Surgical Mesh
Debate between Owen Smith and Philippa Whitford(6 years, 8 months ago)
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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.
Transitional State Pension Arrangements for Women
Debate between Owen Smith and Philippa Whitford(8 years, 9 months ago)
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Dr Philippa Whitford (Central Ayrshire) (SNP)
I would like to challenge the figure that was quoted by a Member on the Government Benches. The Opposition spokesman might have the correct figure, but the figure reported from the Department for Work and Pensions investigation in 2004 was just above 40%, not 75%. Surely, given such a cataclysmic change, every single one of these women should have had a simple letter on the doormat in 1995.
Owen Smith
The hon. Lady is entirely right. Even if 40% of women were unaware, that is 40% too many. As I said, five or six other surveys were done by academics and those in other institutions that suggested that 80% of women were unaware that they were going to be affected, so the reality is that the number was far greater.
The scale of this problem only truly started to dawn on people when the Government decided to double down on their calamity with the Pensions Act 2011.