Surgical Mesh Implants

Emma Hardy Excerpts

Wednesday 18th October 2017 Westminster Hall

[Emma Hardy (Kingston upon Hull West and Hessle) (Lab)]

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.

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

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.

[Emma Hardy]

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.

[Catherine McKinnell (Newcastle upon Tyne North) (Lab)]

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.

[Emma Hardy]

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.

[Sir Oliver Heald (North East Hertfordshire) (Con)]

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?

[Emma Hardy]

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.

[Karin Smyth (Bristol South) (Lab)]

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.

[Emma Hardy]

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.

[Sue Hayman (Workington) (Lab)]

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?

[Emma Hardy]

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.

[Simon Hoare (North Dorset) (Con)]

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.

[Emma Hardy]

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.

[Brendan O’Hara (Argyll and Bute) (SNP)]

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?

[Emma Hardy]

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.

[Jo Stevens (Cardiff Central) (Lab)]

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?

[Emma Hardy]

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 the hon. Member for East Renfrewshire (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 the Member for Pontypridd (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?

[Jeremy Lefroy (Stafford) (Con)]

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.”

--- Later in debate ---

[Emma Hardy]

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.

[Victoria Atkins (Louth and Horncastle) (Con)]

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?

[Emma Hardy]

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 the Member for Washington and Sunderland West (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—]

--- Later in debate ---

[Emma Hardy]

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 the Member for Pontypridd (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.