Cumberlege Review: Pelvic Mesh

Graham Stringer Excerpts

Thursday 5th December 2024 Westminster Hall

[Several hon. Members rose—]

[Graham Stringer (in the Chair)]

It looks as though hon. Members do not need reminding that if they wish to catch my eye they should bob, even if they have put in to speak. I call Sir Alec Shelbrooke.

--- Later in debate ---

[Anna Dixon]

I think the right hon. Gentleman makes a very valid point. Obviously, from my professional background, I see myself as fairly well-informed, but the scale of the damage done by this particular implant—the pelvic mesh—is also a shock to me. It is really timely that new Members are made aware of this issue. Hopefully, we can support any efforts to continue to raise it, and I commend Members who have been in this place for longer on their work to date.

I hope that the Minister will reflect on the specific point about research. As someone with a research background, I absolutely agree with you—I am sorry, Mr Stringer; I meant the right hon. Gentleman—that more effort needs to be put into research, not only on how we might treat such cases in future, but on the remedial effect.

[Graham Stringer (in the Chair)]

I thank the hon. Lady for correcting herself and acknowledging that “you” refers to the Chair. I also remind all hon. Members that interventions should be brief and to the point.

[Sir Julian Lewis]

That being said, Mr Stringer, I am absolutely delighted that the hon. Lady made that intervention. When someone of her expertise and experience says that even she had not realised the scale of this issue, it shows the magnitude of the task that faces us. This is every bit as bad as we heard in the excellent introduction from the hon. Member for Harlow (Chris Vince)—I apologise for not paying tribute to him earlier. He has done us all a great service by bringing this debate to Westminster Hall. This is on a level with the infected blood disaster, and it deserves the same level of treatment and remediation in so far as that is possible.

Reverting to the written question I asked, the Minister of the State at the time answered:

“There are no current studies specifically relating to new and improved techniques for the removal of eroded surgical mesh. However, there are five studies ongoing on surgical mesh implants and the National Institute for Health Research welcomes funding applications for research into any aspect of human health, including on the removal or implantation of vaginal mesh. There are currently no plans to establish a unit in order to train mesh removal specialists.”

I want to quote a third and final written question of those 15. Question 124936, from February 2022, stated:

“To ask the Secretary of State for Health and Social Care, what recent progress has been made in establishing the South East Regional specialist centre for the treatment of women damaged by mesh implants; and whether checks will be carried out to ensure that such women, when seeking remedial treatment from that specialist centre, are not placed in the hands of surgeons who were responsible for (a) implanting the mesh originally, (b) denying that anything had gone wrong with the implants and (c) claiming that women reporting extreme physical pain from the implants were imagining it.”

After a fairly long paragraph in reply, the answer concluded:

“Patients can discuss their choice of surgeon with the multi-disciplinary team if they have concerns regarding a specific clinician and can also discuss a referral to a surgeon in another specialist mesh centre.”

Think of the conversation that would require. A patient would have to explain to the person who had—to quote my right hon. Friend the Member for Wetherby and Easingwold—“butchered” them that, because they did not want to have his or her ministrations any further, they wanted to be referred to somebody else a long way away. Good luck with all that.

I will briefly touch on some points raised by people in the community of damaged women. I have been told about difficulties regarding personal independence payment applications. It has been suggested that staff managing PIP applications and renewals need better training and understanding of mesh injury. There has been some progress, apparently, in the gradual acceptance that many women had not given informed consent at the beginning, and this is perhaps beginning to make itself felt in relation to the legal actions that some people are undertaking. Just imagine being in constant pain and having the burden of undertaking those legal actions.

There is concern that mesh removal centres do not seem to have the same approach across the board for treatment or surgery. There are also very lengthy waiting lists if someone opts for a second opinion, for the reason I have already explained or any other reason. Mental health support and counselling is not readily available, which is another gap. We have already heard an excellent contribution by the hon. Member for Shipley (Anna Dixon) noting that the 10-year limitation for legal action on medical devices needs to be reviewed, because by the time some women have confirmation that the mesh is the problem, the 10 years could well have passed.

I have already mentioned that the Government ought to be looking to assist the legal cases against the pharmaceutical company or companies. It would be interesting to know whether the Government are making any progress on the subject of interim payments, which I believe the Cumberlege report recommended prior to any more bespoke payments based on individual circumstances. Will the Government encourage the yellow card Medicines and Healthcare products Regulatory Agency reporting to be made mandatory? If people are not reporting in when these things go wrong, how can we be sure of the scale of the problem? Finally, it is noted that there is a clear need for transparency for the public to be aware of exactly what payments medical professionals in the health sector receive from the pharmaceutical industry when they recommend these “routine procedures” that so often go wrong.

I conclude with a case that I have deliberately anonymised. Nothing should be drawn from where I happen to represent as to which surgeon in which mesh centre I might be referring to. This is what one victim has said about someone I will call surgeon X. He

“operated on me in 2009 to insert the mesh, which was described as a simple procedure that would solve my problems. Mesh was eroding through the vaginal wall immediately, and I had seven further ‘repair’ surgeries, which did not solve the erosion problem. In 2016, he advised me he could remove the mesh, so I paid privately for the surgery. During the surgery, nerves were damaged, causing severe pain and limitations, and the mesh was not all removed. I am left with the pain and limitations permanently, and have been told by another surgeon that full removal is now not possible. This surgeon is the clinical lead of the mesh centre”

local to her. She concludes:

“No surgeon should ever be allowed to cause damage to multiple patients, yet not only continue to perform the same surgeries, but to be head of the very centre which should be helping women. I feel sick at the thought of passing him in the street, let alone needing to see him as a health professional. I am sure we all feel the same.”

[Mrs Sharon Hodgson (Washington and Gateshead South) (Lab)]

Do you want to give some guidance on how long is left, Mr Stringer, so I can cut my speech accordingly?

[Graham Stringer (in the Chair)]

I intend to call the spokesperson for the Liberal Democrats at 2.30 pm.

[Mrs Hodgson]

In the short time I have available, I will try to make some important points. It is a pleasure to serve under your chairmanship, Mr Stringer. As co-chair of the all-party parliamentary group for first do no harm—along with Baroness Cumberlege, who it is a pleasure to see in the Public Gallery—it is a pleasure to speak in this important debate. I also point out how many officers of the all-party group are here in the Chamber, on a Thursday and on a one-line Whip. That speaks for itself as to how important the issue is to the House and to all of us. I thank my hon. Friend the Member for Harlow (Chris Vince) for securing this important debate to shed further light on this still under-discussed scandal.

Members present, campaigners watching at home, and especially patients, will all be aware of the extent of the injustice. I have had the privilege of working with wonderful campaigners over many years, and I take this opportunity to pay tribute to Kath Sansom from Sling the Mesh, who is a key campaigner for mesh victims and has been a great support to me and to colleagues over the years. I am glad that she is in the Public Gallery to watch the debate, alongside Debbie, who is the constituent of my hon. Friend the Member for Harlow, and who brought this scandal to his attention.

My first contribution in this House on surgical mesh was in 2017, during my time as shadow Minister for Public Health, and I am glad to see the actual Minister for Public Health and Prevention in his place to hear this debate. I have continued to campaign tirelessly on the issue through debates and my work with the all-party group ever since.

The issue is not only of political importance to me; it matters to me on a profoundly personal level. As I am sure some in the Chamber will know, among the thousands of women affected by mesh complications is my mam, who was one of the 617 mesh-damaged women who met, or made submissions to, Baroness Cumberlege for her review. I took my mam along to an evidence session in Gateshead, and she was able to meet Baroness Cumberlege and tell her story personally. She still talks about that to this day—she is very grateful.

After suffering mild stress incontinence, as we have heard from a number of people who went through the procedure, my mam had SUI surgery to have some tension-free vaginal tape inserted, which was a quick and common treatment offered to women for incontinence. However, had she known the life-limiting complications she was about to suffer as a result, dealing with slight stress incontinence would not have seemed very bad at all.

Two to three years post-surgery, my mam had one health complication after another. She suffered all sorts of autoimmune reactions, recurrent urinary tract infections, and was in constant pain in her groin, arms and legs. She became a shadow of her former self, and it took us quite a few years to work out what was causing the symptoms and pain. It was only through my research for that debate back in 2017 as the shadow Minister that I was able to join the dots together, and from that moment on we both wished constantly that she had never had the operation.

My mam will be 80 in January, and she would say that she is one of the lucky ones. Since I first spoke on the topic, she has been able to get the mesh surgically removed. It was a long delicate operation, thankfully carried out by the amazing Suzy Elneil, which she had to undertake in London in order to avoid the surgeon who put it in her in the first place—something that the right hon. Member for New Forest East (Sir Julian Lewis) and others have spoken about. That is something that many mesh-damaged women will understand. With the removal of the mesh, many of her health complications vanished immediately. The road to recovery is far from smooth for many mesh-damage victims, however, and my mam is no exception. She is still recovering to this day and, in her words,

“will never be the same again.”

I sat next to my mam at her local hospital and watched her be gaslit and undermined by her original surgeon when she first sought help with her pain and symptoms. Our doctors, surgeons and healthcare providers are meant to protect us, not harm us. Hence, “first do no harm”—an unwritten contract between patients and healthcare providers that rightly makes us feel that when we seek medical help, we trust that we will be made better, not worse. Surely the least we can expect in cases where harm does happen is accountability and for wrongs to be righted. Instead, we see a culture of defensiveness and a lack of accountability. It is therefore shocking that the surgeons responsible for the implantation of this life-shattering mesh are the very same people tasked with removing it.

I was going to talk about Baroness Cumberlege’s recommendations—which we have had success with and which we have not—but sadly the right hon. Member for New Forest East used up all the time, so I cannot.

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[Sarah Green]

I could not agree more. This is where I must pick up Carol’s story again. She tried to pursue her claim against her original surgeons through the courts, and she hit on an unexpected problem. She approached multiple legal firms who would not take her case because one or both of the surgeons were advising them on other cases and, as such, it would have been a conflict of interest. Indeed, the same surgeon who caused Carol life-changing injuries acted as an expert witness in an unrelated surgical mesh negligence case. The judge in that case said:

“he had cherry-picked those parts of the evidence which were supportive of the Defendant’s case and did not comment on those parts which were consistent to the Claimant’s. That is not the correct approach to be taken by an independent expert, whose duty is to the court. His evidence lacked balance and was unpersuasive.”

On this occasion, the judge called it out, but that is not the only instance of the medical profession closing ranks—it is not a unique occurrence. Such clear bias and conflicts of interest are a huge barrier to justice for mesh victims around the country.

The point of recommendation 3 in the Cumberlege review was to establish a non-adversarial avenue for redress after someone has been harmed in a healthcare setting. Both the Hughes report and, more recently, the Darzi report found that the current clinical negligence system is difficult for patients to navigate and prevents the healthcare system from learning from its mistakes. It is also eye-wateringly expensive for the taxpayer. If it is the dead hand of the Treasury blocking a redress scheme, Ministers would do well to reflect on that. As the Patient Safety Commissioner points out, the clinical negligence system is behind only nuclear disarmament and pensions on the list of liabilities on the Government’s balance sheet. I must ask the Minister when the Department will respond to the options outlined in the Hughes report, and when families can expect to see redress schemes up and running.

Recommendation 5 relates to the establishment of mesh centres around the country, and while such centres have been established, they get mixed reports from patients. My question on the mesh centres is about their outcomes. How is the Department ensuring a consistent service across them all, and how are outcomes being measured? With so many people reporting dissatisfaction with the centres, it is not enough that they exist; they need to be working well for the patients they are there to serve. Recommendation 6 relates to the MHRA, and it is clear that we still need the yellow card reporting system to improve. I would also welcome the Minister’s thoughts on progress against recommendation 7, which is about creating a central patient-identifiable database. To my understanding, it is still a work in progress.

The previous Government’s decision not to take forward the eighth recommendation, which is for a mandatory register, is disappointing. The recommendation called for

“Transparency of payments made to clinicians”

and

“mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.”

I fail to understand why more progress has not been made on that. I know that campaigners have written to the Department asking it to consider a sunset Act that speaks to that recommendation, and I urge the Minister to chase a response to them.

[Graham Stringer (in the Chair)]

Order. The 10-minute time allocation is up. I now move to the official Opposition.

[Dr Caroline Johnson (Sleaford and North Hykeham) (Con)]

It is a pleasure to serve under your chairmanship, Mr Stringer. I congratulate the hon. Member for Harlow (Chris Vince) on securing this important debate. I draw Members’ attention to my entry in the register of interests, as I am a practising NHS consultant, although in paediatrics rather than in any form of gynaecological surgery.

I begin by expressing my heartfelt sympathies to the women affected by injuries from pelvic mesh and, indeed, mesh in other sites, as we have heard about. Mesh is a surgical material and technically, therefore, a medical device, which was implanted in thousands of women to treat organ prolapse and urinary incontinence. However, in many cases, as we have heard today, it has caused serious long-term effects, including chronic pain, infections, organ perforation and, in some cases, permanent disability, which continues even after the mesh has been removed.

The exact number of affected women is still not known. Some have estimated the number to be 10,000, and today we have heard an estimate of 40,000. However, it is clear that it is a very large number of women. I echo the hon. Member for Chesham and Amersham (Sarah Green) in thanking Baroness Cumberlege, the Conservative peer who published the independent medicines and medical devices safety review in 2020. The review panel spoke to more than 700 women and their families from across the country. The document is exceptionally comprehensive, and it puts patients’ and families’ views at the heart of the review. Their experiences make for harrowing reading. The women speak of lives damaged, families put under immense strain, relationships destroyed, careers broken, financial ruin and chronic pain.

Last week, I spoke to a woman who is suffering after having had such mesh put in. Following the surgery, the skin never healed because of a low-level infection. That lady faces awful difficulties. The mesh is visible through the skin, from the surface. It is incredibly difficult to remove. Indeed, she has not been able to find a surgeon who is willing to even try to remove it, so she suffers in the house, unable to go out and experiencing infection after infection, an increasing number of which are resistant to some antibiotics. She knows that without the mesh removal, her prognosis is poor. It is an awful situation to be in, as I am sure the Minister will agree. I know he will be doing his best to try to help. Our healthcare system has to learn from those it has failed, such as that lady, and ensure that patients are put at the front and centre of healthcare so that this cannot happen again.

The Minister needs to focus on two things: how we help those affected by the mesh scandal, and how we prevent similar incidents with medical devices that we do not yet know the harms of, or that may not yet have been invented. People should not have to pay privately for treatment to rectify things that the NHS has done wrong. When someone has had a mesh put in and the mesh needs removing, the NHS should pay for that care. If the NHS cannot provide it, the NHS and the Minister must find a way of funding that care, provided by whoever can provide it, so that women are not financially out of pocket to the tune of tens of thousands of pounds for something that is not their fault.

The nine centres have been set up, and that is a good thing; they have been set up with a full multidisciplinary approach, which is also good. However, as we have heard, the outcomes are not 100% good in all cases. Surely it is intuitive that women should not have to see the same surgeon again. They should not be forced to make that explicit. It should be automatic, unless they want to see the same surgeon; it should be an opt-in system.

I urge the Minister to look at what the centres do. They provide help for women who have had pelvic mesh repair, but there are people suffering with mesh problems who have had mesh put into other places, for example near the rectum or in the abdominal wall. That may be women, but it may also be men, and they may suffer quite significant problems as a result. They need a centre, or several centres, of people who can support them and ensure that their mesh is removed, or their treatment needs are met, to stop the suffering they are experiencing.

We need a balance between ensuring that a similar scandal does not happen again and that long-term effects are picked up, and not restricting people’s access to new and innovative good treatments. In this place, we often have debates on treatments that are widely available, but not necessarily available here yet. We want to make good treatments available here quickly, but we need a robust system to identify problems as quickly as possible.

Part of that system includes the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, on which the hon. Member for Harlow, the Minister and others were recently involved in debate. When that statutory instrument was discussed in the Lords, the noble Lord Cryer said that the Government intended to introduce implant cards, and that the SI was part of a wider review of the regulation of medical devices that would be carried out in due course. Will the Minister give us some information on what that will entail? What are his thoughts on the process, and when will it happen? People need these things quickly.

I recognise the work that my right hon. Friend the Member for Wetherby and Easingwold (Sir Alec Shelbrooke) has done over a long time on many topics affecting women’s health, including the menopause and other concerns, and I congratulate him on that work. He represents female constituents very effectively. He talked about the fact that when surgeons inserted pelvic mesh, they often thought that it was the right thing to do. Only over time did it turn out not to be the panacea that it had been thought to be.

I remember in my medical training being told that a good surgeon is not just a surgeon who can operate well; the best surgeons are those who know when they should not be operating. It is very sad to hear that for many of the women, treatments that did not involve surgery could have been done instead, and that would have meant that those women did not suffer in the way they have done.

I highlight the point made by the hon. Member for Shipley (Anna Dixon) and my right hon. Friend the Member for New Forest East (Sir Julian Lewis) on the importance of research. When we are trying to resolve the problems caused by the mesh, we need to know that we are doing that in the most effective way. We need someone to look at the clinical outcomes and ask what we are doing, whether we are doing it in the best way and what other options might be available. This problem is not limited to the United Kingdom. What is being done elsewhere? Are there international comparators that do this better, and can we emulate what they are doing?

What we need from the Minister is rapid action to address the problems faced by women who have had this mesh put in. We need him to assure us that he is doing what he can to introduce proportionate regulations that will ensure that any other devices in use and in circulation across the United Kingdom do what they are supposed to do, and do not do any harm.

[Graham Stringer (in the Chair)]

I remind the Minister to leave two minutes at the end for the Member who secured the debate to reply.

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[Chris Vince]

I thank everyone who has spoken about this vital issue. At its heart, it is about women who have been let down and made to feel guilty because they are the victims. That is just not right.

I thank everyone who has taken part in this debate. My right hon. Friend the Member for New Forest East (Sir Julian Lewis)—today, we are all hon. Friends—rightly said that we have had this debate time and again. My ask is for the next debate to be after a ministerial statement—

[Graham Stringer (in the Chair)]

Order.

Motion lapsed (Standing Order No. 10(6)).