PARLIAMENTARY DEBATE
Cumberlege Review: Pelvic Mesh - 5 December 2024 (Commons/Westminster Hall)
Debate Detail
That this House has considered pelvic mesh and the Cumberlege Review.
Thank you, Mr Stringer, for your chairmanship. I sincerely thank all Members who have come to contribute to this debate. I thank the Minister, my hon. Friend the Member for Gorton and Denton (Andrew Gwynne), and the shadow Minister, the hon. Member for Sleaford and North Hykeham (Dr Johnson), for attending. I also particularly thank Baroness Cumberlege for coming along to the debate.
In my first MP constituency surgery I met Debbie— I am delighted that Debbie and her husband Ian are here today. Debbie was active. She was into keeping fit and socialising with friends and family but, following her operation to have pelvic mesh inserted, she was forced to give up work. She now suffers from chronic pain in her hips, pelvis, groin and legs. She often suffers from fatigue. She is unable to exercise. She suffers from incontinence, post-traumatic stress disorder, severe depression and autoimmune disease. She later found out that the operation to have the mesh inserted was not even necessary.
When Debbie had her first operation to have the mesh removed, she was told that it was removed completely, but later found out that was not in fact true. She was forced to have a second operation, where, again, not all the mesh was removed.
Despite winning subsequent court proceedings, she has received no compensation, in part due to the surgeon not being covered by insurance. Debbie’s case shows the barriers for victims of medical negligence. It took seven years for Debbie’s case to get to court. Part of her concern is that the surgeons operating to remove the mesh are the same doctors who did the initial operation to insert it.
As many Members will be aware, on 21 February 2018, the then Secretary of State, the right hon. Member for Godalming and Ash (Jeremy Hunt), called for an inquiry. The independent medicines and medical devices safety review, chaired by Baroness Julia Cumberlege, who I am delighted to see here today and whose support I am delighted to have, published the “First Do No Harm” report in July 2020. The report considered two medications and one medical device, but I will focus on pelvic mesh implants, which were used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence. It was hugely emotional to hear Debbie’s story—to hear at first hand the huge impact that this issue has had on her life.
In her report, Baroness Cumberlege described the accounts of women who had been affected by this issue as “harrowing”. I think we can all agree that that is absolutely the case. I will not go through the whole review, because that would take too long, but I will just highlight a couple of things said by women who came forward and spoke about the impact that the procedure had had on them.
The women said that there was a
“lack of awareness of who to complain to and how to report adverse events”
and reported
“breakdown of family life; loss of jobs, financial support and sometimes housing”.
However, the situation is even worse than that. The women also spoke about a
“loss of identity and self-worth”.
Sometimes, we fail to recognise the massive connection between physical health, including a physical procedure such as this one, and people’s mental health and wellbeing. The women also reported
“a persistent feeling of guilt”.
Nobody who is a victim of medical negligence should feel guilty about that fact.
The Cumberlege review made a number of recommendations. First, it recommended establishing a separate redress scheme to meet the cost of care and support for people who have experienced avoidable harm caused by the pelvic mesh. It also recommended:
“Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh”,
and that a database should be created of all patients who received an implant of medical devices, including the pelvic mesh.
The previous Government published their response to those recommendations in July 2021. They did not accept the report’s recommendations about redress. However, in December 2022 they announced that they had asked the Patient Safety Commissioner to explore options for redress, and that project began in the summer of 2023.
On 7 February 2024, the Hughes report was published, setting out recommendations for redress for those harmed by sodium valproate—a medicine used to treat epilepsy—and pelvic mesh. The report calls for the establishment of an independent, two-stage redress scheme to provide both financial and non-financial redress for affected patients.
I realise that I have been talking for quite a long time, Mr Stringer, but I think you appreciate the importance of this subject. I will quickly go through the recommendations of the Hughes report, so the Minister is aware of them. There are quite a few recommendations and they are as follows:
“The government has a responsibility to create an ex-gratia redress scheme providing financial and non-financial redress for those harmed by…pelvic mesh. This scheme should be based on the principles of restorative practice and be co-designed with harmed patients.”
We have seen that throughout this process patients have not had a voice and it is hugely important that they have a voice in finding the solution.
The Hughes report’s recommendations also said:
“Redress should provide all those harmed by pelvic mesh or valproate”—
the other medicine I mentioned—
“with access to non-financial redress. To deliver this, the government should work with other government departments, the healthcare system and local authorities to measurably improve harmed patients’ access to, and experience of, public services.”
Another recommendation was:
“The government should create a two-stage financial redress scheme comprising an Interim Scheme and a Main Scheme… The Interim Scheme should award directly harmed patients a fixed sum by way of financial redress… The Interim Scheme should be followed by a Main Scheme. This would offer more bespoke financial support to directly harmed patients based on their individual circumstances and…those indirectly harmed”.
To continue the recommendations, the report states:
“Patients who received relevant treatment through either the NHS or independent sector should be eligible for the Interim Scheme and Main Scheme…”
and adds that patients should find the application process for both schemes “straightforward”. Again, that speaks about accessibility and making the process non-adversarial, which is really important. It comes across in both reports that victims of the pelvic mesh scandal were made to feel guilty and that it was their fault, which is absolutely not the case.
The report states that both schemes
“should be administered by an independent body which commands the confidence of patients.”
We want those patients to feel confidence in the scheme. Both schemes
“should effectively signpost harmed patients to services which can provide them with free emotional support.”
I reiterate the importance of that emotional support. Finally, the report states:
“The government must ensure that the launch of the Interim Scheme and the Main Scheme is accompanied”—
this goes back to the point made by the right hon. Member for New Forest East (Sir Julian Lewis)—
“by an awareness raising campaign to ensure that all potentially eligible patients are made aware of it.”
As I mentioned earlier, 617 people directly harmed by the pelvic mesh implants contributed to the Cumberlege report, and 471 people directly harmed by the pelvic mesh implants provided evidence to the Hughes report. That shows the huge number of women affected by the scandal. I am delighted to see how many Members from across the House have been contacted, as I was by Debbie, by constituents who have been impacted by this. In August this year more than 100 women who experienced pain and complications from transvaginal mesh implants received payouts from three manufacturers of the product, but there was no admission of liability.
I thank the Minister for his time and for giving consideration to the recommendations. I truly thank everybody from across the House for contributing to this debate and I look forward to hearing from them. I finish with a quote from the Hughes report, from a patient harmed by pelvic mesh:
“It always comes back to we innocently trusted that we were having something that was going to fix our embarrassing health condition and then from that we have had our lives shattered. This is not our fault.”
Can we get back to one very important fact about this? We are dealing with people who have had their lives destroyed in the prime of life because of something they were recommended by the NHS. In all honesty, if we were at, say, the dentist’s and they said, “We need to do this to your tooth”, we would say, “Okay.” We would not say, “Can I come back tomorrow?” and then google for any issues. We trust the clinicians and listen to what they say.
Let us flip that coin and give the other side: at the time, a lot of those clinicians genuinely thought that vaginal mesh was, for want of a better description, a bit of a miracle cure. As time has gone on, it has become apparent that it was one of the worst procedures that could ever have taken place, and it is the time lag that has created the problem.
I have spoken about this topic many times. I have described some of the things that have happened to some of my constituents, including people who were once extremely active now not being able to stand up. When my constituent came to see me, she had to do the entire surgery stood up and leant over the table because she could not sit. She was younger than I am now. She eventually managed to take out private loans and have the mesh removed. There lies one of the big injustices: this was something done by the NHS, and the NHS has run away from its responsibility to solve the problem.
I accept that it is difficult for someone who has had the procedure to accept that the surgeon who put the mesh in might be the person who will remove it. But we do not have enough experts in this area, which goes back to the intervention I made on the hon. Member for Harlow: as the review of the NHS comes forward, resourcing must be considered. I have said it before and I will say it again: I believe the NHS to be a misogynistic and sexist institution that was too quick to pat women on the head and say, “Oh well, it’s just what women go through,” in so many aspects of gynaecological health, as well as other things.
I have known the Minister for a long time. I consider him to be a friend, and I know that he is in the job because he fundamentally believes in people’s rights. He has a hard task ahead of him. That hard task is not because of what the Minister wants to drive into place; it is because of the pushback that he is going to get from the NHS and the Treasury, which will say that it cannot be done. He is going to have a tough time, but we can already see that this is not a party political issue in the House. Many of us on the Conservative side criticised our own Government in debates on this subject, because they were getting the pushback from the Department of Health and Social Care and the Treasury—and we said that it was not good enough.
Removing mesh is like taking hair out of chewing gum. It is not a simple operation. It is not just that it breaks up and starts to infect other organs in the body, which is what can cause the incontinence, as it makes its way into the gut; it has now been shown that there are low-level infections within the mesh.
My constituent who finally had mesh removed had a period for the first time in 10 years. Think about that for a moment—being told, “Well, we’re not quite sure what is wrong,” and then, when the mesh is removed, suddenly having periods again after a decade. That shows how much the issue has not been taken as seriously as it should have been. The shadow Minister, my hon. Friend the Member for Sleaford and North Hykeham (Dr Johnson), and I were speaking only last week about a constituent who has a similar issue. Where could she find the mesh centres? There are nine mesh centres, but the issue affects the entire country.
The hon. Member for Shipley (Anna Dixon) mentioned the NHS compensation scheme. We moved on from that because it simply was not working. People were not getting the compensation from the scheme because it was not really accessible, and it was confrontational. That comes back to the point of the NHS doing something but not wanting to take responsibility for it. I am afraid that the Minister will be under pressure from people saying, “You must defend the NHS. That is your job. You represent the NHS. When people criticise the NHS, they are criticising you and the Government.” But that is not true: the Minister will have our full support for pushing back in that way.
This is the Thalidomide situation again—it is as controversial and, frankly, as scandalous as Thalidomide. We are talking about the “miracle drug” that women took in pregnancy to stop them from getting morning sickness, and it took years before it was banned; in some countries, it was used for several years after that. We pay compensation to victims of Thalidomide for the rest of their lives. I am proud to have been the Member of Parliament who in 2012 got the health grant extended for another 10 years. It is now a lifetime health grant. I am proud of that; it is something we did in this House. People turn around and say, “Redress is something we have to assess because there are so many people,” but why is that? There are so many people because the procedure was done willy-nilly and now those involved do not want to take responsibility.
Many other Members want to speak, and I will let them have their say. The Minister has my full support and, I am sure, the full support of many Members here—and he is going to need it. I ask him to stay strong, to keep in mind why we are doing this and to remember the victims who have had their lives destroyed in every single aspect. They must have the redress and the ability through the NHS to have the situation rectified so that they are not borrowing £25,000 to go privately to the same surgeon they would see on the NHS.
Before entering Parliament I spent 20 years in the health and care sector, including at the Department of Health and Social Care as a senior civil servant. Patient safety and quality were part of my responsibilities. I was involved with some of the inquiries into tragedies of maternal and infant deaths, such as at Morecambe Bay; with the Government response to the Francis inquiry into the tragic deaths at Stafford hospital; and with subsequent reviews by Sir Bruce Keogh. That is more than a decade ago.
As my hon. Friend was saying, the NHS is fantastic at its best; it is there to heal and cure. But it is a tragedy that there continue to be patients who suffer harm as a result of medical care and treatment. The pelvic mesh scandal, I am afraid, follows a long line of other scandals—not least the infected blood scandal. I am obviously pleased that the Government have recognised the harm caused by that scandal and are committed to a full and fair compensation scheme. Obviously, here we are seeking redress for the women who have been harmed. It is important that we learn from the past as well as prevent scandals such as this from happening again in future.
As has been the case with many other Members, a constituent approached me about this issue. I am pleased with the male allyship on show today. The voices of women are often not heard; there are power issues when it comes to surgeons, who are often male. This follows other scandals involving unnecessary hysterectomies, for example. We need to remember some of the horrific consequences for women such as Julie, who lives in Baildon in my constituency. Her story is similar to some of those that have already been shared. The details are pretty harrowing. Her life has been torn apart as a result of both the mental and physical consequences. I will not go into the details of her case, which are similar to those already mentioned. We must look for redress for the unnecessary suffering and seek to put the issue right.
Like other Members, I pay tribute to Baroness Cumberlege for her work on the review. I have admired her from afar for a long time; in the 1990s, she was Health Minister when I was early in my health career and she did fantastic work on maternity services in 2015. That resulted in recommendations and the setting-up of networks; we have seen progress on that as well as care and advice, and obviously I welcome that. For women who had mesh inserted, particularly for urinary incontinence and vaginal prolapse, it is vital that such services are accessible in every region, as my hon. Friend the Member for Harlow said.
More needs to be done. In particular, under the Consumer Rights Act 2015 the statute of limitation for faulty medical devices is just 10 years. That is obviously too short a timeframe for pelvic mesh, because it can easily take longer than 10 years for the most serious negative effects to come to light. I have written to the Secretary of State for Business and Trade, seeking an amendment to that Act to increase the statute of limitation to 20 years for faulty medical devices and products. I am pleased to say that a review is under way. Will the Minister follow up on that and ensure that the representations made are followed through on behalf of people affected in the future and seek justice?
Drawing on my professional background, I want to address the points made about the products. There are significant clinical trials for drugs and pharmaceuticals, but we do not gather sufficient evidence before products such as mesh go into widespread use. I again urge the Minister and others, including the National Institute for Health and Care Excellence and the National Institute for Health and Care Research, to ensure that all devices and products—particularly implants—go through a proper clinical trial process before they are licensed. That relates to the point about device licensing. Drug licensing is very strict and takes place over many years, but do we have sufficient device regulation for these sorts of implants?
On professional regulation, we obviously give the surgeons the benefit of the doubt and hope that they were using best practice at the time, but we have to recognise that in some cases surgeons and doctors do not operate in the best interests of the patient, and that full informed consent may not be given. We have seen examples of that, even after the problems with pelvic mesh came to light. I urge the Government to look at whether the professional regulation is strong enough.
Since my early work in this area, I have maintained an interest in patient safety. As the newly elected vice-chair for the all-party parliamentary group on patient safety, I look forward to continuing to work with the chair, the right hon. Member for Godalming and Ash (Jeremy Hunt); I worked with him when he was Secretary of State for Health and Social Care. Hopefully, we will work with other Members across the House to improve safety in the NHS and address the pelvic mesh scandal and other issues. I hope that no one suffers in the way that women such as Debbie and my constituent Julie have in the past. We must protect patients for the future.
Among those affected is my constituent Rachel. In 2014, she was assured that a pelvic mesh implant was the best solution to her incontinence, but instead it led to years of unrelenting pain, infections and a diminished quality of life. Repeatedly dismissed by medical professionals, she was left self-catheterising and enduring ever-worsening symptoms. She eventually had to borrow £12,000 for private surgery to remove the mesh, only to find that her pain and nerve damage persisted. Today, she is in debt, relies on strong pain medication, and struggles daily with the physical and emotional toll of her ordeal.
Equally distressing is the experience of Suzi, the daughter of two of my constituents. After her initial surgery to relieve mild stress incontinence, she experienced severe complications, including debilitating pain and a hole in her urethra caused by the mesh. Over the years, she underwent multiple surgeries to remove it. Each time she was told that the problem had been resolved, but each time fragments of the mesh remained, prolonging her suffering and leading to permanent damage. Her pain was dismissed as psychological. Today, Suzi lives with chronic pain, relies on a wheelchair and battles PTSD. Her life, once full of independence, activity and joy, has been irreversibly changed.
Thousands of women have suffered avoidable harm as a result of pelvic mesh implants. The Cumberlege review described the health system that allowed this to happen as
“disjointed, siloed, unresponsive and defensive”,
and recommended a comprehensive response, including the establishment of dedicated redress schemes. The recommendations have not been fully implemented, and there is still no redress scheme. Victims have been failed.
The Government must act now to implement the Cumberlege review in full. That includes accepting the call for a moratorium on pelvic mesh implants, ensuring appropriate care and psychological support, and urgently addressing the lack of redress for victims. The absence of a formal compensation scheme is a glaring failure. Even though the Patient Safety Commissioner reiterated the need for action earlier this year, no meaningful progress has been made.
We know the scale of harm is vast. At least 10,000 women in England have been affected, although campaigners suggest that the true figure may be closer to 40,000. These women trusted the healthcare system and were let down at every turn. They were misled, gaslit and left to suffer alone. They were promised a risk-free procedure, only to endure life-altering complications. When they sought help, they were ignored or dismissed and told that their symptoms were imagined. Women’s health must be taken seriously.
There has been a financial settlement for some women, but it came with no admission of liability. That is not justice. The Government must provide clarity on their plans and not leave my constituents, their families and women across the country in limbo any longer.
In 2015, Paula had her mesh fitted to resolve urinary incontinence, but her experience with pelvic mesh has been painful and inconvenient. Between 2020 and 2023, she had various painful bladder stones that attached to the mesh, and in July 2023 she was informed that the mesh had eroded into her bladder. I understand that the mesh is now cutting into Paula’s urethra, causing her terrible pain and incontinence. Paula will now need to undergo three major operations to remove the mesh, and she has told me of the toll that it has taken on her. In her own words, her life has
“gone from working full time, holidaying, socialising and running, my big passion covering 5k around three times a week, to losing my job,”
not being able to run and feeling “isolated and very depressed”.
Paula now plans her life around the availability of toilet facilities. She is unable to take long journeys and lives in fear of the issues that incontinence causes her. As we have heard, this is an issue that affects many women who, like Paula, say that they did not have the risks and potential harms of surgical mesh properly communicated to them.
It is not mandatory for individuals to report the side effects of surgical mesh to the NHS, so many women like Paula were not properly informed of the potential long-term effects on their health and wellbeing. Requiring side effects to be reported would ensure better regulation and allow patients to fully understand the implications of medical procedures, so I will welcome the Minister’s comments on the points raised by Members and the need to implement in full the recommendations of the Cumberlege review.
I have a practical suggestion: at the end of this debate, which will no doubt follow in the footsteps of several previous debates that were equally well informed, passionate and horrifying, we should perhaps put our names to a joint letter to a man called Nick Wallis. He is a freelance journalist who did a wonderful thing: he researched the Post Office Horizon system disaster and wrote a book called “The Great Post Office Scandal”. If I remember correctly, it was serialised for a week on Radio 4, and subsequently he was the consultant to the remarkable production, “Mr Bates vs. The Post Office”. We can have these debates regularly, as we have been doing, and we can upset and horrify each other by recounting our constituents’ pain and the appalling negligence that led to these terrible outcomes, but until the issue grasps the public imagination, I do not think people will get anywhere.
Interestingly, one point that has not been mentioned is the possible responsibility and liability of the large pharmaceutical company that manufactured the mesh in the first place. What research did it undertake? What responsibility does it have? What help can the Government give people who have been irreparably harmed to go after that company for compensation?
There has been one great positive development, which has been referred to several times, and that is the magnificent work of Baroness Cumberlege, who certainly did the whole community of damaged women the best possible service in conducting that excellent review. The question is to what extent will her recommendations be implemented?
I pay tribute in particular to my right hon. Friend the Member for Wetherby and Easingwold (Sir Alec Shelbrooke), who spoke earlier, and the hon. Member for Washington and Gateshead South (Mrs Hodgson), from whom we are about to hear, for their exemplary leadership of the all-party parliamentary group on this terrible disaster and for keeping the flame burning all these years. I say “all these years” because it has been a long time. Looking back on my own website to check my contributions, I see that this is now the fourth full- scale debate in which my colleagues and I have gone over the same ground. If anybody is interested, the dates of the previous three debates, which were packed with testimony and interesting information, were 19 April 2018 —slightly longer ago from now than the entire duration of the second world war—8 July 2021 and 3 February 2022. It would not be appropriate for me to go over in detail what has been said previously, as it is all there on the record, but it is important to recognise that we are talking about thousands and thousands of damaged women—10,000 at the very least, and as we have heard, some estimates put the number as high as 40,000.
Treatment centres have been mentioned, but there is a particular question about who has the skill to practise in the treatment centres. Who will put themselves forward as being appropriately skilled? It will be the very people who inserted the mesh in the first place.
In one of the earlier debates, I cited a constituent who was 35 when she was given what was described to her as “routine surgery”, 16 years before the debate in question took place. I said then:
“She was initially told that it was her fault that her body was rejecting the two mesh implants. She then went through a cycle of implants, the removal of protrusions and eroded segments and seven bouts of surgery. Three TVTs—trans-vaginal tapes—are still inside her, she suffers chronic pain from orbital nerve damage, constantly needs painkillers and has had constant side effects, indifferent treatment and a refusal to admit fault or to refer her to an out-of-area specialist in mesh removal.”—[Official Report, 19 April 2018; Vol. 639, c. 508.]
Over this period of six or more years I have probably tabled about 12 or 15 questions for written answer, obviously to a previous Government. I will quote three, which were all in the aftermath of the Cumberlege report. In June 2021—for the benefit of Hansard it was question 16777—I asked the Secretary of State for Health and Social Care
“what checks his Department carried out to ensure that surgeons awarded NHS contracts for the removal of failed vaginal mesh implants had not previously been responsible for (a) originally implanting them, and subsequently (b) denying that anything had gone wrong with them; and whether any personnel awarded NHS contracts to work at mesh remediation specialist centres are known by his Department to be currently facing legal proceedings for implanting mesh which injured women who are now seeking its removal at such centres.”
The answer, which came from the then Minister of State, read:
“It is the responsibility of the employing organisations”—
presumably the NHS—
“to ensure that the staff undertaking mesh implantation and/or dealing with mesh complications are qualified and competent to do so. NHS England’s procurement process to identify the specialist centres to deal with the complications of mesh considered a range of clinical and service quality issues. No assessment was undertaken regarding National Health Service contracts or staff facing legal proceedings.”
Somebody in the process of suing a surgeon but still needing ongoing care may have no other option but to go to a mesh centre headed up by—guess who?—the surgeon who she is suing because he damaged her in the first place.
The second written question I will refer to was in July 2021—question No. 31274—which read:
“To ask the Secretary of State for Health and Social Care, with reference to the debate on the Independent Medicines and Medical Devices Safety Review on 8 July 2021…what steps he plans to take to research new and improved techniques for removal of eroded surgical mesh implants.”
As we have heard, it is intolerably difficult to remove this stuff. One would think that the very least the NHS could do would be to make a dedicated effort to develop new techniques for doing it. The description of it being like removing hair from chewing gum is vivid. I have sometimes speculated—I am not in any way qualified to do so—that maybe the answer to this might be to develop some sort of technique that could harmlessly dissolve the material and let it be gradually flushed away, rather than physically trying to disentangle it with the risk of doing more damage. That may be completely and utterly impracticable, but my point is that we do not know because no proper national effort is being made to find a way in which this disaster can be, to some extent, effectively rectified without harming the victims further.
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.
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.”
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.
I also pay tribute to the right hon. Member for Godalming and Ash (Jeremy Hunt), when he was Health and Social Care Secretary, and to the former Member for Maidenhead, when she was Prime Minister, for commissioning the review in the first place in February 2018. Baroness Cumberlege has never stopped giving voice to those she encountered during the two years she led that review. She has gone to great lengths to keep this issue on the agenda. She is due to retire shortly and we will miss her. I would like to say how grateful I am, as I know others will be, not just for her advocacy on this issue but for her encouragement and support of hon. Members in this place to do the same. If I may be so bold, Baroness Cumberlege has played her part. It is now up to us in this place to hold this new Government to account and to ensure that her recommendations are implemented in full.
Let us not forget that the Cumberlege review was called “First Do No Harm”, because at its centre are people who suffered avoidable harm—harm done to them by our health system. I was first introduced to this issue by my constituent Carol. I have shared her story before and remain in awe of her dignity and desire to help others despite having experienced the most devastating medical trauma. She needed her MP to help her get a visa for the United States for urgent medical treatment during the pandemic because of the travel restrictions that hon. Members will remember. She had undergone a hysteropexy and a rectopexy using surgical mesh.
Instead of resolving Carol’s pelvic organ prolapse, the procedures left her with a serious autoimmune disease, struggling to walk and unable to continue her normal daily life. She had to take long-term sick leave from her job as a doctor and could not remember a day without pain. When she contacted me for help with her visa, she was seriously unwell and had been told that she urgently needed her mesh removed or her prognosis was not good. We managed to get her the visa she needed. She is now mesh-free following a successful removal, and she is the first person in England to have undergone successful rectal mesh removal. She is still suffering, but is no longer in the same danger that she was. She is clear that she was able to look outside the NHS and the UK only because her medical training and personal resources enabled her to find Dr Veronikis, who treated her successfully. I should say at this point that there needs to be more awareness of rectopexy mesh, which affects men, women and children.
Carol and others like her were given hope when the Cumberlege review was initiated, and again when it was published in July 2020 with its nine recommendations. I am sorry that to say that not enough progress has been made on those recommendations since. The reality is that only two of the nine recommendations have been implemented in full. The first was an apology, which was given as soon as the report was published. The second was to establish the office of the Patient Safety Commissioner.
Beyond that, things have stalled. Recommendations 3 and 4 called for an independent redress agency, and for redress schemes to be established for all three interventions. After originally rejecting those two recommendations, the Health Minister at the time asked the Patient Safety Commissioner in late 2022 to look at the options for providing redress for those who had been harmed by mesh and valproate. The commissioner’s report—the Hughes report—was published in February. I was present at its launch, and it really felt like a milestone; it felt as though progress had been made. Surely the Department would not commission that work if it had no intention of following through on a redress scheme.
That was in February this year. By the summer, when the election was called, the previous Government were still saying that they would respond to the report, so they never gave a formal response. To date, there has been no official response from the new Government to the Hughes report. In the words of the Patient Safety Commissioner:
“it is now urgent for the government to give those families some clarity. Many of them live with pressing financial hardship, as well as physical pain and disability…we must not compound the physical and mental harms experienced by these families by setting and raising false expectations if there is no intention to deliver on redress.”
“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.
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.
I am responding today on behalf of Baroness Merron, who leads on women’s health and patient safety in the Department of Health and Social Care. I will try to address as many as I can of the issues that right hon. and hon. Members have raised in this debate. If for any reason I do not get round to addressing something, I will ensure that Baroness Merron, as the Minister responsible, writes to Members.
This debate came about because of a meeting between my hon. Friend the Member for Harlow and one of his constituents, Debbie. As we have heard, Debbie described undergoing a failed procedure to remove vaginal mesh, which has caused her severe pain. She has remained in constant pain since the operation, and I express my deepest sympathy to her for her ongoing experience. It should never have happened.
My predecessor as a Minister, Nadine Dorries, placed on the record in 2020 the previous Government’s apology. We are a new Government, so I take this opportunity to make the same apology today on behalf of His Majesty’s Government elected on 4 July. This should not have happened, and I say to every single person it has happened to that we are sorry and we have a duty to put things right. That is what this Government will seek to do, and at pace.
This Government will build a system that listens, hears and acts with speed, compassion and proportionality. Complications from vaginal mesh can be devastating and have included severe and chronic pain, recurrent infections, reduced mobility, sexual difficulties and psychological impacts. It can be hard to imagine the avoidable suffering that many women have endured and the damage that has been inflicted on their lives. It is unacceptable that concerns raised by women were not listened to and that women were left to suffer alone. It is vital that we acknowledge those failures and ensure that the mistakes of the past are not repeated.
I assure the right hon. Member for Wetherby and Easingwold (Sir Alec Shelbrooke) that the 10-year health plan that the Government are consulting on will ensure a better health service for everyone, regardless of their condition or service area. A core part of the development of the 10-year plan, including its approach to women’s health, will be an extensive engagement exercise with the public, NHS staff and stakeholders.
We have heard about the nine specialist mesh centres that NHS England has established across England. The intention behind them is that every woman, in every region, who experiences mesh-related complications receives the appropriate support.
I hear the message of my hon. Friend the Member for Shipley (Anna Dixon) that more needs to be done on accessibility, outcomes and listening to women. I agree, and I will take that message back to Baroness Merron.
I share the concerns of the right hon. Member for Wetherby and Easingwold—I thank him for his support on this—about the battles and challenges that lie ahead to get the system right. The Government will consider how we build on existing provision in a sensitive way that meets the needs of the women. At the heart of all we do to try to put things right is addressing the needs of the women involved, and their families, who have been so dramatically affected by what went so tragically wrong.
Each mesh centre is led by a multidisciplinary team that comprises urology, gynaecology and colorectal consultants, in addition to nurses who specialise in a range of things that I am unable to pronounce, and in urology and incontinence, which I can pronounce. Patients also have access to other healthcare professionals, including psychologists, occupational therapists and pelvic floor specialists, to help with pain management.
I recognise the trauma that women have experienced and the vital need to exercise patient choice. That is especially true for women who are rightly concerned about being treated by a surgeon who previously operated on them. I hope that things have moved on since the answer that the right hon. Member for New Forest East (Sir Julian Lewis) received, but I will ensure that what Members have said, with the sincerity and the strength of feeling, is communicated back to Baroness Merron. I agree with the right hon. Gentleman that the process set out in that written ministerial answer is not acceptable. Yes, women have the right to choose treatment from another surgeon, but I actually agree with the shadow Minister that there should be an automatic assumption that their treatment should be done by somebody who did not operate on them previously, unless that woman does not mind. That is a stress and a trauma for many women, and we have to think about their rights.
I also recognise that there is a need to support GPs’ knowledge and understanding of pelvic mesh so that they can identify the symptoms of mesh complications and refer patients on to the appropriate services. I do not want any woman to be in the position of my hon. Friend the Member for Washington and Gateshead South (Mrs Hodgson), or any other woman who has had her body tampered with in the most inappropriate way, when the procedure was not even necessary, and has suffered lifelong complications as a result. We have to move on at pace.
Following Baroness Cumberlege’s recommendations in 2018, the national pause on mesh remains in place for the use of vaginally inserted mesh to treat prolapse and the use of retropubic suburethral mesh sling to treat stress urinary incontinence. That means that mesh can be used only in exceptional cases where clinicians are of the opinion that there is a clinical urgency and no suitable alternative exists. NHS England continues to monitor progress on the conditions associated with the national pause and will only make changes to it linked to clinical advice and following consultation with a wide range of stakeholders, including patients, professional bodies and NHS organisations.
The Cumberlege review made nine recommendations, and the then Government accepted seven. Of those seven, four have been delivered, including the appointment of Dr Henrietta Hughes as the first Patient Safety Commissioner in England, the establishment of nine specialist mesh centres across England and the establishment of a patient reference group. Through our ongoing work, the Government are committed to delivering on the remaining three recommendations.
On redress, I will mention briefly the recommendation set out in the Hughes report, which was published in February. I first thank the Patient Safety Commissioner, Dr Henrietta Hughes, for her commitment to improving patient safety. Although the Government are not yet in a position to comment on the recommendations, I assure Members that we are considering the wide range of work set out in the report. I agree with the hon. Member for Eastleigh (Liz Jarvis) that the previous Government were too slow on that. It is a priority for this Government. We are working at pace, and we remain focused on making meaningful progress. This is a complex area of work, involving several Departments, but we are committed to providing an update at the earliest opportunity. I have heard the desire for urgency today, and I hope that we can make the progress that Members want to see.
I am afraid that I have left my hon. Friend the Member for Harlow 30 seconds to sum up, but I hope we have made some progress.
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—
Motion lapsed (Standing Order No. 10(6)).
Contains Parliamentary information licensed under the Open Parliament Licence v3.0.