We now come to the Backbench debate on surgical mesh, in which Emma Hardy is to move the motion. As is the custom, she has around 15 minutes. I am sure there could be a little leeway, but Members should be aware we have an important debate to follow.
I beg to move,
That this House
commends the recent announcement of a retrospective audit into surgical mesh for pelvic organ prolapse and stress urinary incontinence;
notes that vaginal mesh has been banned in other jurisdictions such as New Zealand;
further notes that NICE guidance recommends against the use of surgical mesh for pelvic organ prolapse and that no NICE recommendations have been made for stress urinary incontinence;
notes that Sheffield University recently announced the development of a new mesh material;
and calls on the Government to suspend prolapse and incontinence mesh operations while the audit is being carried out, to bring forward the NICE guidelines for mesh in stress related urinary incontinence from 2019 to 2018, and to commit to a full public inquiry into mesh if the audit suggests that this is the best course of action.
I pay tribute to the Backbench Business Committee for enabling this debate to take place and to the fantastic work done by the all-party parliamentary group on surgical mesh implants, of which I am a vice chair, and which is led by my hon. Friend Owen Smith. I also thank the hon. Members for East Renfrewshire (Paul Masterton) and for Glasgow North West (Carol Monaghan) for their support in bringing forward this debate, as well as the amazing Kath Sansom and the campaign group Sling the Mesh—many of the women up in the Gallery have done so much to bring this to public attention. It is for the members of this group and everybody else affected by this scandal that I rise to speak today.
Is my hon. Friend as alarmed as I am—she clearly is—that today and tomorrow women will be having operations that might well cause them complications in the future? Does she agree that these operations should be stopped until we find out the truth?
I absolutely agree. One of the main points I wish to make is the urgent need to suspend the use of mesh.
The issue of surgical mesh was brought to my attention by a constituent of mine called Angie, an incredibly brave woman who used to be very fit and healthy, but who, after having incontinence following the birth of her twins and a hysterectomy, was advised to have this mesh operation. She is now unable to work, in constant pain and suffering, cannot take part in sports and has problems sleeping. I remember listening to what she said to me and feeling horrified that this had happened to her. As I have learned, she is most definitely not alone. One story that moved me came in by email this week. The lady who emailed wrote:
“I started noticing that something wasn’t right with me the second day after I was discharged after the operation. It started with my legs—they were extremely stiff and cold, especially my feet, I couldn’t warm them in any way. I rang the hospital, but it didn’t ring an alarm bell to them. Then after a few days, I started having a very bad stomach ache, nausea, headache, chest pain, something happened to my vision, out of the blue, I became very tired and weak, slightly dizzy. I started noticing that I couldn’t focus and think clearly, my scars didn’t heal well and suddenly after a month my biggest scar started producing very smelly discharge.
I requested an appointment with a GP. I was already complaining that something wasn’t right with me. Everything started after the operation…When my health and all symptoms got worse 12 weeks since the operation, I was told that my fatigue is because I have a 2 year old...Now, it’s been 14 months since my operation—I am extremely dizzy and have very poor balance. I can’t feel the ground with my legs. I’m extremely nauseous, I have bad stomach ache, migraines, breathing problems and chest pain. I’m numb. I have vision fog and very painful, sore eyes. My body can’t recognize the temperature. Either I’m too cold or I’m about to faint from the heat. I started having very bad side effects to antibiotics, supplements or even herbal teas. Before the operation, I had no side effects at all. In 8 months, I lost 12% of my total weight and now I’m 8 and a half stone and still losing weight. This mesh wipes my iron out from the system. My fertility is gone.”
The hon. Lady is making a very powerful case. Does she agree that one of the most worrying things, and part of the seriousness, is that the people facing decades of pain, suffering and loss of amenity are relatively young?
The right hon. and learned Gentleman is completely right, because mesh was given to lots of young women following childbirth—many women were still in their 30s—and it has left them feeling disabled.
I am delighted the hon. Lady has this debate. Does she agree that, as well as young women, lots of males are caught in this sorry and ghastly trap? I have personally heard some terrible tales from my constituency, although I will not go into them just now.
The hon. Gentleman is absolutely right. After we have moved on from looking at vaginal mesh, we need to look at rectopexy mesh and mesh that has been used in men as well. I completely agree.
I congratulate my hon. Friend on her work. The NHS audit recently looked at the women who had suffered as a result. Does she agree that it would have been helpful to look at the number of men who have been affected, so that we get a picture of the true severity?
Yes, my hon. Friend is right. The all-party group should push for that after we have looked at the issue.
For those who are more statistically minded, NHS Digital undertook the recent audit, which was published on Tuesday. The facts are these: more than 100,000 women had vaginal mesh inserted between 2008 and 2017 to treat stress urinary incontinence, which is common after childbirth.
My hon. Friend mentioned women feeling that they were alone, which is one of the main problems. I have spoken to a lot of people who were told that there was not a problem and that they were perhaps the only ones experiencing a problem. People were on a host of painkillers and were not told that others had experienced the same and that it was a much wider problem.
Part of the scandal is how many women were treated when they went back to their doctors. The fantastic work of groups such as Sling the Mesh has brought so many women together, and shown them that they are not alone and that many others have suffered.
The number of subsequent gynaecology out-patient appointments per 100 people having the mesh insertion procedure is 79. There are 43 out-patient appointments per 100 for rehabilitation, physiotherapy and occupational therapy. The figures show that the number of women having the procedure has fallen during the last nine years by 48%, which says an awful lot about what doctors think.
These women were injured. These women were ignored. These women are the victims of a scandal.
My hon. Friend is making a very powerful and moving speech. May I include testimony from my constituent, Adele Yemm, from Chiswick? There was a catalogue of errors with her case. She had only mild incontinence, and physiotherapy would have sorted it out. There were issues about consent—she was denied that. She had a full implant fitted. Does my hon. Friend agree that this is the biggest medical scandal since thalidomide?
I completely agree that this is an absolute scandal.
During the debate in October, I asked the Government to do four things: to commit to a full, retrospective and mandatory audit of all interventions and, if the data proves it necessary, a full public inquiry; to suspend prolapse and incontinence mesh operations while the audit is carried out; to bring forward the NICE guidelines for mesh in relation to stress-related urinary incontinence from 2019 to 2018; and to commit to raising awareness with doctors and patients alike.
In December, NICE issued new guidance, ruling that the evidence for the long-term effectiveness of the treatment for pelvic organ prolapse is
“inadequate in quality and quantity”.
The NHS is not compelled to act on these guidelines, but that would amount to a de facto ban.
In January, the Government caved in to demands for a national audit of surgical mesh, which reported on Tuesday. The audit is not perfect. For example, it looks only at NHS hospital figures and misses off private patients and out-patients; does not include men; does not include ventral rectopexy mesh sufferers; does not cover visits to GPs; and does not indicate how many times someone has to visit their GP before being referred for out-patient treatment. However, it seems broadly to agree with what we have been saying all along: that the Government’s claim that only 1% to 3% of women suffered serious complications is just not accurate.
I congratulate the hon. Lady on this important debate. She is right to call this a scandal. A constituent of mine now has a colostomy bag and severe internal pain and probably cannot give birth safely in future. She is 24. She makes the point that ventral rectopexy mesh procedures are not included in the audit, apparently because there is no code for surgeons to enter. May I join the hon. Lady in pressing the Minister to go back and include that in the audit so that my constituent’s suffering can be recorded?
I absolutely agree, and I hope that will be included in future.
Analysis conducted by Carl Heneghan, professor of evidence-based medicine at the University of Oxford and clinical adviser to the APPG on surgical mesh implants, reveals that the 100,516 women who have undergone mesh surgery in England since 2008 have required follow-up treatment in 993,035 out-patient appointments. He has calculated the total cost to the NHS for all incontinence and out-patient appointments to be £245 million. His analysis of the trend in out-patient appointments also shows that more are required by women as each year passes after their surgery, which is completely the opposite of what you would expect after a successful surgery.
The data shows that the number of operations using mesh has halved over the last decade, which shows that doctors and patients are voting with their feet and telling the world that they do not want to use mesh.
I will have to continue.
In February came the welcome announcement of the Cumberlege review of how the NHS addresses concerns about vaginal mesh devices and how patients have been treated when raising those concerns. However, I remain deeply concerned that mesh has not yet been completely suspended and that it remains possible for doctors to use it, especially in the case of stress urinary incontinence. There is also still no universally available physiotherapy as standard for all new mothers, as there is in France, to stop these problems before they even arise.
I still believe that it is an absolute scandal that these devices were aggressively marketed to doctors and then used in patients for whom they were unsuited. We need to ensure that lessons are learned and that more steps are taken to make the medical products industry more transparent. Campaigners have even called for legislation, such as they have in America, to require doctors to declare any grants, inducements or scholarships that they receive from the industry.
Some patients think they are having the mesh completely removed, only to find out later that it has been only partially removed. They feel that they are suddenly better and that they are recovering only to go through the horror of having the symptoms come back later. It is important that, where possible, mesh should be removed in full.
Despite the fact that 100 different types of mesh are available in the UK and that we do not know whether just one type is causing the problem or 100 types; despite the fact that Carl Heneghan has raised concerns about the small amount of evidence that mesh manufacturers are required to provide before their products are approved; and despite the fact that Dr Wael Agur from the University of Glasgow, a one-time advocate of mesh surgery, is now arguing that the Medicines and Healthcare Products Regulatory Agency has only a fraction of the knowledge of the adverse effects associated with mesh, NICE is still not going to bring its guidelines for stress urinary incontinence forward from 2019 to 2018, and the Government seem more focused on process than on the actual product.
Suzy Elneil, consultant urologist at University College London and one of the few qualified surgeons who is able to remove mesh, tells me that she sees 15 women a week who are suffering after mesh surgery. Even if NICE releases its guidance on
I am sorry, but I have to continue.
It seems that our campaign must continue. We must ask again for renewed commitments from the Government to address these problems. Again, I ask the Government to commit to three things. First, we need a full and unequivocal suspension of mesh implant operations. Secondly, I ask them to bring forward the NICE guidelines for stress-related urinary incontinence from 2019 to 2018. Thirdly—this is a new one—will they please offer pelvic floor physiotherapy to all new mums as standard on the NHS, as happens in France, to help restore the core after birth?
I end my speech with exactly the same words I used to conclude my remarks in Westminster Hall. Mesh implants have affected thousands of people all over the country. For some, the consequences of their operation will be life-changing and devastating. A Government commitment to taking these actions will not undo the suffering and pain that these women have endured, but would go a long way to making sure that nothing like this happens again.
This is the second time that I have spoken these words. Let us hope that justice is done before I have to speak them a third time.
I pay tribute to the many women, including those in my constituency, who have come forward to discuss deeply personal and painful accounts of serious complications following mesh surgery, sometimes with life-changing and lifelong consequences for them and their families. I also thank Emma Hardy who, as always, has set out the background to the issue so eloquently. She has been such a campaigner on behalf of victims, and I really thank her for what she is doing. I will not repeat much of the background that she set out, but I will highlight a few points to which I hope the Minister will respond in her closing remarks.
As we have heard, NHS Digital has published a review of patients who have undergone urogynaecological procedures for prolapse or stress urinary incontinence, including those where mesh, tape or equivalents were used. However, as the hon. Lady pointed out, the review does not cover all procedures, nor does it include the men who have been affected. We know that 100,516 women underwent these procedures between 2008 and 2016, of which 27,016 cases involved mesh for prolapse. Although the numbers are falling, I am afraid that this is just a snapshot.
I congratulate Emma Hardy on calling this important debate. Are the figures accurate? I have been told that some of the figures do not include people who are treated abroad and come here having developed complications, or people who have been to private clinics. The numbers that we have may therefore not be accurate, perhaps underestimating the true total.
I was about to come to that very point. Crucially, many of the women I have met have been treated in the private sector. In this House, we should be concerned about all our constituents, not only those who are treated in the NHS. Of course, it is the NHS that often then bears the burden of managing complications, but we must have a much more accurate picture.
I support the call from the Royal College of Obstetricians and Gynaecologists and from the British Society of Urogynaecology for mandatory prospective data collection, using the BSU’s database. That is a well-established method of collecting outcome data. Retrospective snapshots are no substitute for collecting data as we go forward or, most importantly, for being able to track it in the long term. Although the majority of complications that happen after 30 days happen in the first year, many of the women I have met developed complications far later than that. I particularly want to emphasise to the Minister how important it is that we have access to shared databases not just here in the UK, but across Europe. Will the Minister tell us whether the Government will be seeking for us to remain part of the European Database on Medical Devices—EUDAMED—so that we not only get an accurate picture of what is happening here in the UK, where our population is smaller, but can compare our data with the whole European Union?
That brings me to the wider point about Brexit that is highlighted in the report of the Select Committee on Health on the implications of Brexit on medicines, devices and substances of human origin: the issue of access to clinical trials. It is encouraging that the Government have stated that they wish to remain a part of the European Medicines Agency or to have associate membership, but there are all sorts of aspects to forward clinical research on which it is essential that the Government campaign. They must campaign not just to maintain regulatory alignment and harmonisation, but to ensure that we can remain part of all research mechanisms and mechanisms for ensuring that we have the earliest possible awareness of any complications—not just from drugs but, as this situation has shown, from medical devices. I hope that the Minister will further outline the Government’s intention in that regard.
My hon. Friend will remember that I spoke about my constituents in Letchworth during the debate in Westminster Hall. I am delighted that the audit has been done, but another constituent from Letchworth has been in touch with me since then. She has had ventral mesh rectopexy surgery and posterior mesh rectopexy surgery, which I understand are subsets of the mesh cases. Does my hon. Friend agree that if we were to look at a smaller group of people such as her across Europe, we would actually get quite a good picture of what is happening, given that we would be looking at data across a bigger area?
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.
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.
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.
I do agree.
As I say, informed consent is essential, and that was lacking in very many cases. There are cavalier attitudes and assumptions that medical devices are somehow safer than medicines, but we know that that is simply not the case. We have to rigorously make sure that devices are all part of clinical trials, with long-term follow-up and tracking. Perhaps the Minister could update us on how we are getting on with the barcoding of devices, which clearly makes them over time. One of the tragedies is that many women are completely unaware that they have even had mesh inserted at all. That, again, has to be a lesson that we learn for the future about accurate documentation.
I hope that the Minister will comment on whether there are plans to introduce compensation for victims. As I said, many of the women I have met have had profound, life-changing injuries, and many are entitled to compensation.
The hon. Lady mentions the physical injuries and physical pain, but does she agree that these women have also had great emotional pain and psychological suffering? Many are suicidal. The Minister would be well advised to introduce, within a future action plan, counselling services of some kind for these sufferers.
I thank the hon. Lady for making that point. Yes, absolutely: the scars have been profound not only in physical terms but in the impact on how people feel about themselves. There is a great impact not only on them but on their families and their relationships.
On access to services, while we all welcome a tertiary service being set up for victims of urogynaecological mesh, there is concern about current waiting times for those who wish to have a referral to a tertiary centre, and about access to investigations, which need to be timely. When women come forward to report deeply personal and distressing experiences, it is important that they can be seen as rapidly as possible. I hope that the Minister will comment on that.
I congratulate my hon. Friend 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 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 the 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.
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?
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.
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?
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.
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.
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.
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.
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 that 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.
I echo the comments of many hon. Members and express my deep concern for all women who have experienced debilitating and sometimes severe pain and discomfort following the use of vaginal mesh. In all our considerations of the use of such devices, their health, safety and wellbeing must be our first concern.
I welcome the Government’s recent announcements of Baroness Cumberlege’s review of the use of vaginal mesh and two other areas of medical safety—the use of valproate and Primodos. I was in the Chamber when the Secretary of State for Health announced that review on
The Secretary of State said:
“It is an essential principle of patient safety that the regulatory environment gives sufficient voice to legitimate concerns reported by patients, families and campaigners, works alongside them and responds in a rapid, open and compassionate way to resolve issues when these are raised.”—[Official Report,
Vol. 636, c. 166.]
Ministers want to ensure that we do better in future where necessary, and to ensure that patient voices are brought to the table. I support the review and I want to ensure that justice is done for all women who have concerns about the use of vaginal mesh. We need to ensure that we maintain public confidence.
On the hon. Lady’s comments about justice being done, I have been approached by two constituents who have been greatly affected by vaginal mesh. One of them is unable to work. She has to be lifted up to walk as she cannot stand by herself, so she needs carers. Does the hon. Lady agree that in many cases it is not only justice that is needed, but compensation? As the Chair of the Health Committee said, we need to start looking at compensation for some women. My constituent is in her early 50s and can no longer work.
That is something that I have said not only about this issue, but about the use of valproate. It is important that we pay close attention to the experiences and difficulties that patients have endured. We need to be more open to learning what we can from their experiences, making changes where necessary and—as the hon. Gentleman says—examining where compensation should be sought for them.
Baroness Cumberlege has been instructed to look comprehensively at the whole issue. The Government want to listen. We have all seen examples in which people have appeared to listen to concerns, nodded their heads and then gone away and done nothing. That is not what is happening here. I believe that the Secretary of State and Ministers not only want to listen carefully to concerns on this issue, but stand ready to act appropriately. For that reason, I think the proposal in the motion for a full public inquiry is inappropriate at this stage. We need to give time for Baroness Cumberlege to report. We need to urge that that be done urgently, and we need to ask Ministers questions.
I have some questions of my own for the Minister. What is the timescale for the review and what progress has been made already? Does the Minister agree that introducing an outright ban would be inappropriate before the review? Can she assure the House that the new NICE guidelines which recommend against first use of the surgical mesh to treat pelvic organ prolapse are being carefully followed throughout the NHS? Is it correct that in the vast majority of instances the use of surgical mesh has proven to be an effective intervention that has enabled many women to live happily and independently after surgery? I believe that some 1,500 women receive vaginal mesh implants each year and the majority respond well. If that is correct, it is important to balance that against the distressing individual cases that we have heard about today. I also understand that the high rate of success for the use of surgical mesh to treat hernias suggests that an outright ban would be rash at this stage, and certainly premature before the Cumberlege review reports.
What information can the Minister provide on the recent development of a new material for surgical mesh implants? What more information do we have about how that is expected to reduce discomfort because of its greater likeness to human tissue? Can the Minister update the House on what progress is being made to improve GPs’ awareness of SUI and POP and how best to treat those conditions, so that women are given the most appropriate treatment for their circumstances? Will the Cumberlege review take into account international research on this issue? We have heard some mention of it today, but I understand that no other jurisdiction has imposed an outright ban on the use of mesh.
In conclusion, the Secretary of State has made it clear that we are building on substantial work from over the past few years—the Cumberlege report comes on the back of a lot of other work, and I hope the Minister will confirm that that will all be taken into account. I ask Members to await that report before we make any final decision. Professor Keith Willett brought forward the 2017 Mesh Oversight Group report, which followed the Mesh Working Group interim report in 2015. He said that
“there has been significant progress since this work began. Information available to women and clinicians is now better and more consistent, data recording has been improved, including of complications, and women can now be referred to multi-disciplinary teams of health professionals with the experience necessary to advise women who are experiencing complications from mesh surgery on their treatment options.”
John Wilkinson, Director of Devices at the Medicines and Healthcare Products Regulatory Agency, stated:
“We continue to see that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances.”
We must ensure through this review that every circumstance in which these devices are used is appropriate, and that the women involved feel confident of that.
I congratulate Emma Hardy on securing the debate through the Backbench Business Committee. I took part in a powerful debate on the issue in Westminster Hall, and I am delighted that time has now been made available on the Floor of the House. I commend all those involved with the Sling the Mesh campaign and the all-party group, and I commend Owen Smith for the leadership he has shown. This issue is finally getting the attention that it deserves. Like most Members, it was brought to my attention by a constituent who has been affected first hand, and I wish to reflect on some of the experiences and points that she shared with me, as well as considering broader policy issues on which I hope the Minister will respond.
Other Members have already mentioned ventral mesh rectopexy, which has not been included in the UK Government’s proposed audit. Sling the Mesh’s campaign research shows that 7% of its members have been affected by that specific procedure, and there is a certain amount of disappointment that it does not seem to have been included. As the Minister might know, I have written to the Secretary of State about that concern, and asked the Government to think again, particularly given the number of people affected and the devastating effect that this has had on their lives.
I also raised concerns about the need for a hospital episodes code to be allocated to that procedure. Without one, it is difficult to keep track of the number of people affected, and we have already heard about the problems arising from the lack of information about the exact number of people affected by the procedure and the mesh more generally.
There are also concerns that some recent National Institute for Health and Care Excellence guidelines might have been rushed through, partly in response to media attention, which only adds to the argument for a full and comprehensive audit that includes all types of mesh procedure.
The health service is devolved in Scotland, where there is a slightly different situation. In 2014, the Scottish Government requested a suspension in the use of medical mesh by the NHS in Scotland pending safety investigations, and in 2015 the Cabinet Secretary for Health, Wellbeing and Sport, Shona Robison, apologised to women who had been left in severe pain by such operations. Between 2009 and 2016, the number of women receiving mesh surgery in Scotland fell from 2,267 to just 135.
An independent review published in March last year in Scotland made eight recommendations, notably that surgical mesh implants should be used only after all other appropriate alternatives have been exhausted, and—crucially—only when women have given their fully informed consent. Scotland’s chief medical officer accepted the recommendations of that report in full, and has been clear that the requested suspension in the use of mesh implants should remain in place until she is satisfied that all recommendations have been implemented. That means that all women in Scotland who want treatment for urinary incontinence or pelvic organ prolapse should be offered the full range of options available, and they should be fully informed of the benefits and risks associated with those procedures.
Regulation of these devices is reserved, however, and operates at UK-wide level, which is why calls for a UK-wide national clinical audit and database for recording device identifiers are so important. Scottish Government officials are working with UK colleagues to consider the possibility of an automated implant registry, which would allow unique device identifiers to be entered on the patient’s electronic record. As the Minister will know, the now Cabinet Secretary for Health and Sport has written to the Health Secretary to suggest a UK-wide woman’s health summit. That would allow the NHS, and relevant decision makers across the United Kingdom, to work constructively on a range of issues.
I wish to raise other aspects of regulation, and particularly EU regulation on medical devices 2017/745. That will change mesh implants for long-term or permanent use from a class IIB to a class III device, meaning that they are generally regarded as high risk. The regulations will not take full effect until 2020, which is after the Government’s preferred date for Brexit. How will important EU regulations that monitor the use of devices across EU territories be implemented or reflected in UK law and regulation after Brexit? It is important that standards are maintained to the highest possible level.
Campaigners such as my constituent are concerned about the current process of what could be called post-market vigilance, and whether some of the devices are subject to testing that is rigorous enough before they are rolled out to the market. There is a genuine concern that device manufacturers have a profit motive to develop their devices and get them on the market as quickly as possible, although equally, they have a fear of litigation, which is why better and stronger regulation from the start is key.
The risks associated with surgical mesh implants were tragically misunderstood and underestimated by healthcare providers and professionals who provided the treatment, and by patients whose lives have been so badly affected by chronic and debilitating pain. I welcome the conclusions and recommendations of the Scottish and English reviews of this procedure, which must ensure that surgical mesh implants are used only after all other appropriate alternatives have been exhausted and—crucially—only when women have given their fully informed consent.
I hope that Ministers will be willing to work with their counterparts in the devolved Administrations and consider a UK-wide summit on the issue and women’s health more generally. I will finish as I started by paying tribute to my constituent and all campaigners for their bravery and courage in ensuring that this issue has been brought to our attention. It is them we must thank for the small and belated progress that has already been made, and for them we must continue to hope for more and faster progress in future.
I start by saying that I think the steps taken in Scotland, as described by 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 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.
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.
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.
My right hon. Friend is making some very important points. Does he agree that prevention is better than cure? If physiotherapy was offered to women after childbirth, that might obviate the need for any surgery at all as a result of these kinds of complication.
Indeed. The problem with this issue, as it has been impressed on me at any rate, is that this has been put forward as a quick-fix alternative to other procedures, whether surgical or not, which would take much longer.
Having paid thousands of pounds for private specialist assessment, in the end Emma eventually managed to get the sort of referral she wanted. I have been given the following clinical summary of her condition:
foreign body giant cell reaction, chronic inflammation and fibrosis.”
I have a page here that lists some 50 different symptoms related to implant illness and foreign body giant cell reaction. I venture to suggest that if this ghastly catalogue of things that could go wrong had been shown in advance to those 100,000-plus women who have had a mesh implant, more than 90% of them at least would have turned it down.
This is what my constituent Eileen wrote to me:
“The effect that this has had and is still having on my life is massive. I can no longer carry out basic tasks at home or do things with my children due to the pain. I need to take medication every day from my GP to try and ease the pain. I cannot go to work at present due to the pain and I am currently on sickness absence leave from my job. The mesh implant that I have had has and is continuing to destroy my life. I need an operation to remove the mesh implant, but the operation is very complex and unfortunately there are limited amounts of surgeons who are experts in the full removal of these mesh implants. Due to my financial situation, I am not in a position to be able to afford to have the full removal of the mesh implant done privately and therefore I am having to wait for this to be done on the NHS which is taking far too long.”
I turn now to Helen, who probably has the most horrifying story of the lot. She was 35 when given what was described to her as routine surgery 16 tortured years ago. She was initially told that it was her fault that her body was rejecting the two mesh implants. She then went through a cycle of implants, the removal of protrusions and eroded segments and seven bouts of surgery. Three TVTs—trans-vaginal tapes—are still inside her, she suffers chronic pain from orbital nerve damage, constantly needs painkillers and has had constant side effects, indifferent treatment and a refusal to admit fault or to refer her to an out-of-area specialist in mesh removal. She writes:
“I do not want anyone from the hospital coming near me ever again. I have lost complete faith in them. I have been lied to and told repeatedly it was my body rejecting the mesh;
but, unbelievably, they kept putting more in.”
She suffers from truly terrible bowel problems, some no doubt caused by the side effects of the painkillers and the sleep aids she has to take. Consequently, she suffers from depression, loss of confidence and lack of self-esteem. She further writes:
“I feel let down by professionals who were supposed to treat me to the best of their ability. There has been information about the adverse effects of mesh around for years, yet these doctors are still happily inserting them into thousands of women.”
She is desperate to be referred to one of the few doctors who specialise in mesh removal and feels trapped under the control of the very people who have let her down. She continues:
“I want these devices out of my body.”
Who can blame her?
Let me conclude by quoting, from an article in The Daily Telegraph of
“I just wish I had never, ever had it done. I would rather have coped with that very minor problem of stress incontinence than this. If I had known even one of the possible risks of the surgery there is no way I would have had it done. I am furious that I was never told that this could happen.”
I thank my hon. Friend Emma Hardy for securing this debate, which is of paramount importance. I have listened to the contributions from Members on both sides of the House. I was struck by the comments made by Fiona Bruce, who said she felt that we could not say now that the use of surgical mesh should be suspended. I have been brought up to think that if it has four legs, eats grass, produces milk and moos, it is not a fish. If we are hearing from the women who have had the mesh implants that they are not working, that they have destroyed their lives and that they have debilitating painful consequences, why on earth would we try to justify not suspending the use of this mesh? It is horrendous.
Furthermore, according to both the NHS and the MHRA, the risk of vaginal mesh complications after an implant is stated as being between 1% and 3%. However, as other Members have mentioned, a recent study for Nature Research found that 9.8% of people suffered complications within five years of surgery. The Sling the Mesh Facebook page has over 6,000 members. The numbers do not add up: more people are suffering from the mesh complication than are credited in the statistics.
Even former surgeons such as Dr Peter Jones have declared that they would not take the risk of using mesh. A survey by Sling the Mesh found that over 60% of patients are suffering from anxiety and depression. I therefore urge the Minister not to risk more women having their lives blighted. We have heard that mesh can shrink, degrade and twist in a woman’s body—I put that to the Prime Minister in my question—and we now know that women have been left in permanent pain, unable to walk and unable to work because of the procedure.
I would argue that, due to the limited remit of the audit in the Government’s “Retrospective Review of Surgery for Vaginal Prolapse and Stress Urinary Incontinence using Tape or Mesh”, many women have been missed, which is why the stats do not stack up. Women who for years have gone back and forth to their GP for pain relief or antibiotics and have then become resistant to the antibiotics, women who have been treated in the last 12 months, and women who have not yet been referred have been overlooked. An urgent public inquiry must be undertaken into the number of women adversely affected and why the safety of so many has been disregarded.
We have heard about Kath Sansom, the founder of the Sling the Mesh UK campaign, who is in the Public Gallery. She said that she
“lost hope for the future” when she underwent the surgery. She ran a poll of 500 women, and 83% said that they had not been fully informed of the risks. People have the right to make an informed choice and the right to receive the information and understand the implications of undertaking the procedure.
Furthermore, 70% reported having lost their sex lives and that they are still facing adverse events as late as 18 years after the procedure. These events include debilitating pain in the groin, pelvis and legs, as well as infection and inflammation. People are basically not able to conduct their usual business, such as playing with their children or going mountain biking, as I mentioned, and it is not fair. Most women in Kath’s support group added that they do not feel there is any aftercare following the implant procedure. That ties into the availability of information and the ability to make an informed choice.
Despite the recommendations from the NHS England report, less than 27% of clinicians have reported on these adverse events. Private hospitals are not audited for adverse events. Worse still, doctors who have been struck off by the General Medical Council are still able to work in these institutions. That is unacceptable.
Under the US Physician Payments Sunshine Act 2010, manufacturers must submit annual data on payment and transfers of value made to covered recipients. Several studies have been carried out by organisations with shares in mesh manufacturers. Similar legislation designed to increase the transparency of financial relationships between physicians, teaching hospitals and manufacturers of drugs, medical devices and biologics is required in this country. We need to understand what the kickback is. If someone is being asked the question, “Do you think mesh is good?” and have investments in mesh, why would they say no? We need to be more transparent and understand what these women are going through.
These sequential calamities must each be understood and corrected so that they are not repeated. Those who have suffered and faced complications must be referred via their GP to a specialist unit with multidisciplinary teams of professionals who can listen—not just hear what they are saying, but listen and understand what they are going through—advise and support them, and ensure that no more patients are harmed. I urge the Government to suspend the use of surgical mesh and tape for all procedures.
I congratulate Emma Hardy on securing this debate. Although we went in front of the Backbench Business Committee together, the truth is that she did most of the work. I am hugely grateful for what she has done in this space. Having set herself a very high bar with the way in which she opened the Westminster Hall debate in October, I can safely say that mesh-injured women in Scotland will be incredibly grateful for the support that she has shown them through her remarks today.
In the six months since that debate, there have been a number of important developments both internationally and domestically. There have been landmark announcements in Australia and New Zealand, as other hon. Members have mentioned. While the UK Government have so far not chosen to take similar action here, I will certainly continue my efforts with the all-party group on surgical mesh implants to persuade them that banning mesh is the right thing to do, particularly now that the National Institute for Health and Care Excellence has issued guidance that favours an effective ban in practice.
There was a Public Petitions Committee debate in the Scottish Parliament just before Christmas—as I set out at our previous Westminster Hall debate, the Scottish Mesh Survivors group was left with very little option but to continue its fight through the Scottish Parliament Public Petitions Committee following a hugely disappointing report from an independent review group established by the Scottish Government. A further review exercise is currently progressing in Scotland. However, it will not re-evaluate the conclusions of the independent review—it will assess only the merits of the process by which those conclusions were reached, so it has the potential to undermine that flawed exercise even further.
At this stage, I pay tribute to the three amigos in the Scottish Parliament: my Conservative colleague Jackson Carlaw, Labour’s Neil Findlay, and the Scottish National party’s Alex Neil, the former Cabinet Secretary for Health and Wellbeing. All three immediately recognised that there was a serious issue to be investigated and continue to champion mesh-injured women across Scotland, such as my constituents Elaine Holmes and Lorna Farrell.
One of the big difficulties is that it has been very hard to get media uptake, particularly in Holyrood with the male-dominated press lobby. They found it a bit icky and did not want to write about it, so I pay tribute to Marion Scott, a journalist who has been absolutely dogged in her determination to highlight this issue, and to Owen Smith, who has gone out of his way to make sure that it gets pushed up in the media across the rest of the UK, giving it exposure that it would have otherwise been very difficult to achieve.
In February, the Secretary of State for Health and Social Care outlined a number of important measures to review mesh and investigate what had gone wrong. It is fair to say that a lot of the campaign groups found the overall package slightly underwhelming, but it is vital that their input into the process is given the utmost attention. Of course, this week the retrospective audit was published.
As has been said, it is right that the Health Minister, Lord O’Shaughnessy, has instructed the chief medical officer in England to respond to the findings with some urgency following engagement with the medical authorities and, importantly, with the patient groups representing women whose lives have been wrecked by mesh. Too often when there have been statements, guidance and responses, the views and experiences of these women have been completely ignored. They have been talked about as though they are not there. Their experiences have been undermined and dampened down, so if patient groups are to have any faith in the UK Government, it is important that patient voices are front and centre of the process.
I was particularly pleased when the Secretary of State announced to the House that £1.1 million would be provided for the establishment of a comprehensive mesh database. That is a positive development, and mesh-injured women in Scotland have reacted warmly to it, but they have also made it clear that, if the authorities are to gain a true picture of the suffering that mesh can cause, it must be accompanied by a requirement for mandatory reporting of all mesh procedures. Crucially, as a number of others have said, that must encompass not just NHS but private procedures, because many of the women concerned were treated privately. If mandatory reporting is not already envisaged, I urge the Department to explore that possibility.
The setting up of a database in Scotland was one of the six points included in the petition that Scottish Mesh Survivors brought to the Scottish Parliament in 2014 and 2017. It is fair to say that progress has been pitiful, and it was therefore welcome that the Secretary of State made clear that he was open to the idea of a UK-wide database and to working closely with the devolved Administrations with the aim of establishing a clear UK-wide picture. Along with my hon. Friend Kirstene Hair, I wrote to the Scottish Government Cabinet Secretary for Health and Sport about the database, and was pleased when she confirmed that her officials had been liaising with colleagues at Westminster and the other devolved Administrations. Perhaps the Minister will explain exactly how those communications will proceed.
In view of the failure in Scotland to proceed with a database in the four years since the survivors’ petition was first brought to Holyrood, Scottish involvement in the issue of a UK-wide database—
Is the hon. Gentleman aware that the discussion in Scotland was about the need for the database to be UK-wide? We have talked about EU registration. The bigger a population, the sooner a problem is noticed. The Medicines and Healthcare Products Regulatory Agency is UK-wide. It is not a question of small databases. The Scottish Government were not obstructing the proposal. The profession felt that the database needed to be UK-wide, and needed to feed into the MHRA.
I certainly agree that a UK-wide database will be far more effective and beneficial in providing a true representation of the story of the mesh-injured women, but the hon. Lady must accept that the women in Scotland have found the response of the Scottish Government—and, in particular, that of the current Cabinet Secretary—fairly poor.
A lot has happened in the past six months, both at home and abroad. Some progress has been made, and important steps have been taken, but we have much further to go. Members of Parliament are often asked, “What do you want to achieve in this place? What tangible thing do you want to walk away from here and say that you have done?” Securing justice for mesh-injured women is right up there at the top of the list. Let me simply say to those watching at home and those in the Public Gallery that the fight goes on.
Let me begin by adding my voice to those of other Members in congratulating Emma Hardy on securing and introducing a debate on this important issue.
I agree with much of what has been said by Members on both sides of the House. It is good to hear such similar views expressed about the need to think about what action should be taken to help women who are suffering some horrendous conditions as a result of this procedure. Unfortunately I did not have an opportunity to take part in the Westminster Hall debate, so I have found the many speeches that I have heard today very informative. Some, indeed, have been very technical. Questions have been asked, and I the answers will be useful to us because we shall be able to convey them to our constituents. I also welcome the specific recommendations that have been made, particularly by the hon. Member for Kingston upon Hull West and Hessle. There seems to be a difference of opinion on whether mesh operations should be suspended while the audit and other matters are being resolved. I think that many of us are somewhat confused about why the risk should have been considered acceptable.
Like, I suspect, many other Members, I first heard of the issue when I was contacted by a number of constituents via social media. I subsequently met some of them face to face. Dr Lewis described the specific circumstances of some of his constituents, and my experience has been very similar. I have sat and listened to many women describe what they have suffered. Theirs is a strong, powerful story of pain, and of the incredible impact on their lives, their families, their marriages and their relationships. Hearing such stories, we must ask ourselves how such pain, risk and suffering can be justified by the cases in which the procedure does work. I know that many of us are appalled when we hear of the experiences of the numerous women whose lives have been blighted by these procedures.
A number of issues have been raised, and I do not want to reiterate what has already been said. Instead, I shall focus on two elements that I do not think have been dealt with in any detail. First, we need to ensure that all the women affected are identified and fully supported, and benefit from the highest-quality care and intervention that can be provided at this stage. That, for me, is a priority, which involves two important considerations. One is the question of where we are right now—what these women are suffering right now, and what we can do to help them to try to find resolution. That journey will require the highest levels of expertise and support.
As we have heard, many of the medical interventions involved are complicated, and, given their previous experience of medical procedures, many women are understandably deeply apprehensive and worried about undergoing further necessary procedures. The right experience and qualifications, and a wrap-around support service, are critical not only to securing the best medical outcomes but to building confidence among the many women who have been let down by interventions in the past. I emphasise with women who know that they will have to undergo even more medical procedures, even after having such horrific experiences and suffering the consequences of the previous interventions.
There is also the question of the suspension of mesh operations. I have written to the authorities in Northern Ireland and to the Secretary of State requesting a suspension pending the outcome of the audit and the review. In circumstances such as this, I am always very aware that many of us here are not doctors. We are not members of the medical profession. We are told—this has featured in the responses to my correspondence—that even Departments and their civil servants must and do listen to the medical professionals. It is important for NICE to move more quickly, though, because its recommendations will be crucial for frontline care, advice and the pathways that are followed for women who present with the issues that have led to this procedure.
Secondly—this has been discussed at some length today—there are the critical questions of why this happened and why it was not picked up earlier. I welcomed the Secretary of State’s announcement of a review, because it will cover some of those issues, but we need to understand how we have reached this position. I have spoken to constituents, and to members of the lobby from across Northern Ireland, and their common experience is that they were not taken seriously enough at all stages. Complaints made to medical professionals about complications were often dismissed, even when the women were in extreme and chronic pain. The database has been referred to. There should have been a database at an earlier stage so that the information could be located. I fully support a UK-wide database, because, as has been said, it would be the best way of gaining a wider sense of what is happening.
It is worrying that hundreds and thousands of women across the United Kingdom were individually presenting with complications from these procedures, yet nobody joined up the dots until a very late stage. I am glad that that is now happening—I am glad there is a review—but many women have had to suffer for too many years without the dots being joined and action being taken.
It is not acceptable that women presenting with problems were told by some GPs or other medical practitioners that perhaps it was just women’s problems—that these were the types of complications that generally arise in issues associated with the menopause. The problems were dismissed, and women felt dismissed and that their issues were not being taken seriously. That is wrong and unacceptable.
We hear a lot at the moment in Northern Ireland—I am sure it is the same across the United Kingdom—about patient-focused care and the patient-focused experience in the health service. Yet in all the stories I have heard about this issue, there is the common experience of people not being taken seriously and not having a patient-focused experience. That must be addressed urgently.
I look forward to the outcome of the review, and to some of the actions being discussed such as the audit and the setting up of the database, but it is important that we identify not only what went wrong, but clear actions to take to stop it happening again. We must learn from the mistakes of the past and make sure that actions are identified and that we progress.
Finally, I thank the advocates who have done a huge amount of work to raise awareness of this issue across the United Kingdom, including in Northern Ireland.
I thank and congratulate the hon. Members for Kingston upon Hull West and Hessle (Emma Hardy) and for Pontypridd (Owen Smith), as is customary and also entirely justified on this occasion. This issue must be kept in the public eye.
One of the great privileges of being an MP is being able to give people a voice—to represent people in our constituencies who have been wronged, often in terrible circumstances through no fault of their own. In this case, for me that person is here today in the Gallery: Jacqui Cheetham. I am delighted to be able to represent her story, and her words are far more powerful than mine could ever be. When she visited me at my surgery what came across was the scale of the problem and also its traumatic consequences given the relatively minor condition that Jacqui suffered from before the operation took place.
I would like to use Jacqui’s words rather than my own, because, as I have said, they are far more powerful than mine could ever be. She explained that she had two surgeries using mesh, in 2005 and 2006:
“Within a few days of surgery I had severe pain in my groin and bladder. I was referred back to York Hospital on many occasions. The surgeon said he could find nothing wrong with me and eventually recommended I saw a psychiatrist, as he believed it was all in my head. As a teenager I had a history of mental health problems when my parents went through a nasty divorce. I was left to bring up my younger sister and take my main, secondary school exams. I simply could not cope but because this is on my medical records, even though the mesh operation was many years later they still referred back to that time and thought this must also be psychological. My GP spoke up for me and told them I was not depressed and demanded they find a solution. Eventually I was given a MRI scan and the mesh was found sticking into my bladder. I was then operated on to partially remove the mesh. After the operation, the surgeon described the pain of the mesh sticking into me as being like barbed wire as the raw edges of the material had hardened. It’s intended that your body should mould itself into it and removal would be like extracting it from concrete…
Since 2006 I have lived my life in constant pain. I take concentrated Oramorph and wear…Buprenorphine patches. I also take codeine for ‘break-through’ pain.
I was a fit young mother in my late 30s when I had this done, suffering mild incontinence. My ambition was to run the London Marathon and I found the incontinence merely a nuisance. How I wish I could go back to those days! I would never have had this operation, had I known this possible outcome. I was not warned of any such dangers.
I now cannot walk far. I can’t stand or sit for extended periods of time. I struggle with simple tasks that require my concentration. Both my drugs and my pain affect my sleep. I am now 50, though I feel much older.
Quite simply, this operation has ruined my life and has had a massive impact on my family. My children are now grown-up but they were young at that time and I was unable to be a proper mum to them;
unable to run and play with them as a parent should. There seems to be a misconception that the mesh which causes the greatest problems is “prolapse mesh” but this simply is not the case. All mesh can cause problems.”
I know that the ministerial team is very concerned about, and aware of, these issues, in part due to the fine work of parliamentarians. Ministers rightly point out that no healthcare system in the world has yet banned this treatment, and they set about the review in February 2018, which has provided much of the information that we now have to address these points.
As my right hon. Friend Dr Lewis pointed out, the scale of the problem is becoming clearer, but I do not believe we understand the true scale yet. The recent Guardian report said that out of 100,000 operations there were 6,000 removals, so there is an issue with at least 6%, and that is just the ones that have been removed, so we know the scale is greater than is currently acknowledged.
Something needs to be done now. It is heart-warming that the people who come to our surgeries to tell their stories want most of all to prevent this from happening to others, and we must pay credit to the people from the Sling the Mesh campaign for what they have done to benefit others as well as trying to redress some of the difficulties they experience themselves.
The hon. Member for Kingston upon Hull West and Hessle raised the issue of physiotherapy, and she is absolutely right: prevention is better than cure. She mentioned that this problem has cost the healthcare system £245 million; it would be a true economy, not a false economy, to implement what she suggests as a simple first step for new mothers.
We also need to get to the bottom of the issue by having a true audit, including of, for example, private patients, to make sure we know the true scale of the problem; I support those calls. It must also be sensible when there are alternatives to look at a suspension of this treatment today. Burch colposuspension and autologous sling are alternative treatments, and it makes sense to me and certainly my constituent to suspend this treatment and look at other treatments in the meantime while we find an alternative. Perhaps the new Sheffield University treatment will prove effective, but, as the Chair of the Health and Social Care Committee said, it needs to go through a clinical trial rather than women effectively being used as human guinea pigs. I support the extension of that until clinical trials can show that we have a solution without the traumatic consequences that affected so many women.
I congratulate Emma Hardy on securing this debate and on the power of work that she has done on behalf of the women affected by mesh. I also pay tribute to the chair of the all-party parliamentary group on surgical mesh implants, Owen Smith, for his work. I declare an interest as a member and vice-chair of the group. In the run-up to this debate, I have been contacted by many constituents whose lives have been devastated by mesh. Because of the sensitivity of the topic and the embarrassment that many women feel, it is a major step for them to come forward and speak so bravely about their experiences. For these women, what started as a slight leakage of urine and an embarrassing discomfort has escalated into life-changing disabilities, and I want to use this speech as an opportunity to raise some of their cases.
My constituent, Karen, underwent a hysterectomy in 2008. The following year, she suffered a significant prolapse and was given a pelvic organ mesh. After that procedure, she began to suffer from severe incontinence, which affected her ability to work. She mentioned this to the consultant, who said that there was a simple procedure that would help. She had that procedure, but was given no further information about the risks and possible complications. In 2011, she started to experience severe pain and was referred to a new consultant, who told her that the pain had nothing to do with her implant. She finally had the implant removed in 2013, but has been left severely disabled and now has to use a wheelchair when she travels long distances. This has been a real problem for her because, she says, people talk to the person who is with her, rather than to her. She therefore feels as though she has been dehumanised as a result of this as well. Had Karen been told what the mesh procedures entailed, she would never have agreed to have the implant. She and a group of survivors in Scotland have set up a Facebook group. It started with 17 women, but it now has more than 500 members.
Another constituent, Jean, had her implant inserted in 2006, but she realised from day one that it had not worked and that she was still incontinent. She says:
“The full side effects of having polypropylene plastic TVT-O are as yet unknown. What is known is removal is complicated and carries its own risks, due to the fact that the mesh implanted in the woman’s pelvic region is designed to be permanent. In cases where a surgeon does a partial removal and leaves the rest then the long term result can be further degradation and an acceleration of mesh debris into the body. To remove the Monarc sling that I have, a surgeon has to cut through many structures including bone and muscle, and is known to be nearly impossible to remove safely without further damage.”
In fact, one consultant has described mesh removal as being like trying to remove warm chewing gum from someone’s hair.
At the most drastic end of the scale, some women now face losing their organs as a result of this procedure. This has happened to Claire, a mum of three, who says:
“I had a mesh implant in September 2011 for stress incontinence. I woke with excruciating pain and struggled to walk. I had the mesh removed in July 2015 but unfortunately the damage I suffered is severe. I am now disabled for life. I use crutches for short distance, wheelchair for longer. My nerves are severely damaged, I have autoimmune issues, foreign body reactions, currently use anal irrigation system for my bowel as it can’t work on its own. Next for me is to have my bladder and bowel removed. Mesh products are simply not fit for use in the human body. These procedures need to be stopped now.”
Cathleen, from Benbecula, a constituent of my hon. Friend Angus Brendan MacNeil, has said:
“The Government is currently banning the use of plastic because of damage to the environment, destroying sea life and leaching into the food chain. Why on earth place such plastics into the human body when I like many others have suffered mesh erosion as my body rejected the polypropylene?”
The issue that is raised repeatedly in all these cases is the lack of information given to patients. Some were told that the procedure was simple; others were told that a little piece of tape or a sling would be inserted. None was told about side effects or complications. Most were not offered non-mesh procedures, which might cost slightly more in the short term but which would have massive savings in the long term because these women would not need to live on benefits, having had to give up work, with all the other problems that that entails.
In Scotland, the suspension of mesh has been welcomed, but because the regulation of such devices is still a reserved issue, we need the MHRA to stop recommending the use of mesh before it can be banned outright. Medical devices do not go through the same rigorous level of testing as drugs, and the effects are often not experienced immediately. This is why it is so important to carry out an audit of the women who have had the procedure. I welcome the review of surgical devices announced by the Government, as well as the announcement that they will conduct a full registry of all mesh procedures. However, it should be noted that the number of women affected may well be far higher than estimated. Many women who experience problems are told that their issues are not mesh-related. Are those women’s problems being captured in the current mesh figures?
I, too, have constituents who have been affected by this, and one of them has written to me to say:
“I had this operation carried out—it was only effective for a few months and had failed, leaving me with constant discomfort…The operation itself was a long one and I have so far managed to put up with this discomfort as I really don’t want further surgery.”
Does the hon. Lady—and indeed the Minister—have any thoughts on how many people might be going under the radar because they are in a similar situation to my constituent?
I thank the hon. Gentleman for his intervention. That concern has been raised time and again in the all-party group. We believe that many of the women affected are not being captured in the figures, and it is important that we should carry out an audit to find out what is going on. That audit should include GP visits and visits to consultants. They should all be part of it.
Mesh implants have been described as the “gold standard” treatment for incontinence and as a “minor procedure” that would change lives. Sadly, the procedure did change many lives, and crucially, the device manufacturers who have marketed mesh so aggressively are making a profit on it. For the women affected, the manufacturers’ profits have come at a heavy price. My hon. Friend Brendan O’Hara has been working closely with a constituent, Nancy from Dunoon, who was left suicidal after having mesh implants several years ago. Four months ago, Nancy underwent an operation to have the mesh removed, and I am sure the whole House will join me in wishing her a full and speedy recovery. She has said that
“if they’d discovered this kind of serious fault in a car, they’d have recalled them all and stopped making them. So why didn’t they do that with mesh?”
It is important that we now have a complete suspension of mesh implants. Also, a number of Members have mentioned that physiotherapy should be offered as standard for new mothers, to give them other methods of dealing with slight incontinence and to help them to restore their core after birth. Many mesh survivors are now calling for a sunshine payment Act, as there is in America, that lists all industry funding, sponsorship or grants received by GPs and surgeons. This would show any conflicts of interest, and it would help with all medical issues, not just mesh. Finally, I would like to pay tribute to the campaigners from Sling the Mesh and from Scottish Mesh Survivors for all their work in bringing this issue to the attention of the wider public and to the attention of us here in this place.
It is a pleasure to be called to speak in this debate, and I congratulate 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 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 have 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.
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?
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 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 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 us, 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.
I congratulate my hon. Friend Emma Hardy on securing this important and timely debate. Excellent points have been made by all Members who have spoken, so I will be brief to allow time for the Front-Bench responses. We have heard about some harrowing cases involving people’s constituents, most recently from the hon. Members for Torbay (Kevin Foster), for Glasgow North West (Carol Monaghan) and for Thirsk and Malton (Kevin Hollinrake). There has been cross-party support for the motion and the demands on the Government to act. I think that everybody who has spoken today thinks that mesh should no longer be used in surgical procedures until the inquiry reports back.
One thing that I found particularly striking was how many of these women said that they almost did not have the mesh implants but were swayed by the casualness with which they were sold to them when they were weighing up their options on how best to resolve their medical conditions relating to prolapse or incontinence. None was told of the risks of vaginal mesh, and I am sure that if they had been they would have considered other, less risky, alternatives. No one goes to hospital expecting to be cured of one problem only to be given another a thousand times worse. There are serious questions that need to be answered about the mis-selling and promotion of mesh, and we have not had much of a response on that despite many requests.
I find it staggering that, despite the potential risks being known, mesh is still being used today. Surely its use should be stopped and women warned of the dangers. Even by the NHS’s own figures, 1% to 3% of vaginal mesh implants result in complications. The figure is far too high. Other studies have the figure as high as 10%, and it could be higher—we do not know. It is worrying that we have such cases at all. Whether the figure is 1%, 3% or 10%, even a one in 100 chance of being maimed by an implant is a price not worth paying.
The Government should follow the example of New Zealand, which has managed to stop using mesh. Is it really acceptable for the Government knowingly to allow women to be injured by the state in this way? How many more women need to suffer while they wait for NICE to complete its review?
The Government’s retrospective review of surgery for vaginal prolapse and stress urinary incontinence using tape or mesh is a welcome start to finding out how many women have been affected, but the scope of the review is too narrow and there is a real fear that women will be missed. Why cannot women from Wales, Scotland and Northern Ireland be included in the review, and what about men affected by surgical mesh?
I call on the Government to ban mesh implants immediately and to widen the scope of their retrospective review. NICE should bring forward its review and introduce pelvic floor physiotherapy on the NHS as standard for all new mothers. We need to find out what has gone wrong, and why. The victims of the mesh scandal have suffered enough. We need action now.
As a surgeon for more than 30 years, I have to start by pointing out that there is no such thing as risk-free surgery. There will never be an operation about which it could be said there is not a 1% complication rate. When I looked at complications and talked about risks, I used to write them down on the consent form so that I went through every single one with patients. We talk about the complications that are minor and common, and we warn patients, “This will probably happen, but it’s minor.” The complications that are life threatening or quality of life threatening, even if they are rare, should be up there in block capitals so that women know.
We, as surgeons, have a duty to minimise risk and to inform the patient so that, as has been discussed, decent and informed consent can be given. The problem of this saga is that a lot of the surgeons were not informed. If a surgeon is doing 30, 20 or 15 mesh implants a year and they become aware of a problem only in two or three years’ time, it does not register in their brain as being common. We also know that many of these cases really presented only years later, so that feedback loop—“Oh my God, we have a problem!”—was not there. That is why so much of this is to do with regulation, reporting and, inevitably, the yellow card.
Obviously, the hon. Lady has enormous personal experience of surgery and of this area. Does she agree that one of the other possible problems for some surgeons, although I hope not many, is that in this country we have historically been very bad at explaining risk-benefit analysis? If people are being offered an operation for a condition that is not necessarily life threatening, the judgment in a risk-benefit analysis is very different from that for something far more serious.
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”.
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.
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 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 there is utterly no benefit to them 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. 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.
I thank my hon. Friend Emma Hardy for securing this important debate and for her passionate speech. Like me, she has been shocked and horrified by the stories we have heard from men and women who have had their lives turned upside down because of surgical mesh. I also thank my hon. Friend Owen Smith, who spoke with such passion and knowledge. He was campaigning with the all-party group on surgical mesh implants long before I even came across it, and I am grateful for his contribution and continued leadership.
I thank all Members who have spoken in this excellent debate: the hon. Members for Totnes (Dr Wollaston), for Congleton (Fiona Bruce) and for Glasgow North (Patrick Grady); Dr Lewis; my hon. Friend Fiona Onasanya; the hon. Members for East Renfrewshire (Paul Masterton), for Belfast South (Emma Little Pengelly), for Thirsk and Malton (Kevin Hollinrake), for Glasgow North West (Carol Monaghan) and for Torbay (Kevin Foster); and my hon. Friend Bambos Charalambous. Dr Whitford spoke for the Scottish National party with such knowledge, and it was a privilege to be in the Chamber to hear her speech. I thank them all for their thoughtful contributions, and I thank their constituents who have allowed their experiences to be shared with us today. It has been distressing to hear their stories and I sympathise with anyone affected by surgical mesh.
Finally, I thank Kath Sansom, who leads the Sling the Mesh campaign, and who I know is watching from the Gallery, for all her hard work in uniting the women affected by vaginal mesh implants and raising awareness of the tragic impact that they have had on so many lives. I thank everyone who is part of that campaign for everything that they do to raise awareness and support women.
After the Westminster Hall debate in October last year, and the media coverage that followed, more women came forward as victims when they realised that the mesh was causing their additional health problems. I am very sorry to say that my 73-year-old mam was one of them. She likes to watch my debates and speeches, as do all our mams, I am sure. When she was at mine one Saturday, while I made lunch, I sat her down to watch some of the speeches that I had made that week. There she was with my iPad: I put on the Westminster Hall debate, it started to play, and I said, “I’m so pleased you haven’t had anything like this done.”
You see, Madam Deputy Speaker, over the past four to five years my mam has been back and forward to the doctors with loads of health issues, from IBS to constant urinary infections, and from stabbing pains in her groin to pain walking and trouble sleeping because of pain and twitching in her legs—and more. It has been never-ending. She said, “I’ve turned 70 and I’m falling to pieces.” She has had cameras everywhere, which is not always pleasant and can be very uncomfortable, but all to no avail. No diagnosis or solution has ever been found. With that background knowledge, the House can imagine my horror when she said, “Oh, no, I just had some tape put in to stop the leaking when I coughed and sneezed!” I had no idea that she had had that done.
As the hon. Member for Torbay said, sometimes women—even your mam—do not like to talk about these things. When I asked her why she had never mentioned it, she said, “Oh, it was quick—I was in and out on the same day. And you’re always so busy, so I just didn’t mention it.” It had not even occurred to her that there could be a connection between what she had been going through for the past four or five years and this procedure that she had had done five years earlier.
As the House can imagine, I went into panic mode, because although we are talking about mesh today, surgeons use many different names for it—tape, ribbon and sling are the more patient-friendly ones. I am also told that they now like to use the phrase “Don’t worry—it’s not the mesh that they talk about in the media.” Surgeons must be absolutely clear with their patients what treatment they are about to receive and address any concerns that they might have, instead of talking about the success of the majority or dismissing those concerns outright.
After the sudden realisation, all my mam’s symptoms over the years suddenly began to make sense and could be attributed directly to the mesh. I am pleased to say that, thanks to the help of the fabulous Kath Sansom, my mam is now armed with all the facts and arguments to take to her GP and surgeon. She has done that and is on the long road to getting reversal surgery, if that is the best option for her. She has also had to come to terms with the fact that she may never be the same again, with the associated guilt that she agreed to the procedure. She trusted the medical profession to do her no harm.
My mam is lucky at the moment, compared with some of the other cases we have heard about today, which she recognises. A Sling the Mesh survey found that more than 78% of patients have pain when walking and sitting; 69% of women have pain that prevented intercourse; more than 60% of patients suffer with anxiety and depression because of the mesh and the symptoms that it causes; and almost 54% suffer with nerve damage. I have seen the piles of medication and medical equipment that some women have to use on a daily basis to try to live a life with a bit of dignity. Before the mesh, these were fit, healthy and, in some cases, young women, as we have heard. Now they need assistance to do simple things such as tie their shoe laces, pick up their children, or even use the toilet. Some have lost their sex lives, their marriage or their job. This is a tragedy for these women and their families. The effects of mesh have been so unbearable that, I am sad to say, some women have tried to end their own lives. Innovative and effective treatments should not do this to patients, and the Government must not stand idly by while women suffer in pain like this. The Opposition continually urge NHS England and NICE to act immediately to update the guidance before 2019—as we have all said—and to suspend the use of vaginal mesh.
The Government’s “Retrospective Review for Vaginal Prolapse and Stress Urinary Incontinence using Tape or Mesh”, published just two days ago, is a first step in understanding the sheer scale of the number of women affected by this scandal. Unfortunately, the effects of mesh are hidden within the document—it takes a bit of a numbers expert to be able to work their way through it. So hidden and complex is the review that, on Tuesday, the Minister in the other place announced that he was giving his expert a month to work it out. I will be waiting with bated breath for that analysis.
It is clear that the review fails to show up all the women who have been treated with mesh in the UK. It shows only the number of women treated in England on the NHS, meaning that patients treated in Wales, Scotland and Northern Ireland, and patients treated privately in England, were not included. The audit does not include the sheer number of women who have gone back and forward to their GP for pain relief or antibiotics but who have not yet been referred to a consultant, or even those women who have not yet even made the connection and considered that mesh could be the problem, as was the case with my mam. Why were those women missed out? What is the Minister doing to ensure that their concerns are heard and that they are counted in the numbers?
When the audit was announced, I called for a suspension of the use of mesh while it was carried out. As the hon. Members for Totnes and for Glasgow North West and others have mentioned in their contributions, medical devices do not undergo any clinical trials or rigorous evaluation in this country. If ever there were a case to prove that that needs to change, it is surgical mesh.
As I have said, and as the hon. Member for Glasgow North West mentioned, if this were a car, an aircraft or even a washing machine or a dryer that was malfunctioning and causing life-changing harm in 10% to 15% of cases, its use would be stopped and the product recalled immediately while the problem was investigated. It would not even need to be as high as that, or even the 1% to 3% that was referred to—just a handful of incidents triggers a recall.
The suspension did not happen, so will the Minister please tell the House in her response how many women have had a mesh implant while the audit took place? Does she know how many women since March 2017 have been treated with a mesh implant or had mesh removed, as the audit went up to only March 2017—a year ago? These newly mesh-implanted women may not have any symptoms now, or if they do they will not necessarily realise that the mesh is to blame, but they may do so in a few years’ time.
Since the Westminster Hall debate last year, the audit and the wider medicines and medical devices safety review, patients who have been treated with surgical mesh—not specifically vaginal mesh—have come to feel that their experiences and concerns are not being considered by the Government. Obviously, I include men in that category. The majority of hernia mesh operations are successful. However, complications can leave patients in chronic pain, which patients were not warned about.
According to NHS data, 10% of people who have had hernia mesh fitted go back to their clinician at some point after their surgery. The former surgeon Peter Jones says that the risks of using hernia mesh are so bad that he himself would not take the risk. Will the Minister respond to the concerns of patients who have been harmed by surgical mesh and elaborate specifically on what the Government are doing to review the harm caused by all surgical mesh—not just vaginal mesh?
Let me repeat my calls to the Government once again: the use of surgical mesh must be suspended and NICE must bring forward its review. A simple, quick and cheap operation has turned far too many patients’ lives upside down. We must stop playing Russian roulette with these patients’ lives. It really is time to sling the mesh.
I add my thanks and congratulations to Emma Hardy on securing this debate. She approached this issue with her characteristic passion and forthrightness and gave me a number of challenges—again. I am pleased that she acknowledged that, since we last debated this, there has been progress. It is in that spirit that we need to continue this dialogue not just to address the issues, but to make sure that we do the right thing by those women who have been harmed by the use of vaginal mesh.
Ultimately, the tragedy of this case is that women have put their trust in the medical establishment to look after them and to make them well, and they have come out with the most debilitating, life-changing injuries. In many cases, these were very young women. It is very clear from the clinical guidance on these products that they should not be used as a first intervention, and should be used only in very extreme cases. We are to be very concerned about the extent to which this has been adopted.
It is great that the evidence shows that the use of this product is less than it was. Clearly, as Owen Smith pointed out, there was a spike in the use of the product, and that use was not always appropriate. That highlights the need for proper understanding of the risk of any medicine or product, and underlines the need for very mature and sensible conversations between medical professionals and their patients so that people understand the risks of treatments, as opposed to understanding just the benefits. Most of all, it illustrates the need for informed consent on the part of the patient. I have been horrified in this debate to hear how many women did not understand the treatment that they were getting. That is clearly unacceptable.
In that spirit, I want to continue this dialogue. As Dr Whitford pointed out, women are often sent away and told that, “It’s women’s problems.” Women are often patted on the head by members of the medical establishment. None of us women in this place is a shrinking violet, but we have also fallen victim to that behaviour, which is just not acceptable. We need to do more to change the culture of our health service and the way in which medical professionals interact with women. If we do not, the outcome is exactly the experience to which those ladies who are sitting in the Public Gallery can attest. I am very grateful to them for sharing their experiences. Sharing our very intimate and distressing personal details is not the most comfortable thing in the world, but the work they have all done in sharing their experiences has raised awareness and put the issue on the agenda. It has also made us more vigilant about protecting our own health when we are faced with problems. I thank them all.
Although there may be some specific points on which we differ, it is clear that we all share a determination to address the issues that have been raised. Clearly, a number of women have experienced extreme suffering, and it is important that the NHS does its best to make life better for those women and gives them the treatment that they need. I say to Members that if there is any evidence that women are not getting the treatment that they should be getting following a complex mesh procedure, please raise that with me and bring it to my attention and I will take action accordingly.
I am very grateful to the Minister for giving way. She is acknowledging the depth of disquiet, suffering and pain, but she will also be aware from my hon. Friend Emma Hardy, and indeed from my hon. Friend Mrs Hodgson, who spoke from the Front Bench, that there have been persistent calls for NICE to speed up the process. I ask the Minister a very specific question: what conversations has she had with her officials and NICE as to why they cannot bring this forward? Is it a question of a lack of appropriate aggregate evidence; is it a question of their own internal priorities; or is it a question of resources?
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.
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?
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.
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.
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.
Before those interventions, the Minister said that if people are still not getting adequate treatment, it should be brought to her attention. As I mentioned, I have been contacted by constituents saying they felt trapped because the people who did the procedures were refusing to refer them elsewhere for a second opinion and for possible help from the very small number of people who specialise in the rectification and reversal of these procedures. What advice can she give my constituents about how to break out of this restriction on being referred to people in whom they can have more confidence?
I listened carefully to my right hon. Friend’s representations on behalf of his constituents, and they filled me with alarm, because we have given a clear indication on this point and have established 18 specialist centres to deal with the consequences of mesh. There is, therefore, no excuse for patients who require further intervention not being properly referred. Perhaps he and I could take this up offline to make sure his constituents get the support they deserve.
I want to put this in the context of our broader emphasis on patient safety. We have learned, through difficult experience, that there is never one measure or magic bullet to suddenly transform services for patients; it is about sensible dialogue between patients, clinicians and sometimes politicians—sometimes we can have a role in catalysing the debate. We all need to pull together to tackle all aspects of the issue. In some respects it is about the actual product—the vaginal mesh—but it is also about clinical practice and behaviour, as we have talked about. The most important thing, however, is the need to listen to patients, who, in this context, are of course women. We have to make sure that we listen to women when concerns are raised so that we can properly tackle those concerns as they arise. As I have said before, I am concerned about informed consent for patients, but the issues go much further, and generally we could do much to improve the performance of the NHS by placing a greater emphasis on that.
We need to consider the whole issue of clinical advice. We know that this product should not be routinely offered as a first intervention, yet clearly it is. I am horrified to hear of women in their 20s and 30s being treated with this product, when clearly it is not intended for them. It is obviously easy for me to make a superficial judgment on that without knowing about the particular cases, but on the face of it, it seems quite wrong.
The issue has been raised of what is an acceptable level of risk. I do not like to think about that in terms of percentages, because the acceptable level of risk will differ from patient to patient. If we are talking about some new mums, the level of risk clearly would not be outweighed by the benefits, but if we are looking at women suffering from horrendous conditions of incontinence, that is a very different debate. Again, we need to think about the broader issues. It all comes down to making sure that the guidance is properly applied and that clinicians who are recommending the use of mesh are properly making that assessment in discussion with their patients.
There has been a demand for a public inquiry. We have introduced the Cumberlege review, which is designed to make sure that we properly assess the interests of patients going forward. I know that many patients have felt that their views have been ignored. Baroness Cumberlege is very keen to hear directly from individual patients about their experience, and will be going round the country to do exactly that.
I could say much more, but I must conclude so that we can move on to the next debate. I will write to hon. Members, who I thank for contributing to the debate, to address some of their other points. We are determined to do our best for women who have been badly treated in having this procedure.
I thank everyone who has contributed to this debate, and I welcome the continued dialogue between the all-party group and the Department of Health. It was interesting to hear for the first time that the Department recognises that it is not just the process but the product about which there are serious concerns. I also welcome what appears to be an admission that NICE is introducing draft guidelines this year—is that correct?
That is excellent. That is one of the things we called for. One thing that has come out more and more is that there needs to be informed consent. People need to know a lot more about the risks. All the risks need to be written down in front of someone in block capitals so that they know exactly what they are letting themselves in for.
I press again, as I did at the beginning of my speech, for all new mothers to be offered pelvic floor physiotherapy, as happens in France. As the Minister has just said, it is unacceptable that a new mother with a small, relatively minor inconvenience should be offered something that could result in permanent, life-changing disability. I urge the Minister to look into that as well.
I very much welcome the fact that we will have the draft NICE guidelines next year. As we have spent a lot of this debate talking about our mums and what they say to us, I will quote my mum. She always said, “Where there’s a will there’s a way”. If there is a way of bringing forward those NICE guidelines, let us make it happen, because if there is a determination across the House to make it happen, I am sure that the Department can find a way to do it and end this misery for so many women.
I end by thanking again all the fantastic women up there in the Gallery right now watching this debate. We are only talking about this now because of your bravery in coming forward and speaking out, and I thank each and every single one of you. We cannot undo the suffering you have experienced, but by speaking out and being so incredibly brave, you will stop women in the future going through what you have gone through. I and every Member who has spoken today thank you.
I thank the hon. Lady and everybody who has joined us today. I hope that they have felt uplifted by the debate.
We now come, colleagues, to the Back-Bench motion on cancer treatment. [Interruption.] Apparently, before we move on I should put the question on the debate on surgical mesh. I thank the specialist Clerk for his help and for rescuing me. We will now be entirely orderly.
Question put and agreed to.
That this House
commends the recent announcement of a retrospective audit into surgical mesh for pelvic organ prolapse and stress urinary incontinence;
notes that vaginal mesh has been banned in other jurisdictions such as New Zealand;
further notes that NICE guidance recommends against the use of surgical mesh for pelvic organ prolapse and that no NICE recommendations have been made for stress urinary incontinence;
notes that Sheffield University recently announced the development of a new mesh material;
and calls on the Government to suspend prolapse and incontinence mesh operations while the audit is being carried out, to bring forward the NICE guidelines for mesh in stress related urinary incontinence from 2019 to 2018, and to commit to a full public inquiry into mesh if the audit suggests that this is the best course of action.