Cumberlege Review: Pelvic Mesh

Julian Lewis Excerpts

Thursday 5th December 2024 Westminster Hall

[Chris Vince]

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

“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.

[Sir Julian Lewis (New Forest East) (Con)]

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.

[Chris Vince]

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:

“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”.

--- Later in debate ---

[Sir Julian Lewis (New Forest East) (Con)]

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.

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.]

[Sir Alec Shelbrooke]

My right hon. Friend has just made an important point. He spoke about the removal of protrusions and seven surgeries. That almost puts a gloss on what has happened. We have all heard from women who have had the surgery and the experience of many of them is that they have been butchered. It is important to make that clear in this debate, especially for new Members, because we have discussed this in Parliament before: when we think of surgery, we think of any other normal surgery, but this surgery leaves huge amounts of scar tissue and has butchered women in ways that I will not go into now. That must be recognised when we describe some of the remedials that have happened, mainly because those carrying them out do not really know what they are doing at this stage.

[Sir Julian Lewis]

Exactly right. That is why my constituent said at the time, “I do not want anyone from the hospital coming near me ever again. I have lost complete faith in them. I have been lied to and told repeatedly that it was my body rejecting the mesh. But unbelievably they kept putting more in.”

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.

[Anna Dixon]

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

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

[Graham Stringer (in the Chair)]

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

[Sir Julian Lewis]

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

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

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

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

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

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

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

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

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

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

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

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

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

local to her. She concludes:

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