Surgical Mesh

Emma Hardy Excerpts

Thursday 19th April 2018 Commons Chamber

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

I beg to move,

That this House commends the recent announcement of a retrospective audit into surgical mesh for pelvic organ prolapse and stress urinary incontinence; notes that vaginal mesh has been banned in other jurisdictions such as New Zealand; further notes that NICE guidance recommends against the use of surgical mesh for pelvic organ prolapse and that no NICE recommendations have been made for stress urinary incontinence; notes that Sheffield University recently announced the development of a new mesh material; and calls on the Government to suspend prolapse and incontinence mesh operations while the audit is being carried out, to bring forward the NICE guidelines for mesh in stress related urinary incontinence from 2019 to 2018, and to commit to a full public inquiry into mesh if the audit suggests that this is the best course of action.

I pay tribute to the Backbench Business Committee for enabling this debate to take place and to the fantastic work done by the all-party parliamentary group on surgical mesh implants, of which I am a vice chair, and which is led by my hon. Friend the Member for Pontypridd (Owen Smith). I also thank the hon. Members for East Renfrewshire (Paul Masterton) and for Glasgow North West (Carol Monaghan) for their support in bringing forward this debate, as well as the amazing Kath Sansom and the campaign group Sling the Mesh—many of the women up in the Gallery have done so much to bring this to public attention. It is for the members of this group and everybody else affected by this scandal that I rise to speak today.

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

Is my hon. Friend as alarmed as I am—she clearly is—that today and tomorrow women will be having operations that might well cause them complications in the future? Does she agree that these operations should be stopped until we find out the truth?

[Emma Hardy]

I absolutely agree. One of the main points I wish to make is the urgent need to suspend the use of mesh.

The issue of surgical mesh was brought to my attention by a constituent of mine called Angie, an incredibly brave woman who used to be very fit and healthy, but who, after having incontinence following the birth of her twins and a hysterectomy, was advised to have this mesh operation. She is now unable to work, in constant pain and suffering, cannot take part in sports and has problems sleeping. I remember listening to what she said to me and feeling horrified that this had happened to her. As I have learned, she is most definitely not alone. One story that moved me came in by email this week. The lady who emailed wrote:

“I started noticing that something wasn’t right with me the second day after I was discharged after the operation. It started with my legs—they were extremely stiff and cold, especially my feet, I couldn’t warm them in any way. I rang the hospital, but it didn’t ring an alarm bell to them. Then after a few days, I started having a very bad stomach ache, nausea, headache, chest pain, something happened to my vision, out of the blue, I became very tired and weak, slightly dizzy. I started noticing that I couldn’t focus and think clearly, my scars didn’t heal well and suddenly after a month my biggest scar started producing very smelly discharge.

I requested an appointment with a GP. I was already complaining that something wasn’t right with me. Everything started after the operation…When my health and all symptoms got worse 12 weeks since the operation, I was told that my fatigue is because I have a 2 year old...Now, it’s been 14 months since my operation—I am extremely dizzy and have very poor balance. I can’t feel the ground with my legs. I’m extremely nauseous, I have bad stomach ache, migraines, breathing problems and chest pain. I’m numb. I have vision fog and very painful, sore eyes. My body can’t recognize the temperature. Either I’m too cold or I’m about to faint from the heat. I started having very bad side effects to antibiotics, supplements or even herbal teas. Before the operation, I had no side effects at all. In 8 months, I lost 12% of my total weight and now I’m 8 and a half stone and still losing weight. This mesh wipes my iron out from the system. My fertility is gone.”

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

The hon. Lady is making a very powerful case. Does she agree that one of the most worrying things, and part of the seriousness, is that the people facing decades of pain, suffering and loss of amenity are relatively young?

[Emma Hardy]

The right hon. and learned Gentleman is completely right, because mesh was given to lots of young women following childbirth—many women were still in their 30s—and it has left them feeling disabled.

[Jamie Stone (Caithness, Sutherland and Easter Ross) (LD)]

I am delighted the hon. Lady has this debate. Does she agree that, as well as young women, lots of males are caught in this sorry and ghastly trap? I have personally heard some terrible tales from my constituency, although I will not go into them just now.

[Emma Hardy]

The hon. Gentleman is absolutely right. After we have moved on from looking at vaginal mesh, we need to look at rectopexy mesh and mesh that has been used in men as well. I completely agree.

[Jeff Smith (Manchester, Withington) (Lab)]

I congratulate my hon. Friend on her work. The NHS audit recently looked at the women who had suffered as a result. Does she agree that it would have been helpful to look at the number of men who have been affected, so that we get a picture of the true severity?

[Emma Hardy]

Yes, my hon. Friend is right. The all-party group should push for that after we have looked at the issue.

For those who are more statistically minded, NHS Digital undertook the recent audit, which was published on Tuesday. The facts are these: more than 100,000 women had vaginal mesh inserted between 2008 and 2017 to treat stress urinary incontinence, which is common after childbirth.

[Mark Tami]

My hon. Friend mentioned women feeling that they were alone, which is one of the main problems. I have spoken to a lot of people who were told that there was not a problem and that they were perhaps the only ones experiencing a problem. People were on a host of painkillers and were not told that others had experienced the same and that it was a much wider problem.

[Emma Hardy]

Part of the scandal is how many women were treated when they went back to their doctors. The fantastic work of groups such as Sling the Mesh has brought so many women together, and shown them that they are not alone and that many others have suffered.

The number of subsequent gynaecology out-patient appointments per 100 people having the mesh insertion procedure is 79. There are 43 out-patient appointments per 100 for rehabilitation, physiotherapy and occupational therapy. The figures show that the number of women having the procedure has fallen during the last nine years by 48%, which says an awful lot about what doctors think.

These women were injured. These women were ignored. These women are the victims of a scandal.

[Dr Rupa Huq (Ealing Central and Acton) (Lab)]

My hon. Friend is making a very powerful and moving speech. May I include testimony from my constituent, Adele Yemm, from Chiswick? There was a catalogue of errors with her case. She had only mild incontinence, and physiotherapy would have sorted it out. There were issues about consent—she was denied that. She had a full implant fitted. Does my hon. Friend agree that this is the biggest medical scandal since thalidomide?

[Emma Hardy]

I completely agree that this is an absolute scandal.

During the debate in October, I asked the Government to do four things: to commit to a full, retrospective and mandatory audit of all interventions and, if the data proves it necessary, a full public inquiry; to suspend prolapse and incontinence mesh operations while the audit is carried out; to bring forward the NICE guidelines for mesh in relation to stress-related urinary incontinence from 2019 to 2018; and to commit to raising awareness with doctors and patients alike.

In December, NICE issued new guidance, ruling that the evidence for the long-term effectiveness of the treatment for pelvic organ prolapse is

“inadequate in quality and quantity”.

The NHS is not compelled to act on these guidelines, but that would amount to a de facto ban.

In January, the Government caved in to demands for a national audit of surgical mesh, which reported on Tuesday. The audit is not perfect. For example, it looks only at NHS hospital figures and misses off private patients and out-patients; does not include men; does not include ventral rectopexy mesh sufferers; does not cover visits to GPs; and does not indicate how many times someone has to visit their GP before being referred for out-patient treatment. However, it seems broadly to agree with what we have been saying all along: that the Government’s claim that only 1% to 3% of women suffered serious complications is just not accurate.

[Mr Edward Vaizey (Wantage) (Con)]

I congratulate the hon. Lady on this important debate. She is right to call this a scandal. A constituent of mine now has a colostomy bag and severe internal pain and probably cannot give birth safely in future. She is 24. She makes the point that ventral rectopexy mesh procedures are not included in the audit, apparently because there is no code for surgeons to enter. May I join the hon. Lady in pressing the Minister to go back and include that in the audit so that my constituent’s suffering can be recorded?

[Emma Hardy]

I absolutely agree, and I hope that will be included in future.

Analysis conducted by Carl Heneghan, professor of evidence-based medicine at the University of Oxford and clinical adviser to the APPG on surgical mesh implants, reveals that the 100,516 women who have undergone mesh surgery in England since 2008 have required follow-up treatment in 993,035 out-patient appointments. He has calculated the total cost to the NHS for all incontinence and out-patient appointments to be £245 million. His analysis of the trend in out-patient appointments also shows that more are required by women as each year passes after their surgery, which is completely the opposite of what you would expect after a successful surgery.

The data shows that the number of operations using mesh has halved over the last decade, which shows that doctors and patients are voting with their feet and telling the world that they do not want to use mesh.

[Mr Bob Seely (Isle of Wight) (Con)]

Will the hon. Lady give way?

[Emma Hardy]

I will have to continue.

In February came the welcome announcement of the Cumberlege review of how the NHS addresses concerns about vaginal mesh devices and how patients have been treated when raising those concerns. However, I remain deeply concerned that mesh has not yet been completely suspended and that it remains possible for doctors to use it, especially in the case of stress urinary incontinence. There is also still no universally available physiotherapy as standard for all new mothers, as there is in France, to stop these problems before they even arise.

I still believe that it is an absolute scandal that these devices were aggressively marketed to doctors and then used in patients for whom they were unsuited. We need to ensure that lessons are learned and that more steps are taken to make the medical products industry more transparent. Campaigners have even called for legislation, such as they have in America, to require doctors to declare any grants, inducements or scholarships that they receive from the industry.

Some patients think they are having the mesh completely removed, only to find out later that it has been only partially removed. They feel that they are suddenly better and that they are recovering only to go through the horror of having the symptoms come back later. It is important that, where possible, mesh should be removed in full.

Despite the fact that 100 different types of mesh are available in the UK and that we do not know whether just one type is causing the problem or 100 types; despite the fact that Carl Heneghan has raised concerns about the small amount of evidence that mesh manufacturers are required to provide before their products are approved; and despite the fact that Dr Wael Agur from the University of Glasgow, a one-time advocate of mesh surgery, is now arguing that the Medicines and Healthcare Products Regulatory Agency has only a fraction of the knowledge of the adverse effects associated with mesh, NICE is still not going to bring its guidelines for stress urinary incontinence forward from 2019 to 2018, and the Government seem more focused on process than on the actual product.

Suzy Elneil, consultant urologist at University College London and one of the few qualified surgeons who is able to remove mesh, tells me that she sees 15 women a week who are suffering after mesh surgery. Even if NICE releases its guidance on 1 January 2019, Suzy alone will see another 525 patients before that date— 525 more patients living in unbearable pain. I am sorry, but that is 525 people too many. The Government must press NICE to bring forward the guidelines and pay attention to the product as well as the process.

[Mr Seely]

Will the hon. Lady give way?

[Emma Hardy]

I am sorry, but I have to continue.

It seems that our campaign must continue. We must ask again for renewed commitments from the Government to address these problems. Again, I ask the Government to commit to three things. First, we need a full and unequivocal suspension of mesh implant operations. Secondly, I ask them to bring forward the NICE guidelines for stress-related urinary incontinence from 2019 to 2018. Thirdly—this is a new one—will they please offer pelvic floor physiotherapy to all new mums as standard on the NHS, as happens in France, to help to restore the core after birth?

I end my speech with exactly the same words I used to conclude my remarks in Westminster Hall. Mesh implants have affected thousands of people all over the country. For some, the consequences of their operation will be life-changing and devastating. A Government commitment to taking these actions will not undo the suffering and pain that these women have endured, but would go a long way to making sure that nothing like this happens again.

This is the second time that I have spoken these words. Let us hope that justice is done before I have to speak them a third time.

[Several hon. Members rose—]

--- Later in debate ---

[Emma Hardy]

I thank everyone who has contributed to this debate, and I welcome the continued dialogue between the all-party group and the Department of Health. It was interesting to hear for the first time that the Department recognises that it is not just the process but the product about which there are serious concerns. I also welcome what appears to be an admission that NICE is introducing draft guidelines this year—is that correct?

[Jackie Doyle-Price]

indicated assent.

[Emma Hardy]

That is excellent. That is one of the things we called for. One thing that has come out more and more is that there needs to be informed consent. People need to know a lot more about the risks. All the risks need to be written down in front of someone in block capitals so that they know exactly what they are letting themselves in for.

I press again, as I did at the beginning of my speech, for all new mothers to be offered pelvic floor physiotherapy, as happens in France. As the Minister has just said, it is unacceptable that a new mother with a small, relatively minor inconvenience should be offered something that could result in permanent, life-changing disability. I urge the Minister to look into that as well.

I very much welcome the fact that we will have the draft NICE guidelines next year. As we have spent a lot of this debate talking about our mums and what they say to us, I will quote my mum. She always said, “Where there’s a will there’s a way”. If there is a way of bringing forward those NICE guidelines, let us make it happen, because if there is a determination across the House to make it happen, I am sure that the Department can find a way to do it and end this misery for so many women.

I end by thanking again all the fantastic women up there in the Gallery right now watching this debate. We are only talking about this now because of your bravery in coming forward and speaking out, and I thank each and every single one of you. We cannot undo the suffering you have experienced, but by speaking out and being so incredibly brave, you will stop women in the future going through what you have gone through. I and every Member who has spoken today thank you.

[Mr Speaker]

I thank the hon. Lady and everybody who has joined us today. I hope that they have felt uplifted by the debate.

We now come, colleagues, to the Back-Bench motion on cancer treatment. [Interruption.] Apparently, before we move on I should put the question on the debate on surgical mesh. I thank the specialist Clerk for his help and for rescuing me. We will now be entirely orderly.

Question put and agreed to.

Resolved,

That this House commends the recent announcement of a retrospective audit into surgical mesh for pelvic organ prolapse and stress urinary incontinence; notes that vaginal mesh has been banned in other jurisdictions such as New Zealand; further notes that NICE guidance recommends against the use of surgical mesh for pelvic organ prolapse and that no NICE recommendations have been made for stress urinary incontinence; notes that Sheffield University recently announced the development of a new mesh material; and calls on the Government to suspend prolapse and incontinence mesh operations while the audit is being carried out, to bring forward the NICE guidelines for mesh in stress related urinary incontinence from 2019 to 2018, and to commit to a full public inquiry into mesh if the audit suggests that this is the best course of action.