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.
This is such an important debate, and many of us in this room have been working on this issue for a very long time. I point the hon. Gentleman to the Government’s review of the NHS. We only have nine centres. We have to emphasise how important it is that the review addresses the need for more surgeons in these areas. The issues that he is outlining are so common, yet we only have nine centres.
I thank the right hon. Gentleman for that useful intervention. Following my meeting with Debbie, two further Harlow residents have come forward who have also been part of this scandal. I have spoken to Members across the House who have constituents with the same issue. More than 600 women came forward to be part of the Cumberlege review and the subsequent Hughes review. This is a huge issue that affects many people.
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
I think that often the reason people feel guilt is because they feel that they were not given the necessary information at the beginning and they did not ask for it, but if they had only known, they would not have touched this debatable and deplorable procedure with a bargepole.
I thank the right hon. Gentleman for his intervention and I could not agree more. In the case of Debbie, who I have spoken about, she did not even need the procedure in the first place, but clearly that information was not provided correctly to her. Many women absolutely would not have gone through with the procedure if they had known about the dangers—and, as I say, in Debbie’s case she did not need to go through with it.
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:
I thank my hon. Friend for securing this important debate. The NHS has a clinical negligence scheme and it spends a lot of money on lawyers. Does my hon. Friend agree that victims of this particular scandal should, like many others, get no-fault compensation? And does he think the NHS should look at its clinical negligence scheme and move towards no-fault in order to reduce the spend on lawyers?
I thank my hon. Friend for the question. I broadly agree with her. Over the last year we have seen some terrible scandals, the Post Office scandal and the infected blood scandal. When we have debates on those in this House, we recognise that things should have been done much more quickly and that we should have been much more open to providing financial support to the people affected. We should look at this case in those terms.
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.”
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.
It is a pleasure to serve under your chairmanship, Mr Stringer. I congratulate the hon. Member for Harlow (Chris Vince); it is encouraging that new-intake MPs are already raising this issue. As he said in his opening remarks, constituents have been to see their Members of Parliament because of the pain, suffering and injustice that they have gone through, and they are still not getting anywhere. I am not sure who the lady is, but it is very nice to see her in the Gallery because it is an exceptionally important issue for women.
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.
It is an honour to speak under your chairmanship, Mr Stringer. I again congratulate my hon. Friend the Member for Harlow (Chris Vince) on securing this important debate and highlighting the trauma caused to many women, such as his constituent Debbie, by the pelvic mesh scandal.
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.
It is a pleasure to serve under your chairship, Mr Stringer. I am grateful to the hon. Member for Harlow (Chris Vince) for securing this important debate and for the opportunity to speak about the devastating impact of pelvic mesh impacts and the systemic failures surrounding their use.
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.
It is a pleasure to serve under your chairship, Mr Stringer. I thank my hon. Friend the Member for Harlow (Chris Vince) for raising this important issue. As he did with his constituent Debbie, I recently met with my constituent Paula, who shared her experience of the impact of having pelvic mesh fitted.
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.
Listening to the heartfelt contributions of so many new colleagues, I get the impression that most if not all of them had, like me, never heard of this problem until a constituent walked into their surgery and told them of the terrible experience that they had had.
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.
20 of 42 shown
“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 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”.
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.”
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.
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.
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.
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.]