4. Statement by the Cabinet Secretary for Health and Social Services: The Report of the Welsh Task and Finish Group to Review the Use of Vaginal Synthetic Mesh

– in the Senedd at 3:21 pm on 8 May 2018.

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Photo of Ann Jones Ann Jones Labour 3:21, 8 May 2018

Item 4 is a statement by the Cabinet Secretary for Health and Social Services on the report of the Welsh task and finish group to review the use of vaginal synthetic mesh. I call on the Cabinet Secretary for Health and Social Services, Vaughan Gething.

Photo of Vaughan Gething Vaughan Gething Labour

Diolch, Dirprwy Lywydd. On Friday, I published the report of the task and finish group that I established to review the use of vaginal synthetic mesh tape and sheets in the treatment of stress urinary incontinence and pelvic organ prolapse. This report provides a comprehensive account of the use of mesh in Wales and the problems associated with it. Importantly, it makes recommendations on what action we should now take to make necessary and rapid improvement. I thank the members of the task and finish group for the work they have undertaken. I do want to acknowledge the courage and commitment of those women who have worked tirelessly to highlight this issue. Whilst, understandably, they chose not to participate directly in the group’s work, the evidence that they provided has informed the findings and recommendations—and, of course, I've previously reported meeting a group of mesh survivors themselves. 

All reviews to date have shown how difficult it has been to have a reliable assessment of the scale of the problem that can be linked to the use of vaginal mesh. However, what is clear is that while many women may have benefited from such treatment, some women have suffered serious and life-changing complications as a consequence. The report reaffirms this and provides clear advice on what needs to be done to support those who are living with the debilitating effects of mesh complications. It is also clear about the need to improve our approach to the management of pelvic health problems going forward.

There are clear limitations with the adequacy of our data to understand the level of complications. The report explains why this is the case and proposes some short term and longer term solutions to address this. However, what is clear from the data presented is the sharp downward trend in the number of patients who have had mesh procedures in Wales over past 10 years. During the course of this review, the National Institute for Health and Care Excellence published new guidance, in December 2017, stating very clearly that transvaginal mesh repair for vaginal wall prolapse should only be used in the context of research. I note the task and finish group welcomed this decision by NICE and had reached the same view. I, of course, expect that advice to be followed in Wales.

The report’s overall findings and recommendations fall within five key areas: the initial care pathway required to support women’s pelvic health and well-being, which includes access to multidisciplinary teams of clinicians incorporating continence care, physiotherapy, pain management and, where appropriate, psychology skills; providing better information for patients to ensure they can make a fully informed and shared decision about treatment options; ensuring GPs can have direct access to specialist advice, so they can better support their patients; making significant improvements in the processes associated with data capture of both procedures undertaken and any implants used; and ensuring access to specialist support for mesh removal by developing one or more fully accredited multidisciplinary specialist centres. I now want to ensure that the report’s recommendations are taken forward at pace.

What is particularly clear to me, after reading this report, is that we need to have a fundamental change in the way that the NHS supports women with pelvic health problems, moving to a focus on prevention and conservative therapies, with surgical intervention as a last resort. At the same time, we need to ensure there is early access to specialist support for those with treatment complications to prevent the worst outcomes. I am therefore establishing a ministerially directed implementation group to oversee specific areas of women’s health requiring urgent attention and improvement. In the first instance, its priority will be to oversee the implementation of the recommendations from the vaginal mesh and tape review. Alongside this, I also want the group to consider any recommendations arising from the endometriosis and faecal incontinence reviews that are in progress. The mesh and tape review highlights that we can expect there to be a number of overlapping areas that need to be brought together.

Following this initial focus, I will take advice from the chief medical officer and the chief nursing officer in determining what the group’s next priorities should be. The membership of this group will need to be flexible as, although the initial focus will be on mesh and tape, the group will require appropriate representation—both professional and lay representation—from across other areas of women’s health. I'm pleased that Tracy Myhill, the chief executive of Abertawe Bro Morgannwg university health board, has kindly agreed to chair the group.

I've made funding of up to £1 million a year available to support the improvements needed. There will, of course, be much that can be done within existing resources, through service redesign and potentially the shift of services from hospitals to communities, to ensure that a community-based pelvic health and well-being pathway is put in place in each health board across Wales. This resource should help these pathways becoming the norm across Wales on a consistent basis. In the meantime, I expect all health boards to consider the report’s findings and recommendations to consider what local improvements can be made immediately. Our aim must be to ensure women receive the best possible care and treatment when they present with stress urinary incontinence or pelvic organ prolapse, or any other complications as a result of existing treatment.

I've asked my officials to set up the implementation group without delay, and I will expect regular updates on progress. It will, of course, be important for the work to be underpinned by a range of measures in order to be able to demonstrate improvements in patient outcomes and experience. The group will also need to keep its work under regular review in line with any new evidence that emerges. I have also shared the report of the task and finish group with the chairs of the Medicines and Healthcare Products Regulatory Agency and NICE, and asked that it informs their ongoing work in this area. I believe these steps provide the opportunity to have a much-needed focus on women’s health and enable the NHS to tackle key areas that have long needed improvement.

Photo of Janet Finch-Saunders Janet Finch-Saunders Conservative 3:28, 8 May 2018

I'd like to begin by thanking the Cabinet Secretary for taking many of the concerns forward by commissioning this work in the first place and then, again, through your statement here today. Because I've got to be honest, I was totally, myself, oblivious to this issue until it started presenting to me in my own constituency office. Some of the numbers that I've had, and the harrowing experiences by, I have to say, predominantly women, have being quite, quite startling. Then, of course, I've been well aware that many patients that have suffered are now taking to social media, and trying to—you know, we've all been copied in. I admire these people because many of them are patients who have suffered, and they're not suffering in silence. They are getting out there and trying to put out the warnings about just how unpleasant—if things go wrong—this mesh is.

Of course, I need to remind the Chamber that the issue of synthetic vaginal mesh, or the tape, is not one that just affects women, because I think there has been a tendency for it to appear that it's just an issue affecting women. I understand that where it could apply to affecting men hasn't been part of the review. But, of course, it can be used as a hernia mesh for male and female patients. The side effects of the problems caused by mesh are wide-ranging. We're not only talking about the physical pain that patients are constantly in, but also the associated mental issues related as a consequence. Confidence is lost and many people suffer depression whilst struggling to cope, and evidence does suggest that the numbers are increasing as the years roll by, because it is, actually, after a number of years post operation that problems can start. Many patients are calling for an overall ban on this procedure, and I worry that this is something that you will not confirm from your statement today. The National Institute for Health and Care Excellence in England have called for a ban of the use of vaginal mesh, an action that has been taken in New Zealand and Australia, and where it has been referred to as the biggest health scandal since thalidomide. Across the UK, about one in 11 women have experienced problems. In Scotland, former Scottish health Secretary, Alex Neil, requested a suspension of mesh implants by the NHS in 2014, but figures obtained by the BBC in December 2016 showed that hundreds of operations have been performed since. And it is worth noting that a number of Scottish health boards have stopped using mesh implants all together. 

Cabinet Secretary, we are grateful for this statement, but it doesn't go far enough. There is clearly the evidence, the public support and examples of where this mesh treatment is causing horrendous, life-changing problems. Therefore, why will you not commit to following the examples of Australia and New Zealand and bring in an outright ban at the earliest possible opportunity? Now, the dilemma for me here today is that in my own constituency I have a number of patients who have approached me, and I'm dealing with their casework, who are, as they describe, living in agony. But at the same time, I have cases where the mesh procedure is to be implemented quite soon on patients who are suffering. Now, they've raised concerns, or tried to, with the consultants, and it has to be said, they get fobbed off. They raised their concerns with GPs, and there just isn't a clear line on this, and I do think that we need something more definite from you as the health Cabinet Secretary responsible for the health our women and men across Wales. 

So, would you explain why the report has based all its figures on mesh implants, mesh removal and over-sewing. Why have outpatient appointments, covering all documented side effects, been omitted? In recommendation 3.2, you state:

'Meaningful estimates of complication rates related to mesh procedures

would require a retrospective audit'.

Does this mean you will instruct an audit to take place? If not, why not? I certainly would if I was in your shoes.

In recommendation 3.21, do you not agree that the low numbers reported in Wales could be due to it not being mandatory for clinicians to report adverse incidents to the MHRA, and also the difficult nature that may mean that the numbers held by the MHRA are inaccurate? You really should be going all out on this now to establish the absolute and exact state of play here.

What can be done to rectify this? Recommendation 5(c) states that

'Only one health board in Wales currently has a multi-disciplinary pelvic

pain clinic.'

So, you know the natural progression there is to make sure that we've got that available again for everybody in Wales. However, in a response provided to Neil McEvoy in Plenary on December 13 last year, you stated:

'My understanding is that, yes, we do have multidisciplinary teams around each surgical procedure. ' 

Can you now clarify which is accurate—your report or your response to Neil six months ago in Plenary?

Recommendation 6(a) states that

'Ways for GPs to have direct access to specialist advice should be

established.'

How will this be monitored and how soon will it be rolled out? 

Finally, Cabinet Secretary, why, when the UK Government has conducted an audit into the effects of vaginal mesh implants, is your Government still stubbornly refusing to do so? What are you worried about? Why are you not putting the interests of Welsh patients first? And I respond to you today on behalf of myself, but also on behalf of Angela Burns, Assembly Member, who sadly cannot be with us today. She is very concerned about this. She is speaking to the people, like I am, on this. We have this issue approaching us as Assembly Members on a very regular basis. It is down to you, Cabinet Secretary, to make sure that you have a very steadfast approach to these concerns. Thank you. 

Photo of Vaughan Gething Vaughan Gething Labour 3:34, 8 May 2018

Thank you for those questions and comments. I make no apology for saying that the hernia issues are separate matters, with a different group of surgeons and a different process in place to understand the level of complications that exists. This has been unashamedly focused on women's health issues, and, bluntly, if the same level of complications had affected men's health issues, I suspect we would have heard about them much sooner.  

I'll deal with your final point first about the multidisciplinary teams. Of course, recommendation 5 deals with multidisciplinary teams for pelvic pain clinics, as opposed to broader multidisciplinary teams that are in place around surgery. There's a challenge here about making sure that we have the right number of multidisciplinary teams in place, including, of course, for a specialist centre for mesh removal, and to look at one or more of those, and in particular about what happens currently in south Wales and having an accredited multidisciplinary surgical removal centre, but also about the continued use of Manchester for patients in north Wales. 

On your points around the banning of—. No, I'll deal with your audit point first, before I come back to the point about banning mesh, which has featured very heavily in what we've been asked to do over a period of time. If we look at the auditing that's taken place in England, they're looking at it on an experimental basis in England to try and retrospectively audit what has happened. What's been helpful is that, between officials in the Welsh Government and the Department for Health for the UK Government, acting for England, there has been a really constructive transfer of information about the audit taking place, and there are similarities in the range of challenges that we expect the audit in England to reveal. Before I look to undertake retrospective action, where we can't be sure of the exact value of that, I am interested, though, in understanding what happens in England and what lessons we can learn from that, as well as looking more proactively at the issues for new implants of medical devices.

There is a European Union directive, due to be implemented in 2020 or 2021. Of course, that will still be an issue for us, regardless of what the transitional deal is or isn't agreed by the United Kingdom Government and our relationship with the European Union. But that is looking at being able to understand and have a proper register what devices have been implanted into people more generally. Now, there is a challenge there about understanding whether they're able to scan that and understand how that's done, and that is covered in the recommendations in the report. In taking forward these recommendations, we'll need to determine what our approach to that will be. That is not something that is simply covered over or about to be forgotten. And that will help us to deal with some of the requests from the women involved. In the requests they gave us, I think on pretty much every area we're going to be able to show progress, apart from the issue of a ban. 

You mentioned Scotland, and the request for a suspension made by the Scottish health Secretary. Well, it's a matter for the Scottish health Secretary to answer for themselves about their approach, but, as you say, a range of people have still undergone mesh implants since that time. That's because the Scottish health Secretary, just like me, doesn't have the power to ban mesh implants. The challenge is that whilst these are regulated devices that are available, and are available for use, it is an issue of consent between the health provider and the individual citizen about whether they wish to have the surgery provided.

Now, as I say, there are a number of women who have had the surgery without complication. Part of what the women asked us to look at, and part of the terms of reference for the task and finish group, was about properly informed consent to make sure that people really did have the challenges and the risks explained to them, to make sure it really is a very last resort. And even then, some women will choose not to have the surgery, and that should be an informed choice to make, just as women who do choose to have surgery, if that is their choice—it must be their choice on a properly informed basis.

I have, though, written to the MHRA asking them to reflect on the regulated decisions in Australia and New Zealand in particular to ban mesh. The MHRA have responded and said that they do not intend to do so. However, since then, the Cumberlege review is in place to look again at a number of these issues, and there will be engagement both from the NHS and the Government in that review, and I expect women from across Wales will engage in that review too. So, this is not an issue that's about to go away. Whilst I don't have the power—and you'll understand why politicians don't have the power to ban in particular surgical devices or equipment available for the health service—we are fixed with a proper division between a regulator's power and the power that a politician has. But as I say, I have provided them with a copy of this review, and I look forward to the Cumberlege review and what that will tell us and about this decision being kept properly under review in light of the evidence available. 

Photo of Rhun ap Iorwerth Rhun ap Iorwerth Plaid Cymru 3:39, 8 May 2018

(Translated)

May I thank the Cabinet Secretary for the statement? And I thank those women as well who showed such bravery and commitment in working tirelessly, as you said, to underline this issue.  And, yes, women have suffered complications that have changed their lives. I welcome elements in the report relating to several elements of this: the need to work proactively on the preventative aspect to prevent women from having to have surgery in the first instance; the need to stick to NICE guidelines and increase awareness of those guidelines—as with so many things, there's a weakness in the way that this Government operates in general, the failure to keep the kind of data that allows us to plan better health services; and also the specialist centre for tackling the mesh issue—the funding for that is to be welcomed, of course. But, I have several questions, nevertheless.  

Photo of Rhun ap Iorwerth Rhun ap Iorwerth Plaid Cymru 3:41, 8 May 2018

The report highlights that some women, having described their symptoms, were dismissed by medical professionals who had wrongly ascribed symptoms to normal post-operative pain, perhaps. Many women felt they were patronised as a result of that, describing their battles, frankly, to be taken seriously. And this isn't the first time that we've seen this kind of thing; we remember, back in the 1990s, with chronic fatigue syndrome. Can you, as Cabinet Secretary, be a little bit more specific about how that particular issue can be addressed, how awareness, for example, can be raised, and how attitudes can be changed, so that people with unexplained symptoms are regarded as patients first and foremost, with symptoms that need investigating, rather than as people who should frankly just accept a little bit of pain? Because we know now, through the hard work of people who have campaigned for change here, that what was dismissed now has to quite rightly be taken very, very seriously.

The report also highlights the weaknesses with the adverse reaction reporting system for medical equipment, for the medicines healthcare regulatory authority. It's not something that is devolved, but can you describe how your department is going to try to improve that system so that we have earlier warnings?

Finally, regarding the specialist centre for mesh removal, whilst welcome in itself, we could do with something a little bit more concrete in terms of timescales, so I'd be grateful for a proper timescale for that development, so that people can see that words now will turn into action in the not distant future.

Photo of Vaughan Gething Vaughan Gething Labour 3:43, 8 May 2018

Thank you for those comments. There are broadly three questions provided in there. On the point about whether women who were not believed, and the battle to be believed, and how that will be overcome, well, the significant publicity around this—again generated by, as I said in my initial statement, the courageous and determined women who raised the isue—is part of that. The patient safety notice that was issued by the chief medical officer in 2014 is a part of that. The work undertaken by NICE is all a part of that. These are a range of different measures that are being undertaken to try and make sure that people are believed.

And there's also a broader challenge here about the way in which health and care are delivered, and it goes back to prudent healthcare, a concept started in the middle of the last Assembly term here in Wales. It's about understanding what matters to the patient, and about having a much more equal relationship with that person and the healthcare professional. And when that person raises concerns, rather than simply dismissing them and taking a rather more paternalistic approach, it's actually about listening to that person to understand what is happening and to recognise that they do have a continuing health and care need.

In addition to your point about GPs, I think it's worth while referring to recommendation 6 and how we take it forward in ensuring that there is access to specialist advice for GPs. It was part of the concern by the GP representative on the task and finish group to make sure that GPs themselves are properly equipped in being able to understand, not just potential symptoms, but then where they could go for that specialist advice, help and support. That comes back again to the opening of this that there was not a high level of awareness of the problems as they were being reported, and I do think, bluntly, that if there'd been a men's health issue, there'd have been a higher level of awareness and higher and more immediate acceptance of the challenges that people were facing in reality.

In terms of your point about when and how we'll be able to take forward the recommendations, including the specialist centres, well that's why I've announced there'll be an implementation group to take that forward, with the requisite level of weight within the health service. So, that's why there'll be a chief executive of one of our larger health boards taking forward and chairing that group, and understanding the right number of people who will need to be on that to understand how we draw up those service plans and then to make sure there is funding to try and advance that as well, rather than simply asking people to eat into current resources. You will understand that, in the financial position that we are in, adding new money to this area is a significant commitment when we're looking to make compromises in other areas of delivery.

So, this is a real priority, and I do recognise there is more that we will need to do. I mentioned the endometriosis review that is coming in as well, and the faecal incontinence review that is coming in as well, to make sure that we don't just see these issues in isolation, but understand them together, and make sure that we do see a real improvement. When I have more definite timescales, I will of course report back to you and other Assembly Members.

Photo of Caroline Jones Caroline Jones UKIP 3:46, 8 May 2018

Thank you for this and your earlier statement, Cabinet Secretary. Complications relating to vaginal mesh implants have left thousands of women, worldwide, living in constant, debilitating, chronic pain, and it is therefore welcome that the Welsh Government undertook a review of the use of such implants. I would like to thank Professor Emery and his team for their report.

Whilst survivor groups would like an immediate ban on all use of such mesh and tape implants, I accept that these implants have benefits for some women, but their use should not be widespread and should be controlled. I therefore welcome the task and finish group’s recommendations to improve the pathway, to encourage greater informed choice and to affirm that mesh surgery should be a last resort.

Cabinet Secretary, the task and finish group made a number of recommendations and I am grateful that you have indicated that you support their implementation. When do you expect the implementation group to complete its work and ensure that all recommendations are put in place?

Cabinet Secretary, are you aware of the research being undertaken at the University of Sheffield, published in the journal 'Neurourology and Urodynamics', which supports the use of a softer and more elastic material, better suited for use in the pelvic floor, and one that releases oestrogen into the surrounding pelvic tissue to form new blood vessels and ultimately speed up the healing process? They concluded that a different material, polyurethane, would be a much better material to use as a vaginal mesh due to its flexibility and its likeness to human tissue. The next step is clinical trials. Cabinet Secretary, can you ensure that Welsh patients have access to these trials?

I look forward to seeing the details of the new care pathway and support available to women who have stress urinary incontinence or pelvic organ prolapse. Diolch yn fawr, thank you very much.

Photo of Vaughan Gething Vaughan Gething Labour 3:48, 8 May 2018

I'll try to deal with the point the first question raised about the implementation group and the timescale to complete their work. I will of course report back to Members, but as the group has yet to meet, and to consider how to take forward those recommendations, I'm not in a position to give an undertaking or commitment on that today, which I hope Members will understand. But I will report back about that.

On your second point about the research published by Sheffield, there's a variety of research that is carrying on about alternative surgical options, whether that is artificial or biological material to be implanted. But I can't really comment on the clinical trial that they're looking to undertake. I will, though, look to discuss with my officials to see if there is something useful that we can come back to Members with. But of course the Government isn't in control of those clinical trials and access to patients.

What's interesting in the task and finish group report is that I think there are some people they can identify who are more likely to be at greater risk of complications or having significant pain after the event. There's something about understanding and having that conversation about generally informed consent will be women that are involved. Because, as I say, whilst mesh has not been banned, whilst I do not have the power to ban mesh—even if I were minded to do so, I don't have the power to do it—we do need to make sure that consent is generally informed and that people understand the nature of what the current problem is and the treatment available for that, but also the risks and the potential benefits of any form of surgery, whether it involves mesh or not. And that was a really clear part of both the task and finish group's report, but also Members who wish to see a change in practice said, 'If we didn't have a ban, we need to make sure there was a real change in consent.' One of the more upsetting things that I heard about this particular issue was where people said that they just weren't told properly what the risks were, and that there was no problem at all with it. And that can't be a way to practice healthcare in the here-and-now today, let alone in the future.

Photo of Jane Hutt Jane Hutt Labour 3:50, 8 May 2018

Can I thank the Cabinet Secretary for your statement today and can I welcome the recognition, at long last, of the adverse impact of the use of synthetic tape and surgical vaginal mesh sheets for treating pelvic organ prolapse and stress urinary incontinence, leading to appalling, long-term and life-changing consequences for women's health? I welcome the recommendations in your report that relate to preventative measures and conservative management of these conditions and with surgery as a last resort. I welcome also, for example, the recommendation for a new pelvic health and well-being pathway. And can I thank the Cabinet Secretary for meeting with my constituents, Jemima Williams and Nicola Hobbs, whose lives have been so adversely affected by vaginal mesh implants? I'd like to praise them for their courage and their leadership in the Welsh Mesh Survivors group. But can I clarify, Cabinet Secretary, the position regarding my constituents, Jemima and Nicola, and the task and finish group? Because in your written statement you said that they chose not to take part in the group, but can I draw attention to the context of their decision not to take engage? They were deeply concerned about the membership of the group, the papers presented to the group and the lack of notice and draft terms of reference, because both also are suffering from constant pain and severe ill-health.

But it was very helpful that you agreed to meet them, with me. Can you confirm that you took full account of their full and harrowing evidence at that meeting? They did provide an extensive folder of patient experience of adverse impact. And also, can you confirm and clarify, Cabinet Secretary, what cross-border engagement is taking place to share clinical expertise, evidence from patients, mesh sufferers and funding also that could be available for referral to mesh removal experts?

Finally, as you are aware, the Welsh Mesh Survivors group are calling for mesh use to be suspended until a full audit has been carried out. And it's hard to believe that the procedure can still take place in Wales, despite the point that you made today in your statement, that all reviews to date have shown how difficult it has been to have a reliable assessment of the scale of the problem that can be linked to the use of vaginal mesh. That is as we are today. So, Cabinet Secretary, will you consider holding a retrospective audit of the use of mesh in Wales and consider suspending the use of vaginal mesh until this takes place? Thank you.

Photo of Vaughan Gething Vaughan Gething Labour 3:53, 8 May 2018

Thank you. I can confirm that in relation to your last point, and I'll link that to the cross-border work on evidence and progress, as I indicated in response to the first set of questions, the audit being undertaken in England is on an experimental basis and has not been undertaken in that way before. And I will, of course, be interested in the evidence provided by that and officials are engaged around the review being undertaken by the Department of Health. I would not expect there to be a significant difference in the number of problems that arise from these procedures. So, we have to start by recognising that there is a problem here in Wales. We know that because we have people who have survived complications and are living with them now. And part of our challenge is understanding the number of people and understanding the reluctance of some people to come forward. It is quite easy to understand why some people do not wish to highlight the problems that they have, particularly if they feel that they've not been believed at an early stage when complications were arising. And removal can be complicated and difficult and not always completely successful surgery. There are risks in that too.

As I've said in response to a number of people already and I tried to say at the outset, I'm not in a position to ban mesh. I'm not in a position to suspend its use either. What the report, though, does make clear is it should be a last resort. As I said, people then say, 'Well, what is a last resort?' Well, it's something about making sure that all of those conservative non-surgical treatment options are exhausted first, and that's why there has to be a proper focus on making sure that we have a more consistent arrangement surrounding the multidisciplinary teams to make sure those options are provided early, and then, when going through any treatment options, that the potential consequences of each of them are highlighted to the women involved. Because as I've said, I do recognise that some of the real challenges that we have understood are not that the risks have been explained and people have gone in with their eyes open about those risks, many women have said they were simply not given a genuinely informed basis upon which to make that choice about whether to consent to surgery or not.

In terms of the attempt that was made in attempting to try and have people who were living with the complications of mesh engaged in the task and finish group, having decided to set up the task and finish group, I wanted to make sure that there were people living with those complications who could input into that work. That meant the invitation was at relatively short notice, with the terms of reference, the people involved and indeed the evidence they would be considering. It wasn't just at that early stage, though, that an attempt was made to involve women in that work. Throughout the life of the task and finish group, for a number of months, we've tried to find a way in which they could have a real input, either to the whole group or to members of it. That proved not to be possible. I absolutely do not wish there to be any kind of criticism inferred or taken from that at all as to the decision that those women made not to engage directly in the work of the task and finish group. I think it's easy to understand why they chose not to do that. But, they did however continue to have an input around that.

As you are aware, we met your constituents to have that conversation and their accounts and the written evidence they provided were taken into account and were provided to the task and finish group, and it's part of the reason why the work of the task and finish group was extended, because they did consider the evidence that was provided by both Jemima Williams and Nicola Hobbs, and it's referenced in the report. So, I hope that does help provide some assurance that their evidence was taken seriously. And in taking forward the work of the implementation group, we need to find a way for women themselves who are living with complications to actually have an input into the work of that implementation group, as well as those people who are on the pathway already and are undergoing conservative treatment options in the here and now. So, there is much more for us to do and, as I've said in an earlier response, I will happily report back to Members on the work that is being undertaken and the progress that we're making.

Photo of Jayne Bryant Jayne Bryant Labour 3:57, 8 May 2018

Thank you, Cabinet Secretary, for your statement today, and I'm glad the Welsh Government's task and finish group have now completed their report. The Cabinet Secretary is aware that I, like many other Members here, have heard the heart-breaking experiences of constituents suffering from the impact of surgical pelvic mesh implants—experiences of women being left in agonising pain and with extreme worries about the future. For women like my constituent who first brought this to my attention, financial and professional worry still come with the long-term physical and emotional pain. Indeed, my constituent has said that this has had a devastating effect on both her and her family. I'd like to take this opportunity to pay tribute to my constituents and all the other women who have come forward to bravely share their harrowing experiences. So, whilst I welcome the task and finish group's report, can the Cabinet Secretary provide reassurances that any new pelvic health and well-being pathway will include listening to patients' ongoing concerns?

Photo of Vaughan Gething Vaughan Gething Labour 3:58, 8 May 2018

Yes, I really do recognise the life-changing consequences that mesh complications have had for a number of women, including the correspondence and your questions in this Chamber and the conversations we've had outside it, about the physical, social and financial consequences, but also about the very real impact on people's relationships, not just with partners, but with a whole range of other people that the pain and discomfort has caused, and also a lack of trust with people who they trusted at the outset about the advice given, and indeed trust between healthcare professionals as well about the treatment options that have been provided.

Your point about listening to people directly engaged and involved is essential, not just as part of our continued improvement and prudent healthcare and what the parliamentary review has told us we will be taking forward in particular; this really highlights where, if you don't understand what matters to the person and what risks they're prepared to accept, how they have genuinely informed consent, where information is made available to them not hidden from them, but genuinely made available to them so they can make choices about their treatment options, then you understand why people end up in this position where they don't trust everything that is done around them.

It is essential, therefore, that in taking forward the work of the implementation group and taking this report forward, the patient voice is absolutely central to what is done and how that is then explained. Much of the task and finish group's report does focus on how information is provided to people to make choices and for them to say what matters to them. So, I take on board the point, and I can give that reassurance that that will be an essential part of our work moving forward. 

Photo of Neil McEvoy Neil McEvoy Independent 4:00, 8 May 2018

Cabinet Secretary, on 13 December I asked you:

'Given the growing number of mesh implant survivors, England has adopted multidisciplinary teams of specialists who support patients who have had issues with mesh and advise them on treatments. Do these multidisciplinary teams exist in Wales and, if so, where are they?'

You commented, as was mentioned earlier, that

'we do have multidisciplinary teams around each surgical procedure.'

Now, that is simply not the case, and I'd like you to correct the record today. 

Moving on, if we look at pages 6 and 7 of the report, people were informed incorrectly about the potential risks and life-changing effects in consequences. People were not warned of the potential devastating life-changing complications. There was an inadequate consent process. People's problems after operations were disregarded and put down to just simply post-operative symptoms. People were turned away and made to feel like they were making a fuss, and I read here that consultants reduced some people to tears, and that there were inappropriate referrals to other specialist areas, and so on. It's a pretty grim report, and people have been permanently disabled. So, another question that I have is: what is going to be done to compensate these people? 

Thirdly, an expert panel was set up in Scotland on this matter in 2013, in England in 2014. The Welsh NHS was invited to take part then. In December 2014, an oversight group was set up in Engand with no Welsh NHS input. Action was taken in the United States in 2014. So, why did the people of Wales have to wait until October 2017 for the task and finish group to be set up? Was it your negligence or was it the negligence of your predecessor? I don't understand why it's not mandatory to report on problems that have been reported to doctors after surgery has taken place.

I want to move on now to your—       

Photo of Ann Jones Ann Jones Labour 4:03, 8 May 2018

No, sorry. You can't be moving on—

Photo of Ann Jones Ann Jones Labour

A question then, please, because we're short of time as well. Thank you. 

Photo of Neil McEvoy Neil McEvoy Independent

So, that was a question. My next question is: what about men? You seem to dismiss hernia operations. People suffer the same problems using these meshes. I spoke to a constituent just before walking in this Chamber earlier, and he still does not know what material was put inside his body. That's an absolute scandal. Will you undertake to make sure that my constituent is told exactly what was put into his body without his consent? Will you undertake to do that? 

Photo of Ann Jones Ann Jones Labour

Thank you. Cabinet Secretary. 

Photo of Vaughan Gething Vaughan Gething Labour 4:04, 8 May 2018

Obviously, I can't comment on individual matters that I'm not aware of, but your constituent should approach the health board where the procedure was undertaken. I would expect that information to be made readily available to him. 

I also need to deal with the point about hernia that I mentioned in response to Janet Finch-Saunders at the outset. Of course, hernia operations are undertaken on men and women, and I've indicated previously in answer, I believe, to questions from Jenny Rathbone that we would be looking to undertake, and we are looking to undertake, a review of hernia procedures to understand if the same level of complications exist. But it is the case that people do react differently. It is the case that between men and women there are procedures undertaken that simply don't affect men. And, as I say—I make no apologies for saying it again—if a similar issue had affected men uniquely, then I do not believe that it would have taken this long for that problem to have been highlighted and for further action to be taken. I set up the implementation group to look at this issue and the issues that arise on the record for improvement and the range of linked women's health issues that I've mentioned, both endometriosis and faecal incontinence.

There is, of course, more that we need to do, to do consistently and at pace. That's why the implementation group that I have directed be created. And I certainly don't defend a failure to provide genuinely informed consent. I've made that very clear, both before today and on a number of occasions during today as well. I go back to multidisciplinary teams. Multidisciplinary teams do exist as a matter of course around surgical procedures. Our challenge that this report lays out for us is whether we have the requisite amount of expertise within those teams, whether they're as consistent as they need to be, and how we actually recommit ourselves to improvement. That does not mean that there is a widespread failure to do what is right. It does mean you need to take the opportunity to improve, and that means that you have to accept that there is a challenge to be resolved in the first place to be able to set yourselves out on a path to improve on current process and current action. So, I see no reason to correct the record. I'm accepting the recommendations that we have, and I look forward to reporting back to Members in the future on the action that the NHS will undertake to deliver that required improvement.

Photo of Ann Jones Ann Jones Labour 4:06, 8 May 2018

Thank you. Finally, Jenny Rathbone. 

Photo of Jenny Rathbone Jenny Rathbone Labour

Thank you very much. I'm particularly interested in prevention and causes, because, obviously, prevention is much better than treatment, and we need to obviously ensure that the treatment is appropriate. We have to remember that thalidomide was once prescribed as a way of dealing with morning sickness. So, clearly, this has been latched onto as something for dealing with incontinence and prolapse. The issue really is what we can do to support people not to have incontinence and prolapse—things like preventing third and fourth degree tears and, where possible, ensuring they're sutured by an appropriately qualified, appropriately skilled doctor.

I'm interested that other European countries systematically refer all women who've had babies to a physiotherapist prophylactically because, often, the problems that are later encountered by women aren't immediately evident but could be detected by a physiotherapist. So, a thought to bear in mind as we're considering future treatment. Of course, how much of this is something that women previously used to put up with because, before the NHS, women had to put up with incontinence and prolapse because they didn't have the money to get it rectified—. 

One of the issues that concerns me about the report is where we are told that the task and finish group approached both the British Society of Urogynaecology and the British Association of Urological Surgeons for data on the numbers who had undergone this procedure and, to date, they have not had a reply nor, indeed, the clarification that not all surgeons in Wales are necessarily registered with these bodies and, therefore, wouldn't have been able to record their data anyway. So, there's a clear indication there that we need to use digital technology to ensure that we have the data that my colleague Jane Hutt is now calling for retrospectively to be arrived at.

I'm very pleased that you're taking forward the task group in association with the anal sphincter injuries task group and the endometriosis task group, because, clearly, these are related matters, and I look forward to the linked reports when they're ready to be published. Thank you.

Photo of Vaughan Gething Vaughan Gething Labour 4:09, 8 May 2018

I'll deal with—I think there are three particular points coming from that. The first is on a point you've made previously about physiotherapy, and what I'll do is I'll try and make sure that someone from the chief nurse's office is able to provide us with a note on care for women after pregnancy and to understand the role of physiotherapy. I know you've made the point in particular about France, for example, where physiotherapy is offered as a matter of course after birth.

I recognise the point you make about voluntary registries by the two relevant professional bodies, and it is disappointing that those two bodies did not provide information when requested to in the way that it was requested.

That leads into the point around medical coding and recommendation 7, which looks at the coding that we should have available, the improvements that we could and should make in the here and now, as well as the longer term choices we have to make about understanding which implants are put into people—of whatever form, not just in this area—and understanding where that is made available, but, crucially, the requirement will be that that information is publicly available, and so I think will provide real transparency about what has been implanted and where and allow us greater transparency and audit for the efficacy both of those operations and any post-operative complications. So, there is more work for us to do, and that is definitely covered by the recommendations the report has made, and, as I say, I look forward to reporting back to this place on the progress that has been made at a future point.

Photo of Ann Jones Ann Jones Labour 4:11, 8 May 2018

Thank you very much, Cabinet Secretary.