Surgical Mesh

Bob Seely Excerpts

Thursday 19th April 2018 Commons Chamber

[Emma Hardy]

I absolutely agree, and I hope that will be included in future.

Analysis conducted by Carl Heneghan, professor of evidence-based medicine at the University of Oxford and clinical adviser to the APPG on surgical mesh implants, reveals that the 100,516 women who have undergone mesh surgery in England since 2008 have required follow-up treatment in 993,035 out-patient appointments. He has calculated the total cost to the NHS for all incontinence and out-patient appointments to be £245 million. His analysis of the trend in out-patient appointments also shows that more are required by women as each year passes after their surgery, which is completely the opposite of what you would expect after a successful surgery.

The data shows that the number of operations using mesh has halved over the last decade, which shows that doctors and patients are voting with their feet and telling the world that they do not want to use mesh.

[Mr Bob Seely (Isle of Wight) (Con)]

Will the hon. Lady give way?

[Emma Hardy]

I will have to continue.

In February came the welcome announcement of the Cumberlege review of how the NHS addresses concerns about vaginal mesh devices and how patients have been treated when raising those concerns. However, I remain deeply concerned that mesh has not yet been completely suspended and that it remains possible for doctors to use it, especially in the case of stress urinary incontinence. There is also still no universally available physiotherapy as standard for all new mothers, as there is in France, to stop these problems before they even arise.

I still believe that it is an absolute scandal that these devices were aggressively marketed to doctors and then used in patients for whom they were unsuited. We need to ensure that lessons are learned and that more steps are taken to make the medical products industry more transparent. Campaigners have even called for legislation, such as they have in America, to require doctors to declare any grants, inducements or scholarships that they receive from the industry.

Some patients think they are having the mesh completely removed, only to find out later that it has been only partially removed. They feel that they are suddenly better and that they are recovering only to go through the horror of having the symptoms come back later. It is important that, where possible, mesh should be removed in full.

Despite the fact that 100 different types of mesh are available in the UK and that we do not know whether just one type is causing the problem or 100 types; despite the fact that Carl Heneghan has raised concerns about the small amount of evidence that mesh manufacturers are required to provide before their products are approved; and despite the fact that Dr Wael Agur from the University of Glasgow, a one-time advocate of mesh surgery, is now arguing that the Medicines and Healthcare Products Regulatory Agency has only a fraction of the knowledge of the adverse effects associated with mesh, NICE is still not going to bring its guidelines for stress urinary incontinence forward from 2019 to 2018, and the Government seem more focused on process than on the actual product.

Suzy Elneil, consultant urologist at University College London and one of the few qualified surgeons who is able to remove mesh, tells me that she sees 15 women a week who are suffering after mesh surgery. Even if NICE releases its guidance on 1 January 2019, Suzy alone will see another 525 patients before that date— 525 more patients living in unbearable pain. I am sorry, but that is 525 people too many. The Government must press NICE to bring forward the guidelines and pay attention to the product as well as the process.

[Mr Seely]

Will the hon. Lady give way?

[Emma Hardy]

I am sorry, but I have to continue.

It seems that our campaign must continue. We must ask again for renewed commitments from the Government to address these problems. Again, I ask the Government to commit to three things. First, we need a full and unequivocal suspension of mesh implant operations. Secondly, I ask them to bring forward the NICE guidelines for stress-related urinary incontinence from 2019 to 2018. Thirdly—this is a new one—will they please offer pelvic floor physiotherapy to all new mums as standard on the NHS, as happens in France, to help to restore the core after birth?

I end my speech with exactly the same words I used to conclude my remarks in Westminster Hall. Mesh implants have affected thousands of people all over the country. For some, the consequences of their operation will be life-changing and devastating. A Government commitment to taking these actions will not undo the suffering and pain that these women have endured, but would go a long way to making sure that nothing like this happens again.

This is the second time that I have spoken these words. Let us hope that justice is done before I have to speak them a third time.

--- Later in debate ---

[Dr Sarah Wollaston (Totnes) (Con)]

I pay tribute to the many women, including those in my constituency, who have come forward to discuss deeply personal and painful accounts of serious complications following mesh surgery, sometimes with life-changing and lifelong consequences for them and their families. I also thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) who, as always, has set out the background to the issue so eloquently. She has been such a campaigner on behalf of victims, and I really thank her for what she is doing. I will not repeat much of the background that she set out, but I will highlight a few points to which I hope the Minister will respond in her closing remarks.

As we have heard, NHS Digital has published a review of patients who have undergone urogynaecological procedures for prolapse or stress urinary incontinence, including those where mesh, tape or equivalents were used. However, as the hon. Lady pointed out, the review does not cover all procedures, nor does it include the men who have been affected. We know that 100,516 women underwent these procedures between 2008 and 2016, of which 27,016 cases involved mesh for prolapse. Although the numbers are falling, I am afraid that this is just a snapshot.

[Mr Seely]

I congratulate the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on calling this important debate. Are the figures accurate? I have been told that some of the figures do not include people who are treated abroad and come here having developed complications, or people who have been to private clinics. The numbers that we have may therefore not be accurate, perhaps underestimating the true total.

[Dr Wollaston]

I was about to come to that very point. Crucially, many of the women I have met have been treated in the private sector. In this House, we should be concerned about all our constituents, not only those who are treated in the NHS. Of course, it is the NHS that often then bears the burden of managing complications, but we must have a much more accurate picture.

I support the call from the Royal College of Obstetricians and Gynaecologists and from the British Society of Urogynaecology for mandatory prospective data collection, using the BSU’s database. That is a well-established method of collecting outcome data. Retrospective snapshots are no substitute for collecting data as we go forward or, most importantly, for being able to track it in the long term. Although the majority of complications that happen after 30 days happen in the first year, many of the women I have met developed complications far later than that. I particularly want to emphasise to the Minister how important it is that we have access to shared databases not just here in the UK, but across Europe. Will the Minister tell us whether the Government will be seeking for us to remain part of the European Database on Medical Devices—EUDAMED—so that we not only get an accurate picture of what is happening here in the UK, where our population is smaller, but can compare our data with the whole European Union?

That brings me to the wider point about Brexit that is highlighted in the report of the Select Committee on Health on the implications of Brexit for medicines, devices and substances of human origin: the issue of access to clinical trials. It is encouraging that the Government have stated that they wish to remain a part of the European Medicines Agency or to have associate membership, but there are all sorts of aspects to forward clinical research on which it is essential that the Government campaign. They must campaign not just to maintain regulatory alignment and harmonisation, but to ensure that we can remain part of all research mechanisms and mechanisms for ensuring that we have the earliest possible awareness of any complications—not just from drugs but, as this situation has shown, from medical devices. I hope that the Minister will further outline the Government’s intention in that regard.