Cumberlege Report

Caroline Nokes Excerpts

Thursday 3rd February 2022 Westminster Hall

[Caroline Nokes (Romsey and Southampton North) (Con)]

My right hon. Friend has made that point a number of a times during his speech, and it is worth highlighting. I know that my hon. Friend the Minister will do some great work on the women’s health strategy, but time and again my right hon. Friend has said that women’s voices are being ignored and dismissed. They are told that they are imagining things and that it is in their heads. It is not good enough.

[Alec Shelbrooke]

I completely agree with my right hon. Friend. In fact, I will later make a couple of points on what I have discovered about women’s health. The way women are treated is quite appalling.

Another person says:

“I had my TVT in Exeter 12 years ago. Exeter consultant in 2020 told me I couldn’t be referred to Bristol. He said he would refer me to UCLH but I never heard from them, I rang in 2021 to be told UCLH hadn’t received any referral but they then put me on their wait list from when I’d been told the referral was made. I then heard nothing from them for ages so I paid for a private consultant at Bristol to be told I could have been referred to Bristol on the NHS in the first place. Bristol requested NHS tests in Exeter which were done in August 2021 and they referred me back to Bristol in October, so I am now on Bristol NHS list for removal”.

Somebody else says:

“Took 4 years to be referred to specialist mesh centre, after a lot of pushing and pushing for it, referred to Royal Victoria Hospital in Newcastle upon Tyne. The mesh centre was no better, more lies, gaslighting and a really appalling treatment and total indifference, lots and lots of mistakes, cancelled appointments and no regard for any pain or suffering.”

Another person says:

“Told too dangerous to remove…left in agony...self-catheterising, lost job, pain management referral but they are behind 12 months …invisible and invalid is how I feel…is this my life at 54?”

Somebody else says:

“I went for a consultation for removal in 2020 had a scan then asked to contact his secretary when I’d had an MRI which I did in December 2020. Now still waiting for them to contact me. I leave messages and nothing happens.”

I could go on and on and on, and I am sure that many other right hon. and hon. Members will be raising similar cases. What I want the Minister to comment on in today’s debate is this. There is now, from the relevant royal colleges, the “Purpose Statement for the Mesh Complications Management Training Pathway”. That statement outlines several areas, but I will highlight just the “Mesh Complication Management credential”. Its subheading is “Professional Identity: Clinical Expert” and it states:

“The doctor has the knowledge, skills and attitudes required for clinical assessment of patients presenting with suspected mesh-implant complications…The doctor is able to investigate mesh complications, and interpret the results of tests, appropriately…The doctor is competent in non-surgical management of mesh complications…The doctor is competent to undertake mesh removal surgery as part of a multidisciplinary team”.

This is progress, but I think we can all understand that there is going to be a long time around that, so I say this to the Minister. Can the House please have regular updates on how this training process is going, within the royal colleges, for surgeons, because we need to understand what the process is and how long it is taking to try to deal with the main issue?

That brings me to the other parts of recommendation 5 in the report of the independent medicines and medical devices safety review. The written ministerial statement in response said:

“Recognising the need for enhanced data collection on pelvic mesh, the Government in 2018 announced the provision of £1.1 million for the development of a comprehensive database of urogynaecological procedures, including vaginal mesh, to treat pelvic organ prolapse and stress urinary incontinence. I can update the House that the pelvic floor information system has started to receive live data, including historical data from July 2017 onwards, with an initial focus on supporting specialist services to report every pelvic floor and comparative procedure to this national database.

The report of the IMMDS review also recommends that the information system is accompanied by a retrospective audit of mesh procedures, and by the development of a patient reported outcome measure (PROM) or patient reported experience measure (PREM). I am pleased to announce to the House today that the Government accept both these recommendations. NHS Digital has been commissioned to scope and deliver the retrospective audit. Subject to receiving high quality research bids, a new validated PROM for pelvic mesh procedures will be commissioned through the National Institute of Health Research in 2022.”—[Official Report, 21 July 2021; Vol. 699, c. 73WS.]

Again, I ask the Minister whether she can update us on progress in these areas and, after today’s debate, could she speak to her Department about ensuring, even if it is just through a written ministerial statement, that there is a regular update on the progress being made?

I will give a summary of the points that I have made. GPs are unaware of mesh complication centres and the referral process. Many patients are denied access and offered physio and pain management instead. They pay thousands of pounds for private care. They experience extremely long delays for appointments. Many women end up seeing their implanting surgeons, who then dismiss them. That leads to further deterioration in their physical and mental health. There is a lack of experience, particularly in mesh removal. There are only around four to five surgeons in the UK who can do mesh removal. There is no post-op aftercare.

More positively, on recommendations 6 and 7, the Government announced that the MHRA

“has initiated a substantial programme of work to improve how it listens and responds to patients and the public, to develop a more responsive system for reporting adverse incidents, and to strengthen the evidence to support timely and robust decisions that protect patient safety.”

Recommendation 7 was:

“A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”

The Government accepted both recommendations. Again, I ask the Minister for an update.

Recommendation 8 states:

“'Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors' particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.”

The Government said that they accepted the recommendation in principle:

“We agree that lists of doctors’ interests should be publicly available, but we do not think that the GMC register is the best place to hold this information”,

so “publications of interest” should be held by healthcare providers. Having approved the recommendation, how is that progressing and how easy is patient access?

Finally, we get to recommendation 9:

“The government should immediately set up a task force to implement this Review's recommendations. Its first task should be to set out a timeline for their implementation.”

The Government accepted the recommendation in part.

Having probed the recommendations to open the debate, I ask the Minister whether she and her Department are able to say positively that they are meeting recommendation 9. Are the recommendations being implemented properly and is she revisiting the recommendations rejected by the Department initially? We can all recognise from the examples that I have given that the mesh centres are not working, that people’s lives have been destroyed and that they will need to support throughout their lives. We cannot just draw a line, have a year zero and say that we hope such things do not happen again. We have to move forward.

Drawing on what my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) said and on my research, it is clear to me that the NHS is constantly failing women. During the pandemic, I read a report—unfortunately, I have not been able to reference this since, so it is open to challenge—stating that gynaecological surgeons were taken off their operating theatres for longer than any other surgeons, being kept on the frontline of the covid wards.

That says exactly where the problem in the NHS lies. That comes up not just in this debate, but next week, in another debate, on problems with endometriosis. It seems that the NHS is—I do not say this in a positive way—gender-blind to the needs of women and the complications that occur. It is an attitude, a built-in psychology, that we will have to address, and we can only start to do so if we take all the aspects of this report seriously.

Although men have mesh issues too, this debate is dominated fundamentally by women’s health. It speaks to that wider assessment of NHS priorities on women. We have to start doing something about that. We must stand up and say that we are not afraid to criticise areas of the NHS, because I am sure that as we go through the debate we will have example after example from which we can draw only one conclusion: women are being failed.

My hon. Friend the Minister, as a practising nurse, will know the importance and vocation of patient care. With her professional eyes, will she allow the NHS to ignore the plight of people who are suffering every day? To be blunt, her predecessor appeared to. I ask her to apply her considerable and dedicated professional expertise to get the Government to direct the NHS to adopt the recommendations, or at least to mirror them. That is the least we can do for the terrible and horrific damage that the NHS has caused to so many people. To finish: the NHS did this, so the NHS must fix this.

--- Later in debate ---

[Caroline Nokes (Romsey and Southampton North) (Con)]

It is a huge pleasure to speak in this debate. I extend my congratulations to my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) on opening the debate in an incredibly sensitive and thoughtful way. I hope that I can follow his lead and not get angry at the Minister. I do not blame her for this, and I know that she has a very real and personal commitment to the women’s health strategy, which we will see come forward in the spring—I was grilling special advisers on that only this morning. However, I urge her to listen carefully to the voices she has heard today, and to recognise that Members of Parliament speak up on behalf of their own constituents. We hear in our surgeries, week in and week out, about the issues that are affecting women and impacting their wellbeing and health. I urge her to ensure that those voices are listened to ahead of the final strategy being published.

We have heard it all today: sodium valproate; Primodos; mesh. I always hear “the victims of mesh”, and I absolutely regard them as that; they are victims of a surgical process that has left them in absolute agony. Each of us here this afternoon has a different perspective and interest. It is absolutely right that we all have highlighted the particular areas of concern to us.

Of course, I have victims of mesh living in my constituency. I also have a wonderful family whose daughter has been the victim of Primodos. Her story is one that always resonated with me, because she is exactly the same age as I am, and has been living with her disabilities since 1972. However, I really want to talk about sodium valproate. I do not know why that issue stuck with me so clearly, other than the fact that it was through the contribution of two amazing women—Emma Murphy and Janet Williams—who came to see me when I was a very newly-elected MP, and spoke to me about valproate. I am not an evangelist for banning the use of valproate—it is such an important drug, and has a valuable impact on those patients with epilepsy who need it to support them and manage their conditions well—but it is imperative to recognise that the dangers of valproate were known for many decades but not articulated to those women who were taking it and were of child-bearing age.

We have, for decades, had really effective pregnancy prevention programmes for various drugs. I always highlight—as my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) pointed out, we have been here before—the use of Roaccutane, which I remember taking probably 30 years ago. I had to sign all sorts of bits of paper promising not to get pregnant. Then, when my daughter was prescribed it as an 11-year-old, she had to have a pregnancy test every single month— at 11—to demonstrate that she was not pregnant and that it was therefore safe to give her the drug. The same measures were not put in place for valproate.

Emma and Janet went digging around in archives; they have made endless freedom of information requests, and they have had their work recognised by the World Health Organisation. The pressure that they put on Members to convey the importance of a proper investigation to people like my right hon. Friend the Member for Maidenhead (Mrs May) brought forward the Cumberlege report, which was so valuable.

I will give a bit of a timeline: on 8 July 2020 that report was published; on 9 July, I was in the House for the oral statement on the Cumberlege report. I can remember my hon. Friend the Minister’s predecessor, the then Minister of State at the Department for Health and Social Care, my right hon. Friend the Member for Mid Bedfordshire (Ms Dorries), actually giving us hope and confidence.

I listened to her, that day in the House, and thought that she had the tone of her response absolutely right. She promised to take away the issues that we were all raising. She promised to look at all of the recommendations that the Baroness had brought forward so competently and effectively. I had hope, as did the campaigning women from In-FACT, and the hon. Member for Bolton South East (Yasmin Qureshi), who is on the APPG. We all had hope that the recommendations would be accepted and acted on with speed.

Then, on 21 July 2021, a whole year later, rather than having an oral statement in the House, when we could ask the Minister what was going to happen, and what action was going to be taken on the recommendations, the Government snuck out a written ministerial statement on the last day before recess so we had no opportunity to bring forward the concerns that we had on so many of the recommendations either being rejected or only accepted in part. Those campaigners felt despair—not the hope that they had a year before, but despair.

The third date that I want to highlight—this is where I will provide some air cover to the Minister—is 15 September 2021. Rarely in a Member’s career does the opportunity come along to ask question No. 1 at Prime Minister’s questions, and on 15 September is was my turn. It will probably never happen to me again, so I carefully considered what issue to raise. We all have brilliant constituency issues that we want to raise or things that we have been campaigning on, and suddenly, in a Zoom call with Emma Murphy and Janet Williams, I went, “Do you know what? I have question No. 1 on Wednesday.”

I used my question to ask the Prime Minister about the specific issue facing the parents of children impacted by foetal valproate syndrome: their children have learning difficulties and additional needs. Some are born with spina bifida, a cleft palate, heart defects or limb malformations. They have all sorts of additional challenges, which are expensive. They need redress and specialist centres where their children can get the support they need, to lead as full a life as possible. Guess what? Their parents also need respite. They need be confident that their children are being properly looked after, cared for, supported and helped to counteract all the challenges they face, and they need a break, but they have been offered none of those things.

So, in September 2021 I asked my right hon. Friend the Prime Minister if he would recognise that there was an additional cost—a fiscal impact—on these families and if would he commit to making redress available. He responded by indicating that the Government was

“committed to making rapid progress”—

I emphasise the word rapid—

“in addressing all the areas that”

the Cumberlege report

“mentions, including the one that my right hon. Friend covered today.”—[Official Report, 15 September 2021; Vol. 700, c. 964.]

Yet we are still waiting for redress and for the specialist centres, and the families are waiting for an acknowledgment that they face additional costs, day in, day out, and they want help with them.

I want to ask a specific question of the Minister, which was provoked in my mind by my right hon. Friend the Member for New Forest East (Dr Lewis), who sadly cannot be with us for the conclusion of this debate. He made the point about disability and the women who have had mesh implants whose ability to work is impacted forever. I remember being a Minister at the Department for Work and Pensions. We did a lot of work around people who had long-term conditions and whether they should have to go through the reassessment process.

This would be an excellent opportunity for my hon. Friend the Minister to outline to us what work she is doing with the DWP to ensure that these women can be included in that group, so that they do not have to go through endless reassessments time and again to establish whether they are still suffering pain from mesh. That is an important point, because that would give them a sense that we are making some sort of progress. That is my specific question for the Minister, which I hope she will be able to answer.

I will not take credit for my final, really important point, which should be given to my right hon. Friend the Member for Elmet and Rothwell, who passed me a note midway through the debate. We have to make sure that this stops. We must not continue to ignore the voices of women who say they had a procedure that has damaged them, but who are told it is a mental problem and it is all in their head. We cannot have a situation where people continue to be ignored, or where drugs come on to the market and are left in use and circulation for decades, before somebody recognises that there is a problem. If we go back to thalidomide and valproate, it was decades before people recognised that there was an issue.

The point was made earlier that the aircraft and airlines industry has a no-blame, no-consequence reporting system for errors, so that if someone finds something that is wrong, it will not come back on them in their career. As my right hon. Friend said, the career of the doctor who discovered the problem with Primodos was impacted by that discovery, for the rest of her career. We cannot have that situation. Just as the airline industry has a no-blame reporting system, can we also have that in our NHS, so that people have the confidence to report, knowing it will not come back upon them? Then we will not have medicines and devices that do harm, in the same way that we no longer have planes that simply drop out of the air.

--- Later in debate ---

[Maria Caulfield]

I will come to that point. The Government have apologised on behalf of the health and care sector for the time it took to listen and respond. We are doing more than apologising: we are changing the healthcare system so that it responds to women in a much better way.

As the hon. Gentleman has just raised the issue of redress, I will touch on it now. It is not just these cases where it is often difficult for patients to get redress and compensation. I gave evidence to the Health and Social Care Committee this week on the issue of clinical negligence. This week, we announced a fixed recoverable costs scheme, meaning that, for low-value claims, we can speed up the claims process, reduce legal costs and ensure that, whatever clinical negligence they have experienced, patients are able to get compensation as quickly as possible. The findings of the Cumberlege report highlight mesh, Primodos and sodium valproate. However, across the board, it is very difficult for patients to get redress, regardless of the clinical negligence they have suffered.

[Caroline Nokes]

I do not want to be too difficult, but I do not think it is any excuse to say that because it is difficult for everyone to get compensation, we should not try here.

--- Later in debate ---

[Maria Caulfield]

Specifically on Primodos, there is pending litigation so it is difficult for me to comment while that is in progress, but, depending on the outcome, the Government will respond to that.

[Caroline Nokes]

I will go for valproate, because there is not pending legislation about that. Have I understood the Minister correctly? Is she saying that if the Primodos case is successful, the Government will review it, and the women who have had mesh implants or who are the victims of sodium valproate will not be expected to have to go down that legal route?

[Maria Caulfield]

If I touch on the points in my response, hopefully I will be able to reassure colleagues on the progress being made.