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.
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 an 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.