Examination of Witnesses (Questions 80
THURSDAY 22 MARCH 2001
80. All implants?
(Ms Irwin) I mean on silicone gel implants in particular,
possibly all. I only know my field is knowing more about the silicone
implants, I have to say, than I do about the others, so that is
my platform in a way. A form of moratorium rather similar to that
in the US where there is a definite control in particular strictures
and regulations as to who should have them and how that will be
monitored so that you are, in fact, doing some research at the
same time. I make that plea because I felt we were working towards
it a little bit in this conversation here.
81. Going back to the handbook again and leaving
aside your criticism about shortcomings of the handbook, do you
have evidence to suggest that women who are contemplating implants
do actually get it?
(Ms Heasman) I have no evidence as such. Unfortunately
I have not been given a list of who it was being distributed to
but I will say whenever I get an inquiry to the Society I ask
how they heard about us. The numbers are increasing on a weekly
basis who have the Department of Health booklet. Somehow it is
getting out there but I do not know how.
82. Can I just pick up on that. Do you have
any idea of where these booklets might be available when you ask
people how they hear about you?
(Ms Heasman) No, perhaps I should say "how did
you get the booklet?" From what I can work out, it seems
to be BUPA hospitals, private hospitals, that actually seem to
be handing them out, that is all I can figure out so far.
83. We have talked about the sorts of things
which can go wrong with these particular implant operations. I
wondered if you had encountered any problems in actually finding
out information on the numbers of adverse incidents involving
them? Do you have a problem getting the information together or
the statistics on it? Is it dependent on people getting together?
(Ms Heasman) That is a very good question. It is not
possible to have a compulsory Registry because of the Human Rights
(Ms Livsey) That is what we have been told. We do
not know how true it is.
(Ms Heasman) There were no controls in the past over
which surgeons were telling the Registry or not. We have no comprehensive
figures at all.
(Mr Balen) We desperately need, I think, the vigilance
area of the Medical Devices Agency to be made compulsory and extended
to things like ruptures and so on which my suspicion is that manufacturers
do not report because they just accept it is one of the things
which happens. I see no problem as a lawyer with the Human Rights
Act because it is anonymised data and anonymised data should be
sufficient. I think there should be publicly published league
tables, products against side effects, risks and so on, in the
same way there should be surgical league tables so that we can
map "Does implant A tend to rupture after one year, two years,
three years? What is this surgeon's rate of re-operation?"
and so on. It ought to be made compulsory that it should happen
and linked with that it should be compulsory to give a woman an
identification card so she knows what implant she has, what number
of that implant it is.
(Ms Heasman) I have this in the back of my book. It
is like a passport, I encourage them to write this down.
(Mr Balen) The soya implant manufacturers introduced
that scheme. It has worked pretty well. It fell down when it was
used in the National Health Service, the National Health Service
did not appear to register the implants in that way. Certainly
there is no reason for it not to be extended and every benefit
for it to be extended to all implants.
84. It would be helpful if that was included
on the patient's medical records?
(Mr Balen) Not necessarily.
85. Would it not be helpful?
(Mr Balen) Yes, it would, yes.
86. We have heard already often a GP knows nothing
about this operation.
(Ms Heasman) That is right.
(Mr Balen) GPs in my experience usually do not know.
It is very rare they will know.
87. It is the norm?
(Mr Balen) It is the norm that the GP does not know.
(Ms Heasman) They are more worried not about the GP
but about the receptionist in the GP's surgery finding out. You
know, you would not believe how private this is.
88. On the other side of that surely if women
do not want to tell anybody they are going in for the operation,
they are not going to search around for information about it.
If in the end it goes wrong they will probably put up with a great
deal before they will tell anybody.
(Ms Livsey) Absolutely. There are two ways of looking
at that. When Rose and I had ours, as we have said it is a very
private thing, we did it merely to mend. Today it is a fashion
accessory. I was on a TV programme with Ester Rantzen the other
week and there were young girls there who were delighted to have
these implants and wanted everybody to know and touch them. (Mr
Balen) Your point is very relevant if you think there are
a very large number of women who do not tell their GPs, do not
tell their spouses or boyfriends, even their families, that does
raise a real question, how can they possibly have given informed
consent because we all know it is a very high probability they
will need further operations? How could they possibly have thought
they would get away with it later in life? That does suggest that
there has not been proper informed consent.
89. I suppose if you are 20 and having it done
to help your career and whatever, as you perceive it at that time,
you do not think about ten years' time.
(Ms Livsey) No, you do not.
90. Ten years' time will take care of itself.
(Ms Heasman) The attitude is I might get run over
by a bus tomorrow.
(Ms Livsey) When I had mine taken out, they put mine
under the pectoral muscle and it was adhered to my ribcage. Now
I had to go into the Christie Cancer Hospital in Manchester and
I was there for five days because it was such a mess and I really
thought I was going to have a mastectomy.
(Ms Irwin) That happened to you and when we had our
explantations, we know for a fact that an eminent and good plastic
surgeon, very well known, did not put this on the register that
exists today. It is a very ad hoc business the National Implant
Register. In terms of the adverse incidents again, could I take
up the point that the MDA are very reluctant to take on patients'
reports about ruptured implants, for instance. When I wrote to
David Sharp, who was at that time President of BAPS, to ask about
how he considered rupture in relation to an adverse incident,
he said that no plastic surgeon that he knew in the country, and
I have the letter, would regard implant rupture as an adverse
incident. Another official in the MDA said that it was an adverse
incident. In terms of your question about adverse incidents, nobody
quite seems to know how to categorise what is and what is not
an adverse incident.
(Ms Livsey) Actually there is no total commitment
in this country.
(Mr Balen) One of the suggestions I would make is
that this year the Medical Devices Agency I have seen has published
a guide on reporting adverse incidents with coronary stints. It
actually lists what would be regarded as adverse incidents and
what would be regarded as clinical errors and what is regarded
as one of those things you should not report. I think it would
be of great assistance to women and the medical profession dealing
with breast implants if they did that for breast implants.
91. Can I come back, Mr Balen, to you on the
question I put to Professor Sturrock at the end which is about
the tension between the right of people to have whatever they
want done and how we protect them from harm. How do you, as a
lawyer, view that dilemma? Do you have any thoughts yourself,
picking up some of the experiences we have heard of, bearing in
mind, quite clearly, Ms Livsey, you talked about the situation
and presumably you had the operation in the private sector?
(Ms Livsey) Yes.
92. Then went into the National Health Service
to have it repaired.
(Ms Livsey) Yes.
93. Now there is a significant burden on the
National Health Service from things which have gone wrong in the
private sector. In looking at how we protect the public interest
clearly the Committee is charged with looking at how we spend
our money. How do you see us developing a process which would
as well as indirectly protecting the public interest and the public
purse also protect people from unscrupulous people in the market
who want to entice people into operations which quite often they
did not want to have?
(Mr Balen) First of all, you start with products,
you do what you can through your Government Agencies to make sure
that the products you allow to be used in this country are safe.
You have appropriate data, appropriate licensing and appropriate
monitoring, appropriate vigilance.
94. Is not the process further back than that?
Professor Sturrock talked about education, women's perception
of how they should or should not look, should that not be challenged
somewhere perhaps? It is a very big question, I appreciate. That
is what it comes down to in a sense.
(Mr Balen) Education I think is needed about some
of these implants, of all varieties, and that could start with
your PSE or whatever it is classes at school when you are talking
particularly to young women about changes in their body and so
on. You could give them examples. Yes, you can have your body
changed and altered but every operation has a risk and this is
what we know and so on. It is very far removed from the kind of
work which I do which tends to be pick up the pieces and try and
draw, if you like, lessons from that, which is why I am here,
to try and prevent it happening again. There is an awful lot that
can be done to try and help individuals pick up the pieces themselves
and to reduce the burden on the state and so on, not only preventing
what went wrong but, as we have seen with the problems that have
arisen both post soya withdrawal and post Hydrogel withdraw, actually
trying to get the pharmaceutical industry in with the Government
Agencies as well as the private health care sector to reach a
consensus on how they are going to deal with these patients. At
the moment certainly it is an enormous amount of my time, and
that must be reflected in an enormous anxiety amongst the population
affected. It will mean more consultations with GPs, more calls
on the private sector, more people not being able to go to work
because of concerns of the impact of Government announcements
and so on. I have illustrated, for example, the announcement saying
"All your medical costs will be paid" when I do not
think the Government, firstly, had secured that and, secondly,
probably has any power to secure that. The same with the Hydrogel
announcement, yes, but what happens to the women now? There must
be recourse somewhere which allows women affected by such announcements
to actually seek medical advice and so on. There is a problem
that has occurred, you are dealing with the private sector, I
know you have taken steps with your new law and so on but we do
not know how regulated it is going to be. If you are a woman who
has borrowed money to fund itas a lot of women haveand
they think it has gone wrong, they know if they go back it is
going to cost them more money. They are driven into a vicious
circle. I think that is something that is a very great concern.
95. Ms Livsey, if my memory is right, you had
your operation in the 1970s.
(Ms Livsey) 1980s.
96. Was it you, Ms Irwin?
(Ms Irwin) Yes, the 1970s.
97. Sorry, I will ask you the question. You
had your operation in the 1970s and it was for medical reasons,
not for cosmetic reasons?
(Ms Irwin) It was for cosmetic reasons, after childbirth
and so on.
98. It was for cosmetic reasons. I do not want
to ask you the question. I will start again. Ms Livsey, you had
your operation in the 1980s which may not be quite as relevant.
(Ms Livsey) Yes.
99. It was for medical reasons, it was not for
(Ms Livsey) Well, it was cosmetic but it was because
of a hormonal imbalance. I lost my breasts. I did not have them
surgically removed, they just vanished.