Surgical Mesh Implants — [Albert Owen in the Chair]

– in Westminster Hall at 12:00 am on 18th October 2017.

Alert me about debates like this

Photo of Albert Owen Albert Owen Labour, Ynys Môn 12:00 am, 18th October 2017

Before I call Emma Hardy to move the motion, I must tell hon. Members that the list of speakers is over-subscribed. I ask those who wish to speak and are on the list not to make long interventions, which eat into other hon. Members’ time. I may also have to impose a time limit of four minutes for other speakers after Emma Hardy.

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle 9:30 am, 18th October 2017

I beg to move,

That this House
has considered the risks of surgical mesh implants.

It is an honour to serve under your chairmanship, Mr Owen. Many hon. Members present have been contacted by constituents affected by mesh surgery, which is a medical procedure used to treat incontinence and prolapse in women. The surgery, which usually takes less than half an hour, involves inserting a plastic mesh into the vagina to support the bladder, womb or bowel. It can also be used to treat rectal prolapses in both men and women. This debate is crucial, as it gives me and other colleagues the opportunity to be the voice for all those men and women who have been affected. Each individual story fits into the wider national and international narrative. This debate is our opportunity to call on the Government to do something about it and help to end the suffering of thousands of men and women in this country.

The issue of surgical mesh implants was first brought to my attention when I was visited by a constituent. She was advised in her 30s to have the mesh fitted, after suffering incontinence following the birth of twins and a hysterectomy. Its impact on her quality of life is devastating. She cannot walk very far now, she is unable to work, she is in constant pain and suffering, she is unable to partake in sports and she is having problems sleeping.

Photo of Mark Tami Mark Tami Opposition Pairing Whip (Commons)

A constituent of mine has recently contacted me. She has just had a lengthy and painful surgery, but for years she was told that hers was an isolated case and there was no problem. This is a national scandal and needs to be treated in that way.

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

I will go on to talk about some of the problems with people recognising the symptoms later, so I thank my hon. Friend for that.

Since calling for the debate, my inbox has filled up with emails from men and women across the country telling me their horrific stories of having mesh implanted. I will read one of them, which I received just this week:

“Please help me I feel desperate. Who can I turn to to get relief from the terrible irritation and pain I am experiencing. My husband is very worried about my health mentally and bodily, because I keep telling him the quality of my life is dreadful.”

To hear the stories of the women who have suffered complications following their surgery is extremely distressing. Women tell us that they were informed that the surgery would be a quick fix for their bladder problems, that they would be able to continue to have active lifestyles and that their incontinence would be corrected after the 20-minute operation. Women in their 30s, 40s and 50s tell us that they struggle to walk, have lost their sex lives and suffer from horrendous pain day in, day out. Some even suffer from post-traumatic stress disorder following the horrific impact that the mesh has had on their quality of life.

Photo of Catherine McKinnell Catherine McKinnell Labour, Newcastle upon Tyne North

I congratulate my hon. Friend on securing this hugely important and timely debate. One of my constituents contacted me, and in her words:

“I’ve suffered pain, I’ve soiled myself, suffered depression and sepsis. My employment contract as a store manager will be terminated in the next few weeks due to ill health.

My life has changed dramatically but others shouldn’t have to suffer the same fate. It really is unacceptable that we are in 2017 and this is allowed to happen.”

I have no doubt that my hon. Friend will agree.

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

I absolutely agree with that. Sadly, that is also reflected in many of the emails I have read this week. I have no doubt that many women also suffer in silence, either too worried or too embarrassed to see their MPs, or completely unaware that their symptoms are replicated in other women who have had the mesh fitted.

Photo of Oliver Heald Oliver Heald Conservative, North East Hertfordshire

I pay tribute to the hon. Lady for giving national recognition to this important issue. Does she agree with what my constituent said to me: that it is shocking that something so agonising has not had the public recognition it deserves?

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

Absolutely; that is a really important point. The BBC programme “Inside Out West” that aired just this Monday evening highlighted some of the problems with rectopexy, which is a form of rectal mesh, and the investigation a local trust is carrying out on the surgeon, Mr Dixon. I understand that one of the allegations it is looking into is that girls as young as 17 and 18 have had rectopexy.

Photo of Karin Smyth Karin Smyth Labour, Bristol South

On that point and the case that is being investigated in Bristol, I understand from my constituent that NHS England will set up 17 regional teams to look at this. Does my hon. Friend agree that that cannot be done on a local, ad hoc basis? There needs to be national co-ordination on this.

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

I absolutely agree with that. That hospital would neither confirm nor deny that those young girls had been operated on. For background information, all the colorectal surgeons who the programme spoke to said that the young women should have been offered other avenues before surgery. The programme also highlighted the extremely concerning practice of one surgeon attaching part of the rectal mesh to the soft tissue on the wall of the vagina. The shocking reason for subjecting women to this was explained by one consultant, who stated that if the rectopexy mesh is fitted in that way, the surgeon can charge for vaginal repairs as well as for fitting the mesh. Some of the patients being operated on were not aware of where the mesh was being attached, which raises serious questions about the warnings patients are given.

We must remember that it is not only women affected by this issue; men and women are suffering from chronic pain after having mesh surgery for hernias, using the same material—usually polypropylene plastic—used in vaginal mesh surgery. Research shows that between 10% and 15% of people who have had hernia mesh surgery suffer from chronic pain and complications after surgery. However, as with vaginal mesh surgery, not enough information is available to understand the extent of the risks of surgery.

Thankfully, there are organisations that help those affected to tell their stories. The Sling the Mesh campaign has done an incredible job in highlighting the problems, but there must be a wider effort from the Government to inform members of the public that this is an issue and to encourage them to speak out if they experience problems. Thousands of people have had the procedure over the past two decades without knowing what would happen if their body rejected the plastic mesh or if the mesh harmed their internal organs, leading to many people wanting the mesh removed. However, mesh removal is not a simple solution.

Photo of Sue Hayman Sue Hayman Shadow Secretary of State for Environment, Food and Rural Affairs

My constituent Alison had a mesh put in too tight. She was in appalling pain and had to travel all the way from Cumbria to Manchester to get treatment. Now she has had it partially removed, she is in a worse state than ever and has to go back to Manchester again. Does my hon. Friend agree that something has to be done to help people with removal?

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

I absolutely and completely agree. One consultant has written to explain the problems with mesh removal, stating:

“Once stuck the mesh is never fully removed and failure of implanting means that mesh will fuse, erode, stick and adhere to organs, nerves and blood vessels—creating life long…injuries.”

She argues that patients were never clearly told of the risks of mesh fused to organs. She stated further that the

“mesh weave that is stuck will become a perfect breeding ground for bacteria”,

and unless it is completely removed, the patient will remain continually infected and fatigued forever.

Photo of Simon Hoare Simon Hoare Conservative, North Dorset

I apologise, Mr Owen, for arriving a little late. I know that the hon. Lady is talking about consultant surgeons, but does she agree with my constituent, Karen, who has corresponded with me to say that there is also a lack of awareness among the general practice community? The procedures are taking place and are deemed to be a success, but these other problems then present themselves and GPs are just not aware of the causal link and how to diagnose it.

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

Absolutely; I will talk about that later. One of the women who wrote to me this week explained that her surgeon was worried about trying to remove a small piece of mesh from the heart of her vital organs, near her bowel and bladder, which he could not actually see by visual examination, ultrasound or X-ray. She explained that, since having the mesh fitted five and a half years ago, it has prevented her body from healing, causing ongoing problems ever since.

This is not an effort to scaremonger. For most, the surgery is successful, but we have estimates from the Medicines and Healthcare Products Regulatory Agency that about 1% to 3% of women suffer complications. A recent report in the scientific journal Nature showed evidence of about 10% of women suffering complications after surgery, and another research study estimates that the figure could be 15% to 20% or even higher.

Photo of Brendan O'Hara Brendan O'Hara Shadow SNP Spokesperson (Culture and Media)

I thank the hon. Lady for calling this incredibly important debate. My constituent Nancy contacted me recently. She had a mesh implant fitted seven years ago, and her life and that of her family have been turned upside down. She is in constant, crippling pain. She needs tramadol, and when the tramadol has not worked, she has been in hospital for four days on morphine. Does the hon. Lady agree that this devastation for women and their families is absolutely intolerable and must never be allowed to happen again?

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

I completely agree. Sadly, that example is reflected across the whole UK. The Department of Health says that in the past 10 years 136,000 women in England were treated with mesh implants for urinary incontinence and organ prolapse, but it is only recently that NHS England has brought in guidelines that require surgeons to inform patients of the possible risks, and even now we do not have accurate information about just how many women are suffering complications after mesh implants. We know that mesh is the subject of international scrutiny, with legal cases in countries around the world, including Australia, Belgium, Canada, Israel, Italy, the Netherlands, the USA and Venezuela.

Photo of Jo Stevens Jo Stevens Labour, Cardiff Central

Many mesh implants have been fitted at private hospitals rather than NHS hospitals, and we know from the recent case of convicted breast surgeon Ian Paterson that in those circumstances private hospitals deny liability for private surgeons carrying out operations on their premises. Does my hon. Friend agree that that loophole, allowing private healthcare companies to operate under different rules from the NHS, should be looked into and amended?

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

We should be looking into that. I thank my hon. Friend for making that excellent point.

Recently in America, a woman was awarded damages of $57 million in relation to mesh implant surgery, and more than 800 women are currently taking legal action in the UK. Yet so far the Government have sat on the fence on this issue, acknowledging in answers to parliamentary questions from Paul Masterton and my hon. Friends the Members for Bristol South (Karin Smyth) and for Ellesmere Port and Neston (Justin Madders) that it is a problem, but completely failing to create a robust system to ensure that all complications are accurately recorded.

The surgeon Robert Bendavid has argued for longer studies on the women who have had mesh fitted, because in short-term studies the data are not capturing the level of risk. Many of the women who have written to Sling the Mesh have reported difficulties three years after having the mesh fitted. The Department does not even have accurate data to show just how many mesh removals have taken place as a result of surgery complications. We must have a proper framework for building an evidence base to determine exactly how widespread this problem is.

The guidelines from the National Institute for Health and Care Excellence do not provide any information on mesh-removal surgery procedures. I accept the argument for clinical freedom for surgeons and that there are difficulties in testing objects that go into our bodies, but that makes the case for thorough and effective follow-up even more important. There is an ethical duty for surgeons to write and record where there have been complications, so will the Minister commit today to ensuring that all mesh procedures are properly recorded? Will she commit to the mandatory reporting of all complications, and will she commit to raising awareness of this condition?

Raising awareness is not just about raising awareness among the general public. Women are telling us that they are going back to their doctors and surgeons after surgery and being met with blank faces when they describe the complications that they are experiencing. It seems that without adequate research and awareness of the risks of mesh surgery, patients are not receiving the support and aftercare that they need. Although we welcome the resource guide that has been developed to provide GPs with more information about the risks of transvaginal mesh implants, more must be done to encourage dialogue on this issue between GPs and their patients.

Building an evidence base is not the only issue. Many people, most notably the Sling the Mesh campaign, have raised concerns about the fact that previous reviews, especially in England, of surgical mesh have focused solely on the procedural failures of mesh surgery and not looked into the safety of the product itself. That is in line with the findings of a report issued by the EU’s Scientific Committee on Emerging and Newly Identified Health Risks, which said that when assessing the risk associated with mesh application, it is important to consider the overall surface area of material used, the product design and the properties of the material used.

I completely agree with my hon. Friend Owen Smith, the chair of the all-party parliamentary group on surgical mesh implants—he was of great help to me in preparing this speech—when he says that the fact that many companies have already taken their mesh product off the market should tell us that something is not right with these devices. We have to go to the core of the issue and investigate the fundamental safety of the products. Will the Minister commit to doing all she can to ensure that any future reviews of mesh products look at product safety as well as procedural issues?

Photo of Jeremy Lefroy Jeremy Lefroy Conservative, Stafford

I congratulate the hon. Lady on securing the debate. Does she agree that the Health and Social Care (Safety and Quality) Act 2015 —legislation passed by this House two years ago—is relevant? It says:

“The Secretary of State must by regulations impose requirements that the Secretary of State considers necessary to secure that services provided in the carrying on of regulated activities cause no avoidable harm to the persons for whom the services are provided.”

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

I absolutely agree and thank the hon. Gentleman for raising that.

Currently in the UK, there are about 100 types of vaginal mesh implants. Carl Heneghan, professor of evidence-based medicine at the University of Oxford, has raised concerns about the evidence that mesh manufacturers need to provide before their products are approved and made available on the NHS. It is extremely worrying that the Pelvic Floor Society, which is associated with the surgeon Mr Dixon and was set up as a world expert group, is partly sponsored by mesh manufacturers. The BBC spoke to the Pelvic Floor Society on camera during the “Inside Out West” documentary and was told that it had discovered complications only in 2014. However, minutes of a joint meeting of the southern, midland and northern groups of the Pelvic Floor Society in October 2012 say:

“We need to ensure that all individuals are appropriately consented for the risks of mesh placement;
Long term Shrinkage, Mesh erosion, Mesh failure. We need to have a prospective registry for” laparoscopic ventral mesh. Why, if the industry knew about these problems in 2012, are they only coming to light now? That is further proof that the Government must do something about this.

One thing that could be done is to follow the recommendations of the all-party parliamentary group and bring forward publication of the NICE guidelines on mesh for stress-related urinary incontinence. Currently, NICE says that it plans to publish revised guidelines in 2019, but we think that is too long to wait. We want NICE to urgently prioritise them. Mesh as a first-line treatment for incontinence and prolapse should be suspended until the NICE guidelines are revisited.

In May this year, the Scottish Cabinet Secretary for Health and Sport, Shona Robison, confirmed that the Scottish Government had suspended the treatment for people with pelvic organ prolapse. Until we have a proper understanding of just how many women are suffering from mesh injury, we think the surgery should be suspended, but in all cases, not just for pelvic organ prolapse.

Professor Carl Heneghan says that some of the devices used in mesh treatment have not been clinically tested or trialled and that the number of people affected by mesh injury means that this could be one of the biggest medical scandals of our time. Suzy Elneil, consultant urologist at University College London, has also warned about the number of women affected by mesh injury. She is one of the few qualified surgeons in the UK who can remove mesh once it has been fitted and she tells me that she sees about 15 women a week who are suffering following mesh surgery. Consultant gynaecologist Dr Wael Agur from the University of Glasgow was once an advocate of mesh surgery, but has changed his mind since seeing at first hand the evidence of mesh risks. He agrees that there is significant under-reporting of mesh complications and says that, as a result, the MHRA has only a fraction of the knowledge of adverse events associated with mesh.

Photo of Victoria Atkins Victoria Atkins Conservative, Louth and Horncastle

I apologise for arriving late to the debate, Mr Owen. I congratulate the hon. Lady on holding this important debate. The point that she makes about long-term complications is just as important as that about the short-term complications. My constituent developed fibromyalgia as a result of the complications arising from her mesh surgery for stress urinary incontinence. Does the hon. Lady agree that long-term conditions such as that must be taken into account?

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle

Absolutely. Studies need to go far beyond the two years.

I am delighted that Labour has called for a public inquiry into the use of mesh. As my hon. Friend Mrs Hodgson rightly said, it is extremely worrying that mesh surgery has been introduced so widely, with so little evidence and with limited trials to support it.

I call on the Government to do four things. First, they must commit to a full retrospective and mandatory audit of all interventions that involved mesh, followed by a full public inquiry. Secondly, they must suspend prolapse and incontinence mesh operations while the audit is being carried out. Thirdly, they must bring the NICE guidelines for mesh in stress-related urinary incontinence forward from 2019 to 2018. Fourthly, they must raise awareness among the general public and GPs.

Mesh implants have affected thousands of people all over the country. For some, the consequences of operations will be life-changing and devastating. A Government commitment to taking these actions will not undo the suffering and pain that these people have endured, but would go a long way to making sure that nothing like this happens again.

Several hon. Members:

rose—

Photo of Albert Owen Albert Owen Labour, Ynys Môn

Order. I must now impose a time limit of four minutes for each speech.

Photo of Paul Masterton Paul Masterton Conservative, East Renfrewshire 9:50 am, 18th October 2017

It is an honour to serve under your chairmanship, Mr Owen. As co-chair of the all-party group, I am delighted to speak in this debate; I thank Emma Hardy for securing it.

As MP for a Scottish constituency, I will focus on the situation in Scotland, where the devastating effects of mesh surgery were first brought to our attention by the campaign group Scottish Mesh Survivors, which is made up of women and their families whose lives have been ruined by the procedure. The group is led by my constituent, Elaine Holmes, who brought the issue to the Scottish Parliament’s Public Petitions Committee in May 2014. Through the group’s efforts, a request to suspend the surgery was announced by the then Scottish Cabinet Secretary for Health and an independent review group was established.

Scotland had an opportunity to lead the way, but, to my deepest regret, it has lost the initiative. The independent review group’s final report, which was published in March this year, has rightly been termed a whitewash. It refused to recommend a ban on transvaginal mesh implants; an entire chapter with key evidence highlighting the dangers of mesh was omitted; recommendations were weighted in favour of mesh, at the expense of safer non-mesh alternatives; and the review group’s chair was replaced late in the process. Patient representatives were excluded from meetings over 10 months and ultimately resigned from the review group, alongside a consultant physician, branding the report “not in our name”.

Disappointingly, the Scottish Government elected to accept the review group’s recommendations in full. As a result, Scottish Mesh Survivors has been forced to go back to the drawing board and is once again pursuing justice through the Scottish Parliament’s Public Petitions Committee.

One of the most common arguments against reclassification is that the evidence to support such a move is not there. I disagree. I stand shoulder to shoulder with women like Elaine and the numerous other mesh-injured women who have rightly proclaimed, “We are the evidence,”; with women like Lorna Farrell, another constituent who has suffered devastating injuries from the procedure; with women like Leslie McGlinchey, a mum of two who was not even 30 when she had the operation and now spends a huge amount of time in a wheelchair. Leslie frequently has to explain to her two little girls why mummy keeps falling over. She was told that a 20-minute operation would change her life. Well, they weren’t wrong. Women who have lost their careers, their husbands, their homes, their dignity and their lives; who are forced to spend day after day and night after night in agony; who are left with little option but to make use of wheelchairs and walking aids just to get by—they are the evidence.

It is increasingly clear that when women are fully informed of the potentially life-altering consequences of mesh surgery, they reject the procedure outright. Dr Wael Agur, the consultant physician who resigned from the independent review group, spoke at a recent petition hearing on the subject in the Scottish Parliament. He informed the meeting that, out of 22 women who had made use of his health board’s shared decision-making tool to assess whether mesh was right for them, only one indicated that she was in favour of the procedure, and it was later discovered that she had not read the leaflet properly.

The Scottish Conservatives, led on this issue by my colleague Jackson Carlaw MSP, have been at the forefront of the debate in Scotland since the scandal first erupted, working closely with Scottish Labour, which is led on the issue by Neil Findlay MSP. We have stood firmly behind the women whose lives have been devastated by mesh. I urge party colleagues south of the border to be alive to the issue, to act now while they have the opportunity, and—please—to suspend this procedure. If they are not convinced that there is enough evidence, they should suspend the procedure while they gather the evidence.

Mesh is rapidly becoming one of the great global health scandals. I implore all hon. Members to do what we can to protect women from this potentially devastating procedure and to ensure that our nation becomes an example to others of how to achieve justice for all those who have been broken by mesh.

Photo of Owen Smith Owen Smith Shadow Secretary of State for Northern Ireland 9:54 am, 18th October 2017

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

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

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

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

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

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

Photo of Derek Thomas Derek Thomas Conservative, St Ives 9:58 am, 18th October 2017

I commend Emma Hardy for securing this vital debate.

I knew nothing about surgical mesh until I was elected in 2015. Since then, women who have written to me or sat opposite me in my surgery have introduced me to their experience: a world of untold suffering, misery, distress and anxiety, which could and should have been avoided. I can add little to the debate other than to describe the experience of ladies in west Cornwall. A constituent in Helston writes:

“Before mesh, I was a vibrant and active woman, positively contributing to my community and society. Mesh has ruined my life with devastating life-altering consequences. Life is now marked by overwhelming daily challenges to my physical, psychological, social, occupational, and financial health and wellbeing. I am unable to work which adds to the financial stress. I am primarily housebound and not able to participate in the lives of family and friends, which I find most heartbreaking. I have three beautiful granddaughters…who live in…Germany. It has been a year since I have been able to visit and look into their curiously beautiful eyes.

I have a Masters Degree in Psychology which has helped me to cope with the devastating life-altering limitations and overwhelming daily challenges of living with significant mesh complications. The pain, discouragement, depression and anxiety is overwhelming every day, and excruciating on others, which is why I have also sought the support of occupational therapists, health psychologists and mental health professionals.”

Another constituent of mine states that the Food and Drug Administration in the USA has issued strict guidelines for mesh use and that in the USA a warning is given to patients about the potential dangers. She had a mesh implant to correct a pelvic prolapse and was told by her doctor that her quality of life would be significantly better, but it has not been. Her retirement has been ruined. She used to walk miles every day with her dogs but now struggles to walk due to pain and feels she might have to go into a wheelchair, as even the shortest walk around the house causes excruciating pain.

More recently, a lady came to see me in my surgery and talked about her experience. She had undergone an operation where a surgical mesh was used. After complications, she underwent a second procedure, during which the mesh was accidentally compromised, and she now suffers recurrent uterine prolapse. The surgeon has written to her, explaining the damage caused during the surgery, and has stressed the need for urgent further intervention, but she has been told that she cannot have surgery until May 2018. Until my intervention, she did not expect to hear back from the hospital until December at the earliest.

Further stories have emerged, including that of a constituent whose mesh eroded through her bladder and vagina. The mesh had been inserted in 2008 for stress urinary incontinence. At the time her complications emerged, there were only two surgeons in England who specialised in removing such mesh. One was in Oxford and one in London, both of which are a long way from west Cornwall.

Finally, another constituent of mine had transobturator tape, or TVTO, inserted five years ago to treat stress urinary incontinence. The device immediately caused her pelvic pain. Within six months, she suffered complete saddle anaesthesia with associated bladder, bowel and sexual dysfunction. The mesh was removed after two years but my constituent’s chronic pain continues, due to nerve damage.

For those ladies, little can be done to put right years of discomfort, distress and indignity. What they want is for the Department of Health to allow the use of mesh only in the most serious of cases, where no other option is available. A husband of a patient whose suffering continues following her surgical mesh implant writes:

“Our ultimate desire and goal is to see a complete ban on surgical mesh procedures so other women need not suffer the same appalling life-altering complications.”

I pay tribute to my constituents who have lived with this harm and who are willing to face up to the indignity of talking about their experiences, so that others do not suffer a repeat.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Human Rights), Shadow DUP Spokesperson (Health) 10:02 am, 18th October 2017

First, I congratulate Emma Hardy on bringing a major issue to the fore. I say “major”, not because there are necessarily millions of people involved—the final number of women who have been affected is not yet known—but because the impact that this issue has had on the lives of the people who have been affected by it is major and heart-breaking, and it deserves attention and action from this place.

I have received a large number of emails from Northern Irish people outlining their horrific experiences and some of the ladies affected are in the Gallery today. It would seem that in an attempt to access a cheaper form of surgery, we are putting some people at risk of horrific complications. It is clear that this surgery must be used only after the full extent of the dangers is outlined and fully understood by women, and once they accept that this option comes with a massive warning.

One of my constituents contacted me about this issue. She has not worked for two years and she will have an operation very shortly. In the short time that I have in which to speak, I will say that another woman—she is not from my constituency, but from the constituency of my party leader—contacted me and outlined her case. Her experiences are clearly similar to those of other women who have been affected:

“Listed are just a few of what I have and am still enduring since the surgeon inserted this foreign object into my body: Constant agonising pain, as if I was being cut inside…
Inability to bend over without crying out in agonising pain…
Constant urine and bladder infections…
Inability to carry out my duties associated with my occupation…
Inability to enjoy any social life whatsoever”.

She is also unable to have intimate relations with her husband, which she says has been “detrimental to my marriage”. She is also suffering:

“Depression and extreme low self esteem…
Sweating profusely…
Inability to walk or exercise due to chronic pain and fatigue…
Severe agonising pain passing urine…
Visits to A&E with agonising pains in my groin, legs and pelvic area... Visits to out of hours doctors and many visits to my GP practice”.

She says she has had:

“Regular phone calls and visits to the continence nurses to find my bladder was not emptying properly and each time told my urine sample showed up infection and blood. My family as a unit have been affected also, as they too feel my stress and pressure that I have and am under due to no one helping or believing me.”

This is a lady who is wearing what amounts to—I say this with respect—adult nappies, and I for one am not prepared to ignore her story.

There are some 250 members of the Meshed Up Northern Ireland support group and their pleas are very clear. There are no options in Northern Ireland for the surgery that is necessary. All those ladies who have had mesh implants must come across the water for surgery. Some have had operations; some are about to have an operation.

My party is very concerned about that situation and, for the record, we are asking for the best possible information, including better data for women considering this procedure; an improved and more holistic approach to caring for these women; updating of clinical guidance and standards; increased awareness among GPs of post-operative problems, with better access to follow-up clinical expertise for those women with problems; and a more complete picture of the level and seriousness of the complications. There must be standardised information for patients and a more consistent consent process, so that when women are asked about these operations they understand what they mean and the implications, because they have not been told—at least my constituents were never told—about the implications and had no idea what the operation meant. We are asking for specialist centres with multidisciplinary teams to advise on and treat complications and post-operative problems; a minimum workload of cases for surgeons carrying out relevant procedures; and further ongoing research into mesh procedures and adverse effects.

All those things would be best considered within an inquiry. That is what I am asking for today, that is what my constituents are asking for, and that is what all the sufferers from this problem in Northern Ireland are asking for.

Photo of Mims Davies Mims Davies Conservative, Eastleigh 10:06 am, 18th October 2017

I sincerely congratulate Emma Hardy on securing this debate, and it is a pleasure to serve under your chairmanship, Mr Owen.

I, too, have applied for debates on this subject in the House, so this debate is welcomed by all parties. Like other colleagues, I am pleased that this issue is being discussed so openly, and it is absolutely vital that Ministers listen to the UK-wide concerns that are being raised. I have heard from Eastleigh constituents who have shared simply horrific accounts of the long-term difficulties that they have experienced as a result of having had a mesh implant, so I am very pleased to contribute to this debate.

I was also contacted via Facebook by a long-term friend who wanted to tell me her story after having her third child, and to link me into the Sling the Mesh group, which, as we know, is an ever-growing group, with more than 3,500 women involved with it. After an operation three weeks earlier, my friend had to self-catheterise. It was simply hideous. She said:

“It would seem that health professionals do not want to quite hear the truth or tell the truth about the complications of mesh or the TVTO surgery”,

which she had had. She felt that because the condition was so embarrassing, it was just being under-reported.

After a woman has had a baby, especially her first, she always listens to the professionals. Pain and suffering after a birth are not unusual, but two or three years after giving birth many women are in pain, with incontinence, with an impact on family life, with no sex life, and with no opportunity to play sport or to enjoy time with their children down at the park, or to enjoy time as a family and have time with their partner. Too many women are simply being ignored, post-pregnancy and through the long-term impact, as we have heard. GPs seemingly do not have a full understanding of this matter.

Let us be in no doubt: in some cases, but not the majority, this option is perhaps appropriate for women, but it must be carried out by trained surgeons. However, one more woman suffering in the way that many of our constituents have suffered is one woman too many. We have heard such stories today. So today I urge us to look at all those women who have been so dramatically affected by the long-term impact of trusting the advice of their surgeon. We must make sure that if anyone has a mesh implant put in, they really understand the impact.

I will give one further example that I have been informed about, which is the case of a lady in my local area who had surgical mesh implanted five years ago. Further treatment is ongoing; she has had multiple complications and operations. Her case has also been raised with me by her father, who has spelled out the heartbreak of seeing his daughter in so much pain.

I call on the Minister to ask the Medicines and Healthcare Products Regulatory Agency to work further with the mesh working group to ensure that all those who use mesh know that it is the right treatment for them and fully understand all the issues and concerns that exist about mesh. Nobody should come away from this debate unaware of the warnings and complications. There is no doubt that if someone is suffering, mesh could be a good option for them. However, professionals should ensure that it is the right course for them.

I finish by strongly urging the Minister to act on this worrying, UK-wide concern. Let us not be afraid to end the suffering and let us be prepared to make sure that no further harm is caused by this issue. We should also be bold, because women’s health matters and family lives are simply being blighted.

Photo of Carolyn Harris Carolyn Harris Shadow Minister (Equalities Office) (Women and Equalities) 10:10 am, 18th October 2017

It is a pleasure to serve under your excellent chairmanship, Mr Owen. I congratulate my hon. Friend Emma Hardy on securing this important debate. I pay tribute to my hon. Friend Owen Smith for taking the lead on this important issue and for establishing the all-party parliamentary group on surgical mesh implants, of which I am proud to be an officer.

When one in 15 women fitted with the most common type of mesh will require surgery to extract it, it is clear that the issue needs to be addressed nationally. The figures are staggering and the situation is like Russian roulette. Mesh is resulting in women being unable to walk, go to work, go about their everyday lives or enjoy a fulfilling sex life. More than 800 women in the UK are taking legal action against the manufacturers of the product, so it is clear that the problem is not just going to go away.

The NHS tells us that insufficient reporting and under-published data are contributing to the problem. A basic requirement should be a register of women who have had the implants, so that we can truly assess the potential impact. Regulators around the world have been demanding more testing to ensure that the mesh is as effective for treating prolapses as it is for other conditions. We cannot just sit on the fence; the problem is ongoing. We cannot just sit around waiting for the guidance to be published, whether that is next year or not. With so many people affected, there must be an immediate inquiry. We cannot wait—too many women are experiencing severe pain and discomfort because of these products. Now is the time for the Government to carry out a full audit, establish a register and look to find a way to eliminate the damage and destruction to women’s lives that the mesh has caused. Now is the time to sling the mesh.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health Committee 10:12 am, 18th October 2017

I congratulate Emma Hardy on securing this important debate. In the brief time available, I would like to touch on the issues of how we allowed this situation to continue to for so long, consent, clinical quality and governance, including in the private sector, and what we should be doing going forward.

First, I pay tribute to the many women who have been courageous in coming forward and discussing intensely painful and personal experiences, not only with myself but with other Members. I would like to quote one, who said:

“I am in so much pain at times that I just give up on the day…The pain never goes, it just varies in intensity.”

We have heard numerous examples of how these devices are deeply impacting on people’s lives with life-changing symptoms. In many cases, those symptoms were not life-changing before the procedure. Many women have delayed symptoms or were unaware that they had these devices inserted in the first place. Women have told me that they did not consent to these devices being inserted and were not informed of the risks. A fundamental principle of consent is that unless the consent is informed, it is not consent at all.

It is very difficult for women to be properly advised of the complications when we have such poor data, and that goes to the heart of the scandal. The clinical trials of these products were inadequate. We know now that variations in the type of mesh lead to a greater or lesser risk of complications in the first place, yet these products were varied and introduced and marketed aggressively without adequate clinical trials, and that is why there has been such a long delay before action has finally been taken. I hope the Minister will address that in her remarks, because if clinical trials are not a fundamental condition for the introduction of new devices, we will see this situation with other devices.

Another concern is the way that such procedures are used. We saw variation in the techniques with which these devices were introduced. We must have an absolute guarantee that there will be proper clinical trials, just as we would expect for the introduction of medicines.

Photo of Chris Ruane Chris Ruane Shadow Minister (Wales)

Does the hon. Lady agree that if the companies failed to introduce proper clinical trials at the outset, they should now be queueing up to ask these women to come forward so that they can look at the specific cases where the devices have failed? They should be begging these women to come forward.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health Committee

The hon. Gentleman raises an important point, but many women were not even informed that they had the devices in the first place. Other Members have touched on the fact that because the complications can be late in arising and because of the inadequacy of recording, it is very difficult for women to come forward.

In the brief time available, I would like to mention the yellow card scheme—I will add links on my social media later—which enables women to self-report complications. However, if someone does not know they have had the device fitted they will not report those complications. There is work to raise awareness among GPs of the possibility that symptoms that women present with are related to mesh, to ensure that those women are referred. I welcome the specialist centres that have been set up to treat women who have been so adversely affected by mesh, but if mesh is inserted in the first place, it should absolutely be done in specialist centres.

I do not agree that we should ban mesh, because for some women the symptoms of stress urinary incontinence or prolapse can be life-altering. We should retain it as an option where alternative procedures may create worse outcomes or worse complications, but there must be adequate consultation with women about the risks so that they can weigh them up. I agree with Members who have said they hope that NICE can prioritise the development of more detailed guidance, so that we may have it as soon as possible.

A fundamental absence of data is at the heart of the issue. There has been cavalier practice, and we cannot allow that to continue. The women who have been affected deserve an apology and recognition of the extent of the problem and the delays in recognising and dealing with it. I welcome the findings of the mesh oversight group report, which describes pragmatic and practical recommendations, but clear failings have been allowed to continue for so long. At the heart of those failings is the inadequacy of clinical trials, recording and consent. Finally, we know that the devices are regulated by the European Union. I hope the Minister will comment on how the Government propose to take this issue forward after we leave the European Union. At the heart of it is the need to ensure that the safety of women is prioritised at all times.

Photo of Albert Owen Albert Owen Labour, Ynys Môn

I thank the Chair of the Health Committee.

Photo of Jo Platt Jo Platt Labour/Co-operative, Leigh 10:17 am, 18th October 2017

First, I congratulate my hon. Friend Emma Hardy on securing this important debate. I also pay tribute to the incredible work of my hon. Friend Owen Smith, whose campaign has ensured that those women affected by mesh implants have a voice and are being listened to. They may receive some reassurance from the fact that we are debating the issue today.

I have a constituent who is suffering from the consequences of a failed mesh implant. She met me recently and explained the debilitating and life-changing effects it is having on her quality of life. She told me of her experiences of the failed procedure, which left her barely able to walk, and bedridden for three months. She spoke of the pressure that put on her family, with her children left to care for her and her husband unable to work overtime due to childcare commitments. It has prevented her children having friends over, stopped family holidays and left her disconnected from her community, being unable to walk or drive without excruciating pain. The financial burden and personal impact on her family has been immense. She described the effect on her mental health. She has uncontrollable mood swings, angry outbursts and frustration at not being able to care for her young family. She now faces many more procedures and many more months of pain before she can even dare to think about her future.

There are many more women like my constituent, as we have heard today, and I pay tribute to the bravery of these women who have come forward to demand that they be heard and that their stories are told and acted upon; but these are the women we know about. Alarmingly, many are not aware that post-operative issues may be a direct result of the implants. The worrying narrative emerging is that many women who have had the implants and have since experienced problems are only now finding out about the complications that mesh can cause. Women who have had the procedure should be contacted directly and made aware of the issues we are debating here today.

Women who have suffered such debilitating effects deserve a full inquiry to determine how it could have happened and what steps will be taken to ensure such a situation never happens again. I therefore agree with the APPG’s recommendation to suspend the procedures pending a NICE guideline review to protect the health and wellbeing of more women.

I hope this debate will ensure that the Government listen to the women affected by the implants. I hope they will confirm their commitment to investigate the situation fully and take urgent action to prevent other women going through some of the horrific ordeals we have heard about today.

Photo of Alec Shelbrooke Alec Shelbrooke Conservative, Elmet and Rothwell 10:20 am, 18th October 2017

I pay tribute to Emma Hardy for securing this debate. I did not know about the subject until a constituent came to see me on Friday. The stories in the Chamber today from all parts of the realm—from Northern Ireland, Wales, Scotland and England—with every Member of Parliament telling a similar tale, show that this is the tip of the iceberg and that there are many hundreds, if not thousands, of women out there who could be struggling. Of course, they may not know yet that they will have a problem, because we do not have the data.

My constituent who came to see me is incredibly brave. She could not make herself at all comfortable during my surgery, but leant forward with her hands on the table. She could not sit, could not stand straight and could not bend over. As the consultation went on, she was sweating more and more with pain. It is all very well having sweeping statements about ruined sex lives and constant pain, but what does that mean? My constituent, who is only 47 years old, was more concerned about my embarrassment as she told me her story than she was about herself. A lot of women do not want to embarrass us, but we are the postmen for relaying stories back to Government.

My constituent said that during sex four years after the operation her husband ended up with a cut and bleeding penis. Further surgery has taken place and intercourse is now completely impossible. This lady had had a loving and physical relationship with her husband, and after further surgery now has no sexual stimulation at all. Indeed, she told me that any clitoral stimulation had immediately become a huge abdominal pain. She has also been diagnosed with a low level of infection. There is a shocking statistic: research has shown that 83.6% of implants have been found to have vaginal bacteria on them. That is an important statistic because the Medical Devices Regulations 2002 state that before a medical device can be placed on the market, the manufacturer must ensure that the device meets essential requirements, which include sterility and minimising the risks of contamination.

My constituent was a physiotherapist and had led a very active life. She can now barely get through a day. She was not told about the risks of the operation. Her prolapse was not serious enough to demand such an operation, but she was told, “We can sort that out.” It was not until 2013 that she was told she had a vaginal extrusion. Even then she was told by the surgeon, “Don’t worry; you truly have a designer vagina now,” which showed a complete lack of sympathy and understanding that is scandalous.

We are debating the issue and showing that the scandal has moved forward. I did a lot of work on the thalidomide campaign and I thought this was the next thalidomide scandal. That is how Sky News described it this morning in recognition of how serious this matter is. As my hon. Friend Dr Wollaston has said, there may be areas where the procedure can be used, but at a minimum the situation warrants a suspension of use at this stage, as has happened in the United States and in Scotland. My constituent is a generous woman. She said, “I don’t expect you to understand this quickly, but please raise my voice today in Parliament.”

Suspension and study of the data is vital; otherwise, we could be creating the biggest scandal in years in the NHS.

Photo of Tonia Antoniazzi Tonia Antoniazzi Labour, Gower 10:24 am, 18th October 2017

Thank you, Mr Owen, for chairing this debate. I congratulate my hon. Friend Emma Hardy on securing this important Westminster Hall debate on international menopause day.

Women are always reluctant to speak out about the personal and intimate medical issues that they experience. Sadly, they are highlighted only when things go wrong. Two women in my constituency have spoken out about their experiences, but I urge all women who have suffered as a result of a mesh implant to get in touch with their MP, because we know there are many other cases. As we have heard, there are women suffering whom we do not know about.

Recently I met a constituent of about my age whose life has been devastated. She had a mesh fitted in December 2011 and knew immediately that something was wrong. She could hardly move her right leg. She had pain all across her lower abdomen and back and in the right side of her groin. She had infections in the operation sites and was given three lots of antibiotics. Three weeks later the consultant said that she had mesh exposure. She was admitted on 3 February for what she thought was a removal, but it turned out to be for steroid injections, which did not alleviate the pain.

She was then sent for internal physiotherapy. I imagine that was very painful. She has also received physio on her back because of back pain. She saw numerous consultants and had many scans. Eventually, after bursting into tears during a physio session because of the pain she was in, she ended up seeing another consultant, who decided she should be admitted to remove the mesh. The operation was in August 2012 and she was pain-free for about a year after, but then it started again. She had constant pain in the groin, back, and across the lower abdomen, and she went back and forth to the doctor in the familiar scenario that we are hearing about today. It was even thought she might have bladder cancer, but all the scans were clear and still she was in constant pain.

My constituent was under the impression that the mesh had been removed, so when they were all scratching their heads and saying they did not understand why she was in pain, she was told she should try and manage it better. Understandably, she did not know where to turn. Eventually she saw a different consultant who asked her what she could feel inside, and she said it was the mesh. It turned out they had only cut the mesh in half. It was still there—no wonder she was in so much pain. Again, she went in for removal in August 2015. Unable to pass urine for three weeks, she had to self-catheterise at home.

About nine weeks later she started to feel as though she was getting on her feet again and was relatively pain-free for about a year, but it flared up again. She had another round of video urodynamics done, which was not pleasant. She was told that the corner pieces of the mesh were still there and it was too risky to remove them. After a recent flare-up with severe inflammation, she was sent for an urgent scan. Having spent the past six years in constant pain and discomfort, she does not have a partner because so much time is taken up looking after herself and her son and working.

During a visit to the consultant this year he asked what she wanted him to do. She said, “I came to be under your care because I was incontinent. I am still under your care six years later, still incontinent, and in pain as well now, so you tell me what you are going to do.” We must realise these women need help. As the MP for Gower, I have talked about my constituent and the plight of mesh-injured women. Many women do not like to discuss this topic and they do not want to complain. We cannot wait until 2019 for NICE to bring out guidance. I echo the words of the shadow Minister for Public Health, my hon. Friend Mrs Hodgson, by asking the Government to hold a public inquiry into the numbers of women adversely affected.

Photo of Jeff Smith Jeff Smith Opposition Whip (Commons) 10:28 am, 18th October 2017

It is a pleasure to serve under your chairmanship, Mr Owen. I congratulate my hon. Friend Emma Hardy on securing the debate and on her powerful speech. I also congratulate my hon. Friend Owen Smith on raising the issue and on forming the APPG to raise the profile of an issue that I confess I knew virtually nothing about until quite recently. I congratulate the many Members who have made powerful speeches explaining the experiences of women in their constituencies.

As I have said, I knew nothing about this issue, but its seriousness was brought home to me when a constituent came to see me. He had had an inguinal hernia repair that developed complications because of the mesh used in the procedure. It left him in agony; he described it as like having a metal plate wedged in his lower abdomen. Eventually, he had to have corrective surgery, but it did not resolve the chronic pain that he suffers. That points to one of the unique aspects of this problem, which is the difficulty of removing the mesh and correcting the initial surgery. He had the mesh removed, but he is still in constant pain. I think that is partly due to the fact that the expertise in removing mesh implants is not really there.

Photo of Alec Shelbrooke Alec Shelbrooke Conservative, Elmet and Rothwell

My constituent described it as trying to remove hair from chewing gum, which shows just how utterly complicated this surgery is.

Photo of Jeff Smith Jeff Smith Opposition Whip (Commons)

That is an important, well-made point. The failure of the procedure that my constituent went through has changed his life. He was previously a runner, cyclist and mountain-climber—a very active man. He now struggles to get around. When he came to see me, he had to stand throughout our meeting because of the pain that he is in. He is now suffering with a chronic condition as a result of the failed procedure.

My constituent has been in contact with a number of other men—and is aware of many others—who are in this difficult situation. He asked me to ask the Minister two questions. First, how many men have gone through this procedure and had it fail? Secondly, will the scope of any future NHS investigations be widened to include men as well as women? I do not want to downplay the seriousness of the issue for women, which has been clearly explained by a number of Members today, but any investigation needs to take the experience of men into account.

As it happens, my constituent underwent his procedure in a private hospital, which points to three wider issues that he asked me to raise. First, there is a lack of clarity—as we have already heard—about the roles and responsibilities within private hospitals and between hospitals, surgeons and others involved in the process. Secondly, there is no mandatory reporting of chronic pain incidents following unsuccessful operations; that clearly needs to be addressed.

Thirdly, there is a three-year limit to medical negligence claims, which has had an impact on my constituent and possibly others as well. My constituent had his operation just under three years ago, but he has been managing his agonising pain and chronic condition for the last two years and has not really been able to think about whether there is a medical negligence claim. He does not really have time now to lodge one within the three-year limit. I would be interested to hear the Minister say something on those matters.

I conclude by supporting the other points that have been made by hon. Members about the prioritisation of this issue by the National Institute for Health and Care Excellence and the need for a full public inquiry.

Photo of Albert Owen Albert Owen Labour, Ynys Môn

I am grateful to the hon. Gentleman. I want to thank all Back-Bench Members for their co-operation with their interventions and speeches, and for taking such a serious tone on this matter. We will now hear from the Front-Bench spokespersons.

Photo of Patrick Grady Patrick Grady SNP Chief Whip 10:33 am, 18th October 2017

It is a pleasure to serve under your chairmanship, Mr Owen. I will be as brief as I can, because we are all very keen to hear from the Minister.

A lot of the key points have been extremely well made by all the Members who have spoken. I particularly congratulate Emma Hardy on securing the debate and opening it for us. I also want to pay tribute to the chair of the all-party parliamentary group, Owen Smith, for the work that he has done.

Like many Members, the issue was brought to my attention by a constituent and the very powerful and emotional meeting held in one of the Committee Rooms before the formal founding of the APPG, where we heard testimony from a range of constituents and campaigners. Many of those testimonies have been echoed and repeated today, notably, but not exclusively, by the hon. Members for St Ives (Derek Thomas), for Gower (Tonia Antoniazzi), for Strangford (Jim Shannon), for Elmet and Rothwell (Alec Shelbrooke) and for Manchester, Withington (Jeff Smith). They are painful enough to listen to—we saw the reactions of Members in the room as we heard those testimonies—so how much more painful and traumatic it must be for people to have to live in those terrible situations.

Paul Masterton raised the situation in Scotland, and I want to dwell on that for a moment. He must be one of the first opposition politicians—as he is in Scotland—ever to say the words, “I am disappointed that the results of the independent review were implemented in full.” Normally, Governments get criticised for not implementing the outcomes of an independent review.

In 2014, the Scottish Government requested a suspension in the use of vaginal medical mesh by the NHS in Scotland. In 2015, the Cabinet Secretary for Health apologised to women who had been left in severe pain by these operations. Since that suspension was introduced, the use of mesh has fallen dramatically. Between 2009 and 2016, the number of women receiving mesh surgery in Scotland has fallen from 2,267 to 135.

I understand from what was said by Dr Wollaston, who probably knows far more about these issues than many of us in the room, that it would be very difficult to get that figure right down to zero, because there may be occasions when the surgery is appropriate. However, it has to be under very specific conditions and absolutely with the fully informed consent of which she spoke. That comes out clearly in “The Scottish Independent Review of the Use, Safety and Efficacy of Transvaginal Mesh Implants in the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse in Women”.

The hon. Member for East Renfrewshire is right to say that transabdominal mesh is not yet under suspension, but that remains, and should remain, under constant review by the chief medical officer in Scotland. All the evidence that was submitted to the review are available on the website, along with the different drafts. It is important that we make it clear that the evidence has been fully published, and that the recommendations were made independently by the review and have been accepted in full by the chief medical officer in Scotland, who has been clear that the requested suspension of the use of mesh implants should remain in place until she is satisfied that the recommendations have been implemented.

An oversight group will oversee the recommendations and will be expected to put the patient at the heart of everything it does. Professor Alison Britton has been asked to examine the review process itself, to listen to and take on board some of the concerns that the hon. Gentleman raised. I would be interested to hear from the Minister what discussions she has had with colleagues in Scotland about what lessons can be learned from some of the questions that have been asked there.

The Scottish Government have no power to ban the use of mesh, because the matter remains reserved to the Westminster Parliament and, in particular, to the Medicines and Healthcare Products Regulatory Agency. The Sling the Mesh campaign, as we have heard from a number of Members, has asked for some clarity from the MHRA and a stronger, more stringent system of auditing the efficacy of mesh and other medical practices.

One of the most important things that has come through clearly in the debate is the collection and analysis of data, so that a full picture of the situation can be brought up. We have heard so many times of individual cases where people are told, “This is just you; this is an isolated case,” when it very clearly is not. The evidence has to be gathered, and full investigations have to take place and continue.

There is a clear expectation that the MHRA must continue to review the use of medical mesh implants. That should include considering all available evidence and taking lessons from the use of such implants further afield, such as in the United States and Europe. That is important to ensure not only that the best healthcare options are provided, but that women can be confident that the services they have received have been shown to be effective under robust and effective clinical trials—an important point, which was stressed by the hon. Member for Totnes. One of the key things I have learned from this debate is the difference between the testing regime for medicines and the testing regime for implants and other medical devices. There is clearly a cross-party consensus on that, and I hope the APPG will continue to look at the issue.

I welcome the conclusions and recommendations of the Scottish and English reviews of the use of this procedure. We must ensure that surgical mesh implants are used only after all other appropriate alternatives have been exhausted and, crucially, only when women give their fully informed consent.

Once again, I pay tribute to the campaigners for their bravery and courage and for bringing this issue to our attention. I hope it is not a totally inappropriate comparison, but this reminds me of the Women Against State Pension Inequality campaign, during which individual, isolated cases started to snowball, and the issue got on to the agenda. That campaign for justice made progress and is now being heard loud and clear. There is a parallel with this campaign, although it is not exactly the same. I hope the Government listen. We have to thank those campaigners for the small and belated progress that has been made. They will rightly hold us to account to ensure we make progress.

Photo of Sharon Hodgson Sharon Hodgson Shadow Minister (Public Health) 10:40 am, 18th October 2017

It is a pleasure to serve under your chairmanship, Mr Owen. I thank my hon. Friend Emma Hardy for securing this very important debate and for her excellent contribution. The Opposition fully support her four asks of the Government.

I commend all other speakers for their thoughtful and passionate contributions, and I thank their constituents who allowed their experiences to be shared with us. I especially want to thank Kath Sansom, who leads the Sling the Mesh campaign, for all her hard work in uniting the women affected by vaginal mesh implants and for raising awareness of the tragic impact that mesh implants have had on so many lives. I also thank other hon. Members who have spoken out about this issue for such a long time—in particular, my hon. Friend Owen Smith, who spoke with such knowledge and passion. It was vital that he took part in this debate, and I thank him for everything he has done on the issue.

The experiences we have heard about today are incredibly distressing. I have the utmost sympathy for those suffering because of mesh implants. We are here to stand up for those women, and we seek answers and Government action on their behalf.

Let us start at the beginning, when women are told that the best course of action is to have a mesh implant. They are told that the procedure is quick and cheap, but, as we have heard, the low financial cost of the implants is far outweighed by the huge human cost to those women for the rest of their lives.

The NHS and the MHRA say that the risk of complications is low, at 1% to 3%, but a report by nine leading medics put the risk much higher, at 15%. If leading bodies and medical professionals cannot agree, how can patients be expected to make informed decisions? Health professionals are supposed to outline clearly and explicitly the risks of any operation that a patient is asked to undergo to ensure they can weigh up the risks and benefits for themselves.

As we have heard, the mesh implants are made of the same material as some drinks bottles. They can shrink, twist and curl at the edges. The material can degrade, cut through internal tissues, poke through the vaginal wall and stick to organs, causing pain, incontinence, urinary infections and a loss of sex life. Marriages have been destroyed and people have been left unable to walk, work or even to pick up their young children. Knowing those risks, how many in this Chamber would consent to a mesh implant? It is time to take women’s health and wellbeing seriously. They need to be listened to. Their voices need to be heard and their concerns believed so we can put right this injustice and prevent it from going on any longer.

Since this debate was announced, I have been inundated with emails and tweets telling harrowing stories of how women have been affected by vaginal mesh implants. I am sure everyone in the Chamber has received the same sort of emails. Just last night—very late in the day—I received an email from Sling the Mesh with an attachment containing 210 emails out of the 400 it received following the Minister’s answer to my question during Health questions last week, when she said there is not enough evidence to ban the mesh. Those emails are packed with evidence, and I am very happy to pass them on to the Minister. They all detail how the implants have been life-changing, but unfortunately not for the better.

Julie has had to give up her job as a paramedic, and is now trapped in a world of pain and medication. Kath has lost her passion for mountain biking because it is now impossible to get on the bike. Suzi says that her pain consumes her every day.

Another woman, Tina, also shared her experiences. For four years, she went to her GP and accident and emergency several times with excruciating pain, and was sent from pillar to post. She was told that the pain was due to irritable bowel syndrome, painful bladder syndrome and a slipped disc, and that the mesh implant was absolutely not the problem. After four years of searching for answers, she went private and spoke to a surgeon who finally believed her pleas about her pain and partially removed the mesh. She says that her recovery has been successful and she is no longer in pain, which is excellent, but four years is such a long time to lose. We know that many, many women are unable to go private to end their trauma, but they should not have to do so.

After this debate, there is a lobby of mesh-injured women, which I encourage the Minister to attend. We will be joined by Dr Robert Bendavid, who has flown in overnight from Canada. That shows that this really is a worldwide scandal. Many countries, including our own, are just waking up to the horrors of vaginal mesh. In Australia the Senate is holding an inquiry, and in the US vaginal mesh has been considered a high-risk device for nearly a decade. As we heard, vaginal mesh has been suspended in Scotland since 2014, yet across the border the Government have rejected a ban in England and have failed to empathise with the approximately 8,000 women who have been admitted to hospital with a mesh complication. That is not surprising, considering that just 1,000 mesh admissions have been reported to the MHRA as a mesh-related issue. Surgeons are clearly reluctant to report that mesh is the issue, which lets their patients down and distresses them further.

Our next concern is what the Government are going to do to support women who have had to leave because of the effect of vaginal mesh. Most GPs do not attribute the pain to the mesh, so it is very difficult for those women to claim personal independence payments, disability living allowance or any other benefits. They have to rely on their families’ finances, which is incredibly frustrating and distressing to the victims, especially those whose families are unable to support them. We must also consider the women who are suffering in silence and have not come forward yet because of the intimate nature of the issue. After hearing of the experiences of others, some women may be embarrassed or just too scared to come forward for fear of being dismissed as a hysterical woman.

At Health questions last week, the Minister said that a NICE update on vaginal mesh implants is expected at the beginning of next year—my hon. Friend the Member for Pontypridd also mentioned that—but that is too little, too late for the approximately 200 women who will get a vaginal mesh implant on the NHS between now and then and the thousands of women who have already been affected. One of my constituents reached out to me to say that she is worried because she is due to have that surgery soon, and she asked for my advice. Obviously, we cannot give medical advice, so I told her to watch this debate and speak to a surgeon. If there is a chance that a car or an aircraft could cause harm, it would be immediately recalled while the problem was investigated. Why does the precautionary principle not also apply when the health and wellbeing of thousands of women is in jeopardy?

Last week, the Minister said there was not enough evidence to warrant asking the MHRA to reclassify these procedures, but there was so little evidence to justify beginning them in the first place. What exactly is she waiting for? Given what we have heard today, I hope she will recognise the urgent need for action on this issue and justice for those women. I hope she will take these calls back to the Department of Health and ensure that no more women are subject to the risks of vaginal mesh implants. That is why the Opposition are calling for an urgent public inquiry into the number of women adversely affected by vaginal mesh implants and into why the safety of so many women was disregarded. We urge NHS England and NICE to act immediately to update the guidance and suspend the use of vaginal mesh today. It is our duty to ensure that the failings are understood and corrected so that they never happen again. That should be a matter of urgency for the Minister and the Government, and I trust she will respond positively to these calls.

Photo of Albert Owen Albert Owen Labour, Ynys Môn

I remind the Minister to allow the last word to the mover of the motion.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary of State for Health 10:50 am, 18th October 2017

It is a pleasure to serve under your chairmanship, Mr Owen. I thank Emma Hardy for securing this debate and shining a light on a condition that is very distressing for far too many women. Clearly this is not where we would like to be.

Obviously, many hon. Members would like an immediate ban on mesh products. From my perspective, the issue is not with the product but with clinical practice. That is what is going wrong. That is where we need to be much clearer, ensuring that women are treated properly by their clinicians, given proper advice and risk assessments, and given the opportunity to report any complications and the ability to complain and challenge. The Government also need to ensure that all clinicians have the most up-to-date and appropriate advice.

The focus of this debate is the women who are suffering. The most important thing we can do—my priority—is to ensure that they get the support, care and treatment they need to alleviate a debilitating condition.

With regard to the evidence, we expect to produce the NICE guidelines before the end of 2017. We will bring them forward as soon as possible. I am sure that hon. Members will want to review those guidelines, to see whether they are satisfied that they have moved forward.

The advice I have received from the MHRA is that mesh is still the best product for treating stress incontinence, but the evidence regarding prolapse is more mixed. I can give that advice to hon. Members today, but we await the NICE guidelines before the end of the year.

The women are the most important aspect of this debate. We should be focusing on them. We must make sure that they are fully supported to make informed decisions about the surgery, and I have heard from many hon. Members that in many cases they were not. This is a risky process and, as my hon. Friend Dr Wollaston, the Chair of the Health Committee, said, many women have benefited from this surgery but there is a risk to it, and those risks were not properly communicated to allow women to make an informed choice. That is not acceptable and we must make sure that does not happen in the future.

To do all of that, we are working with patients, NHS England and the MHRA, to come together with the mesh oversight group. The most recent report was published in July and its recommendations are being implemented. The updated guidelines will be published before the end of 2017. It is important that regulators ensure that advice and guidance keep up with developments in clinical technology and practice. We will constantly review evidence as it comes in to keep advice and guidance up to date.

A number of hon. Members mentioned that there have been no clinical trials for these devices, and I agree that we need to continue to draw on emerging evidence. There have been a number of research studies which have directly informed the guidelines issued by the regulators and led them to reach their conclusions, on which I have just advised the House.

It is still important that we listen to the concerns of women, and I encourage all hon. Members who speak to their constituents suffering with the consequences, to make sure that they report those complaints through the MHRA yellow card scheme, so that we can build a body of evidence about where things have gone wrong.

Photo of Alec Shelbrooke Alec Shelbrooke Conservative, Elmet and Rothwell

Will the Minister make a specific inquiry to the MHRA about the evidence of bacterial infection on the product, which flies in the face of its advice that the product must have sterility in order to be implanted? There seems to be a contradiction in the MHRA’s advice as to how it should be licensing products.

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary of State for Health

I hesitate to give a full answer, but the advice I have received is that over the years these products have been reviewed and there are clinical standards for the size of the mesh. I will write to my hon. Friend in more detail, because I am not an expert in that.

The hon. Member for Kingston upon Hull West and Hessle calls for a public inquiry. I think it is more important that we get the treatment that is needed, but I encourage everybody to report their cases through the yellow card scheme.

I am horrified to hear from my hon. Friend the Member for Totnes that many women did not know they were having the device fitted in the first place. That general issue indicates some arrogance of the medical profession towards women. The stories I have heard from colleagues, about how their constituents have been treated by their GPs when they have gone for treatment, are indicative of that. Women tend to suffer in silence. Quite often that means they are not the best at championing themselves. That is clearly unacceptable. This issue has been considered by the mesh oversight group, and it has been clear that improvements are needed to ensure informed consent.

Photo of Sarah Wollaston Sarah Wollaston Chair, Health Committee

Will the Minister assure the House that she will investigate clinical governance in the private sector as well as in the NHS, because many women tell me that this issue has affected them in the private sector?

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary of State for Health

I give my hon. Friend that assurance. To be frank, the same standards of consent and regulation apply in the private sector as in the public sector. A number of colleagues mentioned issues in the private sector, but there is no excuse; it is equally regulated by the Care Quality Commission and the General Medical Council, so the same standards apply.

Photo of Jo Stevens Jo Stevens Labour, Cardiff Central

On that point about the loophole between the NHS and the private sector, and the relationship and liability of private surgeons operating at private hospitals, will the Minister see whether that loophole should be closed?

Photo of Jackie Doyle-Price Jackie Doyle-Price The Parliamentary Under-Secretary of State for Health

I am not sure that there is a loophole. Surgeons are required to demonstrate their clinical competence as part of their regular revalidation, whether they work in the private or the public sector. Concerned patients may contact the GMC, just as they would do in an NHS trust. In addition, surgeons will be inspected by the CQC and their procedure examined to ensure that it meets standards. I cannot see that there would be any difference, but if the hon. Lady would like to bring to me a specific example, I would be delighted to look into it for her.

Clinicians working in private hospitals are under the same ethical obligations to ensure that treatment is based on consent, that complications are addressed and that information is shared with regulators as appropriate. Private hospitals are subject to CQC registration and must abide by those fundamental standards.

I am very short of time, but I suspect that we will come back to this matter, particularly after the NICE guidelines are published later this year. The most important thing we can do is make sure that the women have access to the support that they need, and that GPs know what to look for in order to give them that support, and I am always open to hearing representations from colleagues on this issue.

Photo of Emma Hardy Emma Hardy Labour, Kingston upon Hull West and Hessle 10:58 am, 18th October 2017

I thank everyone who has attended and spoken. I had hoped that my summary would be a little more positive. I am sorry, but the Minister’s response is simply not good enough—at all. I am extremely disappointed. I completely disagree with her: it is about not only the procedure, but the product. I hope that the weight of evidence from all the women involved—all the women who have emailed, all the constituents and all the people who have contacted Sling the Mesh—will be enough to show the Minister that this is more than just procedural; this is about the product.

I also disagree that this is the best treatment for women with urinary incontinence, and I urge the Minister to please look again. I urge men and women around the country to send letters and explain this to the Minister, so that hopefully the weight of emails and letters coming to her doorstep will show that this needs to be looked at again.

I thank all the brave women and men who have raised this issue. I want to reassure them that I will continue to be their voice, and so will the other members of the APPG. My hon. Friend Owen Smith has campaigned tirelessly on this issue. We will not let those people down. We will keep pushing until we get a much more satisfactory response to all the problems they have been suffering.

Question put and agreed to.

Resolved,

That this House
has considered the risks of surgical mesh implants.