Licensing of Medical Devices

Owen Smith Excerpts

Tuesday 12th February 2019 Commons Chamber

[Owen Smith (Pontypridd) (Lab)]

I rise to talk this evening about medical devices and the way in which they are licensed and regulated. They are a very important and growing part of medicine, and they can save and transform lives—indeed they have done for millions of patients over many generations. However, when faulty or poorly designed or poorly looked into and proven, they have also damaged, and indeed ended, the lives of many thousands of patients around the world. My principal point is that the regulatory system for medical devices in our country, and across Europe and arguably the wider world, is simply not fit for purpose and must be properly reformed.

The term “medical devices” is rather vague. It refers to everything from bandages to syringes through to heart pacemakers and artificial joints, and I want to be clear that what I am talking about is the more complex end of the spectrum: the more high-risk, class III as they are called, implantable devices.

[Mark Tami (Alyn and Deeside) (Lab)]

I want to put on record my thanks for all the work my hon. Friend has done on mesh. Does he agree that we must be careful that what might appear to be a relatively cheap quick fix can turn out to be a massive problem for a lot of patients?

[Owen Smith]

I thank my hon. Friend for his thanks, and I will talk about mesh shortly as it is illustrative of the wider problem.

The problem is best summed up not in my words but those of the Royal College of Surgeons, which said at the tail end of last year, in response to a big journalistic investigation, that we need to see in our country urgent and drastic regulatory reform and in particular that we need to start with the creation of a compulsory register for all new devices and implants that go into patients in the UK. Will the Minister commit to that?

Let me give a couple of examples of what I am talking about. Last year alone in the UK surgeons operated on patients for 80,000 knee joints, 60,000 hip replacements, 50,000 pacemakers and 7,000 usages of surgical vaginal mesh, down from its height in 2008 when there were 14,000 instances of surgical vaginal mesh inserted into women. Let me pause for a moment to talk about that example of vaginal mesh and why its use has declined so precipitously. The answer lies in what I am talking about—in the development and marketing, and the fact that, as with so many of these devices, their true safety and efficacy is only revealed in the real world once they have been implanted into patients, and sometimes after many years. Many of the variants of vaginal mesh, like most of the other devices now on the market, are developed without any real clinical trials, and certainly without the randomised controlled clinical trials we are familiar with in respect of medicines; that is an extraordinary fact. We understand why that is the case, but there are other ways in which the device manufacturers could ensure their devices were safer and definitely not going to harm patients.

[Paul Masterton (East Renfrewshire) (Con)]

I pay tribute to the hon. Gentleman for the work he does as chair of the all-party group on surgical mesh implants. He will be aware that when the Medicines and Healthcare Products Regulatory Agency appeared before the Public Petitions Committee in the Scottish Parliament it admitted that its verification process for use of mesh implants amounted effectively to a two-week desktop exercise carried out by three people at a cost of £20,000. Does he agree that that example fundamentally shows that the way the MHRA is reviewing these devices is not fit for purpose, is completely inadequate and, as we know from the work of the APPG, puts patients, and in the case of mesh implants lots of women across the UK, at risk?

[Owen Smith]

The hon. Gentleman, who has also done excellent work on mesh as co-chair of the group, is completely right.

Our regulatory system for these devices, including mesh, is more akin to the system that applies to toasters or plugs, and the way in which they get kitemarks, than to the way in which medicines are approved. It is so problematic that, last year, the journalist I was talking about applied to get a kitemark—known as a CE mark—for surgical mesh. However, the item in question was a bag that had previously been used to keep oranges in, but they still succeeded in getting a CE mark for it. It obviously was not put into a woman, but real mesh has been and is being put into thousands of women all over the world, including those suffering from organ prolapse and stress urinary incontinence. The real impact of the mesh has been revealed in the chronic pain, disability and even death suffered by many women as a result of the mesh warping, breaking, morphing, changing its constitution and cutting into organs inside the body. This was revealed only after years of sales.

[Mr Paul Sweeney (Glasgow North East) (Lab/Co-op)]

My hon. Friend is making a powerful speech about the devastating impact that mesh has had on women. I discovered the real impact of it when a constituent came to visit me on Friday. Wendy talked about the impact that it had had on her life. She said that she had been concerned about the mesh and had discussed it with her surgeon, who had insisted that it was not mesh but tape. She was therefore misled by a medical professional. Does my hon. Friend agree that that is another worrying aspect of how these medical devices are being marketed and communicated to patients?

[Owen Smith]

Yes, I absolutely agree. There are many instances of similar mis-selling of these products to women. We need to examine the relationship between the doctors who are selling or marketing these products to their patients and the companies that develop them. Some have an interest in those companies, and others are getting a money benefit through doing this in the private sector. All these things desperately need to be looked at.

The terrible truth is that the surgical mesh scandal that is unfolding is just one of the scandals relating to medical devices. We had the metal-on-metal hip joint scandal, with metallosis poisoning people’s bodies. We had the scandal of textured PIP breast implants poisoning women’s bodies. Those implants are now connected with increased incidences of cancer. We had spine-straightening devices for children that were only ever tested on corpses. We had pacemakers such as the Nanostim, which was designed to sit inside the heart and work for up to 19 years. It has now been removed from the market because the batteries started to break down and cease to work and, worse, it was giving people electric shocks. The devices are now being cut out of people. Between 2015 and 2018, UK regulators alone received reports of 64,000 adverse events involving medical devices. A third of those incidents resulted in serious medical repercussions for patients, and 1,004 resulted in death.

[Ann Clwyd (Cynon Valley) (Lab)]

I would like to pay tribute to the tremendous work that my hon. Friend has done on mesh. Quite a number of people in my constituency have suffered as a result of the use of mesh, and they are extremely grateful for the work that he has been doing. About 20 years ago, we had the scandal of silicone implants, and someone in my constituency had a double mastectomy because the silicone had leaked inside her body. These problems are still happening. We set up a register, but suddenly the register disappeared. I am glad that my hon. Friend has made a point about the register and asked for the Minister’s commitment on this.

[Owen Smith]

I am grateful to my right hon. Friend for her kind words. She is completely right to say that there are devices on the market here and across the world that are still causing grave medical problems for patients. The question we have to ask is: how did these things get on to the market in the first place? How have we got so many of these devices that are causing such significant problems? The common problem that unites mesh with all the other device scandals in our country and across the globe is the weakness of the regulatory system in the UK, in the EU and, to a lesser extent, in America, where the pathway for testing approval, marketing and surveillance of such devices just is not good enough.

How does the system work? It will shock people to hear that we do not have a central body that is responsible for checking out, authorising and licensing devices in the same way as for medicines. If a company in the UK wants to create a new prosthetic hip joint, it does so and then it shops around among a group of what are called notified bodies. These are effectively commercial organisations that are in turn licensed by the MHRA to be a body that checks safety and efficacy through the clinical data provided by the companies and then gives them their conformité Européenne—their EU kitemark. Once a company has received that mark, the device can be sold all across the EU.

Companies do not need clinical trial data in order to substantiate their claims that devices are efficacious and safe. Quite often—this is true of a remarkable proportion of the devices on the market—they do not even have to undertake first-hand clinical evaluations themselves and can rely on being follow-on products that go through a regulatory pathway that is termed as being “substantially equivalent” to the products that have gone before. For instance, there are examples of mesh on the market now that are the 61st iteration of an original licensed mesh that is no longer on the market because it was proven to be dangerous. There is no real mandatory post-marketing surveillance of these devices.

Given that the difficulty of randomised control trials versus placebo for a device—someone cannot put a wooden heart into one patient and a pacemaker into another in order to see which one works—means that there will be a degree of risk in testing such things in the real world, one would think that we would have a system that would test how devices are doing in the real world and get companies or the Government to monitor them, but we do not, which is in stark contrast to the regime for medicines. Changes are coming into effect, however. A new medical devices regulation was launched across the EU in 2017 and will come into effect in May 2020. It was introduced with the acknowledgement of many of the problems that I have highlighted.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Gentleman on securing this debate on an issue that is important to many of us. With the EU’s new medical device rules coming into place in May 2020, as he says, does he agree that the number of available notified bodies is already diminishing? The Government must be aware of that and must work to find a way to secure acceptance of UK notified bodies as part of any arrangement, allowing for the smooth transition of notified bodies and product certification.

[Owen Smith]

I agree in part with the hon. Gentleman. One thing that I did not say earlier is that there are 50 notified bodies across the EU, so if a company goes with its new artificial hip to one body and says, “Will you approve this for my CE mark, because I would like to sell it in the EU?” and the body says no, because it does not think the data is good enough, all the company has to do is go to the next notified body, and if it says no, the company can go to the one after that, and if the third body says no, the company can go to the fourth one. Neither any of the notified bodies nor the manufacturer are under any obligation to disclose that the device had been turned down earlier. I agree that fewer notified bodies would be a good thing, but there are big questions for us in the UK because we will have no notified bodies once we have left the EU.

There are other problems with the new directive, which is a strengthening of the regulations, but it is not strong enough. For example, it now says that companies should summarise their clinical trials data, that they should take clinical data that is, if possible, sourced from clinical investigations carried out under the responsibility of a sponsor—meaning something more akin to randomised control clinical trials—and that they should ordinarily have a quality management system and a post-market surveillance system that should be proportionate to the risk class of the device in question. However, the point is that none of those things is mandatory.



There is no mandatory requirement to conduct proper trials or to max out the tests that are done. There is no mandatory requirement to publish data. There is no mandatory requirement to publish all data, including negative data. There is nothing to stop the companies continuing to conceal data, or shopping around between different notified bodies, and there is nothing to stop the companies doing the bare minimum on surveying how their product is doing in the marketplace. The directive is a strengthening but, unfortunately, it is not the strengthening we need.

If we leave the EU, the directive will not necessarily apply in all regards in the UK. The Government have tried to respond to the concern voiced by others before me by saying that they will effectively apply the regulation in future, but that would bring difficulties in and of itself. As I said, we would effectively be accepting products that are kitemarked and approved elsewhere in Europe, and not by our own notified bodies, because we will not be part of that system any longer. I assume we will be using the European database on medical devices, which is designed to work right across Europe, but we will not be part of the expert panels that reflect on the findings reviewed through that database.

Crucially, I assume that the MHRA will be filling some of those gaps. It will already have an almighty job on its hands in trying to fill the gap on medicines once we are outwith the purview of the European Medicines Agency. I fear that devices will once again be the Cinderella of the medical game. We did not have regulations for devices at all before 1990, and we may find that we are playing catch up with the European Union in future.

Whichever way Brexit turns out, and in reflecting on the flaws in the regulatory system I have highlighted, I ask the Minister, first, to try to get the MHRA, or whatever replaces our current regulatory pathway, to go back to the first principles of protecting patient safety at all times. There is too much talk in Europe of maintaining our advantage over other markets as an early adopter of innovation. Well, early adoption can go wrong if the innovation has not been adequately tested, and mesh is a great example.

Secondly, will the Minister do what the Royal College of Surgeons has asked her and the Government to do and set up a national registry of all “first implanted into a man or woman” devices—the innovations—so that we can track what happens with those devices, as we should have been able to do with mesh? Thirdly, will the Minister make sure that whatever system we have imposes much more stringent obligations on companies to undertake the most rigorous tests in respect of such medicines? In any new system, we should rule out anything like the substantial equivalence model that has been deployed in Europe for so long. It seems crackers to have a system that is basically a paper-based exercise without any real-world tests.

Lastly, I would like our Government to follow the example of the Australian Government, where the Minister’s counterpart, Greg Hunt, issued a national apology to the many women whose lives have been ruined by the debilitating effect of pelvic mesh implants:

“On behalf of the Australian government I say sorry to all of those women with the historic agony and pain that has come from mesh implantation, which have led to horrific outcomes”.

Our Government should similarly apologise to women damaged by surgical mesh. Irrespective of how Brexit turns out, they should pledge to radically reform the regulatory pathway for this class of medicines in order to make sure that no patients, men or women, suffer, as patients have in the past, as a result of medical devices.

Oral Answers to Questions

Owen Smith Excerpts

Tuesday 23rd October 2018 Commons Chamber

[Owen Smith (Pontypridd) (Lab)]

Every week in this country, two children are born with spina bifida or anencephaly, and I am delighted that the Minister has just announced the consultation on the fortification of flour, which could stop 70% of those birth defects. Can he tell the House how quickly he hopes to bring about the conclusion of the consultation?

[Steve Brine]

Let me just pay tribute to the hon. Gentleman for the work that he has done, bringing this matter to the fore and really pushing it forward. The answer is as soon as possible. I also want to make sure that I can involve the other agencies. Public Health England will be very important in this, because, of course, not every woman eats bread and therefore takes the flour supplement.

Fortified Flour

Owen Smith Excerpts

Wednesday 16th May 2018 Westminster Hall

[Owen Smith (Pontypridd) (Lab)]

I beg to move,

That this House has considered the mandatory fortification of flour with folic acid to prevent spina bifida and anencephaly.

I am delighted to serve under your chairmanship, Mr Hanson, in this important debate on the potential for the mandatory fortification of flour with folic acid to prevent neural tube defects. Every week in this country two children are born with a neural tube defect, most commonly spina bifida and anencephaly, and every day two pregnancies are terminated as a result of the diagnosis of such conditions in the womb.

The neural tube is the structure in the embryo that becomes the brain and the spinal cord. It should close between the 18th and 28th days after conception. Failure of the neural tube to close completely and properly leads to conditions such as spina bifida, affecting brain development, mobility, and bladder and bowel dysfunction—other right hon. and hon. Members have personal experience of that and will talk with great knowledge about it—and anencephaly, a fatal condition in which the brain does not develop.

In 1991 a seminal piece of research on prevention of neural tube defects for the vitamin study group of the Medical Research Council by Professor Sir Nicholas Wald showed conclusively that supplementing the diets of women with folic acid, a naturally occurring nutrient found in spinach, liver or Marmite, prior to conception and during the first trimester of pregnancy could reduce the incidence of NTDs by up to 70%. In response to the data, the Conservative Government at the time introduced new guidelines that recommended that all women should take supplements of folic acid prior to conception and during the first 12 weeks of pregnancy.

Eighty-one other countries around the world, however, including the United States, Brazil, Australia, South Africa, Nigeria, Indonesia, Argentina and Canada, took a far bolder position, mandating the fortification of flour and flour-based products in their countries with folic acid as a public health intervention for whole societies. They did so having recognised the data and the long-established fact that at least 40% of pregnancies are unplanned, so NTDs might develop in the womb often even before those women realise that they are pregnant.

The recommendation of voluntary supplementation in our country led to an initial increase in the number of women taking folic acid before conception. The proportion went up to 35% in 1999,but by 2012 it had started to fall back, to just 31%, with much lower numbers seen in the more deprived socioeconomic sectors of society and in black and minority ethnic communities. Among pregnant women aged less than 20, on average just 6% supplement their diet before conception.

In short, the position that we have taken in our country under successive Governments has led to increasing health inequalities, with poorer, more marginalised and younger women having greater risk of their children being born with spina bifida or other conditions. By contrast, in the United States, which in 1998 started mandatory fortification of rye and wheat flour, and in 2016 introduced a new programme to fortify corn flour so as to target the Hispanic population, we have seen a reduction in NTD pregnancies of almost 30%. In Canada, one study of the prevalence of NTDs showed a drop from 4.56 births per 1,000 to 0.76 per 1,000 after fortification. Had we in this country followed the same route as Canada or the US, we would have seen 2,000 fewer pregnancies with a neural tube defect between 1998 and 2012. That is a sobering thought for the advisory committee in the UK to consider.

In fact, the scientific evidence in the case for fortification is not really contested. That is why the Scientific Advisory Committee on Nutrition to this Government and previous ones—it used to be called COMA, the Committee on the Medical Aspects of Food Policy, but understandably changed its name—back in 2000 responded to the evidence and to the US move by recommending that our country should go down the route of mandatory fortification. SACN repeated that recommendation in 2006, in 2009 and in July of last year.

The most recent SACN report, surveying all the evidence available around the world about the benefits and the possible adverse consequences of folic acid fortification, stated:

“Conclusive evidence from randomised controlled trials…has shown that folic acid supplementation during the early stages of pregnancy can reduce the risk of the fetus developing neural tube defects”.

It goes on to maintain its view, expressed consistently by scores of scientific advisers to the committee over the years, that Britain should be fortifying our flour to prevent NTDs. The key question as far as I am concerned—not as a clinician or expert, but as someone who understands the value of evidence-based policy making—is this: why have this Government and previous Governments not acted on the advice and the evidence to take similar steps in our country?

The principal excuse offered by Ministers is that the evidence is mixed and that some studies have shown some possible risks associated with having higher levels of folic acid or folates in our bodies. In particular, two risks have been talked about: first, that higher levels of folates may mask vitamin B12 deficiencies in individuals, possibly leading to anaemia and neurological damage; and secondly, that higher doses of folic acid might run the risk of increasing the likelihood of certain cancers. As far as I can see, however, all the evidence and the science produced over the intervening 25 years have largely debunked such concerns.

The SACN has looked at all the evidence in last year’s review and previous ones and stated, on the issue of B12, that folic acid intakes up to 1 mg per day are not associated with neurological impairment in older people with low vitamin B12 status. The most recent SACN review stated that

“studies of folic acid supplementation and observational studies, indicate either no relationship with cognitive decline or a lower risk associated with higher folate status.”

It goes on to note:

“The prevalence of vitamin B12 deficiency with or without anaemia did not increase after mandatory fortification in the USA.”

Since the SACN provided that evidence, a further, critical study has been done by Professor Sir Nicholas Wald, who produced the original research suggesting the use of folic acid in flour, and Professor Sir Colin Blakemore, who is well known to right hon. and hon. Members. The study shows definitively that there is no evidential base for the suggestion of a maximum tolerable level for folic acid. The question of it masking vitamin B12 is therefore no longer taken seriously by the scientific community in our country or overseas as a reason for not introducing folic acid into flour.

On the potential connection between high folate levels and overall cancer risk, again I quote the SACN’s latest review:

“Findings from the different study types are inconsistent but overall do not suggest an adverse association. RCTs”—

randomised controlled trials—

“show no effect of folic acid supplementation on overall cancer risk. The MTHFR genetic studies suggest higher folate concentrations reduce overall cancer risk.”

Again, observed data from America, Canada and other societies do not show any adverse effects of increased cancer risk.

Support for the notion of mandatory fortification comes not just from our country or the SACN, but from a volume of organisations that I shall reference at some length: Shine, the brilliant spina bifida and hydrocephalus charity in this country; the Royal College of Obstetricians and Gynaecologists; the Royal College of Paediatrics and Child Health; the Royal College of Midwives; the British Maternal and Fetal Medicine Society; the Faculty of Sexual and Reproductive Healthcare; the British Dietetic Association; the Governments in Wales, Northern Ireland and Scotland, where only last year the Scottish Government said that they wished to introduce mandatory fortification but were unable to do so on a Scotland-only basis; the chief medical officers in England, Wales, Northern Ireland and Scotland; Public Health England; Public Health Wales; NHS Health Scotland; Health and Social Care in Northern Ireland; the Faculty of Public Health; the Food Standards Agency; Food Standards Scotland; Colin Blakemore; Nick Wald; Jeff Rooker; and me.

There are many people who think this is a very clear case where the evidence should lead to a policy change. Why do the Government not agree with their own advisers and with the overwhelming majority of scientific opinion? Why, in the light of the evidence, do they appear to have dragged their feet—not just this Government, but the previous Labour Government and, indeed, the Conservative Administration before that?

On 2 May, in response to a written question from my hon. Friend the Member for Coventry South (Mr Cunningham) on the case of mandatory fortification, the Minister said:

“No assessment has been made of potential merits of adding folic acid to flour on pregnant women or children.”

That seems to be slightly at odds with what I have been saying for the past 10 minutes—that there seems to be a lot of evidence in support of it. He went on to say that the recent SACN report, which was published in July 2017,

“made recommendations in respect of folate levels and developing foetuses. Ministers are currently considering the issue of mandatory fortification and will set out their position in due course.”

We find ourselves here because I am looking for the Minister to set out the Government’s position in due course. They have had a quarter of a century to mull over the position, in the light of the evidence. I know the Minister, who I have great regard for, is a man of action. I look forward to him setting out the Government’s case and getting on with it.

--- Later in debate ---

[Owen Smith]

I thank the Minister for his response, but I have to say that I am disappointed by it. I am disappointed principally because I do not think he has taken the action that he could have on the basis of the evidence that has been presented both today and, more importantly, by the scientific community in our country and around the world over the past 25 years, as well as the lived experience of the 80-odd communities, societies and Governments around the world that have undertaken mandatory fortification with no evidence recorded in any studies of any of the potential adverse events in their populations that have been referred to in a few scientific papers.

The Minister concedes that the current process is not working because of low uptake of the advice and because so many pregnancies are unplanned. I am pleased that COT is looking at the Wald paper on tolerable upper limits and the evidence it presents that there is not one, because excess folic acid is excreted. However, I am intrigued to know—I will write to the Minister on this—whether COT has advised the Government not to introduce mandatory fortification and not to follow the advice from their other advisory body, SACN, formerly known as COMA. If it has not offered advice to that effect, I cannot understand where Ministers are getting the advice that tells them not to introduce mandatory fortification.

The only formal advice that Ministers have had from 2000 to 2017 is to do what all Members here and the scientific community have recommended and to get on with mandatory fortification. It is a mystery to me why the Government continue to suggest that there are serious scientific reasons for not doing it. I do not believe that the Government have illustrated that and I do not think that the Minister illustrated that today; unfortunately, I do not think successive Ministers in all Governments have illustrated that.

Today has been a missed opportunity. However, I leave the Minister under no illusion that we will continue to raise this issue and to push for mandatory fortification. I look forward to debating it with him again in the future.

Question put and agreed to.

Resolved,

That this House has considered the mandatory fortification of flour with folic acid to prevent spina bifida and anencephaly.

Surgical Mesh

Owen Smith Excerpts

Thursday 19th April 2018 Commons Chamber

[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.

--- Later in debate ---

[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.

[Mark Tami]

My hon. Friend mentioned removal of mesh. Does he agree that there should have been a lot more research about how easy it is to remove, because it is actually very difficult and only a few surgeons will undertake that work?

[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.

--- Later in debate ---

[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.

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[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.

--- Later in debate ---

[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.

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[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.

Surgical Mesh Implants

Owen Smith Excerpts

Wednesday 18th October 2017 Westminster Hall

[Owen Smith (Pontypridd) (Lab)]

This is an important debate for me and for so many hon. Members because of what our constituents are telling us. I pay tribute to my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) for giving voice, with great eloquence and passion, to an issue that so many of us feel strongly about. We have wanted a debate in this House for a long time, and I am pleased that she secured it.

My hon. Friend spoke for the women, many of whom are in the Gallery watching the debate, who want and need us to amplify their voice. One of the most heart-rending things for them has been the sense that they have not been listened to and their voice has not been heard. Our job is to listen and to be as brave as them by speaking in this debate and amplifying their voice. This topic has not had the coverage that it deserves, because it is complex, clinical and disputed. It is difficult to see a way through the clinical evidence and feel that we, as non-clinicians, can make sensible remarks without scaremongering, but we need to be brave and engage intellectually to try to understand it.

In truth, the story is quite simple. Since 2000, these products have been diligently marketed by the devices industry as a quick fix—an easy solution to stress-related incontinence or other problems for young women who want to maintain active lifestyles post-childbirth by doing exercise and other ordinary things that we take for granted. The products, which had not been widely used by the clinical world, became used all over the world. Approximately 130,000 women in the UK have had devices implanted.

The regulators and the clinical guidelines said that the risk was between 1% and 3%. However, behind those statistics, the reality has emerged that for a significant number of women—not the majority, but a significant minority—the devices have resulted in chronic, life-changing adverse effects such as sexual dysfunction, loss of mobility, and inability to work. Those effects ought to be taken seriously by us and by the medical fraternity. Instead, they have been dismissed and, worse still, women have been patronised by being told that their problems were unique, which is not the case.

There are questions to address, and the Minister needs to come up with some answers—I know that she is engaging seriously with this debate. If a medicine marketed to deal with incontinence led in one out of 10 cases to sexual dysfunction or the inability to walk or work, it would not be on the market. Surely she agrees that that is how we need to look at it. In Health questions last week, I think she said that the NICE guidelines are expected in 2018—next year. That is not what NICE is saying. Will she clarify whether the guidelines are coming forward to next year, as she implied? I am not sure whether she simply misspoke.

Finally, will the Minister ensure that, as the Government’s representative, she listens to the women who have been mis-sold these devices and lied to about the relative risk? They now feel that they are being listened to at last, but they need their Government to listen and to take action. Guidelines should be brought forward and mesh should be suspended until we know what the real risks are.