Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 106 - 119)




  106. Minister, could I welcome you to this final session of this morning's inquiry. We are very grateful for your presence today. Would you like to introduce yourself and perhaps colleagues?

  (Ms Stuart) Yes. I am Gisela Stuart, Parliamentary Under-Secretary at the Department of Health. I have with me Pat Troop, who is the Deputy Chief Medical Officer, and Suzanne Ludgate, who is the Medical Director of the MDA.

  107. Can I begin by asking for your general thoughts on the background to why women feel the need to have implants and in view of the difficulties and problems that obviously have occurred, and you are aware of some of the evidence we have had given to us, whether you feel the Government ought to be more active in this area?
  (Ms Stuart) Whenever you look back over history I think you tease out two strands. One is if you had had the information, if you had had the information on particularly adverse incidents then would you have made different decisions. I think with some of the breast implants which were then withdrawn, of course with hindsight. The other thing is you start saying: "Could we have acted earlier? Could we have been more responsive?" I think what has happened over the last ten years, not just in this area but probably in the health area altogether, is we have given greater attention—and I hope people feel we are moving the right way—to the views of patients themselves, that patients themselves are experts in their own conditions. So probably at the early stages, certainly with breast implants, the women themselves were not listened to quite as quickly. I think one of the biggest responses was in 1997 when the then Parliamentary Under-Secretary in the Lords, Lady Jay, one of the first things she did was to set up the Independent Review Group. We reckoned there was independence. At that stage there was only one woman on the Committee because the Committee was put together simply based primarily on expertise. Subsequently we got to the stage that there were three. Clare Rayner was the lay member who came on the Committee. We wanted a lay member but Clare in particular came on the Committee because she felt they were not safe. Now she has since resigned from the Committee and she will officially do that in May. She feels satisfied on the safety now. We are hoping the Committee will agree next time to strengthen that and have two lay members on there and, again, we have put two women forward as names. That was some influence on there. The other thing which is also happening within health is far greater information on which decisions are based, nothing is ever 100 per cent safe. We should make more information available for patients themselves to make an informed choice.

  108. Can I go back a stage further and perhaps I should refine my question a bit. Obviously we look at information and the information provided by the Government, the information available to women who may be contemplating breast augmentation. What we have picked up in earlier evidence is the way in which this whole process is marketed as a lifetime solution to a problem they perceive they have got. One witness has just said she was told she would end up looking like Dolly Parton and there is this kind of projection of a different image. At what stage do you feel the Government has a duty to intervene to protect people from the marketing of that kind of line? It is very obvious from the witnesses that we have had this morning and from the written evidence that we have received that people have been pressurised into having these operations on the basis of some rather doubtful information about what they will end up looking like or feeling like. When is it your duty as a Minister to protect those people before they reach that stage of signing up to an operation?
  (Ms Stuart) Again, I think I need to separate that in terms of what we do within the National Health Service. The vast majority of National Health Service operations are done following such things as mastectomies, reconstructive surgery, and information where we have a clear duty. The clinicians give the information and then we make the information available. I have brought a leaflet which we have produced on breast implants, some 80,000 of those were produced. That print run was in October, we are at the moment going on a new print run. I think what you are after is really that other sector, which is the private sector.

  109. We were told 80 per cent are done in the private sector so it is primarily the private sector.
  (Ms Stuart) Yes.

  110. Of course, the other side of the story is that we have had evidence in the last session that the National Health Service is picking up the cost of problems which have arisen through surgery in the private sector. Therefore, as a Minister you have responsibility to look at that. What about the earlier issue I mentioned, is there not a duty to say to women "Hang on, think this one through"? We have not got any kind of system, we have the leaflet which arose from the Independent Review Group. We have read the leaflet and there will be questions on the leaflet. Is not the process further back than that, that you should be challenging or the Department should be looking at a system of enabling women to think this through in a way that is not happening at the moment?
  (Ms Stuart) We start off with the image that has been created, so private clinics advertise for what essentially is cosmetic surgery. There are continuing discussions about the code of conduct, that is going on. I remember when I came in as a Minister less than two years ago, if something was done within the private sector and a complaint arose out of this, at that stage I would have to say "This is a contractual relationship". Since then we have had the National Care Standards Act which of course now regulates also the private sector. Part of that will be that they will have to have minimum standards in terms of the information they provide and they have to have a complaints procedure. I think inroads are being made on that. Now you may well feel that does not go far enough but I think we have to strike a balance between saying people have to be able to make a choice and what Government says, "These are the choices you can make".

  111. Let me put a practical concern about the booklet. The booklet advises a woman who reads it who may be contemplating breast augmentation to talk to the surgeon so she is fully aware of the problems that could occur, whether she needs it or not. 80 per cent of the people who have these operations have them in the private sector. If the women are advised to talk to the surgeon, has not the surgeon got an inbuilt incentive to go ahead and do that surgery because the only way they gain is by undertaking that operation? Is it in a sense not only helpful to have the advice "see the surgeon", should we not be looking at a separate system whereby people have no contact with that surgeon until such time as they have had this counselling process which has enabled them to look at whether in the first place they need it? We have picked up examples where women may psychologically have problems which are not going to be helped by radical surgery, other means of helping them may be far more appropriate. Is it not your duty as a Government to look at that very early intervention even before we get to the stage of talking to the surgeon?
  (Ms Stuart) I think the system where patients receive advice at the real stage is through talking to the general practitioner. It is the relationship with the general practitioner which then goes on. I think the line is there. If a woman does insist, and wants to only take that route, I think what we, as a Government, have got a duty to all the other people, whether it is the availability of general practitioners, whether it is what we put on our websites, what we put on NHS Direct, to ensure all that information is there. I think it is increasingly there to make that choice. I would not want to paint a picture that just because a surgeon works in the private sector that their motivation will be totally one of you do not have the relationship of taking the patient into account.

  112. If they do not do the operation they will not earn a great deal of money.
  (Ms Stuart) But that would assume that there is a kind of terrible shortage of work out there.

  113. Perhaps there ought to be a shortage of work.
  (Ms Stuart) But a lot of surgeons who do those particular kinds of operations will also do a lot of other work. I would not want to end up with a picture of the kind of predatory private operating surgeon out there who just takes anybody on and does not have a proper relationship. The Care Standards Act, I think, makes it quite clear.

  Chairman: We are looking at the checks and balances. You are saying the check and balance here is the GP. Now the group of witnesses we had immediately before you indicated from their information that they have talked to thousands of women and, frankly, that is not working. We have had examples of what the GPs have said to women. What I am trying to say is should we be looking at some other system to ensure that checks and balances are there?

Siobhain McDonagh

  114. We have had a lot of discussions about the role of the GP in this particular area. What we have discovered from our discussions with people is that in the majority of cases it appears that the GP is not spoken to before the woman chooses to go to a clinic and that even when the operation is done very often the GP has no idea that the operation has been undertaken. I would just be grateful for your comments on that because Howard has made the point that he thinks it should be a question of reporting to the GMC surgeons who undertake work who do not inform GPs. What guidance does the Department of Health give GPs faced with those women who do go to see them enquiring about the safety of breast implants? What guidance has been given to NHS Direct?
  (Ms Stuart) Coming back to what are we doing about the surgeons, the Royal College of Surgeons has got quite clear guidance on good practice and we are working with that, the line of communication between consultants and general practitioners. One of the things in the Health Bill that is going through at the moment is it actually allows copying the correspondence to patients, it allows that much freer flow of information which we do want to see. Coming to your very particular point about guidance, there are a whole variety of sources of information which we fall back on, whether it is from newspaper articles to seeing our GP. The moment NHS Direct is rung up, depending on whether it works with health information or not, they will immediately send out to a patient the leaflets which we have produced which outline all the areas. NHS Direct On Line, the website, has got a reference. The Medical Devices Agency's own website, in something like the last five months I think they had over 5,000 hits. In terms of the information which we provide to practitioners out there it is a whole range both from the Chief Medical Officer, the Medical Devices Agency, there has been guidance and newsletters going out. We have tried to make sure that it is as comprehensive as possible. If I can just say, the booklet, we printed 80,000 last October, we are going now into a reprint. We really are trying to do everything to make that information available out there to all those concerned.
  (Dr Troop) On the Royal College guidance that has been produced, I think the issue that you have raised, particularly where the woman has not yet decided and wants to go and discuss whether or not to have an implant, it is certainly something to make sure that in their guidance, as it is finalised, there is a mechanism in there for that to happen more independently. If we have good practice guidelines and there are complaints that a consultant or a doctor working in a private practice is not following those guidelines, then I think we have got recourse to the GMC if they really are not following guidance which has been agreed by everybody. I think we have to have the checks in there but then the good practice needs to include in there—as it will be finalised soon—that initial check that women have the opportunity to discuss the issue separately from the surgeon. I think, as you say, that way there is seen to be some independent advice whether or not it is appropriate to go ahead with the operation.


  115. The point was made earlier on that a significant number of women do not see their GP. They do not want their GP to be aware of that, not so much the GP but the receptionist. This is a highly personal intervention that people want to keep to themselves understandably.
  (Dr Troop) Yes.

  Chairman: This is why we are looking at the whole process of how counselling and advice could be improved.

Dr Stoate

  116. I would like to ask a question of the MDA and it is about the CE marking because it seems to me there was this perception that because it is a device which has been approved, it has got a CE marking, somehow that is some sort of guarantee of safety. How do you comment on that?
  (Dr Ludgate) I think the problem is that, yes, I think you are right, there is that perception out there that the CE marking means safety. The trouble is that I think the women who are having breast implants maybe see that CE marking as absolute safety whereas in the Directives it makes it clear that what they are defining as safety is a positive risk benefit analysis, in other words that the benefits outweigh the risks. They admit that there are risks but that the benefits outweigh those and I think that is where the problem comes in.

  117. It is quite a difficult concept for a member of the public to accept. What is a risk benefit analysis to a woman who wants a breast implant? How can they possibly say that CE mark means that the balance of probabilities are this? It is a difficult concept.
  (Dr Ludgate) I think communication of risk is a very difficult thing and I think the way one can address that first is really giving people as much information as possible in order for them to take the decisions, the correct decisions for them, but knowing that they are aware of the risks at the same time. That was really what we tried to do with this document, to set out what could happen, what were the long term and short term side effects which could be associated with these so that if they decided to go ahead they knew that they might rupture, that they might have to have them replaced, that there might be problems of contracture, there might even be long term problems.

  118. That helps the view of people outside but how does the MDA make decisions on when something ought to be given a licence? Obviously all these products are licensed medical devices?
  (Dr Ludgate) Yes.

  119. How do you assure yourself that this is a fair thing to do?
  (Dr Ludgate) Right. Unlike drugs, we do not license medical devices. A medical device can be placed freely on the European market once it has this CE marking. This CE marking means that the manufacturer can show that it complies. There are a number of essential requirements which cover all sorts of aspects of safety and performance and that the manufacturer has the evidence to show that it complies. Now, with the exception of the very low risk devices, there is a third party that comes into this to check that is in fact correct. These third parties are known as Notified Bodies. There are a number of Notified Bodies, there are in fact 60 across the European Union. The manufacturer can go to any one of these in any one country to get the compliance approved by a Notified Body. Now there are controls on those Notified Bodies by the Member States. We have eight in this country. We accredit them, we audit them to make sure that they are keeping up to scratch. We do recognise that there are real problems here and that is why we have been fighting for improved controls in the case of breast implants because we have recognised a number of things. The first really is that these are not currently classified as the highest risk devices and we think they should be. We are pushing for that, indeed we have pushed for that and have got the support of other Member States. That will mean they are subject to higher controls. It will mean that they have more pre-market testing and, indeed, more pre-market clinical testing, which we think is very important.

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