Examination of Witness (Questions 20 -
38)
THURSDAY 22 MARCH 2001
PROFESSOR ROGER
STURROCK
John Austin
20. Given that that may be the case in some
cases, is there not therefore some argument for saying that there
should be some independent source of counselling and advice?
(Professor Sturrock) Yes, I agree with you and whether
that should be the general practitioner in the first instance
or whether it should be some independent counsellor is another
matter, but I do agree that there should be some other independent
advice given. I know that, for certain forms of plastic surgery,
often the surgeon in the Health Service will refer the patient
to a clinical psychologist to discuss the issues that might be
involved prior to the surgery and maybe this is one kind of route
that one could think about.
Dr Stoate
21. I would like to just follow up on that issue
briefly before I go onto my main question. Personally, as a doctor,
I take an extremely dim view of a surgeon who would treat and
operate on a patient without the GP being involved somewhere along
the line, perhaps not involved in the decision making but certainly
informed of the decision making. I would personally have great
difficulties with a surgeon who refused to do that and I am very
disturbed to hear that there are surgeons out there who will carry
out quite major surgery, often with quite far reaching consequences,
with the GP knowing nothing about it. I think that is extremely
worrying. To follow on from that, we are talking about a group
of often very vulnerable women who have been swayed by all sorts
of pressures and facts to have surgery in the first place, maybe
against their own better judgment in some cases, and I think that
to then have the operation explained by somebody who has a personal
interest in that operation and the GP being kept out of the referral
altogether is a recipe for disaster.
(Professor Sturrock) I could not agree with you more
and that was one of the concerns that we had and you have probably
seen in our report that we said that communication should take
place between the surgeon and the general practitioner because
the general practitioner, as you know, is the gate-keeper and
he or she must be informed, but I am sad to say that it does not
always occur.
22. My training in medicine always led me to
believe that a surgeon would refuse to see a patient without a
letter from a GP. I am extremely disturbed to hear that there
are incidents where this has happened. It certainly would not
happen within the Health Service because if, for example, I referred
somebody to a surgeon and the letter went astray, that surgeon
would ring me up saying, "I am sorry, I cannot see your patient
because I do not have the referral unless you give me the personal
go-ahead that in fact you have sent that letter and it has been
lost somewhere."
(Professor Sturrock) That is absolutely correct and
obviously in private practice that should normally occur as well,
but we are aware that, in this particular situation, that does
not always take place.
23. We are of course talking about sometimes
the fringes of medical practice, particularly when this tips over
into cosmetic clinics rather than true surgical indications for
operation, and I think it gets much more confused and much more
worrying. One of the things I ought to explore is in fact the
frame of mind of women who undergo this operation and the fact
that some of them may already have quite significant psychological
problems that drive them to think that an operation might solve
their problem. I really fail to see how a surgeon with a surgeon's
training could possibly be the right person to help that woman,
with all the ramifications, to decide whether to undergo the operation
or not.
(Professor Sturrock) I think that is true and this
is why I made the suggestion about the possibility of a clinical
psychologist being involved, once the initial approach has been
made, to talk through issues which might need to be dealt with
which are part of the whole reason for the initial consultation
in the first place.
24. The main criticism that I wanted to come
onto was in fact the scientific and the medical data about the
safety of breast implants. I have read through your report and,
in your summary, you state quite categorically that there is no
conclusive immunological evidence for an abnormal immune response
to silicone, that there is no epidemiological evidence for any
link between silicone gel breast implants and any established
connective tissue disease, that there is no evidence of a condition
such as silicone poisoning and that there is no evidence that
children, for example, of women who have had breast implants should
get any further problems, so you are fairly confident in your
recommendations that there is no established proven medical problems
from these breast implants. Could you perhaps elaborate on that.
(Professor Sturrock) Yes. Obviously we took a very
thorough review of all the literature. As you will see from the
report, we heard evidence; we took personal evidence from patients
and reviewed the literature. In terms of established connective
tissue disease for example like scleroderma, which in itself is
an extremely rare disease—and Professor Carol Black is here
and will be able to give you more detailed epidemiological data—we
are talking of an incidence of between two to 20 cases per one
million per year, so it is a very, very rare disease. Then, when
you are trying to see whether there is an increased incidence
of that in the context of a group of women who have had a breast
implant, you need quite a considerable rise in the incidence of
scleroderma, for example, before you can pick that up statistically.
The relative risk of developing an established connective tissue
disorder compared with a group of women who have not had a breast
implant are certainly no greater than 1.5, but the statistics
suggest that it could go the other way, in other words the error
could mean that in fact there is a protective effect of about
1.5. So certainly there is nothing to suggest that there is a
major risk from established connective tissue disease and silicone
gel breast implants. That does not mean that they are safe. It
depends what you mean by "safe" because obviously there
are local problems which can occur, but one of our remits was
to look at the effect on general health in terms of established
connective tissue diseases and the evidence at the moment does
not suggest that there is a significant risk.
John Austin
25. Having looked through, you have concluded
that there is no evidence in certain areas, particularly the evidence
of harm that may be done to children. Your report actually says
that there is no evidence that the incidence of abnormalities
is any greater than in the general childhood population, but you
also said that there are no epidemiological cohort of case control
studies comparing the symptoms of children born to women who had
had implants to those of children who were born to women who had
not. Would you say that there is a case for such a study being
made?
(Professor Sturrock) Yes, I think there is. We made
some recommendations about further research and this could well
be one of the areas. I think one has to be aware of the fact that
babies are exposed to silicone, not just from women who have had
breast implants but also from bottle feeding and even from the
baby foods which are prepared. All involve, to a certain extent,
a degree of silicone base, so that we are all, in daily living,
exposed to small quantities of silicone as part of modern living.
Mr Burns
26. If a female child were born suffering from
Poland's Syndrome, would you feel that at some point in that child's
development, possibly when they reach puberty, an implant would
be the best way of seeking to rectify the problem or do you think
there are other better ways of trying to rectify the problem?
(Professor Sturrock) Of course I am not an expert
in this area but I think one has to take each case on its merits.
Obviously one cannot make a general comment. Plastic surgery is
developing rapidly with new techniques of breast augmentation
and so on, so that using breast silicone implants is only one
of the strategies that one might use in that situation. In some
instances, it is very effective and very acceptable to patients
but there are of course other ways of augmenting breasts.
Dr Stoate
27. You have been quite clear that there is
no solid scientific evidence for any association between breast
implant and negative disorders, yet this Committee has received
evidence from people who are convinced that their particular problems
have been caused by breast implants. Obviously those are anecdotal—and
you are saying that there is no scientific proof of that—but
I want to ask something that is a little contentious and sensitive.
Do you think there is a possibility that, in some of these cases,
there was an underlying psychological problem in the first place
that could have been related or do you think there genuinely is
a medical effect that we have just not discovered yet? I am trying
to tease out why women are getting those problems if you are saying
there is no conclusive evidence of any damage.
(Professor Sturrock) I think the answer to your question
is "yes" to both parts. There may well be a group of
women who have had previous problems which continue to manifest
themselves after breast implantation, but there may also be a
group of women who have genuine breast implant related illness
which as yet is ill defined. One of the issues which we raised
in the report was the question of low grade infection because
some of the symptoms that some of the women have complained of
would fit with the presence of low grade infection and that is
an area that we recommended for further research.
John Austin
28. Could I go on to the issue of informed consent.
The Consumers' Association have suggested that there should be
a checklist of topics which should be discussed which requires
both the surgeon and the patient to confirm that various subjects
have been thoroughly discussed. What are your views on the current
level of informed consent and how available is it?
(Professor Sturrock) This is a very big issue as well
about what is meant by informed consent and it is, as you know,
very topical at the moment. I think that, in the past, informed
consent has not been very well developed generally in medicine
and surgery and I think the steps to improve that recently have
been very much in the right direction. The problem is, how far
do you go with informed consent in terms of detailing all the
possibilities that a particular procedure or drug might lead to
if a patient embarks on that particular treatment or on that particular
surgery because some of the information is of a very technical
nature which is quite difficult to comprehend unless you have
some kind of professional background and you understand all the
potential risks, so it is difficult. Some of these informed consent
forms are very daunting to patients. I have seen some of them
myself and seen some from other areas and looked at them myself
and thought that, even with my own medical training, they looked
pretty daunting in terms of reading all the detail and trying
to weigh up the implications. Having said that, I think patients
do need to be provided with the relevant information and it needs
to be properly explained to them. Certainly in my own clinical
practice for clinical trial situations, we give informed consent
forms and then we get one of our nurses to sit down with the patient
and talk through all the issues and, in my experience, they are
far better than doctors in doing this kind of thing.
29. That is precisely the point I was going
to make. In the Department of Health brochure, I just opened it
at one page and it refers to potential risk of capsular contracture.
I am not sure that most women would know what capsular contracture
was and probably they would not be inclined to ask the surgeon
to explain it, whereas if there were an opportunity to go through
the whole procedure afterwards with a nurse or someone with some
special experience and expertise, then you are more likely to
get more informed consent.
(Professor Sturrock) Yes, absolutely and it is in
my own clinical practice and I would certainly recommend that
a properly trained nurse or some other health care professional,
rather than the doctor, should go through with the patient after
the initial consultation and discuss all these issues.
30. Do you think that this could be written
in more simpler language as well or with a more detailed explanation
of some of the terms that are used in it?
(Professor Sturrock) I think it could be. It is always
very difficult because you do not want to leave anything out.
Having seen many other kinds of booklets, I think this booklet
is quite a good first stab at it. Obviously it is not perfect
and it is going through a second edition and I think it will need
to be modified, but I think this information together with the
consultation and discussion with a health care professional, is
probably as good as we are likely to get.
31. One of the questions that a patient may
wish to put to the surgeon may be in relation to the number of
implant operations that that surgeon may or may not have undertaken.
Do you think that perhaps there should be some requirement from
the clinic or the surgeon to give the information without having
to be asked for it and putting the onus on the individual patient?
(Professor Sturrock) Yes, I think you are right. It
is very intimidating and daunting for patients to have to ask
a surgeon about his or her expertise in a particular area and
many patients obviously do not have the confidence to do that.
Maybe a way forward is in clinics and in hospitals where there
is an established website so that you can click on Surgeon X or
Dr Y and you can have a series of information about the number
of operations they have done in this area, the infection risk
or whatever. I know that this happens in places in the States
where you can actually do this and determine how proficient a
particular clinic or doctor is in this particular area, but we
are quite a long way behind in this country yet with going down
that line.
32. Whose responsibility is that? Is that the
GMC's?
(Professor Sturrock) It could be that the local hospital
institution, the trust, might produce that kind of information
in agreement with the surgeon, but again these are big areas which
are not entirely within my remit. However, I certainly feel that
more information of that nature should be available to patients.
Mr Burns
33. In your view, what do you feel has been
the effect of the various alert notices that the MDO has put out
about different types of implants?
(Professor Sturrock) Obviously they do produce a degree
of panic amongst women and confusion, not just amongst women but
amongst the members of the media who have been unable to distinguish
between the various different types of breast implants and the
risks associated with them. For example, problems with Trilucent
implants or soya bean implants have been automatically translated
across to silicone gel breast implants, so there has been a great
deal of confusion over this issue. For example, when the problems
came up with the Trilucent implants, I received a number of phone
calls from the media and others because they felt that this was
all to do with silicone gel implants. I think it is difficult
for the general public and for the media to sort these different
implants out in terms of their risks and benefits and, when a
warning notice goes out with one, the assumption is made that
it applies to all.
34. I know you have partly given your view on
this document from the Department of Health but may I go back
to clarify something because I believe I am right in saying that
this document purports to be based very much on your Committee's
findings, but many of those who have been submitting evidence
to us in advance of this hearing have criticised this booklet.
Do you think it is a useful document or do you think some of the
criticisms are valid and that it needs to be updated?
(Professor Sturrock) I think it will need to be updated.
I think the strength of this document is that it was produced
by a committee which included a whole range of people, health
care professionals, women who had had silicone gel breast implants
and been through the surgery, so that the group that produced
this document was as comprehensive as one could get it. However,
no document is ever perfect and it will need to be revised in
the light of comments and any new evidence that might develop
with time. I think it is a good start but it is certainly not
perfect.
35. Do you know if this document is under constant
review?
(Professor Sturrock) The second edition is in the
process of being put together in the light of comments that have
already been made and there are some factual inaccuracies, minor
ones, within this document relating to some of the organisations
in the booklet, so it is about to go into a second edition and
comments can still be made to the Department of Health so that
they can be taken on board if necessary and I suspect there will
be more iterations of this document as time goes on.
Chairman
36. Before we conclude, can I look again at
this area picked up by questions from Siobhian and Howard regarding
how people may be counselled and I am interested in broadening
this beyond breast augmentation because certainly the picture
we have had in other inquiries is that increasingly there are
interventions available, some of rather dubious value, that are
marketed coming over from the States and in the private sector.
I am interested in your views on how one deals with the tension
between the freedom of the individual to do whatever they want
to their own body and the duties, in a sense, of governments to
protect people from rather unscrupulous operators within the private
sector. You have talked about clinical psychologists. In a previous
inquiry, I recall that we picked up on the increasing marketing
of penis extensions, so it is not purely and simply relating to
women, men are being drawn into this area as well. I wondered
what your views were on whether, within a society that permits
a free market in health, there can ever be a system that protects
people from those who are unscrupulous in that private market.
(Professor Sturrock) That is a huge question. I think
probably one has to begin with basic health education and I think
that, to a certain extent in the long term, you need to begin
with children and we need to improve the general public's awareness
of health and health matters and what medicine is about. To a
certain extent, perhaps doctors have not been particularly good
at explaining what they can and cannot do. There is a perception
amongst the general public that, if you have a problem, it can
and must be fixed. I think that is a culture which needs to be
changed and it is also partly related to the public's understanding
of science, not just the public but the media as well, which also
needs to be addressed. So these are very big issues. Coming back
to your specific question as to whether, in a free society, one
ever regulate for this kind of problem, I think the answer is
"probably not" but perhaps the way to start is by attempting
to improve the general public's awareness and understanding of
science, medicine and health and maybe one should begin with children
in the first instance.
Dr Stoate
37. If I may just follow up on that very briefly
by saying that I would go further than that because I am very
concerned indeed to hear your findings that a number of surgeons
are not involved with general practitioners and are quite happy
to carry out quite extensive operations on people. Personally
as a GP, I would like to put on record that I would refer such
a surgeon to the General Medical Council if I found that a patient
had been operated upon without informing a GP. I personally would
be in touch with the General Medical Council to have their general
practice reviewed and I think that the GMC would take quite a
robust view of that sort of practice.
(Professor Sturrock) I would hope that they would
and I entirely agree.
Chairman
38. There are no further questions and I thank
you for a most interesting discussion and I am grateful for your
co-operation this morning. Thank you very much.
(Professor Sturrock) Thank you.
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