Face the facts



Download 83.76 Kb.
Date31.05.2016
Size83.76 Kb.
THIS TRANSCRIPT WAS TYPED FROM A RECORDING AND NOT COPIED FROM AN ORIGINAL SCRIPT. BECAUSE OF THE RISK OF MISHEARING AND THE DIFFICULTY IN SOME CASES OF IDENTIFYING INDIVIDUAL SPEAKERS THE BBC CANNOT VOUCH FOR ITS COMPLETE ACCURACY.
FACE THE FACTS

Medical Devices




Presenter: John Waite



TRANSMISSION: Wednesday 22nd January 2014 1230-1300 BBC RADIO 4
Actuality – Operating Theatre
Clips

He said he was going to make me a new woman. But in fact I’ve been so ill, very, very ill, and I’m very, very cross.


Life became a nightmare every single day and you’re also suffering pain in an area which is very difficult to talk about.
I don’t think as any human being you should be having anything put in you that has not been properly tested, checked, validated and actually followed up for many years.
Waite

Today on Face the Facts, why thousands of women have been harmed by medical devices they were told would make them better. Women who were suffering from either urinary incontinence - involuntary leaking because of a weak pelvic floor - or pelvic prolapse, which is when the vagina or uterus bulges out of its normal position. In both cases, an implant called a trans-vaginal mesh – in tape or patch form – is often fitted with, for some women, devastating effects. Pain so crippling that they’re registered disabled and have to use a wheelchair to get about. Holding down a job, running a household, having sex – all can become impossible. They’ll be telling their stories which are personal and emotional.


And we’ll be reporting the growing concern at the current system where medical implants like theirs can come on to the market, but without first being trialled in people. Something Professor Carl Heneghan from Oxford University finds incredible.
Heneghan

Well it seems bonkers doesn’t it? What happens is they test it in animals but there is no clinical testing in humans when it goes out in the market. Early people are actually the test and the clinical trial but they don’t know it and they’re not being informed.


Knocking on Door
Russell

Hello?
Waite

Karen?
Russell

Oh yes.
Waite

John Waite, Radio 4?
Russell

Oh hello, come on in.


Waite

Thank you very much.


Seven years ago, Karen Russell from Peterborough had a vaginal mesh implant. She was suffering from stress incontinence following a pregnancy. At the time she was an active 37 year old who enjoyed the outdoor life, she told me, but the pain that resulted after surgery meant that was to change dramatically.
Russell

The weeks went by, the months went by, it didn’t get better and it was very difficult because I had young children, in fact they had to go and stay at my mum’s – I really was in an awful lot of pain. And as time went on not only was it the pain but you weren’t obviously able to get out and about and do anything and that was the point we decided well for the short term let’s buy a wheelchair and I would say for the first couple of years the pain was so horrendous that I was literally shuffling around. I honestly think that the doctor and the consultant, at the time, probably didn’t know what to do with me. These risks aren’t minor risks, they’re major, they’re life changing and psychologically and emotionally not only have you got to cope with what you’ve lost you’re also suffering pain in an area which is very difficult to talk about – people might have thought I had a bad back or something else, it’s very difficult to be open about one, the operation you’ve had and why – well why has it had such a major effect on your life Karen, why can you not walk?


Waite

Karen says she was never warned that the mesh implant might leave her so physically debilitated that for a while she was registered disabled. That she would have to live with what she called the “cheese wire effect” of excruciating pain. She was simply told that the implant would be a quick and efficient procedure that would soon have her back on her feet.


And that’s how the mesh implants were originally marketed, according to surgeon Professor Sohier ElNeil of University College Hospital in London. As a marked improvement on the old method of operating on damaged bladders.
ElNeil

The gold standard operation was known as Burch colposuspension whereby a small incision was made on the anterior tummy in the front of the abdomen and then special support stitches were put in to hitch up the mechanism around the bladder neck and hitch it on to special ligaments to sort of recreate almost like a fan shape support or hammock to hold the bladder up and that also restored continence. And for years that was the operation of choice and more recently, in the last decade or so, people have also done it using keyhole methodology.


Waite

And when this procedure that we’re talking about, the tapes, the meshes, when that was introduced was it hailed as some great breakthrough?
ElNeil

It was seen as a breakthrough operation because it required less surgery and less time in hospital and the recovery was very quick. So many patients could have this done almost as a day case and they were able to then go off and go back to work within a few days. The other operation – most of our patients would need to be in hospital for two or three days and then would need to be off work for at least four to six weeks to recover from the incision sites and the type of operation it was. So it was a huge breakthrough in terms of surgery but in terms of continence management it did change the way we did continence because a lot of patients previously before having the Burch colposuspension would always have to have all the lifestyle behavioural changes, have physiotherapy extensively before they went through surgery. Whereas nowadays that part can sometimes be missed because the operation is seen as such a simple intervention that people think well maybe you don’t need to do the physiotherapy or the lifestyle modifications such as change your drinking habit or stop your weight gain and try and make sure you lose some weight to try and see if you can improve the continence and so on.
Waite

Professor ElNeil told me, however, that she’s coming across more and more women for whom the mesh implants have had dire consequences. She used to perform around one operation a month to remove the mesh now it’s two or three a week. One of her recent patients is 64 year old Marion Ward from Devon. In 2009 Marion had a mild form of stress urinary incontinence and was prescribed a mesh implant to prevent it. The result, though, was – like Karen – to see her whole way of life thrown upside down.


Ward

It was about three weeks and I couldn’t wee properly. To proper wee I couldn’t.


Waite

Was that it or was there more?


Ward

I’m going to tell you – no, no, no…


Waite

Didn’t stop there.


Ward

No, for four and a half years I suffered with about 100 infections, urine infections, and I took hundreds and hundreds and hundreds of antibiotics. And one top urologist, in fact he said if I take the tapes out – in a letter, I’ve got all the letters – I will probably make it worse. And – but I never had no quality of life and I was seriously ill, I was in a lot of pain all the time, I just couldn’t get a job and I stayed in most of the time because of the bad pain with the urine infections and the burning and the back pain. I had a letter from a top gynaecologist who said to me: “Sorry Mrs Ward for your discomfort but there’s nothing we can do. Yours sincerely… so and so.” So he finished with me. And I didn’t know where to turn. I got the letter dated at home, I’ve got a big pile of letters. So I suffered for four and a half years.


Waite

And how much did it change your life – the last four and a half years?


Ward

Terrible, terrible, you don’t realise. I lost a friendship because I didn’t realise where all the infections was coming from.


Waite

And you felt poorly presumably all the time?


Ward

All the time, all the time. And I kept saying to the specialist I’ve got no quality of life, I’ve got no quality of life.


Waite

Marion eventually heard from a fellow sufferer of a surgeon who might help her – Professor ElNeil in London. She agreed to operate on Marion and remove the mesh - an operation that took place successfully a few months ago. Today Marion’s back at UCH for a follow-up operation which she and her surgeon hope will fix her original incontinence problem once and for all.


Operating Theatre Actuality

Right are we ready to start everybody? Thank you very much.


ElNeil

Her situation at that time was so desperate that we decided to go ahead and remove the tape and so once we removed it she actually told us almost as soon she got up that she felt so much better so quickly. And I had already warned her that her stress incontinence was likely to come back again, which it did and so we then did a special test known as a urodynamic assessment to look at how bad her stress incontinence was and we were able to identify that she’s got significant bladder support weakness and we made the recommendation for her to have a culposuspension operation which is what she’s having today.


Operating Theatre Actuality

May we have some head down please?


Waite

As Marian was prepared for surgery, I changed into surgical scrubs to watch the operation that Professor ElNeil hopes will finally end Marian’s years of misery.


Operating Theatre Actuality

So we’re just making the incision on the patient’s abdomen and we use a low transversal Pfannenstiel type incision to try and access the retro pubic space. So…


Waite

Professor ElNeil isn’t alone in being critical of the current system which allows implants like these meshes to be placed on the market without first being tested in patients. At Oxford University, Dr Carl Heneghan agrees. He’s Professor of evidence based medicine and the evidence is clear, he says, that there’s already been a stream of defective devices in what’s become an enormous sector of modern medicine – the implantable medical device.


Heneghan

There are thousands of medical devices – think about the implantable ones – metal hips, heart valves, there are ear implants, cochlear implants – so there’s a whole vast array of implants. And I reckon probably if you look in the UK you’ll probably say somewhere between about 5 and 10% of the population has a medical device at one time – so we’re talking three, four million people have some form of medical device – pacemaker, artificial hip, heart valve. So it’s actually quite a lot of people.


Waite

Professor Heneghan says that, following the thalidomide scandal, a proper drug testing regime was put in place. But there’s no such regime, he says, for medical devices that after all can be placed inside people possibly for the rest of their lives. Instead we have a paper based certification scheme.


Heneghan

Well let’s take the European certification system, it’s called the C marking. The manufacturer takes a device to what’s called a notified body. There’s a number of them dotted around the European countries, you only have to pick one and they’re a private organisation outside of public systems who then say to you – we’ll look at your evidence that you submit and then say based on that evidence we’ll approve you to have C marking. Then you can put your own C marking. One of the issues about the evidence requirements though of that system is there’s no requirement to produce clinical data because most people use what’s called “equivalence” and this is the real problem. In equivalence they say my device is a bit similar to somebody else’s on the market, I’ve done you a literature review to show that, I should be able to have access to the European market tomorrow. And that literature review can be done in a couple of days.


Waite

From what you’re saying Professor Heneghan notified bodies can issue certificates without actually testing, perhaps even seeing, these devices, they just read the literature and if it seems okay they give the okay.


Heneghan

Yeah that’s totally correct.


Waite

So a device could be designed to be implanted into people, marketed and sold here in the UK without it ever having been tested on people?


Heneghan

Yes.
Waite

And what do you think about that?
Heneghan

I think there has to be minimum requirements for any device. What will that do? Yes it will put up the upfront costs but it’ll incentivise people to produce high quality.


Waite

What about a register – can you tell me about this idea?


Heneghan

Yes, so one of the things about registers – and this is – what the idea is is a register is every single person who has the implanted device will be put on a register which allows you the ability to say this is the exact device you had and then can be followed up.


Waite

And the vaginal mesh, which we’re looking at, that’s a classic case, you’re saying, of the introduction of a quick fix without proper consideration of the long term consequences?


Heneghan

Yeah because every single trans-vaginal tape mesh that’s been designed has used what’s called the equivalence route, so they’re all saying we’re a bit similar to the ones that have gone before.


Waite

When we look back how do you think we’ll make sense of this situation – what has been allowed to become the system?


Heneghan

I suspect this will be a great historical time that people will look back and think oh my gosh look at how bad what they were doing, how bad it was, how much damaged they caused.


Waite

Well none of the “notifiable bodies” we approached for comment was available to take part in today’s programme. However, according to the health watchdog, the MHRA, there were only 321 so-called “adverse events” in English hospitals involving vaginal mesh implants in patients with incontinence or prolapse in the years between 2005 and 2013 – out of tens of thousands of implantations.

Yet according to Hospital Episode Statistics – complied by the Health and Social Care Information Centre – and which cover a slightly shorter period – there were more than 4,000 mesh incidents. Even that wasn’t precise we were told – it could be being under reported or over reported. The fact is no one really knows. And that’s another problem, according to Professor Heneghan, there’s no reliable evidence and not just in the UK.
Heneghan

It seems in America they’re reporting much higher rates than the UK. Certain countries, like Sweden, are reporting different rates. So we’re getting this mess. This current system underreports, it doesn’t actually give you the true picture and so somehow we’ve got to get to a position where we have much more accurate data and we can’t have this system where we’re going we’re not quite sure whether the data’s correct or not.


Waite

Well, what we do know is that there are two types of mesh that form these trans-vaginal implants. There are strips of mesh, or tape, used for patients with urinary incontinence, and there are larger patches of mesh which are used for people with prolapses.


According to surgeon Ash Monga, chair of the British Society of Uro-Gynaecologists, the failure rate for the tape can be up to 10%, with about 1% of women experiencing severe complications. When it comes to patches of mesh, however, the complication rate is much higher - 20 times higher in fact. And taking a huge toll on those affected.
Monga

What we’ve seen over the course of the last six to eight years is that there were much higher complication rates with these meshes, problems with intercourse, erosion, infection of the mesh and pain. And therefore, right from their inception, our society, the Royal College and NICE have always recommended that these women be properly followed up and audited and be properly counselled prior to surgery. But as I say we have problems with intercourse in 15-20% of these women.


Waite

So an unacceptably high level of failure?


Monga

In my opinion an unacceptable complication of not being able to have intercourse.


Waite

As we’ve heard, when it comes to how these devices were tested the vaginal mesh used in tape form was monitored in the first patients in whom it was implanted, when it was on the market in other words. However, when it came to the patches of mesh they didn’t need even that level of monitoring as they came under what’s called the equivalence rule. In other words, they were a variant of an existing device and so they needed no such monitoring at all. So only now, more than 15 years after they were introduced, is a large scale trial finally underway to see whether their benefits outweigh their drawbacks. The trial’s called Prospect, includes almost 1500 women, and won’t have even preliminary results until autumn 2015. Professor Cathryn Glazener is the uro-gynaecologist running it.


Glazener

In the first instance somebody has to be a trail blazer and try out and see if it works. But at some point somebody has to say right, okay that’s enough at seeing if it works now you need a trial to see if there is an overall benefit.


Waite

Well exactly and isn’t that something, as many people have told me making this programme, that is wrong with the current system when it comes to surgical procedures?


Glazener

Well yes I would entirely agree with that and I think that what are basically called interventional procedures, that’s kind of surgical or the investigations for example which currently can be introduced fairly easily, should certainly be subject to more monitoring and more evaluation before they’re introduced.


Waite

The trouble is how much do we know about who’s received this, when they received it, how it’s working – I mean aren’t we still very much in the dark about all those sorts of things?


Glazener

I would certainly say that is the case.


Waite

And that can’t be good.


Glazener

Well that can’t be good.


Waite

And do you think for other surgical procedures that we should do more in future than we have in the past to ensure that they’re as safe as they can be before they go ahead?


Glazener

Well I think that’s true of any healthcare isn’t it, I mean…


Waite

But you said yourself drugs would be really quite thoroughly tested, sometimes it appears surgical procedures not so much.


Glazener

Yes I think that’s probably correct.


Waite

And if I was to ask you right now, considering this procedure has been around for 10, 15 years, how safe is trans-vaginal mesh, would you even now be in a position to tell me?


Glazener

Well I certainly can’t tell you the outcome of the trial because I don’t know it myself.


Waite

So no is the answer?


Glazener

No is the answer.


Waite

Ash Monga agrees. But the chair of the Society of Uro-Gynaecologists goes further. He wants not only a new system of in depth testing introduced but a full record kept of all those medical devices that are being implanted into people.


Monga

And that should entail the proper experiments done before they’re ever implanted into human beings, then the proper case series being done, the proper randomised control trial being done before with proper safety assessment before introduction. And the only way with devices – and I think this may be true of many medical devices – is that we have to have some form of registry for all devices and that is the way forward in this field and many others.


Waite

And how would the registry help?


Monga

Well if every device that was going to be inserted, the patient had to do the necessary information leaflet and the operation was recorded and the patient was followed up and every complication was reported you’d be able to monitor every device and be alerted to problems much, much earlier.


Waite

Who needs to get this going?


Monga

NHS England, MHRA, the relevant Royal College whose surgeons deal with the devices and with patient input.


Waite

And what about the manufacturers?


Monga

Well I think if we bring all this – this process into place they will have no choice.


Waite

Well in a statement, NHS England told us the current evidence shows that while a small number of women have experienced distressing effects, the benefits of tapes and meshes outweigh the risks. However, they’ve recently reminded NHS acute trusts of the importance of reporting any adverse events.


For its part, the MHRA said any decision about setting up a registry should be led by the clinical community. And while in its view the general European system of organisation needed strengthening the current assessment of medical devices by notified bodies was generally performing well.
So what of the mesh and medical device manufacturers themselves? Unfortunately, none of those we approached was available to be interviewed today. Instead we were referred to their trade body - the Association of British Healthcare Industries - which represents around three quarters of the UK’s medical device makers.
Mike Kreuzer is the ABHI’s regulatory affairs director. So what does he make of Professor Carl Heneghan’s blunt assessment that the current regulations for new medical devices are bonkers.
Kreuzer

Well we would completely disagree with that. We believe that it’s an extremely good system which has benefitted society very considerably over the years.


Waite

But why don’t device manufacturers ensure their products go through the same rigorous testing as medicines?


Kreuzer

Well because they’re different to medicines, in fact they do go through very rigorous testing. There is a great deal of testing performed on devices – this is a sort of misconception, people keep comparing them with medicines, they’re different in the sense that we do not use randomised control trials…


Waite

Why not?
Kreuzer

Why not? Because, for instance, would it be sensible to implant a hip in a patient and have the patient running around with it for 10 years and then say oh well yes maybe this works? During those 10 years there would be a development of new products which would have replaced that hip, for instance.
Waite

But if you don’t have full randomised control testing in humans – on humans – as they do with drugs the situation we’ve been told on this programme is you use patients as unwitting guinea pigs for these devices.


Kreuzer

We don’t use anybody as an unwitting guinea pig, that’s absolutely the case. No what we do is make sure that there is very extensive post market surveillance – in other words you keep very close track of what is happening with the product. And I’ve got a very good example of that. We have developed, in this country, something called beyond compliance which is a new initiative in the orthopaedic area which will seek to add to the regulatory system by ensuring that orthopaedic implants – new ones – are released in a way that will ensure that they are properly tested and controlled before they’re finally released for full use. We can foresee the day where it may well migrate into other product areas.


Waite

So finally, you’re telling Mr Kreuzer, you’ve got round to doing something about hips, which you have known about as being a big problem for years, so congratulations on that but why is it only hips, why isn’t it everything?


Kreuzer

Well for the simple reason that there are not big problems with everything.


Waite

And isn’t that ironic that something has to go wrong in a major way before the regulatory system and maybe the manufacturers do anything about it?


Kreuzer

We’re always striving to improve the system and when things go wrong that will lead to improvements.


Waite

Manufacturers currently benefit from the equivalence rule, in other words if a product can be shown to be quite like another product then no pre-marketing testing on humans is required. So we’ve heard how you get there for a so-called daisy chain effect, stretching back years, one product’s quite like another and so on, all the way back to an original product which may be entirely different and indeed have been withdrawn from sale. Isn’t that another part of what Professor Heneghan calls this bonkers situation?


Kreuzer

Well what we’ve not discussed is the fact that the regulatory system is undergoing very considerable review and equivalence is one of the things that is being brought under the microscope and that is changing.


Waite

So are you saying it is ripe for overhauling the system – is that what you’re saying?


Kreuzer

Parts – certain aspects of the system are ripe for overhaul.


Waite

Like what?


Kreuzer

You mentioned for equivalence, like the control and designation of the notified bodies. We want to see the whole system of notified bodies better organised, we want to see better designation, better control.


Waite

Well at this point I played Mr Kreutzer part of that interview I did with Devonian Marian Ward, who suffered four years of pain after being fitted with vaginal mesh.


And what do you think of the manufacturers who would say look we did this with the best of intentions, these were meant to help and they have helped millions of women all over the world?
Ward

Well you know I can’t name them because they’ll sue me and I’ve got nothing but I think they were disgusting – it’s like the hip they put in, that went wrong, it’s like the breast thing they put in – not that I’ve had that but I read about it.


Waite

So what do you think should happen in future about these sorts of medical devices?


Ward

Well they should keep a register of who’s having them in and then they should follow up procedures of seeing them every three months, well for at least 18 months, to see how they’re getting on.


Waite

And do you think they should be tested more before they’re allowed on the market?


Ward

Oh yes, yes, yes I do, I think it’s terrible, it ruins people’s lives.


Waite

So what do you say to Marion there?


Kreuzer

Well what we would say is first of all we agree with her entirely as regards registers, we think that is an excellent idea, we thoroughly support it. We believe that follow up post market surveillance and following up the patients afterwards is very, very important.


Waite

But these things that you say you’re very in favour of are you pledging to introduce them?


Kreuzer

We are pledged absolutely to see registers introduced yes.
Directory: radio4 -> transcripts
transcripts -> Presenter: peter white producer: kathleen griffin
transcripts -> Radio 4 Sunday Worship from Blackburn Cathedral Sunday 14
transcripts -> This transcript is issued on the understanding that it is taken from a live programme as it was broadcast. The nature of live broadcasting means that neither the bbc nor the participants in the programme can guarantee the accuracy of the information
transcripts -> This transcript is issued on the understanding that it is taken from a live programme as it was broadcast. The nature of live broadcasting means that neither the bbc nor the participants in the programme can guarantee the accuracy of the information
transcripts -> Presenter: peter white producer: kathleen griffin
transcripts -> -
transcripts -> Presenter: ian macrae
transcripts -> Radio 4 Sunday Worship On the Feast of Stephen The Revds. Ricky Yates and Petra Elsmore lead a service from St Clement's Church, close by Wenceslas Square in Prague,
transcripts -> Presenter: jonathan dimbleby


Share with your friends:




The database is protected by copyright ©essaydocs.org 2020
send message

    Main page