Examination of Witnesses (Questions 60
- 79)
THURSDAY 22 MARCH 2001
MR PAUL
BALEN, MS
ROSE IRWIN,
MISS BRENDA
LIVSEY AND
MS MAXINE
HEASMAN
60. Do you think it was wrong to give a CE marking
in the first place?
(Mr Balen) CE marking is simply the manufacturer's
statement that it complies with the regulations but people do
not understand that that is all it is. I think the CE marking
has been used as a way to allow, if you like, free flow of products
throughout the European Community with one sort of mark on it
with people thinking that this means it is safe. It transparently
is not.
61. To come back to silicone—and it is
confusing with different types of products—what do you say
to Professor Sturrock and his report where he is very solid in
saying that he found no increased risk with silicone implant over
the normal background risk of the population? How do you square
that with the problems you are seeing?
(Mr Balen) First of all, obviously I am a lawyer not
a medic, but if you forensically examine the information that
he provides you, what he is saying is that, doing a meta search
of the literature, he found no evidence but there is no original
research. He recommended, as you heard, research. My understanding
is that that has not even commenced; there is a problem with government
funding and so on for it, but all that shows is that there is
no long-term human safety data on silicone implants and that does
concern me. This goes to the information that the women are given.
What I regard as a great step forward is that this leaflet is
going to be looked at. I have done for you, which I will leave
for you to read at your leisure, a comparison between the booklet
supplied for the same products by the Medical Devices Agency or
the Department of Health, which is this booklet that you
have, and the Food and Drugs Agency in America and i give you
just one illustration. With saline implants in the British booklet,
the advantages are stated as being "long history of use".
In the American booklet—and bear in mind that these products
are largely supplied from America—"saline implants,
long term safety and effectiveness have not been studied."
The British view, if you like, has been—and we have looked
at the literature—that they have been used for a long time
and therefore must be all right. The American view, which adopts
American manufacturers' own view, is that long term safety and
effectiveness have not been studied, and you can relate that right
along the way. One of your colleagues mentioned children and so
on. I have compared that. As regards pregnancy in breast feeding,
the Department of Health booklet says,"Do not interfere with
ability to breast feed." The American booklet says, "May
affect your ability to produce milk for breast feeding. Not known
if silicone can pass through the nipple. One study reported up
to 64 per cent of women with implants were unable to breast feed."
So there is a disparity on information and bearing in mind that
Britain, by and large, does not produce or manufacture these implants,
they are largely American orientated, and bearing in mind the
way in which the Food and Drugs Agency actually has a more pro-active
approach to examining not only manufacturing centres but the products
for themselves, you will see there is a great disparity in emphasis.
If British women are reading this booklet, they may be misled.
I am much more in favour of an interactive approach as has been
described and also the involvement of general practitioners and
other people, but the problem is that the state of knowledge in
this country is woefully inadequate and so you have a danger of
the blind leading the blind. That is my concern about all these
very good suggestions. You are still faced with the problem, no
long term safety date for silicone implants, no long term safety
data for saline implants and the remaining two implants, Hydrogel
now suspended and trilucent banned because of the lack of safety
data after they got the licence.
Chairman
62. Yes, Ms Livsey?
(Ms Livsey) Can I just say I am greatly concerned
that there is not an international standard for the contents of
these implants and that each manufacturer can put in their own
formula. Therefore, women having these implants, we do not know
whether they are contra indicated. The sensitivity rate obviously
in myself was very high, with Rose she had them in 12 years before
it started to affect her. Some women probably should never have
implants in the first place. Some women do not suffer with any
sickness but there again I could have McGhan and somebody else
could have another implant and we could both be ill. There is
no uniformity. You need a universal standard and then women need
to be pre-tested before having implants.
(Ms Irwin) Could I add a point on this particular
area about the perceived safety or otherwise and the information
that we have. I would like just to endorse about the IRG Report,
for instance. If you look into the website detail of the IRG Report
you see that there is careful mention about migration, which they
agree exists, and no infection which Professor Sturrock was talking
about. When we had a meeting with the IRG—and this looked
like a very good sort of PR exercise—we prepared very carefully
a number of questions which still have not been answered. One
of them was "You agree that silicone gel can migrate. You
agree that it can cause local inflammation. You agree it can migrate
to places like the liver. So if it goes to the liver and causes
inflammation, what are the implications in terms of systemic disease?"
There was a reply which ended in the words "don't know"
from Professor Rosemary Walker at the IRG. We said again, and
I have got the transcript, "Are you saying you do not know"
and she said "Yes". Subsequently we actually wrote in
a feedback letter, which Professor Sturrock had promised we would
and that he would take up the points. There were several very
technical questions that we had had consultations and submitted.
One about the platinum effect, etc.. One from a dossier of doctors
who disagreed, which the IRG had lost. Professor Sturrock undertook
to follow up these questions after the meeting. I have a letter
to say that. He said it at the meeting too. After the meeting
he decided that he was not going to answer the questions after
all. So what I am saying here is that we have a great big question
mark on this area of inconclusiveness about the links between
disease and silicone gel still hanging in the air.
John Austin
63. Can I ask a question, first of all, to the
witnesses who clearly are in touch with the consumers in this
case. I was watching a television programme not so long ago when
there were some young women and the argument being put forward
about the age of consent was if you can consent to sexual intercourse
at 16 and control your own bodies then you ought to be able to
consent to an operation for an implant. There was one young woman
who was saying that her eighteenth birthday present was going
to be a boob job from her parents. Are you aware of the extent
to which young women who may not be yet fully developed may be
undergoing implant surgery?
(Ms Heasman) Yes, it disturbs me greatly. I get a
great number of young ladies on the phone. If you ever get a chance
to read through my literature you will see in my very first chapter
that I very clearly state that I do not think anyone under the
age of 25 should have this operation done. You need to know who
you are inside before you change your exterior appearance. It
is not until you have some of life's ups and downs that you get
to know who you really are inside. I do try, without being patronising,
to dissuade young ladies from doing so by pointing out to them
things that maybe other people would not. I say "Have you
considered having children? Have you got a boyfriend now? You
are probably going to change boyfriends quite dramatically over
the years, are you going to be able to tell them you have got
implants or are you going to spend your life hiding your scars,
etc?" So there is a big problem. We heard one public story
where a young girl made out she was 18 to the clinic, it turned
out she was only 16. She had the operation because she was pushed
into it by her 31 year old boyfriend and the clinic made no attempt
to find out what age she was.
Chairman
64. There was no parental consent given?
(Ms Heasman) You do not have to have parental consent
once they reach 16. If it is under 16 it is classed as assault.
65. She was 16?
(Ms Heasman) Yes, but she was not 18. I think 18 is
too young, I think 21 is too young.
(Mr Balen) There are a very significant number of
young women, what I would regard as very young women, students
and so on. One of the problems, apart from the peer pressure and
the advertising pressure we have heard about, is conveying what
lies ahead in that choice and that goes back to informed consent.
I am very much in favour of the interactive element but you still
have to decide what information is right and also what impact
that information is going to have. Going back to the American
example, the Food and Drugs Agency on its website shows pictures
of complications. In the paper I will leave with you I have just
randomly taken from my files, because we do not ask for photographs,
the pictures that have been sent in. Some of the questions that
you and I might think they ought to ask, I think most doctors
would find it very difficult to answer because the information
is not available. For example, we all know around this table that
they are not lifelong and the Department of Health accepts they
are not lifelong. If you are 18 and you are considering this implant,
one question that you ought to ask that actually is not in the
Department of Health booklet to ask is "How many operations
will I require in the future?" Now I do not actually know
that any specialist—well some specialists may be in a position
but very few and certainly not the ones that are dealing with
the mass market here, many of whom are just cosmetic surgeons,
they are not qualified plastic surgeons—would be in a position
to know that. There is not really the data captured, certainly
in this country, of the failure rates and the complication rates
to say. I would guess personally, just from my own experience,
that they are probably on average facing three or four operations.
They are certainly not going to be told that at the moment.
John Austin
66. You have raised an interesting point there.
You suggest it may not be clear to the patient whether a surgeon
is a cosmetic surgeon or a plastic surgeon or what sort of surgeon.
(Mr Balen) Yes.
67. In an earlier inquiry we were told that
surgeons could call themselves specialists without necessarily
being specialists in the field that they may be operating at the
time.
(Mr Balen) Certainly anyone can call themselves a
cosmetic surgeon. Usually a plastic surgeon will be an accredited
specialist by the College and so on. The majority of the insertions
in the private clinics will be carried out by cosmetic surgeons.
They could be moonlighting general practitioners with some surgical
experience. I have given you an example in my submission of one
major clinic which does a lot of the private breast implant work
that actually wrote to patients after the Trilucent recommendation
came out and said "We cannot use your normal surgeon to take
them out because taking out and replacing is really the work of
a plastic surgeon so you will have a different person because
what we use are cosmetic surgeons, ie the people we use are not
actually the specialists".
(Ms Heasman) Could I just make a comment? This is
a true observation from my five years or more now of dedicating
my life to this. It is the cosmetic surgeons who provide a better
level of information, both written and verbal, and a better level
of after care than the actual plastic surgeon within the NHS.
The typical NHS pre-operative consultation lasts ten to 15 minutes,
in the private sector 30 minutes to one hour.
68. Can I turn now to Rose Irwin because you
made some criticisms of the DoH booklet.
(Ms Irwin) Yes.
69. On the grounds that it inadequately covers
anecdotal accounts of silicone survivors. How realistic do you
think it is to put anecdotal stuff in the guide book?
(Ms Irwin) I think under the particular circumstances
of this particular medical device I can open by saying that I
do not know how realistic it is in terms of all the pragmatic
interest involved but I think it should be realistic, not only
realistic but imperative that it goes in, and perhaps I can give
you one or two reasons why I think that. In the first place the
phenomenal amount of reports on casualties from silicone gel in
particular would seem to justify it in itself. Then we do have
to back that up with the fact that, whatever we say and whatever
the consensus by the IRG and so on is, there are some good peer
reviewed clinical studies which do back up these reports from
the women and which also ought to be included. You cannot put
it in on its own but they ought to be there. There are, in addition,
problems with the situation so far that would justify it. For
instance, the IRG—I am sorry to continue about the IRG but
we did have some criticisms—offered and invited women to
send in accounts, women who were casualties, of why it was thought
they were casualties. There was a good compliance on this, the
only problem was that in the IRG Report there was absolutely no
assessment whatsoever of what these women had said, whether they
agreed or whether they did not. This would lend something to my
argument, I think. As we have already said, there is a lot in
terms of inconclusiveness surrounding the whole issue from the
clinical evidence and so on. Added to that, stacked on the other
side of the argument, there is a tremendously forceful advertising
industry which is inviting people to buy these implants. I think
in terms of those points it would be justifiable to realistically
expect it but may I say that I would not obviously expect just
to have anecdotal evidence written in the booklet without substantiating
it with the pros and cons. The fact is that there is clinical
evidence to support it. The fact that the IRG received views does
not support it. The fact is, may I add, that we have a growing
number of doctors, and I have a list of 16 or more in contact
patients, who are concerned, seriously concerned, about the effects
that patients are having. You would need to give pros and cons,
it would have caveats and surrounding remarks and provisos rather
in the way, I think, of the FDA booklet, which Mr Balen has mentioned.
You would have a much fuller booklet in the end. If we are going
to be honest and try to reflect a complicated situation as it
stands, yes, I do think it is realistic to expect that.
70. You have specifically referred in your evidence
to the procedures in New Zealand.
(Ms Irwin) Yes. Well, this is about informed consent,
is it not, I think? I think this is ever so important as well,
it is something we do not have here. We know that consent in itself
to have or not to have a treatment is legally binding, there is
a legal obligation for that but in fact there is no actual legal
obligation for people to have the information which makes them
make that decision. I would certainly like to see some moves which
tied up the consent with the information in terms of having some
legal obligation for both. I realise, as Professor Sturrock was
saying, it is a difficult process to find the information that
you would give. Perhaps it would go with the reading of the booklet.
In New Zealand it becomes a sort of disclaimer. The patient has
to sign to say that they have read the information and this would
seem to me like a reasonably good compromise in the situation
that we have today.
(Ms Heasman) It protects both the surgeon and the
patient as well, does it not?
(Ms Irwin) Yes, indeed it does.
(Ms Heasman) It is a written confirmation that all
the subjects have been discussed.
71. Can I just go back to the point which Maxine
Heasman made about age and consent to the operation. Whilst it
may be difficult to have an arbitrary age at which the age of
consent can be given, would you all agree that there should be
some very clear guidelines for health professionals as far as
young women are concerned?
(Ms Heasman) Yes.
(Ms Irwin) Yes.
72. Do you feel that the General Medical Council
itself ought to have some ethical guidelines which are binding
upon its members?
(Ms Heasman) Yes. As long as people at the heart of
it and on the front line have some help in developing those guidelines,
then yes.
Dr Stoate
73. Obviously our witnesses are all in favour
of more informed consent and I am sure the Members of the Committee
would like to see much more informed consent for all sorts of
very good reasons. Perhaps I can start with Mr Balen, do you honestly
think that if you did increase the informed consent it really
would reduce the number of women having the operations?
(Mr Balen) Well, all I can do is respond by indicating
what the patients say to me when it goes wrong, and obviously
that is at the retrospective stage. A lot is associated with the
advertising, the marketing and so on. Trilucent would be a classic
example where they were clearly marketed direct to the women,
on the backs of the silicone concern, as having natural safety,
whatever it is A lot of women swapped from silicone, and a lot
of women who would not otherwise have considered them were attracted
by the idea that this was safe ;so it impacts in that way. I think
that you would probably have to show them things: capsular contracture
someone picked up, what does it mean? I think you have to show
them. You have to show them what a haematoma is. You have to show
them that once you have a breast implant it is highly likely you
will always have to have them because otherwise you are going
to be disfigured. I think it will lead to a reduction but obviously
it is a free society and if people really do say they want to
do that to their body I suspect the only concern of the Government
is really can we take the risk of the cost because when it goes
wrong, although it is in the private arena, there is inevitably
going to be a cost to the state, whether it is benefits payments,
loss of employment or National Health treatment or whatever it
is.
74. I accept that. I entirely agree with you
but if you look, for example, at the case of smoking, I think
everyone in this society knows the risks of smoking or ought to
by now. Schools are pretty much focused. School kids these days
are taught about the dangers of smoking and yet there is a huge
increase in smoking amongst 15 year old girls. Is the message
getting across? Even if we have all this information, if we have
all this stuff out there, do you really think it is going to change
behaviour because that is my concern? I want it to change behaviour
but I want to be sure that it would do.
(Mr Balen) I think you have to be careful because
there is a significant reason for doing these operations anyway
in the reconstruction sector.
75. I am not talking about that so much. I think
reconstructive surgery is a different issue but 80 per cent of
operations that we have been informed about are more for cosmetic
reasons than for reconstructive reasons. That is the bulk of women
who want this operation. Do you honestly believe that just giving
them more information and more informed consent is really going
to dissuade them from that path?
(Mr Balen) I suspect it will but perhaps not as much
as some people would like to happen. I do not think we can continue
to have a situation where we cannot even agree on the information.
I think if you cannot agree on the information because you do
not have it then there is a real question mark as to whether this
product should be licensed. I think once you have got over that
hurdle and you have demonstrated long term safety, you set it
out and it is like any other product. Tobacco would be one product.
Once you are 18 or 21 or whatever it is you do have that freedom
to choose but then the areas of criticism are going to be substantially
reduced.
76. Ms Heasman, what do you think?
(Ms Heasman) In my experience, because of the high
level of publicity about implants, most women know already about
the hardening, about the rupture, about the possibilities of what
silicone can and cannot do. They already know this. What they
do not get told, and this is what often puts them off when they
speak to me, is that when they get home they are not allowed to
lift anything heavier than two pounds for at least ten days, they
cannot pick up their small kids, they are not allowed to raise
their arms higher than their shoulders which means they cannot
wash their own hair or grab things from cupboards. They are not
allowed to drive for at least two weeks unless they have got a
power steering car. Women do not realise this. It is these practical
aspects. The problem of visible rippling through the skin, this
is one of the most common problems and yet it is not discussed.
77. You are talking more then about general
information rather than safety aspects?
(Ms Heasman) Yes. They come to me and they say "Well,
I have heard about this hardening and I have heard about ruptures
and I have heard about silicone" but what they have no idea
about is just how vulnerable they are. There is a 50:50 chance
of post-operative depression, women are not warned about this.
The anaesthetic stays in their system for up to 100 days, it leaves
them weepy, tired. The general impression they get is that it
is going to be in and out and feel instantly delighted, absolutely
not. I thought I had turned into Dolly Parton, I was out here.
My scars looked like they were half way up my breasts and I had
a terrible, terrible recovery because I was not given the right
practical advice.
78. That is not so much about the safety, it
is more to do with the general day to day information that you
would have wanted that you did not get.
(Ms Heasman) Yes, it gets overlooked. So much emphasis
is put on ruptures, silicone hardening, that the more likely things
are totally dismissed.
79. That is very interesting because we are
looking more at the terrible problems of breast implants rather
than the routine day to day problems.
(Ms Irwin) Could I come in, again on Mr Balen's point.
I think between you, you are working very much towards what I
would pick up as a strong plea, which I know is going to be entirely
ineffective but I might as well make it, for some form of moratorium
on these implants as we have in the US and in Canada.
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