Surgical Mesh

Philippa Whitford Excerpts

Thursday 19th April 2018 Commons Chamber

[Paul Masterton (East Renfrewshire) (Con)]

I congratulate the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on securing this debate. Although we went in front of the Backbench Business Committee together, the truth is that she did most of the work. I am hugely grateful for what she has done in this space. Having set herself a very high bar with the way in which she opened the Westminster Hall debate in October, I can safely say that mesh-injured women in Scotland will be incredibly grateful for the support that she has shown them through her remarks today.

In the six months since that debate, there have been a number of important developments both internationally and domestically. There have been landmark announcements in Australia and New Zealand, as other hon. Members have mentioned. While the UK Government have so far not chosen to take similar action here, I will certainly continue my efforts with the all-party group on surgical mesh implants to persuade them that banning mesh is the right thing to do, particularly now that the National Institute for Health and Care Excellence has issued guidance that favours an effective ban in practice.

There was a Public Petitions Committee debate in the Scottish Parliament just before Christmas—as I set out at our previous Westminster Hall debate, the Scottish Mesh Survivors group was left with very little option but to continue its fight through the Scottish Parliament Public Petitions Committee following a hugely disappointing report from an independent review group established by the Scottish Government. A further review exercise is currently progressing in Scotland. However, it will not re-evaluate the conclusions of the independent review—it will assess only the merits of the process by which those conclusions were reached, so it has the potential to undermine that flawed exercise even further.

At this stage, I pay tribute to the three amigos in the Scottish Parliament: my Conservative colleague Jackson Carlaw, Labour’s Neil Findlay, and the Scottish National party’s Alex Neil, the former Cabinet Secretary for Health and Wellbeing. All three immediately recognised that there was a serious issue to be investigated and continue to champion mesh-injured women across Scotland, such as my constituents Elaine Holmes and Lorna Farrell.

One of the big difficulties is that it has been very hard to get media uptake, particularly in Holyrood with the male-dominated press lobby. They found it a bit icky and did not want to write about it, so I pay tribute to Marion Scott, a journalist who has been absolutely dogged in her determination to highlight this issue, and to the hon. Member for Pontypridd (Owen Smith), who has gone out of his way to make sure that it gets pushed up in the media across the rest of the UK, giving it exposure that it would have otherwise been very difficult to achieve.

In February, the Secretary of State for Health and Social Care outlined a number of important measures to review mesh and investigate what had gone wrong. It is fair to say that a lot of the campaign groups found the overall package slightly underwhelming, but it is vital that their input into the process is given the utmost attention. Of course, this week the retrospective audit was published.

As has been said, it is right that the Health Minister, Lord O’Shaughnessy, has instructed the chief medical officer in England to respond to the findings with some urgency following engagement with the medical authorities and, importantly, with the patient groups representing women whose lives have been wrecked by mesh. Too often when there have been statements, guidance and responses, the views and experiences of these women have been completely ignored. They have been talked about as though they are not there. Their experiences have been undermined and dampened down, so if patient groups are to have any faith in the UK Government, it is important that patient voices are front and centre of the process.

I was particularly pleased when the Secretary of State announced to the House that £1.1 million would be provided for the establishment of a comprehensive mesh database. That is a positive development, and mesh-injured women in Scotland have reacted warmly to it, but they have also made it clear that, if the authorities are to gain a true picture of the suffering that mesh can cause, it must be accompanied by a requirement for mandatory reporting of all mesh procedures. Crucially, as a number of others have said, that must encompass not just NHS but private procedures, because many of the women concerned were treated privately. If mandatory reporting is not already envisaged, I urge the Department to explore that possibility.

The setting up of a database in Scotland was one of the six points included in the petition that Scottish Mesh Survivors brought to the Scottish Parliament in 2014 and 2017. It is fair to say that progress has been pitiful, and it was therefore welcome that the Secretary of State made clear that he was open to the idea of a UK-wide database and to working closely with the devolved Administrations with the aim of establishing a clear UK-wide picture. Along with my hon. Friend the Member for Angus (Kirstene Hair), I wrote to the Scottish Government Cabinet Secretary for Health and Sport about the database, and was pleased when she confirmed that her officials had been liaising with colleagues at Westminster and the other devolved Administrations. Perhaps the Minister will explain exactly how those communications will proceed.

In view of the failure in Scotland to proceed with a database in the four years since the survivors’ petition was first brought to Holyrood, Scottish involvement in the issue of a UK-wide database—

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Is the hon. Gentleman aware that the discussion in Scotland was about the need for the database to be UK-wide? We have talked about EU registration. The bigger a population, the sooner a problem is noticed. The Medicines and Healthcare Products Regulatory Agency is UK-wide. It is not a question of small databases. The Scottish Government were not obstructing the proposal. The profession felt that the database needed to be UK-wide, and needed to feed into the MHRA.

[Paul Masterton]

I certainly agree that a UK-wide database will be far more effective and beneficial in providing a true representation of the story of the mesh-injured women, but the hon. Lady must accept that the women in Scotland have found the response of the Scottish Government—and, in particular, that of the current Cabinet Secretary—fairly poor.

A lot has happened in the past six months, both at home and abroad. Some progress has been made, and important steps have been taken, but we have much further to go. Members of Parliament are often asked, “What do you want to achieve in this place? What tangible thing do you want to walk away from here and say that you have done?” Securing justice for mesh-injured women is right up there at the top of the list. Let me simply say to those watching at home and those in the Public Gallery that the fight goes on.

--- Later in debate ---

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I, too, pay tribute to the APPG and to the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy). I also pay tribute to the women who have campaigned. If they had not campaigned, the issue would not be at this point today.

As a surgeon for more than 30 years, I have to start by pointing out that there is no such thing as risk-free surgery. There will never be an operation about which it could be said there is not a 1% complication rate. When I looked at complications and talked about risks, I used to write them down on the consent form so that I went through every single one with patients. We talk about the complications that are minor and common, and we warn patients, “This will probably happen, but it’s minor.” The complications that are life threatening or quality of life threatening, even if they are rare, should be up there in block capitals so that women know.

We, as surgeons, have a duty to minimise risk and to inform the patient so that, as has been discussed, decent and informed consent can be given. The problem of this saga is that a lot of the surgeons were not informed. If a surgeon is doing 30, 20 or 15 mesh implants a year and they become aware of a problem only in two or three years’ time, it does not register in their brain as being common. We also know that many of these cases really presented only years later, so that feedback loop—“Oh my God, we have a problem!”—was not there. That is why so much of this is to do with regulation, reporting and, inevitably, the yellow card.

[Gordon Marsden]

Obviously, the hon. Lady has enormous personal experience of surgery and of this area. Does she agree that one of the other possible problems for some surgeons, although I hope not many, is that in this country we have historically been very bad at explaining risk-benefit analysis to patients? If people are being offered an operation for a condition that is not necessarily life threatening, the judgment in a risk-benefit analysis is very different from that for something far more serious.

[Dr Whitford]

I thank the hon. Gentleman for his intervention. In fact, there are studies showing how difficult it is even to explain risk, let alone risk-benefit, to patients. Certainly in the cancer field, in which I spent so much time, patients will go through really appalling treatments even if there is only a relatively small chance of cure. As a clinician, it is difficult to explain a lot of this.

Sufficient information has not been given to the medics, and therefore clearly not to the patients. We have heard this described as a “minor, straightforward procedure”.

[Owen Smith]

Does the hon. Lady agree that part of the problem is that mesh was marketed so widely as being a quick fix? Previously, far more expert urogynaecological surgeons would have undertaken what was far more difficult and invasive surgery—colposuspension or autologous sling. When it went to day-case surgery and, effectively, keyhole surgery, a much wider range of less expert surgeons was suddenly involved.

[Dr Whitford]

I would echo that. We should always be a little suspicious whenever an impression is given that an operation is easy and quick. We hear talk within the medical system of the problems of specialisation and how, actually, we need to go back to having more generalists. The depth of knowledge on breast cancer now would make it impossible for a general surgeon, who might also be doing upper gastrointestinal and lower gastrointestinal surgery, to keep up with that knowledge. That is why we will always need specialists. The danger is when something is thought to be trivial and straightforward.

Although it has been mentioned that the two problems—pelvic organ prolapse and stress incontinence, and particularly the latter—are very minor, there is a broad range. There will be patients for whom the condition is incredibly distressing and who simply cannot leave the house because of their incontinence. We should not put everyone in the same basket.

As has been mentioned, the traditional repair for prolapse would have been colposuspension, which lifts the womb and then buttresses the muscular tissues of the pelvis. The surgeons thought that by adding mesh to muscle that is clearly weakened—that is why prolapse happens in the first place—they would make the muscle stronger.

There was a perception that the results of colposuspension were poor, and a big American paper in 1997 suggested that prolapse recurred in 29% of women. As a surgeon, that seems like catastrophic failure, but, reading the small print of that paper, two thirds of those women were hugely obese and one third had bronchitis and were coughing all the time. There was also a high rate of smoking. It was not the average range of women with prolapse; it was actually a particularly high-risk group. Unfortunately, the paper seems to have dominated the profession’s perception for years.

The problem right across this is that not enough trial work and research were done at the beginning and that the follow-up was far too short. What we have seen is that the mesh problems emerge only after time goes on. There was a Cochrane review in 2007 looking at multiple smaller studies, and it showed no benefit from the use of mesh in prolapse. Since then, we have seen a slow decrease in the use of mesh, but the recent review shows that 2,500 women with prolapse in England had mesh put in last year. That means the issue is still happening.

A 2011 EU study showed no benefit from mesh in prolapse even for recurrence, and one of the few prospective studies, in which the data is collected as time goes on, also shows no benefit. That prospective study was published in 2016, so the information has not been available for decades, and it found that the mesh complication rate at two years is 12%. That is at two years, so the rate can only go up. The Scottish review of 20 years of data from 1997 to 2016 shows only a 4% recurrence of prolapse after the traditional repair. Mesh is no better at avoiding recurrence.

Colposuspension has surgical complications: a surgeon might damage something; a surgeon might injure the bowel or bladder, which is much more common; or a patient might get a wound infection. Those complications fade as time goes by whereas, as has been reported in the Chamber today, the mesh complications do not occur early, but occur as time goes on. In Scotland, after the review, the advice is absolutely clear: mesh should not be used in cases of prolapse as a routine first procedure.

We have heard about stress incontinence and the option of physiotherapy has been talked about. That option should have been used much earlier; there should have been trials of it. As has been said, this is about getting to women in the post-childbirth period so that we have the chance of strengthening their pelvic muscles. The initial repair for stress incontinence was the tension-free vaginal tape, which developed in the late 1990s. A randomised controlled trial was carried out in 2002, with the one-year follow-up report finding only a 1% complication rate and finding that the patients had less pain, and that they recovered more quickly and went home more quickly. This seemed like a great solution, which is part of why the surgeons were so convinced by it; it seemed quick and easy. They were talking about a keyhole approach and the way we deal with gallbladder and other procedures.

The problem that has gone on since has been talked about. We have had the morphing of one tape into another, and one material and so on changing, with little other research having been done and little follow-up. When that trial did follow up its patients, it found that at 10 years the mesh complication rate was 5%. Because the focus was on not injuring the bladder, we find in clinical terms that that has been the focus of the clinicians, because that is what they knew from colposuspension. The idea that two, three, four or five years later people would develop mesh complications was something the clinicians were not expecting and certainly not looking out for.

The incidence of bladder injury for the retropubic tension-free tape was about 10%, which is why the transobturator developed. Someone who has seen an X-ray or a pelvis skeleton will know that the front of the pelvis is made of two struts, so that we are not so heavy that we cannot actually stand up, and the obturator is that hole. The idea was to keep away from the bladder and therefore reduce bladder injuries, and indeed this did that.

Bladder injuries were reduced from 10% to 1%, so, again, everybody was patting themselves on the back. But what happens is the spikes—the trocars—used to put these things in are going through muscle and close to nerves, and are coming out in the groin; they are coming near the muscles that allow people to pull their thighs together. That is where a lot of the side effects and complications have come, and there was definitely a huge upswing and surge in these complications after the obturator tape became the common approach. We also had such slow recognition of what was happening. Many of us women in here, particularly us women of a certain age, will recognise that old story of women simply being dismissed, patted on the head and patronised.

An odd quirk of regulation is that the Federal Drug Administration’s regulation 510(k) allows any similar devices to pass through in a very simple fashion and they are not re-examined. Class I is low risk, and initially these tapes were all classed as class I, which means no research had to be done. They are now class III, which means a randomised controlled trial is required, and we see that Johnson & Johnson, and others, are withdrawing; they are stopping making these things because they would have to go back to carry out trials. The problem is that the tape and the trocars might have looked similar, but when the move was made from tension-free retropubic to a transobturator tape, we were talking about a totally different operation, and there was simply no evidence to show that this was either similar or better.

If something has been passed by the FDA, it tends to get passed in Europe, and the Medicines and Healthcare Products Regulatory Agency tends also to accept it without doing anything else. The European CE mark is only a mark of the quality of production; it does not imply anything about research. As my hon. Friend the Member for Glasgow North (Patrick Grady) mentioned, there is a plan to develop the EU medical devices regulation system from 2020, but, unfortunately, the UK will not be part of that, unless there is a specific negotiation.

The problems began to be recognised in 2012, because of the campaigners, their persistence and their speaking out. In 2014, the then Cabinet Secretary for Health and Wellbeing, Alex Neil, advised all health boards in Scotland to suspend meshes until there was some degree of clarity. It might have been stimulated by that, but certainly at the same time the Australian Therapeutic Goods Administration started to look at its products, immediately de-licensing a third, reviewing a third and, initially, keeping a third as standard. But last November it de-registered all prolapse meshes, so these materials are simply not available in Australia.

The Scottish independent review was set up from 2014 to 2017, and its advice was unequivocal: there should be no routine use of mesh for prolapse, and as regards incontinence, if mesh was being used, registration was made mandatory. There has been discussion about where this registration will occur. Obviously, the colleges have been developing a registration, but we need to know about everyone who had a mesh in. This could be done through scanning the barcode off the mesh and registering it in the notes—that is the obvious way to do it. Having had to review all the case sheets of breast reconstructions after the PIP— Poly Implant Prothèse—silicone implants scandal, I know that it is really important that if something is being left permanently in a patient, we know how to recall it and who had that done.

As has been mentioned, we had the NHS England review and a paper was produced last year, using hospital episode statistics, that showed a 9.8% complication rate at five years. Again, we can expect that to climb. The review published on Tuesday showed that about a third of the 72,000 patients who were treated for prolapse were treated by mesh; that is between 2008 and 2017, and we see a fall over time, so the rate might be higher during the earlier period between 2000 and 2008.

We have seen a 13% drop over that time in prolapse meshes, but, as I say, in prolapse they have utterly no benefit and therefore there can be only loss, so it is hard to justify why so many patients in England are still having prolapse meshes. Some 100,000 women have had mesh incontinence tapes, and this has decreased by 48%, meaning that the overall decrease in the use of mesh over that period is about 32% in England. Since the Scottish inquiry, the reduction in the use of mesh has been 94%—and that is continuing.

The hon. Member for Kingston upon Hull West and Hessle mentioned Dr Wael Agur, whom I am lucky enough to have as our local gynaecologist. I have been able to meet him and get information with him. The only places that are using incontinence meshes are the two specialist units in Glasgow and Edinburgh. In Scotland, a consent process has been developed, which is now being looked at by the colleges so that it can be rolled out, and, obviously, we are talking about usage in tiny numbers here.

Even though registration is mandatory, none of the other health boards is doing this, so it is not expected that Scotland will have many patients registered. What Dr Wael Agur and other colleagues are using is a small piece of rectus sheath, which is the tough tissue we have in front of our muscles. Those who are lucky enough to have a six pack—I do not see many in here— will find that that is very strong tissue. [Interruption.] We do not ask anyone to show them, please. Only about 6 cm of this is required. So we are using the patient’s own tissue and we will be back to an autologous repair, where there might be complications, wound infections and failures, but we would not see this progressive problem.

So what went wrong? Not enough research was carried out and, categorically, there was not enough follow-up. The survey that was reported on Tuesday now gives NHS England a denominator of how many patients have had mesh, but I am sorry to say that just using hospital episode statistics does not give a numerator as to how many women have problems, so I suggest a survey of all those patients or a review is necessary, in order to know how many, even within the NHS, have got these problems.

In addition, as we have heard, there was poor information on which people could base their consent; as I say, the clinicians did not know, because no detailed trials were being done of these new techniques and certainly there was no decent audit. Women were being dismissed and patronised. The regulatory system was far too complacent, simply taking things from the FDA all the way to the MHRA and not looking at changes in technique. The audit was very poor, with a recent survey showing that only 27% of patients who had had meshes were registered.

Finally, the yellow card system failed, yet again. The hon. Member for Congleton (Fiona Bruce) mentioned the other scandals associated with sodium valproate and Primodos. Unless patients are aware of the yellow card system and unless GPs and doctors have it literally in the front of their brains, people will not send a yellow card until they are sure that the drug or the mesh caused the problem. For any new drug, for any new technology that is being implanted, and for any baby born to a mother on medication, there should be a yellow card, because the whole point of the yellow card system is that someone centrally is able to notice. That is why we need more of these yellow cards. There is clearly a problem, so we need better registration and reporting, so that we do not have to have another similar debate in future.