Examination of Witnesses (Questions 106
THURSDAY 22 MARCH 2001
STUART MP, DR
CBE AND DR
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
(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of the breast implants which were then withdrawn, of course with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 attentionand I hope people feel we are moving
the right wayto 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
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
(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?
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 thereas
it will be finalised soonthat 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.
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
(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.