Owen Smith
Main Page: Owen Smith (Labour - Pontypridd)Department Debates - View all Owen Smith's debates with the Department of Health and Social Care
(6 years ago)
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Dr Wollaston
My right hon. and learned Friend is absolutely right, and his point applies not only to medical devices. When it comes to relatively rare conditions, we need to look at the widest possible population base in order to detect any complications. It is also important to use the widest possible population base when detecting rare complications. I thank him for highlighting that.
If we are to have informed consent for women, it has to be based on high-quality, balanced and evidence-based information, and that has been lacking. We also need to be clear that if a medical device is altered in any way, it must be part of a clinical trial. That was entirely lacking in this situation. The types of device, including the size and thickness, were changed without anyone properly recording or following up on those changes. That has to be the key lesson for the future.
Owen Smith (Pontypridd) (Lab)
The hon. Lady is making an extremely important point. Does she agree that the issue here is that all one effectively has to prove for a follow-on device is its equivalence with the original device? There is therefore a fundamental flaw in how we license devices versus the far more rigorous way in which, for example, we license molecules.
Dr Wollaston
I absolutely agree. It strikes me that there has been a kind of wild west out there, with representatives saying, “Why don’t you try this one? This is probably going to be better”, without organisations setting up clinical trials from the start so that we could compare different devices, and without women giving properly informed consent that a different kind of device would be used. Lessons have to be learned not just for mesh surgery, but for other medical devices. Just because something sounds like it might be better, it does not mean to say that there will not be serious complications. Those complications may also happen at a late stage. We need databases such as EUDAMED so that we have access to the widest possible population base and clear device tracking.
Owen Smith (Pontypridd) (Lab)
I congratulate my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing today’s debate. This is the first occasion on which we have debated this issue on the Floor of the House—in the main Chamber—and it is a very important moment in the campaign.
I thank and congratulate all the women who have been campaigning on this issue, long before it was raised by any of us in Parliament—particularly the indefatigable Kath Samson, who has led the Sling the Mesh campaign quite brilliantly in recent years and made this such a salient issue in the media, and now in Parliament. From a personal perspective, I very much thank my own constituent, Carolyn Churchill, who came to see me about this issue several years ago and revealed to me the scale of the suffering and trauma—life-changing trauma—that she had experienced as a result of having mesh implanted. We campaigned to have her mesh removed, and that has been life-changing for her. I am delighted to see her with us today in the Gallery.
It would be easy to be extremely angry and passionate about this, but I do not want to do that today, nor do I want to list the many life-changing, debilitating ways in which people have been affected. I am sure that many other Members will speak about that. I want to speak a little more dispassionately about how we have got to where we are, the history of mesh, and some of the wider lessons. While this is a tragedy for individuals, it is clear, as the hon. Member for Totnes (Dr Wollaston) highlighted, that it also speaks to deep, substantive issues not just about mesh but about licensing, monitoring and the diffusion of devices into the health marketplace more generally.
So what is the history of mesh? Mesh was introduced in the 1970s, and withdrawn because it was not felt to be an effective way of addressing issues and because many doctors felt that there were too many side effects associated with it. Like many devices, it was then improved marginally, and it was reintroduced in the late ’90s and early 2000s. As my hon. Friend the Member for Kingston upon Hull West and Hessle said, it was marketed incredibly aggressively among doctors because it was perceived as being quick and easy—day case keyhole surgery as opposed to much more invasive, difficult and costly means of treating stress-related urinary incontinence, in particular, through colposuspension and autologous sling, using individuals’ own tissue to raise the bladder to deal with incontinence.
One understands why, in that set of circumstances where mesh was seen as safe and effective, doctors picked it up in huge numbers. In 2008-09, 14,000 women had an implant—the high point, as it were, of the usage of mesh. As my hon. Friend said, we have seen a general decline in usage over a period. Throughout that period, the Medicines and Healthcare Products Regulatory Agency, the National Institute for Health and Care Excellence, the royal colleges and Ministers in this place and elsewhere have said, in effect, that it is safe, with side effects in only 1% to 3% of patients—perhaps 3% to 5%, they have conceded on occasion, but still relatively small numbers and arguably, they say, within the bounds of acceptability for surgery.
Bambos Charalambous (Enfield, Southgate) (Lab)
Does my hon. Friend agree that had doctors not sold mesh aggressively to women, many women may not have chosen it as a way of solving their problems and may not have had the problems and complications they have now?
Owen Smith
Yes. The long and the short of it is that this has become such a widespread problem because younger women, in particular, were told by their doctor that there was a quick and easy way in which a minor inconvenience for many women—although a major inconvenience for some—could be dealt with.
Clearly, the scale of the side-effects was not apparent, for all the reasons my hon. Friend the Member for Kingston upon Hull West and Hessle listed, but notably because there is no long-term trials data in respect of devices. The sorts of complications that we now see emerge over a long period. That is why, in our country and across the world, such widespread concern about mesh has been emerging in every health market.
Owen Smith
My hon. Friend is right. The whole point of mesh is that it is designed to induce scar tissue in order to fuse the mesh with the muscle, and therefore trying to excise the mesh is incredibly difficult. That is why there are partial removals and some women are left with pieces of mesh inside them, even after surgery. Those sorts of complications are clearly very worrying. They ought to have been explained properly to women, but obviously were not, in very many cases.
Dr Julian Lewis (New Forest East) (Con)
The hon. Gentleman is making an excellent speech, and I thank him for his work. Will he go back to what he said a few moments ago about the idea of it being acceptable that 1% to 3% of cases might go wrong? It might be acceptable if we are dealing with a small overall total, but when we are dealing with over 100,000 cases, we are saying that it is acceptable for 1,000 to 3,000 people to suffer devastating, life-changing injuries as a result of this procedure. Surely that is anything but acceptable.
Owen Smith
It absolutely is not acceptable. I hope that the Minister is not going to repeat what other Ministers have said in written statements and in this place, which is that 1% to 3% is the sort of failure rate, or complication rate, that one would expect with all sorts of surgery. The reality is that the numbers are far greater than that—far, far greater—as the audit this week shows. I will come on to address that.
Lloyd Russell-Moyle (Brighton, Kemptown) (Lab/Co-op)
Does my hon. Friend share my concern that some hospitals are still advertising low failure rates, particularly for tape? That disguises the issue, particularly when they refer to failure rates in the first year and do not talk about long-term studies.
Owen Smith
Yes. We have heard that many women have this undertaken in private clinics—perhaps half of them, although we do not know how many that means. Those clinics advertise success rates very widely; we can find it all over the internet. The fact that this is described as mesh, sling, tape or ways to uplift the bladder obfuscates what we are really talking about and makes it difficult for women—and indeed, I suspect, occasionally doctors—to know the nature of what they are dealing with. What has emerged, as evidence has come through, is that there are greater problems than was appreciated. That is why, given that mesh was originally licensed to treat stress-related urinary incontinence and then extended to pelvic organ prolapse, we should be deeply concerned. Mesh is already effectively banned in our country for pelvic organ prolapse—that happened just last year. It is now to be used in research only, which is tantamount to a ban. That is happening in countries all over the world—just last year New Zealand effectively banned mesh for both SUI and POP, although I gather it may lift the ban in future. This is a worldwide problem.
We have had the audit results this week. Let us be clear that we only had an audit because of the great campaigning by Sling the Mesh, the APPG and other bodies. We asked Ministers directly to conduct it, they were good enough to do so, and I am pleased they have. The results show that far from there being just a 1% to 3% occurrence of serious complications, there is a 4% rate for complete removal of mesh. Five hundred and fifty out of the 14,000 women who were given mesh in 2008, the first year of the study, have had it removed at some point in the last decade. That is not rates of complications such as pain or sexual dysfunction: the mesh is so problematic that women have had to go back under the knife to have it cut out.
As for the complications, which the audit has tried to measure by looking at the volume of outpatient appointments, the 100,000 women who have had mesh inserted have needed almost 1 million outpatient appointments. They have gone to their GP to say they have a problem and been referred to a consultant for an outpatient appointment, whether for pain management, residual gynaecological problems or some other problem—trauma, in some instances. That must be indicative of the scale of the problem and the cost to the NHS, as illustrated by the work done for the APPG by Carl Heneghan. Some £250 million may have been spent in a decade to sort out the problems.
Mesh is a much bigger problem than has been appreciated by the clinical community, which has been incredibly defensive in dealing with it. The community must be much more open and honest about it. We have to address the issues of licensing: it cannot be enough for follow-on devices to only have to prove equivalence, or for a registry to be run simply by the royal colleges, which have been resistant in the past to having a registry. We should have a standardised process to put a registry in place to follow patients. Crucially, NICE must also get its act together. Why have we waited three years for NICE to bring forward new guidelines? It is still saying that that will not happen until next year—it needs to be done this year. This issue needs to be dealt with tomorrow.
Dr Julian Lewis (New Forest East) (Con)
I start by saying that I think the steps taken in Scotland, as described by the hon. Member for Glasgow North (Patrick Grady), sound extremely sensible as interim measures until final decisions can be taken. I echo the thanks due to the hon. Members for Kingston upon Hull West and Hessle (Emma Hardy) and for Pontypridd (Owen Smith), their associates in the all-party group, and Sling the Mesh campaigners. I also thank my three constituents, Emma, Eileen and Helen, who have all shared with me their harrowing experiences of the procedure.
There is no doubt that when vaginal mesh procedures go wrong, the results can be truly catastrophic. A letter from the Minister states clearly that
“women have suffered atrocious and debilitating complications”
from these implants. Her counterpart in the Upper House, Lord O’Shaughnessy, has conceded this:
“While these treatments can be effective, in a small minority of cases meshes can cause serious long-term injury and disability, and prevent or reduce the ability of affected women to work.”
According to a letter from the Health Secretary to parliamentary colleagues in February:
“Clinical experts here and abroad agree that, when used appropriately, many women gain benefit from this intervention, and hence a full ban is not the right answer.”
I find it difficult to follow that logic. There might be an acceptable argument if we were talking about a procedure in which the numbers of interventions were in the hundreds, but, as I said in an intervention and as the hon. Member for Pontypridd (Owen Smith) endorsed, we are talking here about over 100,000 people. When we are talking about over 100,000 people, if even the Government’s low figures of 1% to 3% going badly wrong are right, that is still 1,000 to 3,000 people. I have been given, by my constituent Emma, a leaflet from Sling the Mesh that says that its estimate is that at least 15% of people are seriously and badly affected. On that scale, we are talking about over 15,000 people being seriously damaged by this procedure.
Owen Smith
I thank the right hon. Gentleman for giving way and for his kind remarks. Would he be surprised to learn that the chief medical officer, Dame Sally Davies, speaking alongside the Health Secretary in a Facebook Live broadcast just a few months ago, said that she thought the serious complication rate was between 15% and 20%? I have written to her asking where she got those numbers, although as far as I am aware she has not replied to me, because that is at odds with all the previous comments by Ministers and officials.
Dr Lewis
Indeed. I would be surprised at that, because if that is what Dame Sally believes she ought to be making different recommendations.
I have been given a particular study, which is described as the largest study of surgical mesh insertions for stress urinary incontinence. Over 92,000 women were surveyed in this particular examination, including all NHS patients in England over an eight-year period. The conclusion states:
“We estimate that 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally within 30 days or within five years of the initial mesh insertion procedure. This is likely a lower estimate of the true incidence.”
I reiterate my point about acceptable and unacceptable percentages. When we are talking about these very large numbers, even relatively low percentages make the procedure too risky to be used in anything other than last-resort circumstances similar to those described by the hon. Member for Glasgow North.
In the past decade, my constituent Emma has undergone X-ray-guided injections, ultrasound scans, MRI scans, in-patient stays, tests galore, more and more scans, and, eventually, a biopsy. She has been refused referral to a mesh specialist centre. It seems highly likely that she should never have been given a mesh implant in the first place after the trauma of such a difficult birth, which leads me to the next point about inadequate warnings. I understand from my constituents that they were given little warning, and in many cases no warning at all, about the potential dangers.
Kevin Foster (Torbay) (Con)
It is a pleasure to be called to speak in this debate, and I congratulate the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing it. It has been quite something to listen to the many stories that have been repeated here this afternoon. My involvement in this issue was prompted not only by conversations with my former colleague in the Ministry of Housing, Communities and Local Government, my hon. Friend the Member for Eastleigh (Mims Davies), but by the case of my constituent, Mrs Beverley Jelfs, who had mesh inserted for a prolapse.
When she emailed me, she said:
“My life has changed so much since having this device inserted in me in 2011. I can no longer work due to pain, fatigue, not able to sit or stand for long. The mesh eroded through my vaginal wall, which 7 weeks later had to have part removal. I have no intimate relationship with my husband, due to the mesh damaging me…I have gone from a very busy and socially active life, to being a depressed lady.”
That sums up the impact that the issue has on her. Although her work was done at a local private hospital, I also asked my local Torbay Hospital—the main NHS hospital serving my constituency—for details of the approach it adopted.
Given the age demographics of Torbay, I had expected slightly more cases to be raised with me. Those that have been raised involve people who have been treated at a particular private hospital. Given that this is a wider issue, I do not think that it is constructive to bring the name of the hospital into the debate, but it is interesting to note that that is where these queries come from.
I was pleased to get a detailed response from Julian Barrington, the consultant in obstetrics and gynaecology at the hospital, giving me some of the figures for the work he has done. I am pleased to note that the failure rates reported back on some of his cases have been a lot lower than some of the averages, but in his letter he makes the point that none of the patients in Torbay has been treated with Ethicon meshes, over which most of the concerns and complications have arisen. His other comment is welcome: given some of the issues being raised, since October 2017 he has suspended all vaginal surgery using synthetic mesh until the results of the NICE recommendations are published and until professional medical bodies make a decision.
Owen Smith
The hon. Gentleman is making an incredibly interesting point. Does he agree that it is inexplicable that NICE continues to say that it cannot produce its new guidance until the spring of 2019, when we and the medical fraternity have been asking for it for the past two years?
Kevin Foster
I think that the comments make it clear that medical practitioners are waiting to hear what the guidance is and would like it as soon as possible. As politicians in this Chamber, we should not necessarily look to say what the NICE guidance should be and should not put pressure on NICE to come up with particular outcomes, but NICE should look to resolve this uncertainty.
I welcome the pre-emptive approach that my local hospital has taken, but that then leads to a debate about whether other practitioners are continuing and whether my hospital is taking the right approach—I believe it is, and I suspect that Opposition Members who have been involved with this issue believe that it is, too. It is clear that guidance needs to be produced as quickly as it sensibly can be to allow hospital clinicians dealing with patients day to day to know that they are making the right decisions. I welcome the fact that my hospital has made a pre-emptive decision, but agree with the hon. Member for Pontypridd (Owen Smith) that it makes sense for NICE to try to resolve the issue as quickly as possible and provide clarity.
It would be interesting to hear from the Minister whether it is becoming common practice in the NHS for individual hospitals and surgeons to adopt the approach taken by Torbay and South Devon NHS Foundation Trust. Is it more common or does it involve only a small number of hospitals? Is there an emerging body of medical opinion on this matter? Although I might welcome what Torbay Hospital has done, if individual hospitals effectively start forming their own policy that will raise questions in other locations.
Given the concerns raised with me, I welcomed the review announced in February 2018. I can remember being in the Chamber to listen to the Secretary of State’s statement on this and a range of issues affecting women’s health, as well as on whether some of the processes we have in place are as strong as they are in other areas. To reflect on the point made by the hon. Member for Glasgow North West (Carol Monaghan), given the issue, many of those affected are reticent about making a noise. I sought direct permission from my constituent to mention her name and condition in the Chamber, but one wonders whether there are a number of people who do not want to make a noise about this—through embarrassment, to put it bluntly—which makes it different from concerns about other treatments.
I would also be interested to hear from the Minister what liaison is taking place between the UK Government and the Governments of New Zealand and Australia, who have adopted an approach that is similar to my hospital’s. What impact is that having? I have not had complaints from people about not being able to have a procedure for a particular problem while this treatment is suspended, and that tells me that the hospital’s decision has not had a negative effect. I would be interested to know the experience of clinicians in other jurisdictions that are incredibly similar to ours, particularly those from New Zealand.
Reading the motion, I can understand the call for a public inquiry. My only reticence is that such inquiries can become lawyer-fests. I would much rather we were dealing with the situation now, and getting guidance to clinicians in place quickly. We could decide at a later date, perhaps, whether such an examination of what happened would be appropriate. For me, the priority is to get action towards a resolution and for those women and men who have been affected to find medical solutions that can deal with their existing, ongoing pain.
I welcome the debate. It is good to have had contributions at such a level. I am pleased to note the approach my local trust has taken, and I would be interested to see whether that trend is emerging across the NHS and, if it is, what impact it is having on statistics for those who are negatively affected. Does it have any impact at all on waiting times for a particular treatment? If it does not, the pre-emptive approach would seem to be right clinically, in dealing with the problems we have heard about today and in preventing more people from being affected.
I hope that today’s debate will also give hope to those who are suffering that their plight has not been ignored—it is not something that has been talked about quietly somewhere else because of any perceived embarrassment. I hope that lessons will be implemented that prevent others from having to go down the same path as my brave constituent, Mrs Jelfs. I know that her priority in speaking out and having her story relayed was to prevent at least one other person going through what she has been through over the past seven years.
Dr Whitford
I thank the hon. Gentleman for his intervention. In fact, there are studies showing how difficult it is even to explain risk, let alone risk-benefit, to patients. Certainly in the cancer field, in which I spent so much time, patients will go through really appalling treatments even if there is only a relatively small chance of cure. As a clinician, it is difficult to explain a lot of this.
Sufficient information has not been given to the medics, and therefore clearly not to the patients. We have heard this described as a “minor, straightforward procedure”.
Owen Smith
Does the hon. Lady agree that part of the problem is that mesh was marketed so widely as being a quick fix? Previously, far more expert urogynaecological surgeons would have undertaken what was far more difficult and invasive surgery—colposuspension or autologous sling. When it went to day-case surgery and, effectively, keyhole surgery, a much wider range of less expert surgeons was suddenly involved.
Dr Whitford
I would echo that. We should always be a little suspicious whenever an impression is given that an operation is easy and quick. We hear talk within the medical system of the problems of specialisation and how, actually, we need to go back to having more generalists. The depth of knowledge on breast cancer now would make it impossible for a general surgeon, who might also be doing upper gastrointestinal and lower gastrointestinal surgery, to keep up with that knowledge. That is why we will always need specialists. The danger is when something is thought to be trivial and straightforward.
Although it has been mentioned that the two problems—pelvic organ prolapse and stress incontinence, and particularly the latter—are very minor, there is a broad range. There will be patients for whom the condition is incredibly distressing and who simply cannot leave the house because of their incontinence. We should not put everyone in the same basket.
As has been mentioned, the traditional repair for prolapse would have been colposuspension, which lifts the womb and then buttresses the muscular tissues of the pelvis. The surgeons thought that by adding mesh to muscle that is clearly weakened—that is why prolapse happens in the first place—they would make the muscle stronger.
There was a perception that the results of colposuspension were poor, and a big American paper in 1997 suggested that prolapse recurred in 29% of women. As a surgeon, that seems like catastrophic failure, but, reading the small print of that paper, two thirds of those women were hugely obese and one third had bronchitis and were coughing all the time. There was also a high rate of smoking. It was not the average range of women with prolapse; it was actually a particularly high-risk group. Unfortunately, the paper seems to have dominated the profession’s perception for years.
The problem right across this is that not enough trial work and research were done at the beginning and that the follow-up was far too short. What we have seen is that the mesh problems emerge only after time goes on. There was a Cochrane review in 2007 looking at multiple smaller studies, and it showed no benefit from the use of mesh in prolapse. Since then, we have seen a slow decrease in the use of mesh, but the recent review shows that 2,500 women with prolapse in England had mesh put in last year. That means the issue is still happening.
A 2011 EU study showed no benefit from mesh in prolapse even for recurrence, and one of the few prospective studies, in which the data is collected as time goes on, also shows no benefit. That prospective study was published in 2016, so the information has not been available for decades, and it found that the mesh complication rate at two years is 12%. That is at two years, so the rate can only go up. The Scottish review of 20 years of data from 1997 to 2016 shows only a 4% recurrence of prolapse after the traditional repair. Mesh is no better at avoiding recurrence.
Colposuspension has surgical complications: a surgeon might damage something; a surgeon might injure the bowel or bladder, which is much more common; or a patient might get a wound infection. Those complications fade as time goes by whereas, as has been reported in the Chamber today, the mesh complications do not occur early, but occur as time goes on. In Scotland, after the review, the advice is absolutely clear: mesh should not be used in cases of prolapse as a routine first procedure.
We have heard about stress incontinence and the option of physiotherapy has been talked about. That option should have been used much earlier; there should have been trials of it. As has been said, this is about getting to women in the post-childbirth period so that we have the chance of strengthening their pelvic muscles. The initial repair for stress incontinence was the tension-free vaginal tape, which developed in the late 1990s. A randomised controlled trial was carried out in 2002, with the one-year follow-up report finding only a 1% complication rate and finding that the patients had less pain, and that they recovered more quickly and went home more quickly. This seemed like a great solution, which is part of why the surgeons were so convinced by it; it seemed quick and easy. They were talking about a keyhole approach and the way we deal with gallbladder and other procedures.
The problem that has gone on since has been talked about. We have had the morphing of one tape into another, and one material and so on changing, with little other research having been done and little follow-up. When that trial did follow up its patients, it found that at 10 years the mesh complication rate was 5%. Because the focus was on not injuring the bladder, we find in clinical terms that that has been the focus of the clinicians, because that is what they knew from colposuspension. The idea that two, three, four or five years later people would develop mesh complications was something the clinicians were not expecting and certainly not looking out for.
The incidence of bladder injury for the retropubic tension-free tape was about 10%, which is why the transobturator developed. Someone who has seen an X-ray or a pelvis skeleton will know that the front of the pelvis is made of two struts, so that we are not so heavy that we cannot actually stand up, and the obturator is that hole. The idea was to keep away from the bladder and therefore reduce bladder injuries, and indeed this did that.
Bladder injuries were reduced from 10% to 1%, so, again, everybody was patting themselves on the back. But what happens is the spikes—the trocars—used to put these things in are going through muscle and close to nerves, and are coming out in the groin; they are coming near the muscles that allow people to pull their thighs together. That is where a lot of the side effects and complications have come, and there was definitely a huge upswing and surge in these complications after the obturator tape became the common approach. We also had such slow recognition of what was happening. Many of us women in here, particularly us women of a certain age, will recognise that old story of women simply being dismissed, patted on the head and patronised.
An odd quirk of regulation is that the Federal Drug Administration’s regulation 510(k) allows any similar devices to pass through in a very simple fashion and they are not re-examined. Class I is low risk, and initially these tapes were all classed as class I, which means no research had to be done. They are now class III, which means a randomised controlled trial is required, and we see that Johnson & Johnson, and others, are withdrawing; they are stopping making these things because they would have to go back to carry out trials. The problem is that the tape and the trocars might have looked similar, but when the move was made from tension-free retropubic to a transobturator tape, we were talking about a totally different operation, and there was simply no evidence to show that this was either similar or better.
If something has been passed by the FDA, it tends to get passed in Europe, and the Medicines and Healthcare Products Regulatory Agency tends also to accept it without doing anything else. The European CE mark is only a mark of the quality of production; it does not imply anything about research. As my hon. Friend the Member for Glasgow North (Patrick Grady) mentioned, there is a plan to develop the EU medical devices regulation system from 2020, but, unfortunately, the UK will not be part of that, unless there is a specific negotiation.
The problems began to be recognised in 2012, because of the campaigners, their persistence and their speaking out. In 2014, the then Cabinet Secretary for Health and Wellbeing, Alex Neil, advised all health boards in Scotland to suspend meshes until there was some degree of clarity. It might have been stimulated by that, but certainly at the same time the Australian Therapeutic Goods Administration started to look at its products, immediately de-licensing a third, reviewing a third and, initially, keeping a third as standard. But last November it de-registered all prolapse meshes, so these materials are simply not available in Australia.
The Scottish independent review was set up from 2014 to 2017, and its advice was unequivocal: there should be no routine use of mesh for prolapse, and as regards incontinence, if mesh was being used, registration was made mandatory. There has been discussion about where this registration will occur. Obviously, the colleges have been developing a registration, but we need to know about everyone who had a mesh in. This could be done through scanning the barcode off the mesh and registering it in the notes—that is the obvious way to do it. Having had to review all the case sheets of breast reconstructions after the PIP— Poly Implant Prothèse—silicone implants scandal, I know that it is really important that if something is being left permanently in a patient, we know how to recall it and who had that done.
As has been mentioned, we had the NHS England review and a paper was produced last year, using hospital episode statistics, that showed a 9.8% complication rate at five years. Again, we can expect that to climb. The review published on Tuesday showed that about a third of the 72,000 patients who were treated for prolapse were treated by mesh; that is between 2008 and 2017, and we see a fall over time, so the rate might be higher during the earlier period between 2000 and 2008.
We have seen a 13% drop over that time in prolapse meshes, but, as I say, in prolapse they have utterly no benefit and therefore there can be only loss, so it is hard to justify why so many patients in England are still having prolapse meshes. Some 100,000 women have had mesh incontinence tapes, and this has decreased by 48%, meaning that the overall decrease in the use of mesh over that period is about 32% in England. Since the Scottish inquiry, the reduction in the use of mesh has been 94%—and that is continuing.
The hon. Member for Kingston upon Hull West and Hessle mentioned Dr Wael Agur, whom I am lucky enough to have as our local gynaecologist. I have been able to meet him and get information with him. The only places that are using incontinence meshes are the two specialist units in Glasgow and Edinburgh. In Scotland, a consent process has been developed, which is now being looked at by the colleges so that it can be rolled out, and, obviously, we are talking about usage in tiny numbers here.
Even though registration is mandatory, none of the other health boards is doing this, so it is not expected that Scotland will have many patients registered. What Dr Wael Agur and other colleagues are using is a small piece of rectus sheath, which is the tough tissue we have in front of our muscles. Those who are lucky enough to have a six pack—I do not see many in here— will find that that is very strong tissue. [Interruption.] We do not ask anyone to show them, please. Only about 6 cm of this is required. So we are using the patient’s own tissue and we will be back to an autologous repair, where there might be complications, wound infections and failures, but we would not see this progressive problem.
So what went wrong? Not enough research was carried out and, categorically, there was not enough follow-up. The survey that was reported on Tuesday now gives NHS England a denominator of how many patients have had mesh, but I am sorry to say that just using hospital episode statistics does not give a numerator as to how many women have problems, so I suggest a survey of all those patients or a review is necessary, in order to know how many, even within the NHS, have got these problems.
In addition, as we have heard, there was poor information on which people could base their consent; as I say, the clinicians did not know, because no detailed trials were being done of these new techniques and certainly there was no decent audit. Women were being dismissed and patronised. The regulatory system was far too complacent, simply taking things from the FDA all the way to the MHRA and not looking at changes in technique. The audit was very poor, with a recent survey showing that only 27% of patients who had had meshes were registered.
Finally, the yellow card system failed, yet again. The hon. Member for Congleton (Fiona Bruce) mentioned the other scandals associated with sodium valproate and Primodos. Unless patients are aware of the yellow card system and unless GPs and doctors have it literally in the front of their brains, people will not send a yellow card until they are sure that the drug or the mesh caused the problem. For any new drug, for any new technology that is being implanted, and for any baby born to a mother on medication, there should be a yellow card, because the whole point of the yellow card system is that someone centrally is able to notice. That is why we need more of these yellow cards. There is clearly a problem, so we need better registration and reporting, so that we do not have to have another similar debate in future.
Jackie Doyle-Price
It is actually an issue of rigorous process. We need to make sure that NICE guidance has clinical integrity. The guidance to which the hon. Gentleman refers comes at the end of a longer process of other guidance that is going through the system. None the less, that intelligence is shared throughout—it is an entirely consultative process. The issues that we need to settle are all part of the public debate. Essentially, the publication of the NICE guidance comes at the end of that. The important thing is that everyone knows the issues and that we are very clear about the context in which this is an appropriate treatment. The guidance is very clear: this treatment should not be offered as a routine first intervention.
Owen Smith
I am not sure that that answer is correct, in as much as we know that there is no new clinical evidence to be produced in this area; there are no outstanding trials. Therefore, there is no reasonable reason why NICE cannot bring forward that guidance, and it certainly does not make sense for it to wait another year.
Finally, was the Minister surprised when the chief medical officer, who was sitting next to the Secretary of State, said on Facebook Live that she thought that the rate of complication in respect of mesh was between 15% and 20%—a stark difference from all previous estimates by Ministers or officials?
Jackie Doyle-Price
Let me emphasise that it is the robustness of the process that is at issue here. The guidance will be published for consultation later this year, and completed next year. There is a robust process for doing so.
The hon. Gentleman is right that the CMO suggested that there was a 15% to 20% complication rate, but I understand that she has written to him explaining that she misquoted the statistics and that the situation is more complex. That is one reason why the retrospective audit is so important. We now have a body of evidence that we can properly analyse, and as has been mentioned, my noble Friend Lord O’Shaughnessy has tasked the CMO with properly analysing the audit published this week so that we might more quickly draw conclusions.
Owen Smith
That is very interesting. I do not believe I have received a letter from the chief medical officer explaining that she got the statistics wrong. May I press the Minister to make sure that when the CMO looks at the register she offers a proper narrative analysis of what the numbers mean? We still have contested analyses of whether they show a bigger problem than we thought or whether it is the same. I think it shows a much bigger problem, but we need to understand the numbers.
Jackie Doyle-Price
I can absolutely give the hon. Gentleman that assurance. It is crucial that we address the matter transparently—that is very much the spirit in which I want to take this forward.