 welcome you to the 17th meeting of the Public Petitions Committee in 2017. You can remind members in others new rooms to switch phones and other devices to silent.We have one item of business today. That is the consideration of petition 1517 on polypropylene mesh medical devices, lodged by Lane Holmes and all of McElroy who are in a gallery this morning. Can I welcome our non-committee MSPs, Neil Findlay, Jackson Carlaw, John Scott and Alec Neill. We will hear evidence from two panels. First is Dr Will Agar. Dr Agar was a clinician member of independent review before resigning on 1 March. After we hear from Dr Agar, we will take evidence from the petitioners, Elaine Holmes and Olive McElroy. Members have a note by the clerk, which summarises the evidence that we heard in May from the chair of independent review, the cabinet secretary and chief medical officer. The note also provides an overview of the submissions provided by the witnesses in advance of today's meeting. The submissions from the witnesses are included in the correspondence and members also have a copy of the timeline of email correspondence referred to in the petitioner's submission. The committee has also received a number of submissions from mesh survivors, describing the impact that mesh has had on them and their lives. The submissions that were received before our meeting papers were issued and included with our papers. Submissions that were received after that date are in the process of being published and will be on the petition website. We should note, for the committee's interest in others, that the scale of the response has been very significant across the world, indicating an interest in the petition that goes way beyond Scotland itself. There are a number of areas to cover this morning. I would propose therefore to move on to the first evidence session. I welcome Dr Will Agar, consultant gynaecologist in obstetrician and formerly a member of the independent review. Thank you for attending this morning, Dr Agar. You have an opportunity to provide a brief opening statement after which we'll move to questions. Thank you, convener, and I'm truly grateful for the opportunity to appear before the committee to provide evidence and to answer questions from members. I would like to thank the patient campaigners, Elaine Holmes and Olive McElroy, for bringing this important subject to public awareness by petitioning Parliament to urge government for action on the six points in order to reduce harm to women considering surgery for stress injury incontinence and pelvic organ prolapse. I was invited to participate in the independent review of transvaginal mesh procedures as a clinician member, and I would like to thank all members of the review group for all their efforts and teamwork over the last three years. I signed up to the publication of the interim report on the 3 October 2015, but I resigned four weeks prior to the publication of the final report on the 27 March 2017. I believe the government's final report could have done more to reduce harm without losing value, to highlight the details of mesh-related risks while maintaining patient-centered approach, and to promote shared decision making between patients and their clinicians while striking a good balance of the trade-offs to be considered. I believe more needs to be done to bring this report up to the standards and up to the principles outlined in the Chief Medical Officer's framework document, Realistic Medicine. I am here today to request the committee to urge government officials to open the final report to a public consultation period for six to eight weeks, for example. During this well-recognised transparency process, officials will publish the feedback received from various stakeholders, publish the responses from the review body, and amend the report if necessary. Similar procedures were adopted by the European Union prior to publication of their final report on the mesh procedures and devices, and is a well-recognised procedure prior to publication of clinical guidelines by the Clinical Guideline Development Group of the National Institute of Clinical Health and Clinical Excellence in England. Along with the announced review of the process by Professor Britton, I believe an accompanying review of the outcome or of the content, which is the report itself, will restore full credibility and public confidence to the mesh report, and more importantly, would reduce harm to women considering surgery for incontourism prolapse. Since this petition was lodged in May 2014, this committee has heard from patient campaigners, journalists, lawyers, health ministers, medical officers, public health consultants, two chairmans of the review, as well as a representative from the device watchdog the MHRA. This is the first time the committee hears from a surgeon who used these medical devices during performing the surgical procedures. A surgeon who used to be a member of the government short-life working group, a member of the expert group, as well as a previous member of the independent review group. All views expressed in this statement in my submission and during answering your questions are mine and are based on my interpretation of scientific evidence, my own values and the standards upon which I practised medicine. I do hope that my appearance today will be helpful to the committee to take matters forward and I am ready to take your questions. Okay. Thank you very much for that. Neil? I wonder if I could raise a few issues in relation to your register of interests before we begin this session, convener, where your indulgence I think might be helpful. In the final submission you point to a piece of work for the University of Aberdeen. The description in it is ensuring accuracy and integrity of the Sims pilot short and long-term study. I just want to tease that out a bit. What was the issue around accuracy and integrity? I participated or collaborated with the Sims study. That was the pilot study that recruited in 2010. This is different from the definitive larger Sims study that finished recruitment last year. I collaborated with the pilot Sims study but I did not recruit patients for the definitive Sims study. In the study I collaborated on in 2010, the outcome reported by ourselves, the researchers have different parameters. We look into some different parameters to assess the outcome and decide which mesh procedure is the best. I felt that these parameters may have changed during the course of the study itself. I wanted to be absolutely sure that whatever patients are reporting to us is what we are reporting in the manuscript for publication as part of the scientific literature. Clearly this is a very high profile issue with a lot of interest from several stakeholders. I just wanted to be absolutely clear that all the figures and all the parameters are 100% accurate before we do the publications. I continue to collaborate with the University of Aberdeen to make sure that the two studies, the one that has already published for papers and the one that we are about to publish, are 100% accurate before they go into the scientific record. I am currently waiting for the University of Aberdeen to provide me with a governance report. Once that happens I plan to visit the university to review the data myself because it is so important that before I put my name on the publication that I am 100% comfortable that it is accurate. I do have questions about the register of interest in relation to the review group. Is it appropriate to raise that now or later? We may meet some progress first and we can come back to that when I call you. I wondered just in opening up the question if you could summarise for us what you think the difference between the interim report and the final report was and why those differences mattered? I think from my point of view the main differences are in chapter 6. This is the clinician chapter and also in the conclusions. The differences between chapter 6 and the interim report and that of the final report is in the way the data were presented. The interim report, we were very clear on the methodology that was adopted. I did describe this methodology in one of the appendices here where it is entitled Notes on Chapter 6. We approached this by summarising top evidence from international studies. The study that summarised, reviewed and meta-analysed the data internationally in this particular topic comparing two different mesh procedures, the two commonest mesh procedures performed in Scotland and identified the important outcomes for us clinicians and for patients as well. We looked into the details of how the trade-offs between these two procedures or the trade-offs of the advantage and disadvantage, we added the accurate figures from the review and put it in a format that the lay person would understand, highlighted what the authors of the study would come to a conclusion which procedure is better and what do we after interpreting the evidence itself, not just going to the conclusion of the authors but going deep into the data, what we believe is important and what is which one is better than the other. Then we took the patient's views into consideration as well what outcomes are important for them and we came to a conclusion at the end of the chapter that at the time was unusual in expressing concerns about the procedure, the contrast procedure most commonly presented in Scotland. So we were leading, we were the first, so the Scottish Independent Review Group was the first authority in the world to formally express concerns about a procedure that many clinicians and surgeons and other authorities around the world consider it is a gold standard. So that was a big step for us and we've achieved this because we looked into the details of evidence not just as clinicians but as clinicians, patients, regulators, representative from clinical societies and this is where evidence comes to life because if evidence that is just in the literature is not interpreted then it is not living. But it comes to life when clinicians, patients, regulators and other stakeholders interpret it. That was a huge success and other institutions and organisations has followed our path. At least we did not receive any formal feedback that I am aware of that criticizes our unique position at the time in October 2015. And that was a big step forward that we do express concerns about the procedure most commonly performed in Scotland prior to the suspension of procedures. Unfortunately this particular expression of concern was removed from the conclusion of the final report. So that concern is not there anymore. And when I speak to my colleagues, clinicians and surgeons, what do they understand by the removal of these concerns? You get different responses so some would say well these were used to be concerns about these concerns are not there anymore. So that means that procedure perhaps is better. Or there are no more concerns about it so we can go on and perform it. Others would understand that they have to remove this procedure completely from the conclusion. That means these concerns are being firmed up. So the recommendation in my view was ambiguous and from speaking to my own colleagues it gives an ambiguous message. So that is one of the reason. And I believe that the concerns were removed because the format and the content of chapter 6 has significantly changed between the interim and the final report. So all the methodology I've expressed prior, the methodology that we followed prior to the publication of the interim report has completely changed when the chapter was deleted in January this year. And it is now replaced only by clinicians opinion in only four page chapter that does not have references and expresses the opinion of the majority of the clinicians currently. And unfortunately I do believe that this chapter has very cleverly expressed all the advantages of the mesh procedures for incontinence but did not mention the most common adverse events which is mesh erosion and it also did not mention the most debilitating adverse event which is chronic pain. And I do believe that these are important adverse events that should have been mentioned in the current chapter 6. They were mentioned in the previous chapter 6 both in the interim report and in the one that was deleted in January with the addition of the three additional tables. So I do believe that the original chapter 6 has given far more information in a format that both patients and clinicians would understand and would help them to reach a shared decision making when they are considering these mesh procedures. Thank you, Angus. Okay, thanks, convener. Good morning, Dr Agar. Following on from the convener's initial question, you've stated that you have a number of concerns about the use of best available evidence. Could you expand on that? Could you give us some more detail with regard to your concerns? The concerns about the use of best available evidence in the chapter 6 or in general? In general. So there are several available resources available to the review group and the chapter 5, which has been written by our colleagues in the public health department, has reviewed several sources of primary research and secondary research for summarising the studies, as well as government reviews and those from regulators all over the world. The evidence can sometimes be conflicting and that conflict needs to be resolved. So there has been differences in the conclusions of some of these reviews and differences between international evidence, evidence generated here in Scotland, evidence coming from England, and it was our duty that we set it together and resolve all this evidence, agree on what are the most likely outcome or comparisons between mesh procedures and bring the patients with us on board to be able to provide good leadership of this. I believe more could have been done in this respect and that mainly in relation to safety, with regard to efficacy or with regards to the ability of these mesh and non-mesh procedures to control the condition of stress injury and incontinence, there is no significant difference between the two. And the mesh procedures never promised to control stress incontinence better than the non-mesh procedures. All they promised is recovery related advantages. So shorter theatre time, shorter anesthetics, shorter hospital stay and quicker return to normal activities which are important outcomes for many, many women but may not be as important when the lifetime mesh related risks are considered at the time. So I do believe that there has been some evidence that could have been scrutinised better. There has been some differences in outcomes of evidence that we could have brought together to resolve that conflict. Thank you. In the case of us, of advantages there, cheaper also, a cheaper procedure? Yes, it is. There is evidence that adopting mesh tape procedures for incontinence saves the NHS a significant amount of money. That is true. Is there a ratio? Is it five times twice? Well, the original difference has shown that between 100 and 200... I can't remember the figure exactly but between 100 and 200 pounds per procedure. Brian. Thank you, convener. Good morning, Dr Tiger. In evidence to the committee, the chair of the review said that the evidence presented in the nature journal was not considered by the review because it did not meet the Cochran review criteria. I wonder if you would care to comment on that. Okay, so the Cochran review criteria looks at only randomized evidence. Randomised control trials are the best trial that can be conducted and that would be the best evidence. The vast majority of randomized control trials do not follow the patients long enough. The randomized control trials themselves, that their design is not the best to identify exactly the differences in safety or in adverse events, particularly if these adverse events can happen years and years later, long after the researchers have stopped following up the patients. So the best design study is to look at retrospectively on analysis of large databases. So the nature study that you've referred to has looked into over 300 studies that describe the mesh-related adverse event. I do believe that this is currently the best evidence summary of the mesh-related adverse events. It's commissioned by a leading journal with nature and the study was conducted over at least two or three years. I do believe that this currently summarizes the best evidence in the mesh-related adverse events. It did say that the risk of having a negative outcome is 15%. So that is 1 in 7. But that negative outcome also includes failure of the procedure to control incontinence. I wished we had more time to discuss this study in detail. So this study was circulated to the group twice, once by the secretary last year and again directly by myself, but it was not included in the agenda. I do believe that if it was included in the agenda, we would have described the mesh-related adverse event a little bit better. We would have been more informed. The cabinet secretary has advised the committee that the review to be undertaken by Professor Brittney will consider the process of the independent review but will not re-examine the evidence. Again, I would appreciate your comments. That is so important and I very much welcome that move because I do believe that there are issues with the process and obviously the health minister also felt that a review of the process is necessary. So that is really good. I do believe that there is a very important that we do have a parallel review of the content or the outcome of this process. So if we are concerned about the process, then we are concerned about the outcome as well. If there are stakes are high and there are lives at risk of being ruined, then I think a review of the content is quite important. I do believe that obviously we cannot roll this back so this process will not change and the review by Professor Brittney, I don't think it will change the process that has already happened but there will be lessons to learn for other independent reviews performed by government. And there will be lessons to learn and to look back and to reflect as ourselves, as ex-members of the group. But I do believe that the best way to look at the content, the outcome of this review would be by opening the report to a public consultation process. This is a well-recognised process on issuing clinical guidelines and issuing independent reviews. Thank you. Can I ask whether you have a view on whether actually this review was independent and is that part of the problem in terms of people having confidence in it? I did hear the criticism that the previous chair was more independent than the current chair. As a clinician member of the group, I don't look much at the independence. I have a task in front of me to go and find the evidence and discuss this with my colleagues, present it in a way that lay members of the group, particularly the patients, would understand and bring everyone together around the conclusion even though it is not in line with other views of other organisation and we managed to do that successfully before the publication of the interim report. Unfortunately, that did not happen prior to the final report. I have heard the criticism that an independent review is only independent if the chair is independent. I am a clinician and I am not a politician really, so I will leave this to politicians to decide. Good luck with that one. John Scott. Thank you, convener, and good morning, doctor. Thank you for making me so welcome. Can I just recap and for the record, and perhaps I missed it, but can you tell me and put it on the record why you think chapter 6 was withdrawn and what the implications of that are in medical terms and for patients as well? Please. So I do not know why chapter 6 was deleted, because no means that you ask a question why was it deleted and then you receive an answer it was deleted because 1, 2, 3. I did ask the question why are we deleting the chapter, but I did not receive a response that is formal and that is convincing. So the chapter I did put in one of the appendices, a timeline of how the chapter was drafted back in May in response to the publication of a very important Cochran review in March. We followed the same methodology that we started with in summer 2015 with the interim report, and it was so important for me that we maintained consistency even if the conclusions, even if the figures are different to what we believe, or even if the figure challenges our own belief. So prior to drafting this chapter, prior to summarising the review that was published in March, there were no disagreement whatsoever, and in fact the meeting in March 2016 was expected to be the final meeting, but the publication of a new review prompted us to go back, look at the figures, and address the review in exactly the same way we did in 2015, and consistency was quite important for me. So I did draft the summary again of that review, exactly as I did in summer 2015. But they were surprising for me, because they did challenge my own belief. I did believe that the vertical tape, or the retropubic tape, is a gold standard, and it is safer than the non-mish alternative called for suspension and autologous link, but the figures challenged what I believed. So I felt like I'm stumbling on the truth, that I could just stand up, brush it off, and carry on as if nothing happens, and there would not be any problems at all, or I could sit down, reflect on it, is it really true, and present it and ask my colleagues what they think. And I've chosen to do the second part, which is sit down, reflect, summarise it exactly in a consistent way as I've done in summer 2015, and present it to my colleague and to the rest of the group. So that's exactly what I've done. Your timeline makes a number of references to the calls to delete table one, which is obviously the concerns. Can you clarify for me, was this made by clinicians, who was making those calls? So we sat together, and we looked at all the evidence, the summary of the evidence, exactly in the same way we did with the interim report. The calls to delete the tables, and there has been several reasons given, as in the figures are not accurate. So we went back to look at the figures, and we ensured that they are accurate. That claim was made again that these figures are not accurate. So we went to the original author of the independent review, who is in South East Asia somewhere, and she responded very quickly, and I put an acknowledgement to her work in the deleted chapter, actually. And we verified beyond doubt whatsoever that these figures are accurate. So it was the clinician members of the group that decided at the end, by majority, to remove the tables. I'm struggling to understand why. I mean, why would they do that if the figures were accurate? So the figures were accurate. Perhaps, I say I do not know, because I did ask the question, and I said, and I'm sure Professor Britton will look into the process of completely changing the format of chapter six has come about. And, well, because I don't know, then I have to tell you, I don't know. But the reasons were given at the time that these figures were not accurate, we ensured that these figures are accurate. Reasons were given further later on where all the evidence should be in chapter five, not in chapter six. But my view was that we need to maintain consistency if we publish something in the interim report and has worked very well and the patients have signed up to it. There is no need to change the format. And I put it to the whole group that doing a U-turn on our methodology and risking consistency is not healthy for the group. Thank you. Can I just ask one more question? Are you surprised that more than 400 people have appeared to have been given mesh implants since the moratorium in 2014? Does that surprise you? Yes and no. Well, there is a government suspension in place. There was a request to health board to suspend all procedures. Some health board decided to follow the suspension. Other health board decided not to follow the suspension. And I must say I did advise my board to partially suspend. So I advise my board to suspend the mesh procedures for prolapse because I already suspended this in my practice. And also advise my board to suspend the mesh procedures for incontinence, the horizontal tape, but I wanted to continue doing the vertical tape because at the time in 2014 I was convinced that that is the best treatment. However, the managers in my health board decided to follow the government suspension in full and in retrospect they were right and I was wrong and I did tell them that. So the health boards have complete autonomy in whether to actually follow these guidelines or not? Absolutely. So when the request from health minister goes to the board, goes to the chief executive and the medical director, the medical director will ask the group of clinicians and surgeons who perform these procedures about their views, saying the letter of government from government asking us to consider the suspension. Are we going to suspend or are we not going to suspend or are we going to partially suspend? So there has been variation in practice from different health boards. That is true. Thank you. Neil? Thank you. Can I begin just by going back to the report? Can I ask you, given the evidence taken and researched by the independent review group and looking at that evidence today, does that evidence support the conclusions of the final report or do the conclusions basically ignore some or all of the evidence? So we could all look at the same thing and see it differently. So we could all have a look at the same figure where you're sitting on your side, you see it as nine, I'm sitting here, I see it as six. It is so important that we publish that figure as it is and let people decide what it is. So that is why I was so keen that we publish the table as they are in consistency with what we did in the interim report. Looking at the conclusions just now, I did not feel that I would be fulfilling my duty as a doctor in reducing harm to patients if I follow these recommendations. I thought they could reduce harm without losing value. I do believe that no member of the independent review would want to risk patients. No member of the independent review would want to cause harm or to reduce safety or anything like that. But I think there has been worry about value and I think from my own interpretation of evidence I thought we can significantly reduce harm still without you losing that value. So looking at the conclusions now, I don't think they are... I'm talking about conclusions seven and eight, by the way, because you have some conclusions one to six. These are about the safeguards, information, research, mandatory reporting to watchdog, et cetera. I'm talking about seven and eight because these are the ones that relate to the procedure. Seven relates to stress incontinence and eight relate to pelvic organ prolapse. So if I can put the question another way, recommendations seven and eight, do they, in your view, maximise patient safety in relation to these procedures, or is there still a big question mark around the patient safety of these recommendations, implications of these recommendations? I believe these conclusions could have done more to ensure safety of women considering these procedures. So it doesn't maximise patient safety? It could have done more. Right. I thought you weren't a politician. Can I ask, okay, I think that's reasonably clear, can I just ask, is it your opinion that members of the independent review other members were noble to make the changes? Ask me the question again, please. Do you think there were any external influences impacting on the difference between the interim report and the final report, where members of the independent review group, in your opinion, possibly knobbled to make the changes that happened between the interim and the final report? No, I am not aware of any external influences that has affected the conclusions of the report. So was there any additional academic, scientific, medical research undertaken or concluded between the interim report and the final report that would have impacted and would have informed the difference between the interim and the final report? Yes, there have been publications that came into the scientific literature between the publication of the interim report and the final report. We summarise this in the deleted chapter, but they are not in the body of the report now. That's a substantial point. In other words, the additional evidence that became available after the interim report would have reinforced the interim report rather than led to changes. That's correct. Can I just ask a final question? Clearly a key demand of the campaigners who have done a fantastic job on this issue is that there should be a ban on the use of mesh implants. Do you support that demand? So this is a very important question. That's why I'm asking it. Yes. So mesh procedures are not created equal. This has been a learning process for myself and for many other of my colleagues as well. Prior to the suspension of mesh procedures in June 2014, I had already stopped performing transvaginal mesh for prolapse. I stopped these procedures already several months before the suspension in my own practice. A few months before the suspension, I already stopped performing the transopterated tape. At that time, I did not have any of my patients coming with complications with it. Life is too short to learn from my own mistakes. I must learn from others as well. After I stopped, I started to see my own patients coming back with complications. In retrospect, it was the right thing to stop. When the mesh was suspended in Scotland, I was still convinced that the retropubic tape, which is the original procedure that came out in the late 90s, is the best procedure, is a gold standard, and is much better than the non mesh procedures. Having reviewed the evidence, that belief is not there anymore. Is the vertical tape? That's right. That view is not there anymore. If you ask me, do I believe that the use of mesh procedure for prolapse should be banned? Yes, I do. If you ask me, do you believe that the transopterated tape or the horizontal tape should be banned? Yes, I do, except in very rare situations. It's like if a young child has a brain tumor and we're thinking of doing a laser. We are damned if we do and damned if we don't. This is not a single surgeon's decision. It has to be a decision by a group of surgeons nationally. This is what I suggested to the chair in my comments on the conclusions. If you ask me whether the vertical tape should be banned, I would say it should be restricted to situations where the patient has already considered the non-mesh procedures where the patient either do not want to have the non-mesh procedures or at least two or three surgeons have decided that the non-mesh procedures would carry significant risk that outweith the risk of the mesh procedures, if you know what I mean. I think it's also important to say that I've noticed that it is not only about the incidence of adverse events. As I said before, it's not about efficacy at all. Both procedures control incontinence in a similar way. It's all about safety. The trade-off that patients will need to do or will need to consider when they are choosing these procedures is would a patient accept the risk of chronic pain taking painkillers for the rest of her life, losing the ability for intimate relationship with a partner for the rest of her life just because she wants to stay in hospital one night or two nights less or just because she wants to go back to work three or four weeks earlier. I think that is a very important trade-off. Increasingly, I found out in my own practice that when women are giving unbiased information, balanced information on both mesh and non-mesh procedures, they go for the non-mesh procedures. That could be the influence of the media, though. Or maybe I'm worried about litigation as well. Maybe I used to direct my patients to have the mesh surgery by now directly to having non-mesh surgery. In my unit, we drafted a shared decision form and that one is in the last appendix in my submission. We started using this form just over a year now, completely taking out the influence of the surgeon of the healthcare professional and asking patients just to read the leaflets and to document on the shared decision form what do they want. Women who heard about the mesh problems in the media and women who did not hear about the mesh problems in the media, the vast majority of them has chosen the non-mesh option. I do believe that is because of the acceptability, even if the risk is just so small, even if the risk is less than 1%, but the stakes are quite high. That's very much. Can I take Brian briefly, then Michelle, and then I'll take Neil. Thank you. Just for my own information, if I can go back to the clinicians' response to the moratorium. I think I certainly myself and I know some of my colleagues were quite surprised that health boards have autonomy in accepting or declining a moratorium. Is there any feedback from health boards back to the cabinet secretary on whether there's an acceptance or declining of a moratorium? Do you note that? I wonder if that's a question you could answer. I have not seen this feedback, but my understanding is that there has been correspondence from the cabinet secretary asking individual health boards to suspend these mesh procedures or to consider the suspension of these mesh procedures. Health board have considered some have agreed to suspend, others did not agree to suspend, so I presume that there has been some sort of feedback to the cabinet secretary of what is the situation on the ground. Yes, but I'm not sure if that happened. Okay, thank you. Michelle? Okay, thank you, Dr Agarra. In the evidence on the 18th of May, and the committee were told that all the information that was in Chapter 6 in the interim report is still available, but some concern was expressed about access to that. Can you just tell us what your view is around that? Correct, that is correct. So all the evidence has been published, but the important table that made a huge difference in expressing concerns and has put Scotland in the lead in restricting the use of the horizontal tape has been moved to an appendix at the end of the main report. And the new tables that were generated last summer that inform the crucial decision whether a patient should have a mesh procedure or a non-mesh procedure have been moved into an annex online completely outside the report among the minutes and the agendas. Can I just ask as well? I want to slightly revisit my colleague Geronimo Mackay's question to you, because listening to what you've been saying, you started by saying when you gave your opening speech that there was a very collegiate approach during the development of the interim report, that the clinicians discussed it, they came together, and the report was pretty much constructed without too much conflict. And then when you came to do the final report, suddenly that seems to have fallen apart. And yet you've just said in the last five minutes that actually the evidence that came out since the publishing of the interim report actually strengthened some of the arguments from what you put in the interim report, and yet it was changed. Rona asked specifically where did the calls come from to remove chapter six? And I was unclear from your answer was it the clinicians themselves, individually that started saying actually I think we should change this and remove this, or did the call come from outside the clinician group? There are no calls from outside the clinician group. Right, so it was all internal. So can you just revisit that and clarify for us what was it that changed within the clinician group that took you from being collegiate and designing that interim report in agreement to suddenly wanting to change it when the new evidence seemed to suggest strengthening it rather than removing it? I'm quite confused about that. So I've explained that when the... I also put that in a group email to the group before. So when we are faced with facts reported by top level evidence that contradicts our own belief, it's natural and it's human that we respond differently. Some would be able to get the belief out, challenge it, examine it, spring clean it and put it back in or replace it with something different according to the truth that was in this particular study. And it's not just this particular study. It is quite important that if this study contradicts our own views or if this study contradicts other study that we study them together and resolve any issues, and then we can reach consensus on the content. And it was so important for me... The content is more important than the format, isn't it? So the message is so more important than the package. So as long as we agree on the content, we can present it in the form of paragraphs, we can present it in the form of tables. There was a view to move all evidence into chapter 5. Now chapter 5 is written by a public health specialist and it is very meticulous, it is very comprehensive and I really admire the way that was presented and the amount of effort that went into it. It's probably the most comprehensive review of all the evidence into that mesh procedure. But it is difficult for patients to understand. It's difficult even for me to understand some of the things in chapter 5. So that was the whole point of presenting chapter 6 in a table format. Some members believe that a table format is not a good idea, other members believe that let's move all the evidence back into chapter 5. I wanted to get the best evidence out of chapter 5, put it in a table format that is understandable by patients exactly as we did in the interim report and we had the patients on board with that methodology prior to the interim report. Was there a fear by clinicians that if it was made terribly accessible in effect for patients and for late people to read that the work they had done up to date would be very challengeable? Well, I do believe, I mean, I'm expressing my views here and my view is probably not shared by the majority. So I think it's so important that this committee would hear from a clinician who strongly supports the way the evidence is presented, strongly supports the way the conclusions were presented and I think that the committee will benefit a lot from the presence of a clinician that does not agree 100% with my views. Thank you. Reading the number of submissions from the women, I didn't know this morning whether it would cry or whether to smash the computer up because I was so frustrated by reading those submissions. And you have said that it's not about efficacy. So can you describe then, if we have two systems of dealing with these problems and it's not about efficacy, can you talk about the complications of both? Talking about the adverse events of both, the mesh procedure and the number. So let's talk about, I mean, there are several non-mesh procedures and several mesh procedures, but we will talk about the standard in each. So we're not going to talk about the standard mesh procedure, which is a vertical tape. And we're going to talk about the standard non-mesh procedure which is called colpo suspension or some patients like to call it hitch and stitch. So the advantages of the mesh tape procedure, as I mentioned briefly, are all related to recovery. So it's a minimally invasive procedure. It is easily performed. It is easily trained, relatively shorter learning curve, saves money to the NHS, shorter theatre time, shorter hospital stay and quicker recovery and quicker return to normal activities. The disadvantage of the mesh tape are immediate and delayed. The immediate ones is a significantly higher risk of bladder damage during the operation. Now, we clinicians believe, or the vast majority of us believe, that the intraoperative or the damage to the bladder during the operation by the trocar of the mesh tape does not have any long-term consequences. Basically the trocar, though the needle comes back out and goes back in the right place, we do not need to close the bladder. It heals nicely and there would be no problems. The reason why there is significantly more bladder damage with the mesh tape, because it's a blind procedure. I can see where the needle is going and I can see where it's coming out, but I don't see what happens in the 15 centimetres it's inside the body. It can go into the bladder. That's why the manufacturer suggests that we put a camera in the bladder to make sure that it did not go in the bladder. I think again. On the other hand, the non-mesh procedure does not have this or have a less risk of bladder damage because I can see where the needle is going all the time. It is under vision. Also the non-mesh procedure respects the patient tissues. I tailor the procedure to the patient. I know exactly where the needle should go for this particular patient and where it needs to come out. There usually no need to put any cameras because everything is under vision. It's a very fine technical surgical procedure. If we now talk about the late advantages or the late adverse events, the most troubling late adverse events of the mesh tape procedure is chronic pain and pain during intimate relationship with the partner. The risks are small, but when it happens, it happens significantly and it really impacts quality of life. That is usually due to damage to the muscles or to the nerves. Damage to the nerves also affects mobility. That seems to be less than 1%, but when it happens, it is absolutely devastating. When a patient comes to me and she needs to make a decision between a mesh procedure or a non-mesh procedure, it is not only the percentage. It is also about what is the severity of the adverse events, what is the impact on quality of life, what is the best case scenario, what is the worst case scenario, what is the most common case scenario. Can I predict this problem? Can I prevent it? If it happens, can I reverse it? The answer to this, if we are talking about nerve pain, we know because the procedure described by a manufacturer does not respect the variations in individual patients. Let me say that again. The procedure described by the manufacturer does not respect the variation between individual patients. It is 2 cm below that point, it is 2 cm later to that point. This is where you introduce the needle and all of a sudden it has just come down the other end. That is the same procedure regardless of what you wait, regardless of the anatomy and regardless of this. It really frustrates me that long after I stopped performing some of these procedures, I found publications in the literature by members of the manufacturer themselves saying that we have done studies and we found out that actually the mesh is much closer to the nerve than we used to think. That really frustrates me because I expected the manufacturer to communicate that to me. That publication, for example, was published in 2011. I think that is the difference between drug companies and device manufacturers. A headache tablet that works for only four hours and disappears from the body goes under massively rigorous procedures before they come on the market, before I can prescribe it. A medical device, it is not a lot of rigorous procedures. Come over quickly. That is a system issue. I alluded to this in one of the appendices about the Swiss cheese model. In relation to... I would imagine that there is not a huge group of people who can perform these procedures. I would imagine that it is a relatively small amount in Scotland. But they seem to be very powerful. For example, you have said that you had a conversation with the health board about whether there would be a suspension or not. I am sure that the health board relies pretty heavily on their local group of surgeons who can produce that evidence or verification. In the procedure... Sorry, in the review group and in general, the issue of declaration of interest is pretty critical. My understanding is that review group asks people for one-year declaration of interest in relation to whether they had been involved in trials or anything alongside some of the companies involved. Some people in the review group produced a much longer list going back several years of their involvement, but the Government insisted that it was only one year. Were some of the people who were involved in the review compromised, are some of the people who advise health boards, some of the surgeons, are they compromised by their connections to some of the companies and some of the organisations that are promoting those products? If there are interests that are not declared, then I do not know about it. If you are asking about my opinion, then I do not believe that any member has failed to declare their interest. Because it only went back a year? I agree with you. The form could become better and perhaps this is something that Professor Britton would look at, the review of the process by Professor Britton will look at conflict of interest and how to ask members about the conflict. Forgive me, but I am not sure whether that will ask the questions that say Mr Sonso, Mrs Sonso, you were on this committee, you were on this review group, sorry, and you declared your one-year declaration of interest. If you had gone back further, would it have been more transparent to the whole process for us to see whether you had a conflict? I do not know for a review of the process will identify whether there were conflicts there or whether it will just be a generalist approach that says that this should happen in the future. If it had gone back further and asked people to declare, do you think that would have been a much more transparent process? I believe so. The more declared, the better. Can I just mention that it is not only about competing interests with manufacturers. It is also about other interests, as invested interests, as if members have heavily invested in a certain position and have advised their health boards on a certain position, then that change is not only financial there is no credibility. Or you may call it arrogance. Or you may call it arrogance. It is not on the form. It is not on the form. I believe I was lucky because my own health board just suspended everything against my advice at the time which they were right and I told them that. But that brought me to the independent review on equal footing. I invested with using the mesh procedures. I received funding from mesh manufacturers and I also invested in non mesh procedures. So I just came to the independent review with all my competing interests as reconciled as possible. I believe if my health board would have taken a different position then I perhaps could be a bit more biased but that does not come on the conflict of interest form. It is not asked by the conflict of interest form and I did not declare it and I don't think I don't think those who did not declare it have done something wrong. That's something in our considerations or committees that what we might want to ask the independent review of the review to look at that in terms of giving confidence to the independence of the review itself and that may be something that we can pursue. Can I take Jackson Carlaw and then Michelle's indication once again? Good morning Dr Rugga and I'll just ask two quick questions because you've given evidence extensively and can I pay tribute as well to the professional way you've done this. You haven't done anything sensationally in the way in which you chose to resign from the review group. I have before me in relation to conclusions 7 and 8 which have been referred to several times. The interim report wording the final report wording and the suggestions that you sent in February 2017 which did not find support and then led to your resignation from the committee. I suppose I do want to ask again the question that Alec Neil put to you. In its final wording in the report which is the one publicly available today and on which people are making decisions do you think the wording in conclusions 7 and 8 is safe? It will be much safer if we take the word routinely out of conclusion 8. I believe the full stop should come after offered so it should not be offered full stop until there is evidence in the future that could show there is benefit from prolapse mesh procedures. So I believe conclusion 8 could be safer if we take the word routinely out and that was the whole subject of the first page of my submission. In conclusion 7 you make quite specific alterations there too in relation to the balance that you think is now left in the wording. Yes. The concerns expressed about the horizontal tape the most commonly performed procedure in Scotland these concerns expressed in the interim report in 2015 were removed from conclusion 7. I expect these concerns either to remain or to be firm up saying we've now concluded that the horizontal tape has risks that outweigh the benefit and it's either should not be performed at all or should be performed in very highly exceptional circumstances with agreement of a national team. The second question in relation you drew a distinction between clinicians and those operating and the manufacturers of the devices. The manufacturers of the devices are regulated by the MHRA who have a responsibility in this regard. As a consequence of your experience throughout this process do you feel that the MHRA in the way that it has performed in relation to mesh devices has proved itself to be fit for purpose? The MHRA has issued a blanket judgment that benefits outweigh the risk. I do not agree with this and I believe that there are a large majority of clinicians who believe that at least one procedure or one device the risks outweigh the benefit. I would have been happier and far more comfortable if my device watchdog suspends this procedure or bans these devices, not the manufacturer. The initiative has always come from the manufacturer and it has always been communicated to us as commercially non viable. Just finally on the MHRA I understand that the MHRA is a reserved responsibility not a devolved one but notwithstanding that do you believe as a result of the process that you have seen in relation to mesh that there is an argument for an examination of how the MHRA does review these devices and do you think there has been sufficient public transparency about what that review or regulatory responsibility upon the MHRA has been and how it has been exercised? To answer your question, the first question I do believe that the MHRA could have done a lot more. The other point about the transparency the MHRA has proposed years ago to publish a transparent database of the reported adverse events for all medical devices really and that would bring it in line with the Australian the TGA the therapeutic goods administration in Australia the equivalent of the MHRA down under appears to have done a lot more work in publication of the adverse events because as a clinician when I see patients coming to my clinic with an adverse events of a medical device I want to find out is that me is that the device is that the procedure itself is it the surgical package so I would like to go on the website of the device watchdog put in the search box the name of the device and find out what's going on someone else in Basingstock had the same problem sorry that sort of stuff, is that a bad lot I want to find out now you can do that in Australia but you cannot do that in the UK and I think the MHRA is looking into doing things but it looks like things are not as fast as we wanted them to be so not transparent enough as matters stand it can be a lot more transparent thank you just a final one for me the numbers in terms of women who are reporting problems and we see in a lot of reports about not being believed and we talk about the chronic pain but is it your view then that there are a lot of women out there who have had the procedure that may have low level pain and may not be associating this and be not reporting it and if they were would we be seeing larger numbers and is that what's bringing you to your conclusion that actually it should be banned so what bringing me to the conclusion that some devices have risks that outweigh the benefit is by balancing the risks outweigh the benefit what's published already in the literature from the evidence from the retrospective 20 year review in Scotland and from my own experience as well as that of my own colleagues if you're talking about chronic pain there is some evidence that the average time period between having the transvaginal mesh device and the development of this problem is about four to five years so we had a peak of performing this procedure in Scotland in about 2010 and maybe 2011 so we've reached the top already these procedures have significantly dropped even before the suspension so the peak of the adverse events has been already reached in 2014-2015 the patients I'm seeing now I rarely now see patients coming forward for the first time presenting with mesh related adverse events what I see now in my own unit are those patients who's been in the system and they're coming for a second review so this is something that I would expect because we have already hit the top and we are on the down slope for both the procedures and the adverse events and there is a four year gap John Scott Thank you convener I'm just interested in an analysis of these outcomes and the fact that I think I heard you correctly when you said that this is a 15cm blind procedure now 15cm is half of an old ruler in old money at six inches and it's a blind procedure for that so it must be an enormously skilled procedure is there an analysis of different health boards where these problems have been found is there a different analysis of individual hospitals or even individual surgeons because it must be if it's a blind procedure very subject to different outcomes depending on the skills of the surgeon Yes that is true so if the 15cm could be in a person with a different build but this distance could be 5cm could be 10cm so anything between 5 and 20cm Yes it is a blind procedure there has been no analysis at board level to say which board does this procedure better there has been no analysis at surgeon's level to say which surgeon is better but there has been a national analysis to find out whether high volume surgeons are having a good outcome or a worse outcome with these procedures and the outcome of this was the vast majority of mesh procedures done in Scotland were done by high volume surgeons so I personally have little surgical skill is important and training and learning curve is important and maintaining competency by performing certain number of procedures every year is important if the surgeon wants to carry on with this but the learning curve will only reduce the adverse events that are related to the surgeon which is sometimes erosion sometimes the bladder perforation I do not believe that this will have long term impact so that in other words if a surgeon has done if at the adverse events is because of the surgeon usually the patient is treated moves on and goes forward and we don't get letters from her solicitors but regardless of the surgeon's skill there will be patients regardless of whatever we do there will be patients who will sustain injury that the risk is low is less than 1% but it can be close to a nerve can cause nerve damage and that can have serious consequences no one can tell you the figures on that because no studies have looked into the impact of quality of life of nerve damage following these procedures I do believe that training surgeons is quite important and I do believe that will reduce the risk that we are reducing are the ones that do not have long term impact to reduce the risk or to eliminate the risk of nerve damage and the long term impact is to stop these procedures completely and because there will be women may require this procedure in the future by agreement of surgeons then that person has to consider very carefully is the problem severe enough is the risk too high can it be reversed all these discussion this conversation must be had in full details all the informations that are required for this conversation were present in the deleted chapter 6 thank you I was going to take one question from Angus MacDonald name we'll just finish there okay thanks if I could move us on to the issue of the shared decision tool which you've included within the appendices in your submission and it's been helpful to have sight of that can you explain what you see as the benefits of the shared decision tool and can you give us an indication of how much time you might expect to spend discussing and talking through the forum with a patient this shared decision tool has been an eye-opener on lots of things really can I just mention that that was not my idea it was expressed within the expert group by the chairman last year discussing the concept of request for treatment to perhaps be offered alongside consent so instead of I go to the patient and say to her look I have these two procedures and this one I believe is better than the other and I'm taking her consent the patient is actually reading all the information and coming to me and saying I am requesting that treatment and I believe that the shared decision form has been absolutely crucial in teaching me back what the patient understands from the leaflet because some patients will read the leaflet and they don't understand everything at all I believe they do understand but they don't health literacy can be a lot better and I've gained a lot of insight on individual patient's values what's important to them and what matters to them simply by reading what they write on this form I encourage them to to take the boxes and tell us what's important to them and then they choose the procedure they want and they write why and next to the other three procedures they don't want, they also write down why and it's not only myself who interpreted this form I take this form to our team meeting that we meet every month with the physiotherapist who have already seen the patient because they supervised the pelvic floor exercises with the continence nurse who has already seen the patient because she did her bladder test before the procedure and we also have a clinical librarian to find us the answer to important research questions about individual patients so this form has been absolutely brilliant we've been using this since September and we've been significantly relying on it in one of the recent team meetings one of the patient did not complete her form so the team decided not to discuss her because we don't know what she wants which was absolutely brilliant so that is really patient choice and that is very much in line with the CMO's documents to realistic medicine ok so that's a prime example of good practice coming out of all of this one final point convener in your submission you requested the final report be subject to a public consultation process and you suggested that this could be included in a Professor Britton's review of the process could you perhaps expand on that so that is the main reason I'm here today is to open the report to a public consultation process so stakeholders were registered their interest in giving feedback on the report and putting their own views in it and then the government officials would publish the feedback and publish the responses and why are we not changing the conclusions or why are we changing the conclusions in a very transparent process exactly as the European Mesh report has done it that's the main reason why I'm here today this is not part of Professor Britton's remit Professor Britton's remit is the process my request is regarding the content or the outcome of the process then there may be something not quite with the outcome that's also something opportunity for the committee to reflect on further I'm going to take new very very briefly for those who have used your forum how many would choose to use mesh to two patients have completed the form in the last year only one chosen mesh and the team realised that she did not actually read the leaflet well okay can I thank you very much doctor agar for your time and for the thoughtful way in which you responded to the questions I think we got a great deal from that and really appreciated the way in which you've tackled this literally serious issue in such a measured way I know the people in the gallery for whom it matters a great deal I think we found your evidence very very thought provoking indeed so can I thank you again before we take the next panel of witnesses I wonder if I can call the meeting back to order I would like to restart the meeting can I just say that because of parliamentary procedures we need to stop by 20 to 12 at the very latest I would be intending to stop by half past 11 and that allow us a little bit of flexibility but can I say to our witnesses that if you don't get to see everything that you want to see contact the committee thereafter through the clerks and they will make sure that any further points they wanted to make are provided to us and indeed we may come back to you with further questions however we've got something just short of an hour so we should be able to pursue the questions as intended so can I welcome to the table the petitioners Elaine Holmes and Olive McElroy the petitioners were patient representatives on the independent review resigning on 4 March can I thank you both very much for attending this morning and I would invite to provide a brief opening statement before we move to questions thank you, good morning committee MSPs thank you for inviting us to speak today we'd like to thank our Scottish mesh survivors families and friends who are all sitting behind us in the gallery as we spare a thought for the mesh injured women too ill to be here we appreciate all submissions received in support of our petition from Scotland, England Northern Ireland, Wales, Australia and New Zealand as you can now see mesh truly is a growing global scandal sincere thanks to Dr Will Agour for giving comprehensive and compelling evidence regarding the whitewash final report unfortunately Dr Agour's experiences mirrored our own in several respects the adversity and pressure we endured for almost three years as patient representatives in the review group came flooding back as we heard his words we agree with almost everything Dr Agour says this is an accurate account of how he and we were marginalised how vital evidence was ignored deleted or hidden after the independent chair resigned and much to our regret the review group lost its focus and transparency in fact it completely lost its way when former health secretary Alex Neil asked us to participate in the mesh review we did so despite our own health issues we did so because we firmly believed we'd a role to play in ensuring changes were brought in so that hundreds of women in future would be protected and saved from the life changing injuries hundreds of thousands of women around the world have needlessly suffered we knew that nothing we did would change the course of our own lives or that of the women already injured by these devices but we felt we could not stand by and do nothing Mr Neil took one look at us in our wheelchairs struggling to stand without walking aids he listened and he decided we were all the evidence that was necessary he recognised that something was terribly wrong with mesh we believed him and trusted in him when he promised that patients would be at the very heart of the review that we would be listened to but through no fault of Alex Neil those promises were not fulfilled our voices were not heard in fact once he was no longer health secretary things changed dramatically we are here today to state clearly that justice was not done our voices were drowned out stifled by the pro mesh lobby which did their best to silence and marginalise Oliver and I despite that we carried on determined as we were to bring change to ensure women were given fully informed consent something few of us were given something that the chief medical officer has already admitted to the committee when the original chair resigned from the view things took an even more pernicious turn apart from not including us in meetings for a period of 10 months the proposed final report exposed women to unnecessary risks it bore no resemblance to the interim report which had achieved group consensus we went to the cabinet secretary for help what we asked that she delay publication of the report at least until our concerns were investigated it was to no avail she accepted the final report and its conclusions ignoring our concerns and publishing the final report just 11 days after our meeting any hope we had for change was completely dashed the final report is certainly not in our name it is nothing more than a whitewash we repeatedly asked all our evidence be removed as we did not want associated with it our requests were ignored and denied it is apparent to us there was never any intention of removing our input we were cynically used to make the report appear less bias to the public and to those of you here today we were duped we are not politicians doctors or statisticians we are ordinary women but we are horrified by failure rates of an operation of injuries that can be life changing and life threatening the benefits of mesh simply cannot outweigh the risks Mr Neil and MSPs who have all voiced their concerns over this issue are correct we are all the evidence you need to know that surgeons cannot continue putting mesh devices into women when safer alternatives are available we fully back Mr Neil's call for an international summit to uncover the truth about plastic polypropylene mesh and we hope Scotland continues to lead the way and take a central role in this we ask you today to use the power you have to ensure that the mesh suspension remains firmly in place you have the power to make changes that are needed to protect patients once and for all and to change the system so that nothing like this ever happens again to other patients across the world we can see the medical watchdogs have been useless toothless and far too close to the manufacturers who make billions from the very medicines and medical devices they are supposed to please we need new health watchdogs who will insist on proof to show that devices and medicines are safe as well as effective you have the power to ensure we have proper registers and mandatory recording of data as well as mandatory reporting of adverse incidents so that patients are not put at risk please don't let what happened to all of us happen to others please do the right thing thank you for hearing our voice I don't know if you want to add anything all of this point thank you very much we have basically a joint statement from us both and I think Dr Agour thank you to him for his integrity his honesty and the evidence that he's given basically measures off the menu measures should be stopped right now thank you very much for that can we just move in to questions Brian Whittle good morning to the petitioners and thank you very much for coming along to give evidence in your submission you state that you consider the final report and have surgical mesh to the highest risk class 3 I think you're finding here to the information set out on page 12 of the final report I wonder if you could clarify to the committee what your main concern is here that was just a discrepancy about when the actual EU regulations came into force there was a miscommunication the health minister and the CMO seemed to think it was the 5th of February 2017 but there's actually a fact sheet came out from the EU all about this EU reclassification to class 3 and it said on there that all ministers in the EU had been notified and had agreed to the content of the new package of device regulations and getting upgraded to class 3 so they all knew about it in I think it was October 2016 and it was adopted by the EU council on the 7th of March I think it was just a legislative date that was the 5th of February 2017 so it was more than anticipated that the reclassification was going to go ahead it had been passed it wasn't an anticipation which was put in the final report it should have been in the final report that it was going to happen it was happening it wasn't anticipated just to add to that to say in the report from a European perspective the current position is that reclassifying these medical devices would not confer any material difference that is just nonsense why would the EU consider making these devices into the highest risk category if there was no material difference I think that's a very nice question Neil Balton Can you refer to over 400 women having received mesh implants in the time since the monitorium was announced by Alex Neil in comparison to fewer than 100 women having received treatments using non-mesh alternatives Could I just clarify for the committee's understanding that these numbers are only about the number of women who have received surgical interventions but would be much lower than the total number of women who have sought assistance due to SUI or POP Well, we don't know how many other women have received help this is just the official figures we were asked for it was just the surgical procedures and they gave us the mesh data which was 400 women or just over 400 women and the non-mesh procedures were 100 but there may be many more that have sought help but we don't have those figures and they're not absolute Yeah, they're not absolute Yeah Rona Mackay Good morning Elaine Before I ask my main question can I just go back to something you said Elaine in your opening statement who are the pro mesh lobby in your opinion If you'd sat round the table with us at the meetings you would know who the pro mesh lobby were let's say, Oliver and I weren't Dr Agour So are these clinicians manufacturers the whole medical establishment would you say? We were marginalised Definitely You could tell by the minutes if you read a lot of the minutes you'll find you'll see in the minutes the group was not unanimous in this decision of this discussion was usually Elaine and myself objecting we had to really fight every single meeting even the word safety or the word mesh we had to fight to get the word mesh put in front of the word tapes because they kept saying tapes we aren't mesh To fight to get the word safety put in the heading of the review where we're told safety wasn't the remit That's pretty shocking to hear Can I move on to informed consent you'll have heard the previous evidence about the fact that there's a lot of outdated information lying about in doctor's surgeries and the information given to women was not available or out of date your submission suggests there's still outdated information on a number of government and NHS websites and you refer to the leaflet being developed by the Scottish Government expert group has been adopted and published in the rest of the UK but not Scotland Can you explain a bit more about that? It's just not on the Scottish Government website it's the initial leaflet that was developed in 2014 for mesh tapes for stressure and the reincontinence and that's the leaflet still displayed on the Scottish Government website yesterday I believe this morning so from our last session where this was discussed nothing's happened so if women are looking for up-to-date information if they go on to the BESUG website British Society of Urugine Ecology or the English NHS they'll find the leaflet that was actually developed in Scotland by the Scottish Government's expert group it's available there so anyone consenting to mesh tape procedures can go there for up-to-date information but they won't receive that in Scotland if it is maybe it's an appendix or something I don't know we can't find it If you try to find it here it's absolutely nigh impossible I've had one of the girls I contacted her I said go on the NHS inform see if you can find this leaflet and she was back on the phone to me saying geez oh how am I supposed to find this eventually I had been going round the houses and I explained to her how to find it and we found it on the NHS England website and if you go directly to the NHS England website you'll find it within two clicks on the NHS inform you've got to go through that's known for transvaginal mesh information you've got to go through the prolapse process and you come to an NHS choices logo you click on that and it takes you and you just round about the houses before you find it and that sounds like something that could be easily put right I think that the Government has been notified in several occasions highlighting the fact that they've got the version 1 on their website they've still not changed it okay thank you that was quite an issue at the last evidence session when the chief medical officer made a rather throw away remark about out of date magazines but is a concern that still hasn't been updated can I take out Neil now convener, just in that point I think we should write I'm not a member of the committee, it's up to the committee but I think you should email the health secretary today to point that out to her because that's very important that that's easily accessible and patient safety is supposed to be and is the number one priority for the national health service in Scotland the very least is that the websites should properly reflect that and I think we should demand that be sorted this week not any time later can I just probe first of all in terms of the review itself can I ask two questions maybe three questions number one have you had an opportunity to meet with the professor who's reviewing the process or is there a date fixed up for that has she not been in touch she hasn't been in touch right secondly the period of 10 months when you said that you had been kept in the dark and so on was the rest of the review group actually meeting during that period and were you not invited to the meetings there were certainly subgroup meetings and even if it was subgroup meetings that perhaps weren't pertinent to us there was never any minutes published or updates as to what had happened I mean we were involved in a subgroup meeting several years ago but afterwards the minutes were published and shared with the wider patient group we had no updates for 10 months I think that's a major area for investigation and I hope the professor will look in detail at that because that seems absurd to me and looking back it seems to me one of the lessons for the future is the percentage of people in a review group representing patients has to be substantially higher in future so that the so-called experts don't have an inbuilt majority and more genuinely independent people exactly so as a whole I think we could spend all day in all of these issues because it seems to me this has not been administered genuinely as an independent review group which was the whole intention the third question I have is become clear this week that allegedly the MHRA has been involved in this cover-up about pregnant women not being told about the consequences of potentially their unborn babies developing epilepsy because of a particular medication that was presented to them this is the third major scandal in the last two or three years that I can think of including this one where the MHRA's role has been less than professional or helpful and I know one of my concerns is that part of the funding does come from manufacturers of devices I don't see how you can be an independent regulator if you're even partially funded by the people who are being regulated so I presume you share my concerns about the MHRA and I know the MHRA has already given evidence to the committee but I do think that that is a major problem in the whole system that the independence of the MHRA has been part of the problem and certainly I have to say when I was health secretary and my dealings with them on this issue, I was to say the least less than satisfied I don't think they're a very professional organisation I don't think they're a very caring organisation I don't think they care at all about Scotland and I don't think they've got patient care as their number one priority was my impression now I might be being unfair there but in terms of your communication and contact with MHRA how have you found the MHRA? I find the MHRA totally frustrating as well as being a waste of space I don't know what purpose they serve apart from saying the benefits outweigh the risks when regulators around the world have issued safety alerts have issued advice they just continue to say the benefits outweigh the risks the girls have made posters whereby their portrayed is burying their head in the sand and nothing could be closer to the truth we don't even rate the MHRA and I don't know how they can make the benefit risk in a ratio when they've already acknowledged about the severity of the adverse incidents that go unreported so they don't have the information and analysis and make that statement and Dr Agour has kindly and his evidence in the last session he's basically backed that up The Health and Sport Committee is sitting next to me but I do think that this is an issue in its own right the failings of the MHRA are potentially endangering lives not just in this but in a whole range of other things as well and I do think it's an issue we do need to address sooner rather than later Okay, can we move on then to Jackson please? Good morning, I can just say that Elaine Holmes was my local hero at the opening of Parliament I suppose I should say that and tribute to the work that she has done in relation to all of this I suppose my first question to you and you maybe can answer it but actually Alec Neill would have been I can't ask him the question but were you surprised at the MHRA were on the review group in the first place? Yes Given that they were the manufacturer of the device into which the review group was undertaking an investigation what was there not in your mind a sense that whatever they said was obviously going to be compromised by the position they'd already taken and were they in your experience one of the principal cheerleaders for the mesh lobby as you described it? I don't know if they were the principal cheerleaders or not we did actually try very very hard to bring more balance to the group by requesting that surgeons who were not pro-mesh be invited to participate every surgeon we suggested they would find a problem with them or they couldn't contact them or they didn't respond to emails it was just ridiculous to participate in a group where the surgeons are all pro-mesh you heard Dr Agour saying he was partially for some devices when he joined the group although his opinion later changed the others didn't they never changed their opinion and you know from reading who participated on the group which hospitals they work in which hospitals have flouted the mesh suspension is interesting and intriguing given the way in which he described the balance of the group and we haven't had the opportunity to speak to other members of the group so there's not the opportunity to respond to that comment but there was unanimity around the interim report that was achieved and then the final report was clearly a disappointment so looks in the interim report as if people were at least willing to come together and be a bit more open in their thinking absolutely, I mean we didn't agree with the interim report 100% we obviously published our thoughts and concerns in a minority opinion but there was general consensus and we really did believe in the right direction we were waiting in studies to publish such as Prospect that was the largest study of prolapse mesh in the whole world Scottish lead study which in fact worked in our favour because it backed up everything we said there was no benefit to polypropylene mesh and prolapse so if anything the studies in that that we were waiting on should have strengthened the conclusions and the recommendations in the final report but when we saw the draft final report we couldn't believe what we were reading when it told of the benefits of mesh but not the risks and then the benefits of the risks of the non-mesh alternative I'm saying this right the risk of the non-mesh alternative but not the benefits it was just directing patients towards mesh are you you actually used the word duped you felt that in a sense that both of you had ended up being window dressing within the review group in order to be able to say we'll hear a couple of sufferers who as evidence at what point was it with the dropping of the interim report or was there a growing perception in your part at what point did you come to believe that the frustration was growing in your own mind as to what the actual credibility and weight was being given to your contribution and evidence and views on that review group we got the draft final report through in an email and we both were so shocked practically I think your comment was you were nearly physically sick what we saw and that was we realised then what was going on and then we asked I don't know how many times we asked for all our input to be removed from that report cos it wasn't in our name and yet it still went ahead so you continued to trust the process effectively until you finally got that report we saw that draft report it was like day and night totally changed and I think the most important thing was the transobterator mesh tapes were given cause for concern in the interim report totally brushed under the carpet on the final report and just putting more patients at unnecessary risk by removing that prior to receiving the draft final report we hadn't been invited to participate in meetings for 10 months so we received an email telling us that there was no new evidence so we would be receiving a draft of the final report soon with no new evidence so we sent a list of the new studies and said this is new evidence it's important new evidence and we got an email back saying oh yes I knew about that and we said well why it wasn't it shared with the group we haven't received any communication we asked about the inclusion of the tables what happened to the tables we're doing it this way now and it just was totally confusing for patients there was no dialogue it seems that for 10 months I don't know what meetings went on or what discussions went on but we weren't party to them but it seems they almost had the report ready to go and I think they were hoping we would just quietly sign our name to it and those emails that you received were from the new chair no they were from the Scottish Government they were from am I allowed to say names Dr Sarah Davis right okay then just two quick questions one you have subsequently given evidence to the investigation taking place under the auspices of the parliament in Australia and have you formed an impression that Scotland which was very much at the forefront of the eyes of the international community has been compromised by the process and that other countries are now taking a more direct and dramatic interest in these matters and how do we remedy that and I suppose the other quick question does come back to the issue it was me that asked Dr Calderwood who unfortunately drew an equivalence between out of date copies of okay magazine and leaflets and information leaflets do you have a network of supporters within your group who are keeping you informed about the availability of literature in GP surgeries and has the assurance in relation to that aspect that we received this committee received from it last took evidence that there was going to be a further clear out and updating to ensure that nothing other than current information was now available in GP surgeries to your knowledge from your group has that taken place so the Australian issue and the local issue yes I feel Australia are forging ahead they're more organised after we lost Alex Neil as health minister and after we lost the independent chair of the review group things started to go haywire and the next part of your question sorry information in GP surgeries information in GP surgeries my understanding is there is no out of date information in GP surgeries that I'm aware of there's actually no mesh information in any hospitals told that it's printed on a I need to print basis you know if someone requests mesh they'll then print the leaflet because I think it's about I don't know about 20 pages or something like that so there's no information and it will just be printed if and when necessary so that is positive but the negative is that on the websites the out of date information is still showing you said your views have been ignored evidence was skewed excluded from meetings for 10 months no minutes from the subgroup completely changed between the interim report and the final report chapters removed if that's not whitewash I don't know what is and 97 members of this parliament signed a statement saying no whitewash this is the clearest evidence that there's an oil tanker fully whitewash in this report I don't know what this committee is going to decide but one thing we have to do something because this is completely unacceptable I think Scotland was watching the world was watching Scotland and we have flunked it big style I think this is becoming embarrassing absolutely embarrassing so I don't know what the committee's decisions will be I think there are a number of things we could suggest could I ask though on the issue of your experience of the people who were sitting round the table and your knowledge of the conflicts of interest that may have been there do you have knowledge of that or is that something that other people need to look into I think we'd get ourselves into a whole lot of bother if we said anything you'll see that conflicts have been declared does it concern us that there are witnesses for the central legal office that's the NHS lawyers within the independent group but this is all declared on their conflict of interest so at least they declared it and I'm not going to say anything else even the fact that the current chair the new chair was an acting member an acting employee of NHS you know so did the changes and the change in tone and practice on the review group change when the chair changed you wouldn't listen at all we had a teleconference call because we actually later gave up physically attending the meetings because the pressure on us was enormous you know we'd come out sometimes would be in tears we just couldn't hack the stress one meeting lasted for five hours it was actually two meetings rolled into one kind of thing and it was five hours one meeting I'd had enough and embarrassed myself and had to leave and there was an independent I hate saying that word it was a review meeting I think the 23rd of January this year and we laid out again all our concerns about the final report in its present form was not in our name we asked for our concern to be documented in the minutes of that meeting never was we would just get poo poods it was as if we were never actually at some meetings that's how bad it got I printed off a list of how many was actually on the review board how many was members and I think it came to 26 so it was two against 24 they'd always be sitting where you are and all of them I would be here for some reason I don't know why and in Quentynance isn't captioned are you there I've been to a few meetings like that as well before I ask my question can I just concur with comments that have already been made about each MHRA we had representatives from the MHRA giving evidence to this committee on the 24th of February 2015 and I think it's fair to say that their performance at this committee was poor to say the least and I'm sure I speak for the whole of the previous committee at the time that we were all left extremely frustrated by their stance and the evidence that they gave we've already covered Elaine and Olive have already covered the issue of the dropping of salient points from the report but I'm just curious having heard Dr Agar a wee while ago specifically mention his frustration with regard to the dropping of chapter 6 I was just wondering if you've got anything else to add specifically with regard to chapter 6 the only thing I would say as it started off I mean on the review there was patients with a good outcome represented there was patients like ourselves with not so good outcome it should have been the same for the clinicians I mean there was four clinicians on that review but one clinician was basically bullied to resign as far as I could see his opinions even if they didn't agree with him should have been in the report so as then people could have made up their own minds even if it was him in a minority opinion they just dismissed it out of hand completely changed the report transopterator mesh tapes the most one used in Scotland and that's the tape that was another issue can't be removed in its entirety and there was a meeting we actually one of the clinicians through eventually admitted going round about the houses again yes it can't be removed in its entirety and that was in the interim review given cause for concern then it went on to the final report and it was now in the final report you'll read that it can any surgeon can remove any mesh any time if they've got the experience so that's a big change from given cause for concern to we can remove it anytime don't worry about it that's the extremes of it they may be able to remove it at any time and that's just not true they could remove it then again so could my local butcher the safety is the point moving on to the review of the review you've already said that you haven't heard from Professor Britain and I presume you hope to contribute to the review are there any particular aspects of the process that you would like to see considered the review is a waste of money and time and maybe the health minister should consider previously contacting every single patient in Scotland who's had one of these mesh procedures find out what the health status is and go from there rather than review a review that's not going to have any effect on the outcome of the final report so I would I would presumably you would agree that it can make sure this doesn't happen again that's true as well but I think it could be unless it considers the content of the report it won't help us it won't help us at all we understand it will help future patients but it won't help us have you had any indication that Professor Britain is going to contact you? but I think that's only a couple of months we've got quite a few to go yet okay just ask briefly about this issue about the inclusion of your input within the final report because I understand how contentious that must be for you and you provide a timeline of the commission which has been published and the committee also had site of the email exchanges which were not, I think, with the cabinet secretary but with the new chair can I ask if there was a point within that timeline when you felt assured that your input would not be included at any point do you think your concerns about your input being in the report were taken seriously? when we met with the cabinet secretary she was noting it down she said you've already said that I've got a note of this I'll pass it on, I'm in the meeting with Dr Gillis so we actually felt quite assured that the cabinet secretary that Dr Gillis would listen to the cabinet secretary about our concerns we'd already put the concerns to her ourselves and we were actually quite shocked with all the excuses and the blame and well you've got the timeline and when Dr Gillis said well yes she could take the request we wouldn't necessarily have to cede to them who do you think finally took the decision that your input would remain in the report well I'm not sure because that was getting thrown about the houses as well it was like either the chair said she'd went back to the review group or she said that it was the health minister, it wasn't me we were too late I think the last meeting the evidence was absolutely shocking there was a storage at the evidence that the last petitions meeting here and the chief minister's issue which we would hope that Professor Britton would be looking at is the role of patient representatives and your responsibility to your broader group which must also be quite a pressure on you that you're not somehow brought into a group to give I think the phrases used earlier as cover so there must be some kind of procedure can I just also check with you though you talked about there being a 10 month period when you weren't involved at all you're not very sure if people were having continued meetings, there might have been subgroups and then at the end of the process you were brought back in again to look at the final report how many meetings would there have been at that point that you actually either attended or were involved in we had been well three years of meetings I don't actually recall in front of me how many meetings it is I just wanted to get a sense of where the gap came did the gap come when the new chair came in or was it before that and then was there an attempt at least to bring you into the very final conclusion today you know well there was a gap because it was a summer recess and then the new chair resigned and then we got told that from the interim report there hadn't really been any new evidence and that's when we begged to differ and then it was admitted there was evidence and you know we took it on from there how did things change yeah I think it definitely changed when the new chair came into being we did try to have discussion with or put across our points of view but they weren't taken on board and when we met with the cabinet secretary and the chief medical officer we did actually feel that our views would be conveyed to the Dr Gillis but who had the final say regarding our input remaining I don't know, was it Dr Gillis, was it the cabinet secretary was it the CMO, we don't know all us we know is they went against our express wish I'm tempted to ask a former cabinet secretary whether he would have that expectation that he would be able to direct the group in that way I mean the cabinet secretary the CMO in situations like this and the chair I would have expected to take guidance from the cabinet secretary obviously but unfortunately as we heard with the suspension in the health service it doesn't always happen that way because when I issued the suspension I expected and I made it absolutely clear to every chief executive in chair I expected the wishes to be carried out by every health board not just some of the health boards you can issue a formal directive what nine times out of ten that's not necessary but clearly there were forces at work here which became apparent later on that allowed some health boards to ignore effectively the suspension I suppose it's just the challenge for a cabinet secretary to create an independent body cannot be seen to direct as well so that's something that perhaps the independent review I think there's also an issue of delivery I mean one of the things I think is needed in government is a central delivery unit to make sure that the instructions of ministers are actually carried out and particularly in the health portfolio in the audit committee of which I'm a member in some of the evidence we've had recently on various things that under successive health secretaries under successive governments some of them get these instructions you know way back to the lab packed in here instructions instructions just weren't carried out they just weren't carried out and I think that's an issue a general issue that needs to be addressed Gareth Whittle just firstly just with a great work to Alan Neil just said I think if there's a directive sent out when a moratorium is sent out from the health minister I find it surprising that there's no feedback to say whether a health board has upheld your directive I think that's probably something we should look at I think just a very quick one I think that given your consistent desire to have your evidence removed from the final report and given there was a 10 month period where you weren't involved in any input within that report in your opinion does that then make the final report void? Yes Yes, because we don't agree with a large part of the content and that is why we went to the cabinet secretary for help but she didn't listen 11 days later she published the report she could we ask her to wait and at least investigate our concerns what harm would it have done to suspend publication for a month or two to investigate the concerns we had to investigate the concerns Dr Agour had to speak to the previous chair who had resigned for personal reasons or whatever reasons I feel as though it was rushed and we'd actually like to know why it was rushed what was the hurry? I think that's a consideration for us I don't have any final questions Michelle then you'll briefly name we need to come to conclusion I just want to ask you about the tone because you've talked a bit about things changing and then being excluded when you started out on this journey as the independent enquiry you were very much from reading the papers it looks like you were very much looking at what do we need to do going forward and the interim report talks about the need to change processes and looking at the benefits and detriments of mesh etc did that conversation ever talk about looking backwards I mean you just said in the last couple of minutes how is it going to help us those of you who have already had the procedure so at what point if at all up to the interim report did that conversation take place in the review group? Yeah they did speak about retrospective studies going through every health board doing a study to find out how many patients have suffered I mean a lot of patients don't even know what device they have inside them we have one in our group that I've got three medical devices inside them and you know it's not in their medical records records have been lost so we asked for a comprehensive study we were told that it would take far too long and too much money and when you look at the cost of this review I think perhaps Neil will be able to correct me because he asked a parliamentary question but I think it was 4,000 and something pounds was the cost of this entire review and you know perhaps if more money had been spent and there had been a retrospective study for all the women here that have been harmed and all the women that haven't yet came forward or all the women that have been told of get sciatica or some other obscure disease we might have been looking at a very different scenario but when we're told at the start that safety is not the remit of the review and we had to ask quite strongly to get it in the title of the review that actually said it all for us Can I ask them bluntly looking forward in terms of the review body saying okay there's a problem with this we shouldn't do this anymore if they're being blunt saying there's a problem with this should we have known that and therefore is there any liability was that discussed? I think it's more about what was known then as opposed to what is known now we've come a long way you heard Dr Agour saying he was used mesh, all mesh at one time you know it was one particular procedure but now he's not for it so it's what is known now so I don't think there should be gosh I don't want myself into bother a foot and mouse I'm asking if there was any discussion in the review group no none at all no thank you I want to confirm that when that request was made to Shona Robison for not to put that to include Eleanor Noff's submission both Jackson and I were in the room when that request was made and as far as I was concerned at that meeting the inference was that that was a guarantee that was given and that did not materialise Ieams because the health minister actually said you've already said that already to me I'll just make sure that you understand that's what we want okay we've come to a conclusion in terms of the questions we want to ask thank you very much for responding so honestly and thoroughly and to realise appreciate both for you and for the people behind you that this is a very personal matter and therefore it takes a great deal more energy than to deal with something that's not so directly hints at the massive impact on your lives we have to now think about how we're going to take this forward I should say I think that a letter to the cabinet secretary on accessing the relevant information on the website can easily be done if the committees agree to that simply that can be done today because that is a concern I think that there are broader issues around how the health service treats people one of the things that struck me in the report between the interim report and the final report that they removed the women felt they were not believed which but that's a pretty substantial point there are broader issues that have come out about the way an independent review should be conducted, the role of patients the balance of medical interest which is something we would also want to consider I think there's process issues that obviously we would want to explore with the cabinet secretary around what did she expect of the group what were the limits of it and so on I think these are all things but on the really substantial issue actually what happened in terms of this process and whether women are now any safer for the review having taken place I think that's a massive question I think we have been taken aback by the response from I mean literally across the world that rather spooked me out when I read that somebody in New Zealand was carefully watching our proceedings but that is something that's beyond Scotland so I think we would be very keen as a committee that we are taking further action on this that we have secured a debate in the chamber on the question where it allows more broadly the Parliament and people watching to understand some of their very complex issues and some of the frankly quite straightforward issues and it means that the minister will have to respond there but I think in terms of us really thinking through what we want to do next stage I think what would be useful would be to get a note from the clerk which really brings together all the strands that are here including oversight from the MHRA and that would allow us to come back in public session to really report on what we think we need to be doing next because I think all of us are very alive to the very strong interest and concern around the issues that you've and your campaigning group have been so effective in highlighting but I don't know if anyone else has particular suggestions of things that we would want to be included in the clerk's notes in terms of taking action forward Alex Can I just mention two things convene, I'm not a member of the committee so this is just a personal opinion but I think the suggestion by Dr Ogher that even today putting the final report out to a formal public consultation is one and perhaps one way of getting the content eventually changed. The second point is as you know I've suggested and I know there's support from the campaigners and I know there's other support round the table for the idea of a global conference it might be a good idea to consider that this committee should actually host a global conference in this because the committee has the advantage of being cross-party representing the Parliament rather than any one individual party or one individual group and it's maybe something I think would be a first for the Parliament to do that. I mean today we're hosting the Scottish Business and Parliament conference so we do host conferences as a Parliament and I think it would be a good idea to consider whether the committee should actually host a global conference you would obviously need the appropriate support and authorisation from the Parliamentary authorities but I think it would give a dimension to this that it deserves. Any other comments on Michelle, then Brian, then Gona. Sorry. Could we write to the chair and just ask about minutes and minutes from all the meetings I mean as a review group meeting should have been minited so I think it would be worth asking the chair for silent minutes. I'm assuming that the part of the review of the review whether we're going to work through can I suggest some of these technical things about who we can speak to but I think you're right to raise the issue of minutes and recorded meetings let's think about who best we should then have that conversation with. I'm just concerned that the review group is not planning on reporting to the middle of next year and I'm hoping that we're going to move a little bit quicker. Brian. I'm kind of struck as with there being perhaps being a cultural issue and I don't know how that's specifically for this petition but across a number of petitions and across some other evidence that probably most of I've heard from constituents around this cultural issue of protectionism quite frankly within within certain sectors of the NHS and I wonder if that's something that should be considered within this committee on this issue or on more broadly. I think if we're producing a report and having a debate these are all legitimate issues to raise within that it's clearly specifically an issue to women so is there an issue about women's health and the way in which people respond to that I think the points made earlier about the impact of a ministerial directive naively my assumption that if you say that something shouldn't happen it wouldn't happen and that there would be no such procedures while there was an investigation and I think it's something that would be worth while looking at and I think this point about the retrospective study it's also an important one to understand properly what the impact was and explore that further. I just picked up on something you said there John and that was about this effect in women this is now affecting men too not getting men coming through who have had hernia mesh implanted and also it's been affecting the partners or husbands of women so we just need to be a wee bit careful. I appreciate that, I think that point is well made because we do know that even from my distance from it it's clearly an impact on families which goes beyond just the individual patient themselves. What power the petitions committee has got but I think from today it's very very clear that mesh procedures should stop until we have all the answers because we don't have them and it should stop right now and don't put any other patients at further risk. We will certainly be in as part of our decisions around this one of these will obviously be to have a conversation with the cabinet secretary and of course when this debate comes to the Parliament while the committee members will bring their experience of the petitions committee members right across there would normally not be a vote on the public petitions committee would probably produce a report and it would be noted and all of those issues could be explored and that's not to stop these matters when then the Government would have to come forward within eight weeks it's absolutely compulsory for the Government to come forward with it's response to the committee's recommendations very briefly I don't want to attempt to direct the committee God forbid but if this committee was to make the recommendation that given the evidence that it has heard that there should be a suspension that suspension could continue I think that would be very powerful that is something certainly I think we have to without misrepresent the power of this group and its capacity to make those decisions we can reflect those views in our report and ask the Scottish Government to reflect on them but certainly wouldn't be the matter of this committee to make those clinical judgments but I think we have afforded the opportunity for those arguments to be presented in public and I think that has been very useful can I just say in conclusion clearly there's a great deal more to be done this can I thank our visitor MSPs for being here in the gallery for their attendance too and really just to reiterate this whole series of issues here that we recognise are of great importance to me one assurance I can give you I think from the committee that we take our responsibility in this regard very seriously and we'll obviously reflect on the evidence session and we'll come back at public session to report on what further action we want to take and with that can I close this meeting