 I am grateful for the opportunity to make a short statement today in relation to transvaginal mesh in NHS Scotland. I was appointed Cabinet Secretary for Health fewer than 80 days ago, but since then, this issue is amongst those to which I have given my highest attention. I expect that most of us in this chamber have either received letters from or met women who have suffered significant and life-changing complications following vaginal mesh surgery. I think that all of us here would want to acknowledge the bravery of the women who have come forward to tell their story, something that would be by no means easy, given their own pain, the impact on their lives and the very sensitive nature of the problem. As members will be aware, regulatory powers over medical devices are reserved to the MHRA and the UK Government. Within the limits of the powers available in Scotland, progress has been made in restricting the use of mesh and improving surgical consent procedures under the guidance of my predecessors, Alec Neill and Shona Robison. In 2014, in response to concerns about safety, the then acting chief medical officer requested that health boards suspend the use of vaginal mesh, leading to a substantial reduction in mesh implant surgeries. An independent review of the use of vaginal mesh was established and a final report was published last year. As a result of the recommendations made by the review, which are similar to those made in other reviews across the UK and further afield, a number of actions are already being taken. The development of clinical pathways are being progressed by individual health boards and also through work at a regional level. Management of patients through the care pathway has been considered, including care for women who experience complications from treatment. It has been stressed that the care for each and every patient must be considered by a multidisciplinary team, and that that must occur in all cases. In addition, the need to restrict the number of surgeons undertaking procedures has been highlighted to medical directors and the application of existing nice guidance relating to the minimum number of procedures to ensure sufficient experience has been advised. Healthcare Improvement Scotland has established an oversight group that is reviewing evidence and trends in procedures and reported adverse events. That will influence the nature of clinical pathways going forward and provides high-level external review. The chief medical officer, Dr Catherine Calderwood, has been clear that all patients must be provided with information to help them to make informed decisions about their treatment. Scottish Government officials are working in partnership with colleagues from the Department of Health in England and the devolved nations to establish a mesh registry that will collect information on all procedures. The chief medical officer has continued to keep the issue under review. Listening to the voices of women who have been affected, she and I have discussed what steps would be necessary that would satisfy me that every action has been taken to ensure that NHS treatment options available are as safe as possible irrespective of the views of the MHRA. As a result, I have today asked the chief medical officer to instruct health boards to immediately halt the use of transvaginal mesh altogether in cases of both pelvic organ prolapse and stress urinary incontinence, pending the implementation of a new restricted use protocol that will ensure that procedures are carried out only in the most exceptional circumstances and subject to a robust process of approval and fully informed consent. This halt in use will not affect other uses of mesh, for example transabdominal and infernal repair, but those are areas that we will continue to keep under review. The instruction to halt is, I believe, a proportionate measure, while a rigorous, high vigilance, restricted use protocol for any future practice is developed and put in place. The lifting of this halt in use can only be considered once there is confidence that there is sufficient evidence that the protocol will only be triggered in only the most limited of circumstances, informed by any new evidence and the forthcoming nice guidance that is expected in the spring of next year on the management of pelvic organ prolapse and stress urinary incontinence. There is one exception to this effective ban. There are currently a very small number of women who are presently waiting for a mesh procedure under the treatment time guarantee. These operations will be allowed to go ahead, provided that this is the women's express wish, with clear informed consent demonstrated. The chief medical officer will today write to health boards to set out the High Vigilance Restricted Use protocol to be taken forward, many elements of which are already occurring as a result of the recommendations of the independent review. The purpose of this High Vigilance Restricted Use protocol is effectively to ensure that transvaginal mesh is not used in Scotland's NHS except in the most exceptional circumstances where there is absolutely no clinical alternative and it is the fully informed and consented wish of the women concerned. Subject to the evidence, should the halt be lifted, transvaginal mesh would only be available in the NHS in Scotland under this restricted use protocol and that would require the health boards medical director who would become the accountable officer to consider and agree each case individually, taking account of the clinical evidence and subject to evidence-informed and voluntary consent from the women. The medical director will therefore be responsible for signing off the use of transvaginal mesh on an individual named patient basis and no transvaginal mesh will be able to be used or procured by a surgeon except under those circumstances. Even in those circumstances and with those requirements, NHS procedures would only then be permitted in a very small number of designated centres of expertise and only where the women concern have made the choice with full information to have the procedures using transvaginal mesh. Health board directors will be responsible for ensuring that the appropriate high vigilance process is followed in each individual woman's case. Clinicians will be asked to document and retain confirmation of the information provided to patients, the agreement and consent of the patient and the discussions of the multidisciplinary team assigned to the case. To ensure that documentation is given to every patient detailing their procedure, the product used and the name of the surgeon. Document all procedures in a local or national registry, report all complications to Health Facilities Scotland incident reporting and investigation centre, give patients information on how to report any complications. The chief medical officer will also make clear that this high vigilance procedure must apply to all treatments for pelvic organ prolapse and stress urinary incontinence, not only when mesh is the treatment option. Finally, the chief medical officer has announced a prospective audit of all procedures carried out in Scotland going forward, which will run until such time as a UK-wide registry, which I touched on earlier, is developed. In addition to the measures being taken directly by the CMO, the further nice guidance that I have already mentioned is expected to be available for consultation in October and November of this year. We will of course consider any additional recommendations given in this guidance when it is published and take those into account when treating women in Scotland regardless of the treatment chosen. As a power over the approval of medical devices as a reserved one, the instruction to halt that we are instigating cannot extend beyond the bounds of NHS Scotland. The measures that I have set out here today are intended to underline the clear message and determination that I have that our care is as safe as possible and that patients are listened to, are heard and when confronted with decisions on their care have the full facts available so that they can make informed decisions. I want to put on record my thanks to the women who have campaigned tirelessly on this issue and I hope that all that we have done, including the additional measures that I have announced today, gives them confidence that we have heard what they have said, taken their concerns seriously and within the limits of our powers acted. I welcome the cabinet secretary to her post and as one of those who has been associated with the issue for a long time say that I want to reflect and consider with care the statement that she has just given, but to say that I do welcome it, it does seem to many, I hope, as a decisive step on a pathway to a different approach to the whole question of mesh. I hope that Elaine Holmes, Olive McElroy and all the women who will, I hope, be watching the statement this afternoon can at least give one unqualified cheer for the progress that it represents and to do so while still recognising and paying tribute to the women who have died, Eileen Baxter and Michelle McDougall, one directly, one indirectly of this process. It is an unhappy coincidence that it is a process that has been available since 2007, but I believe that a Government of any stripe within NHS at the time would have embraced it. Only in recent times has it felt to many that in the face of the evidence have we not been pursuing the path that is now clear and singularly appropriate. So I still think that there is an opportunity for the Government and for this Parliament to apologise to all the women across Scotland whose lives have been so irredeemably and irreversibly compromised by the whole mesh scandal. The cabinet secretary mentioned the MHRA. I have offered here before and I want to repeat again. This is not an issue of devolved or reserved, it is not an issue of party politics, but I am happy, as others in this chamber, to join with the Scottish Government in making the strongest representation to the UK Government that the MHRA has proved to be a hopelessly ineffective vehicle for considering the appropriateness of the whole mesh implant process. Can I ask? Is this a high vigilance restricted use protocol? Is this a completely new procedure or is it a new protocol? I ask only to know whether this is a process that was available to the Government for and it chose not to implement or whether the cabinet secretary has identified a different way forward. Alex Neil previously wrote to health boards and I know that this is now within the domain of medical directors, but of course that advice was set aside and not always followed in the way that the Scottish Government then intended. What enforcement can the Scottish Government say will be available to ensure that this new protocol is absolutely and rigorously implied? Finally, at least for today, can I say that the cabinet secretary is well done? I thank Jackson Carlaw for his comments and commend him on the wisdom of wanting time to reflect on what I have said and what he has had only a limited sight of, albeit earlier than I stood up to speak. I think that this is an issue that deserves mature reflection and continued consideration, and I am grateful to him for that. I am also happy to take up his offer to join with us in making representations to the MHRA. My predecessor, Ms Robison, did write to them and we have raised that, but I am happy to look at that again and to discuss that further with him. In terms of whether that is a new procedure or a new protocol, it is not a procedure, it is a protocol that is designed to put in place further steps that restrict the use of this procedure and of mesh in these instances in a way that allows for clinical judgment, gives assurance about fully informed and voluntary consent from the women, knowing all the options that may be available to her and the consequences as best as they can be anticipated of all the options available to her, but makes the medical director of a health board, the accountable officer, for ensuring that every step in that high vigilance protocol has been taken and that that triggers the use then, in those circumstances, if all of those steps have been made, that triggers then the use of mesh in those very limited circumstances and, as I said, and I keep repeating, provided the woman has given her fully informed and voluntary consent and that is evidenced as I read out. In terms of ensuring that health boards are compliant, the chief medical officer has today instructed health boards to halt the use of transvaginal mesh in the two procedures that I identified. We have a number of steps that we can take to ensure that boards are compliant with what I have read out today and previously, what my predecessors also put in place. That includes, of course, the engagement between the CMO and medical directors. It includes the involvement of Health Improvement Scotland in those matters and in looking at how boards perform and what they do. It also includes the annual review by ministers of health boards as well as the work that is undertaken on a regular basis between officials in the health directorate and boards themselves to ensure that all of those steps are put in place. We will give some further thought on whether or not there is more that we can do on that, but we should take the time to consider and hear the views of those medical directors and the clinicians involved as well as other voices. There is a degree of potential further work that we might do to ensure compliance that we too should take a bit of time to reflect on. Neil Findlay is to be followed by Alison Johnstone. The cabinet secretary makes an appeal for mature reflection, but it is sometimes difficult to have mature reflection when you are looking into the eyes of people whose lives have been ruined. I thank the cabinet secretary for the early sight of her statement. I warmly welcome today's decision to halt the use of mesh in Scotland. That is something that I and the Scottish mesh survivors have been calling for for the past six years. As the Scottish Government acted at the time, thousands of women would have been spared the enduring anxiety and misery of loss of mobility, constant pain and ruined lives and, as we know of last week, even death. We know that the MHRA is not fit for purpose. I agree with Jackson perl on that. Successive Government ministers have hidden behind the MHRA using it as a shield claiming that because medical devices are reserved, it prevented the Scottish Government from acting. Today that claim is exposed as the bogus smokescreen that we all knew it was. All of the steps announced today have been suggestions made by the mesh survivors for a year. Will the cabinet secretary confirm that the procedure that she has put in place today now brings Scotland into line with what is happening in the rest of the UK already? Will she confirm that the claims that were made last month in the media by the chief medical officer about Scotland's more robust system were wholly misleading? Does the cabinet secretary accept that the independent review into mesh was indeed a whitewash? When will the review of the review be published? Does the cabinet secretary have that on her desk? Does she accept that the campaigner's demands have been right all along? Will she now, in very clear and unambiguous terms without ducking the question, accept that the evidence available in 2014 was stark and more than enough to have allowed consecutive cabinet secretaries to take the action that she has taken today to prevent many more women from being horribly injured or leading a life of anxiety and uncertainty? Finally, how will today's decision and the implications of it be communicated to all past and present mesh patients? Thank you very much. Mr Findlay, for those comments, can I just make a point about what I mean by mature reflection? I do not expect anybody else in this chamber other than those who have held this post, as Cabinet Secretary for Health, to feel sorry for the job that I have to do. It is a brilliant job. However, it always involves the careful balance of evidence that comes from more than one source. When in opposition, it is entirely your right and your responsibility to argue your case hard, but mature reflection requires that we recognise that, although it is absolutely the case that very many women have been damaged by this procedure, you, Mr Findlay, will have received the email that I received only last week from a woman pointing out that no other procedure had helped her but this one. It is not possible to be so binary on some of these matters. What I have attempted to do today is listen to the voices of the women who have campaigned on this matter, look again at the evidence and decide whether or not there is more that we can do. What I am not going to do is agree with you that our chief medical officer was wholly misleading because she was not. Nor am I going to agree with you that what I have set out brings us into line with the rest of the UK because, in fact, it takes us ahead of the rest of the UK. We have taken steps beyond what the rest of the UK has done, and I have done that because I consider it proportionate and justifiable. The review of the review is independent. I do not know when it will be published—it is certainly not on my desk at this point—and I expect that we will all know, broadly speaking, at the same time when it is published and we will be able then to look at that matter. What I am trying to do today, as I said, is recognise the evidence that is before me, recognise the importance of clinical decision making and that I, as a politician, like everyone else in this chamber, am not a clinician and try to make the best possible decisions that I can for the safety and the care of our health service and, in particular, for those who come to it for that care and support. I believe that what I have set out today in this statement takes us in that direction. I am not closing the door to any further issues that may arise. We will always be happy to look at that, but I think that today we should be able to say that we have heard what the women have said and we have put in place steps that will ensure that any woman coming forward can be confident that she has given all the information that she needs and the opportunity to make a fully informed and voluntary choice about what happens to her body. I, too, welcome the cabinet secretary's announcement. I thank all those whose work has got us here, although I think that it is fair to say that this halt is overdue. Can the cabinet secretary advise—in her statement, she said—that only where the women concerned have made the choice with full information? Can she advise that a woman who chooses to go ahead with a transvaginal mesh implant, will she be informed of the decision that this Government has taken today? Will she have an opportunity to meet those whose experience has informed this decision? The woman that I met in Parliament said that their lives were limited because of incontinence. They were limited, but they were not limited to the extent that they have to now use crutches, wheelchairs, that their relationships have been severely impacted. I would just like to understand what full information means. Of course, what we have done today is to put in place a halt on the procedure, a halt, with the exception of those women currently with the treatment time guarantee in place—a very small number that we have identified. Those women, too, will be given the opportunity in the light of what I have set out today to determine whether they wish to go ahead with that treatment. However, that halt will only be lifted when we have absolute confidence that all the steps that I have outlined are in place, including that High Vigilance protocol. At this point, with the exception of those women who currently hold that treatment time guarantee, should they, in the light of all the circumstances and what I have set out, and they will be advised of that, wish to carry through with their procedure, with the exception of those, there will be no other procedures using mesh, as I have described it, until we are certain that all the steps that I have outlined are in place and that we are confident that that is the case. That will involve making sure that we can evidence as fully as possible that any future woman who is coming forward with that treatment option that is presented to her has full information about what that option entails, what previous complications have been, what the clinical advice is and what the alternatives to that may be, so that she can take time to discuss it with her family before she makes a decision about what she might best do. In devising what that full information might be and how she would evidence that fully informed consent, I am, of course, open to having propositions made to me from members in this chamber, as well as groups around the country. Alex Cole-Hamilton, to be followed by Alex Neil. Thank you, Presiding Officer. I am very grateful for the advance sight of the cabinet secretary's statement and very much grateful for the contents that it contains. I have a constituent who has a hernia mesh problem. She is having to go to London to have that removed. I hope that in her answer, firstly, the cabinet secretary will cover what the touchstones of the review of hernia mesh will be and when that will be revisited. Secondly, what provision the NHS in Scotland will make for surgery to remove mesh implants where it is appropriate to do so and what consideration her Government is considering for compensation for those survivors of the mesh implants. Thank you to Mr Cole-Hamilton for his comments. In terms of the use of mesh for other procedures or other conditions in the two that I have outlined, the halt that I have advised the chamber of today does not apply to those other procedures, because we have no evidence at this point that would justify doing that. We will keep that situation under review. What I mean by under review is that we will be reviewing constantly whether there is evidence coming forward from our boards internationally or otherwise that suggests that we should look to take different steps in those circumstances. In terms of arrangements for removing mesh, as Mr Cole-Hamilton asked, I cannot give him an answer to that in detail today, but I am happy to get back to him on that question. With respect to compensation, there is a procedure in place that women, I am sure, are informed of, and we will certainly make sure that, if they are not, they will be, that they can pursue in order to have their case considered and determined whether they are due financial compensation for a procedure that the health service has carried out. I am conscious that there are at least 11 more members who wish to ask a question. That is a very sensitive and emotional issue for many. I urge all members, all from bitches, to make a point. I ask each member now to keep their questions succinct and to administer similarity in their answers. Alex Neil, to be followed by Miles Briggs. Thank you very much indeed, Presiding Officer. I too very much welcome the statement by the Cabinet Secretary for Health and Sport. I think that it lays out a clear direction of travel and that, at long last, our foot is on the accelerator. If the Cabinet Secretary for Health and Sport is satisfied with the enforcement procedures in the national health service to ensure that, this time, her instructions are carried out in full, unlike what happened when I issued the suspension request four years ago. Secondly, can I suggest that the three or four ministers of health, currently three in the UK, get together and really agree a programme of action to deal with the MHRA? It is totally unfit for purpose, that is agreed by all parties. Any regulator funded by those who are regulating it is not fit for purpose, in my view, and any organisation that does not test devices before they authorise their use in the national health service is completely failing in their duty. I think that dealing with the MHRA, because this is not the only issue where the failed patients across the UK, is a top-urgent requirement if we are going to put an end to incidents and examples of devices being misused, as has happened in the case of mesh. I thank Mr Neil for those comments. In terms of being satisfied about the instructions that have been issued today and the requirements that I have set out are being followed, I have already set out what those procedures are, but I am interested in considering whether there is more that we need to do in order to ensure that that halt is adhered to. Of course, the halt is the halt, and it is not lifted until I am satisfied that all the steps that I have put in place are in place and are understood and will be enacted. I think that that gives some assurance, I would hope so, and we will certainly look at whether or not there is more that we can do. In terms of UK ministers of health, it is interesting because I have been discussing the opportunity to invite my colleague ministers for health to Scotland to discuss matters of common interest. We are likely to pursue that approach, and in that instance, should we be successful and accept the invitation, I am very happy to include MHRA in that discussion. Miles Briggs to be followed by Emma Harper. I certainly hope and sincerely hope that today is a step in the right direction in regaining the confidence of men and women across Scotland. Given the restricted use that has been announced in the past and the instruction to halt today, can I ask the cabinet secretary what guidance has also been issued to health boards about additional costs associated with more complex treatments and procedures, and is that not forming part of any consideration? As it is clear that some health boards in the past, since the announcement of restriction was made, have carried on with their use, most notably Glasgow and Clyde, whereas other boards such as Grampian, Ayrshire and Arran and Tayside have completely stopped using them. I am grateful to Mr Briggs. In terms of instructions to health boards, as I said, the instruction from the chief medical officer has issued today, as I was speaking, advising the halt of the use of this procedure, with, as I said, the exception of those women who have the treatment time guarantee. In terms of bringing the procedure back in any respect, I think that I have outlined that. In terms of instructions to health boards about cost, what I have made very clear to health boards is that they should not be removing capacity in any respect on the grounds of cost. That is not my expectation of how they should be delivering the services in the name of the health service in Scotland. I will reflect a little on what Mr Briggs has said and look at the evidence from myself, but if I think that that may be a factor in a health board's decision about how it now enacts what we have set out, then I will make it clear to them that cost should not be a factor in their decisions about alternative treatments. I understand from the statement that NICE is currently carrying out a further review of the mesh. Can the cabinet secretary therefore confirm that the halt has been put in place? It will remain at least until the new guidance is completed and how can you advise how members of the public can provide their views to this further review? The halt will certainly remain in place until I am satisfied that every one of the steps that I have outlined are in place and will be followed. That includes the high vigilance protocol in terms of use. The NICE guidelines, as we expect them shortly to be consulted on, will form part of that, but they will not of themselves be the trigger for any halt that we have put in place today to be lifted. They will inform that, but they will not be the trigger. In terms of how members of the public may be involved in the consultation exercise, then we will make sure that, on the Government's website, we will put the necessary link there for people to follow in order to provide their views in terms of consultation on those guidelines, and I urge members to make that available via their own channels to their own constituents. In her statement, the cabinet secretary set out an exception to the ban, and that is for women who are currently waiting for a mesh procedure under the treatment time guarantee. That effectively means that the minister announcing a halt today, yet a woman could technically undergo a mesh procedure tomorrow. Following on from the answer to Alison Johnstone and giving the series nature of the statement, will the cabinet secretary instruct the chief medical officer to not only write to health boards setting out the new protocol, but also to all the women who are currently waiting for a mesh procedure, so that they are fully aware of the new protocol being issued and have full knowledge of the situation, in essence, giving them renewed and fully informed consent? Mr Sarwar knows that, but we do not hold the data on the women involved who have the treatment time guarantee for very obvious reasons. Each of the boards holds that data, but I am perfectly happy to ask all the boards involved to contact the women if they have any in their board area who holds that treatment time guarantee, to ensure that they are aware of what I have set out today, and to ensure that they are aware of all the information that they should have in order to make a decision about whether or not they want to go ahead with that treatment. Thank you, Presiding Officer. I fully welcome the statement from the cabinet secretary today. Can the cabinet secretary confirm if the effective ban will also extend to the use of prop devices by private healthcare providers, or would that be within the powers reserved to the national health service and the UK Government? We have, as I have described, the CMO has included in that a letter to the chief executives and medical directors of private healthcare providers, advising them of the decisions that we have taken and the halt that we have put in place for the NHS, but that applies to the NHS. We cannot halt procedures in private healthcare. That would be something that the MHRA would do, should they determine at some point that this procedure or the use of this device is not acceptable, but it is not something that I can do as a cabinet secretary. I thank the member and the ministers for the contributions. I am sorry to have to cut this session off here, but we are already six minutes over the time allocated. It is a subject of particular sensitivity and interest, however, so is the following debate on suicide.