason there was such a gap in time was because of the awaiting of much of those reports, such as the Cochran reports. That was built in to the final report recommendations. In terms of the lifting of the suspension, I have outlined in my statement that the chief medical officer will have to be satisfied that all of the safeguards that are laid out in the report and, indeed, in the CMO's letter to boards, which go beyond the report, will have to be in place before any board starts to routinely offer those procedures. It can only be done with fully informed consent from those women. I hope that, in some way, we will reassure Jackson Carlaw. The Scottish Messe survivors and their families are furious at the report, and it is a scandal that we only have a few minutes to discuss it as a statement at the end of the parliamentary term. Will the Government bring forward a debate on that in Government time when Parliament returns? Why, despite assurances from the chair that their submission would be withdrawn because of a complete lack of confidence in the final report, have Elaine Holmes and Oliver McElroy being betrayed and their evidence included in the final report? Why was the draft report agreed by all members of the review group in 2015 and then changed beyond all recognition by the time of publication? Why was research published in the medical journal Nature that suggested that one in seven women will suffer serious mess risks in their lifetime, omitted from the final report? Why are unavoidable and unnecessary procedures that too often cause irreversible problems being continued when there are safer alternatives? I have many, many, many other questions on this report, but a lack of time will not allow me to ask them now, but they will be asked. The world has been watching Scotland on mesh. What they will see is a cover-up, a mission and a medical establishment stitch-up, and that is both a tragedy and a disgrace. Scottish mesh survivors have been betrayed and misled, but let me say this. The cabinet secretary knows these women. They will not lie down and they will most certainly not accept this whitewash. Shona Robison Can I also begin by paying tribute to Neil Findlay and the work that he has done in pursuing this issue and indeed supporting the women in doing so? He talked about other parliamentary opportunities to discuss this in more detail, and I am sure that there will be more parliamentary opportunities to do that. He compared, as Jackson Carlaw did, the interim report and the final report. As I said to Jackson Carlaw, the reason that there was such a time gap between the interim and the final report is that Neil Findlay will be aware that there were studies that were being published in-between those reports that were then considered and incorporated into the final report. Neil Findlay outlines a number of specific questions, many of which are in the response that I sent to Elaine Holmes and Olive McElroy in terms of the detail of the changes to the chapters that I raised with the chair and have detailed in my response to them. On the expectation that many women who have written to me over the past few months had, they would have been understandably disappointed with anything short of a complete ban on mesh from the report. However, I have to say that the Scottish Government and the independent review never had the power to introduce a ban on mesh. As I have said in my statement, that power only lies with the MHRA, which is the UK regulatory body, and they have chosen and decided not to do so. We have to be guided by that. If that changes, then clearly that is a different matter, but it has not changed. That is their position. The independent review was looking at, and what circumstances did the clinical evidence say that those procedures should or should not go ahead? The evidence that has been brought forward and the chief medical officer has said that it is the best available evidence at this current time. However, I am happy if Neil Findlay wants me 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. That was a long question and answers for the openers for very important information from everyone. I would ask everybody else to recognise that, so short questions and answers please to get through everyone. Rona Mackay to be followed by Alison Harris. The report says that, in the case of pelvic organ prolapse, mesh must not be used. Does the Scottish Government support that recommendation? Is it your expectation that it should be followed by all boards? Shona Robison. Yes, it is absolutely the case that the report is very clear that pelvic organ prolapse mesh must not be used. It goes into some detail around why it has come to that conclusion. As I said in my statement, what is really important is that not just that conclusion, but all the other conclusions are now implemented by health boards, including the additional safeguards, the reporting and making sure that all of those are in place before boards routinely reintroduce procedures on mesh. I am very clear and the chief medical officer is very clear that that has to be the case and she will be keeping me very closely informed as we take that forward. Alison Harris, followed by Sandra White. Thank you, Deputy Presiding Officer. The eyes of women from across the world are on Scotland. Mesh injured women, not just in Scotland, not just in the rest of the United Kingdom, but across the western world had been eagerly awaiting the independence review report and will be rightly disappointed with its contents. I would ask the cabinet secretary if she shares my disappointment with the removal of an entire chapter and its accompanying evidence highlighting the dangers of transvaginal mesh surgery from the final report. If she can explain why it is not recommended for transvaginal mesh procedures to 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. Shona Robison Can I thank Alison Harris for her questions? The chair has assured me that all the evidence is either in the final report or is on the website. All the evidence that was received and indeed the clinician who resigned from the group provided an alternative commentary and chapter based on his clinical view that has also been provided on the website for everyone to be able to see. The member talks about reclassification. The MHRA is the body that would reclassify mesh and we would await any reclassification from MHRA, but it is its responsibility to determine the classification of mesh, not the Scottish Government's responsibility. Our responsibility is to give clear guidance to clinicians around what circumstances they should or should not be undertaking the procedures. That is what the independent review was set out to do. Those are the recommendations that it has made. I understand that, for many women, they wanted the review to ban mesh. I hope that I have explained that it 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, but I am happy if the member wants to write to her in more detail. Can I also thank the chief medical officer for the very important meeting today? Myself and others have been contacted by many women who underwent this procedure and are still suffering greatly the consequences of it. Can the cabinet secretary explain why, when there are women who have been left in such pain, are mesh implant procedures resuming? Surely, women should have the choice. Sandra White's last point about the choice is critical here. What the report clearly says is that there should be a fully informed choice. For many women, 43 per cent of women at some point in their lives will suffer urinary incontinence problems. For some, those are very devastating symptoms. It is very important that women have the 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, because it lays out very clearly in what circumstances procedures should or should not be used. For stress, urinary incontinence both mesh and non mesh procedures should be fully explained, and the benefits and disbenefits and the risks should be fully explained so that women can make a fully informed decision. The report's recommendations will strengthen that, and we will make sure that the guidance, particularly the guidance and the patient information, is as good as it can be so that women can make that informed choice. Anna Sarwar, to be followed by Alison Johnstone. Deputy Presiding Officer, the most important individuals in this 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 that review group have asked for their submissions to be withdrawn, and they asked why those submissions weren't withdrawn. The First Minister at First Minister's question is right. Can we have a question, please? I'm coming to the question. Rightly, I apologise for the consequences of that treatment. Will the health secretary now take this opportunity to apologise for this botched process that has let down so many individuals? I say to Anna Sarwar that right at the beginning of the process when myself and the chief medical officer were in front of the committee. I apologise to women for the hurt that they had undertaken, the damage and the injury that they had suffered and undertook to make sure that, going forward, there would be clear clinical guidance that procedures would have to have fully informed consent and that the suspension that I, like Neil, put in place would continue until all that work had been done. Anna Sarwar referred to information that the women themselves had asked to be removed. When I met the women, they asked me that the minority report that they had written should be removed. I passed that information on to the chair. The chair of the independent review group agreed to do that. They then subsequently asked for further information to be removed. That again was passed on to the chair, but at that point the report had already been published. It included a request to remove information from the interim report, which was published 18 months ago. That information is there, but I don't think that anybody is under any illusion of what their women's views are of the report, and I understand that. As I have said to other members here, I think that one of the issues here was that the expectation of what the independent review group could achieve in terms of the expectation of many women, as they have written to me that it should be nothing less than a ban on mesh procedures, was not something that the independent review could have delivered or that the Scottish Government could deliver. That responsibility and power lies only with the MHRA, and they have chosen not to do so in the light of the evidence that they have seen. That is the fact. 98 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, their incomes, and it has impacted on their relationships. They have experienced— Do you come to a question, please, Ms Johnston? Yes, I would like to understand that women are unable to lift up their own children. I would like to understand what ongoing support the Government is giving to the survivors, their partners and their families. Alison Johnston makes a really important point here, and that is about fully informed consent. Many of women who have horrendous stress urinary incontinence symptoms, if they come forward for treatment, is important that the clinician fully informs them of all the risks of any procedure, and that this report 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 of that are explained fully to them. Plus, patient information leaflets have to ensure that that is clearly set out for those women, so a fully informed decision can be made. In terms of on-going support, we would expect our services—whether that is a health service or other services—to support women who need that support. If Alison Johnston wants more detail of that, I would be happy to write to her with that. Mike Rumbles, Alex Neil. I would like to thank the minister for advance sight of his statement. My question focuses on the precautionary principle. How many health boards ignored both the previous health secretary, Alex Neil and the current secretary's request for a suspension of the procedure until this independent review reported? Does the minister know how many of those procedures have taken place across the country since the health secretary's request was first made and ignored? Let me say to Mike Rumbles first that, as I have said a number of times and Alex Neil previously said, because this was not a banned procedure, if a woman agreed in the light of all the risks being explained to her that she wanted to go ahead with the procedure, there was nothing that would stop that if it was fully informed consent. Moving on to the specific question about how many mesh procedures have been carried out, I can tell the member that between June 2014 and September 2016, there were 148 transobjutorator tape procedures carried out, 38 transvaginal mesh procedures for pelvic organ prolapse and 327 transabdominal procedures also for pelvic organ prolapse. What I can say is that those procedures, trans-operator tape procedures, the report now recommends retro pubic tape, not trans-operator tape procedures. As I have said in answer to a number of questions, in terms of the pelvic organ prolapse, the report is very clear and recommends that that must not be routinely offered. Those numbers of procedures, the 38 transvaginal and the 327 transabdominal procedures, we would not expect health boards to now routinely offer those in the light of clinical guidance. The chief medical officer will take forward the detail with every health board and we would expect them to implement that before the suspension is lifted. We have already used up the time allocated for questions on that, but I am willing to have a few more minutes to allow more questions. Alex Neil will be followed by Donald Cameron. As the cabinet secretary who set up the inquiry, I am disturbed and disappointed that we have ended up where we have ended up. We cannot just leave things as they are. Therefore, I welcome that part of her statement where she said that she is minded to carry out a formal review of the process. How we got from a unanimous decision of the review group on the interim report to where we got to with the final report and all the unanswered questions from the women, the allegations from the consultant to also believe that this was a betrayal, I do not think that we can leave it there for the credibility of the report, its recommendations and indeed for the implications for future reviews of this kind. If we do not carry the confidence and trust of our patients, then those reports will not be worth the paper that I have written up. Let me start by saying that I absolutely recognise Alex Neil's role when he was previously Cabinet Secretary for Health and Establishing much of the work around this issue. As I said in my statement, I think that there is an issue about the process here of the independent review that we need to learn lessons from. However, I need to be absolutely clear what this is not about is opening up and reviewing the clinical evidence or the conclusions and recommendations of the report. What we will do is to look at the lessons learned about the process. It is important that, when patients are involved, particularly in independent reviews, there cannot often be a power imbalance in terms of the dynamics of reviews. It is really important that we learn lessons from this and that recommendations are brought to ministers and that that can then inform the guidance to not just the chairs of future independent reviews but also the members and the terms of reference that those independent reviews have. I am very happy to keep Parliament informed of the detail. I would expect someone independent to take that forward. I am very happy to keep Alex Neil informed. The cabinet secretary will be aware that the report discusses the use of a standalone database system. However, given that the current BSUG database can only be used by a relatively small proportion of surgeons and not 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, as well as track patient progress? As I said in my statement, the monitoring of adverse incidents and the data gathering is really important and a key part of the recommendation. The oversight group that is being established will be taking forward much of the detail of the report. I am very clear that we need to make sure that there is transparency to all of the data that is coming forward so that people can see for themselves the information and data that is coming forward. I am very happy to keep Donald Cameron involved in the detail of that as we take it forward. That ends the question session on the statement on transvaginal mesh and plants. We will move on to the next item of business.