Examination of Witnesses (Questions 39
- 59)
THURSDAY 22 MARCH 2001
MR PAUL
BALEN, MS
ROSE IRWIN,
MISS BRENDA
LIVSEY AND
MS MAXINE
HEASMAN
Chairman
39. May I welcome our next group of witnesses
and may I ask you to briefly introduce yourselves to the Committee.
(Ms Irwin) I am Rose Irwin and I belong
to the campaign called Action Agaist Silicone Gel. I am a casualty
of silicone gel implants. I am also part of the BIP information
booklet group that discussed the composition of the booklet you
have been discussing.
(Miss Livsey) My name is Brenda Livsey. I am co-founder
of Action Against Silicone and I am also a silicone casualty.
(Ms Heasman) My name is Maxine Heasman. I am the founder
of the Breast Implant Information Society and author of `The Ultimate
Cleavage' and I was also involved in the creation of that booklet.
(Mr Balen) I am Paul Balen. I am a partner in a firm
of solicitors called Freethcartwright. I specialise in medico-legal
work and I represent approximately 4,000/5,000 women who have
experience of silicone, Trilucent and Hydrogel implants, many
of whom have consulted me following, for example, the Trilucent
hazard notice and the recent Hydrogel notice.
40. May I thank you for your written information
which has been very helpful to the Committee. I wonder if we could
begin by hearing of your own personal experiences, if that is
possible, if you would share with us the concerns that have arisen
from your own personal experiences. Obviously you heard the areas
that we were touching upon in the first session and perhaps now
we need to look at the way in which women end up having operations
that perhaps may not be the most appropriate course of action
for them. Ms Irwin, would you like to start by briefly talking
about your own personal background and your own concerns arising
from what has happened to you.
(Ms Irwin) I had silicone gel implants quite some
time ago in the 1970s. I took a long time to recover from the
operation, longer than I had been given any idea about. I was
given absolutely no information about any possible risks such
as ruptures which we have since learnt so much about, possibly
because it was not known at that time. I was led to believe that
they would last a lifetime and there was a great feeling of almost
idealistic approach to them, that they were the most marvellous
devices under the sun. After a time, the implants grew old, some
12 years in my case, and I felt what I thought was a sensation
of rupture or leakage or something that I had not felt before
but I took no notice. It seemed that coincidentally I developed
symptoms some months later which became, to cut a long story short,
classified as ME: tingling in the fingers, joint pains and so
on. I did not associate them with the implants. I then began to
hear some of the media reports about the symptoms that seemed
to be going along with implants and I thought that perhaps mine
were and so, of all people, I went to see a plastic surgeon. Incidentally,
I was interested to hear Dr Stoate say that plastic surgeons could
be reported to the GMC and that the GMC would be concerned because
of course they are not; they obviously are not concerned. I went
to a plastic surgeon without my GP knowing and explained my fears.
He assured me that there was nothing at all in it, that it was
all newspaper reports and people wanting money and so on. He offered
at the same time to perform external/closed capsulotomy where
you press the hardened implants and so on to soften them. In fact,
what happened then was that they did soften but the leakage, as
I perceived it, increased and the sensations I had had and my
symptoms increased horrifically. I had bruising, swollen lymph
nodes, lumps and illness. I finally had some x-rays taken and,
when they were removed, it was discovered that there were in fact
bilateral ruptures. I told the GMC all about this but the GMC
were not interested—there were months of delay and no interest
shown whatsoever. Therefore, I felt that I was able to put some
cause and effect progress to the leakage and the continued leakage
with the increasing symptoms that I had. After I had them removed,
my health improved over a long period of time and I am very pleased
about that.
41. Going back to when the first operation took
place in the 1970s and I appreciate that it is some time ago,
was that done in the private sector?
(Ms Irwin) Yes, it was.
42. I am interested in what kind of information
was available to you at that stage regarding the possible outcomes
and possible problems because clearly this inquiry primarily relates
to the information on safety and we are especially anxious to
ensure that we look at the processes whereby women are made aware
of what may or may not happen. Did you receive any independent
advice at that time about what the possible outcomes might be?
(Ms Irwin) No, I did not and I think a problem arises
here in that this is a very private and intimate business and
very often women do not want to go to a number of outside people.
At that time, there were not the official bodies that one could
consult. We now have some help-lines that we ourselves have set
up and we are very aware of the confidential nature of the whole
business but, at that time, there was not really anywhere else.
The only thing I can remember that the surgeon said to me in the
way of any warning note was that I had to tell any doctor if I
was going to have an injection of any sort in the breast, otherwise
everything was fine and dandy.
43. So you had to tell them?
(Ms Irwin) Yes, if ever in the future.
44. You heard in the previous session the point
that was made about frequently GPs not being aware of their patients
having had augmentation, so it was left to you to give that information?
(Ms Irwin) Yes, absolutely.
45. Ms Livsey, are you able to share with us
similar experiences or was yours a different experience?
(Miss Livsey) It was similar to Rose. I came back
from the States—I had been working out there as a beauty
therapist—so I had done all my homework before returning
to the UK. I decided to have breast implants because I had had
a hysterectomy several years before and obviously a hormonal imbalance
because, having been a rather well endowed lady, they just disappeared,
so it was basically to mend the way I was. I went along to a private
clinic and, within weeks, I had them done.
46. Was any advice given to you at that stage?
(Miss Livsey) No. I asked about the contra-indications.
I had done my homework, I knew the questions to ask and I was
given what I would consider were the correct answers. From the
outset, I had nothing but trouble for two-and-a-half years. They
either moved upwards, moved under my armpits or went hard. In
fact, in the end, after the first year, they had to put a new
set in. Then I started with a kind of fever; I collapsed, I was
burning all over. I had blood tests. I had to give up my job as
a beauty therapist because I became physically incapable. I used
to do a lot of body massage and body work and I did not work for
two years because I was so sick, but every blood test was negative.
My GP said, "I know you are sick, I can see that you are
sick but I cannot tell you why you are sick." I never ever
related it to the breast implants. I was told when I had them
inserted that they would last a lifetime, that I would go to my
grave with the breasts of a young woman and that they do not rupture.
Dr Stoate
47. Were you referred by your GP? Were your
GPs kept informed at every stage?
(Miss Livsey) No.
48. You were not referred by your GP?
(Miss Livsey) No. I went independently.
49. Ms Irwin, is that the same position with
you? Did you go to the clinic without being referred by your GP?
(Ms Irwin) I am sorry, there is confusion here. I
was referred when I had the implants done. I am talking about
the process of capsulotomy much later, which was more distressing
in a way because we are talking about 1991.
50. But your GPs were not involved?
(Ms Irwin) Not in that area when I had the capsulotomy
performed.
51. Were your GPs informed after this all happened?
(Ms Irwin) No. And the GMC were not interested.
(Miss Livsey) No. At one stage, I had a massive haematoma,
my breast was absolutely black, and they wanted to take me back
into theatre but I just said, "No, leave me alone" and
I went to my own GP who just looked at it and said, "Well,
the guy must know what he is doing" and left it at that.
He did not want to look, so I coped with it myself and it is still
happening.
Chairman
52. Ms Heasman, can I come to you and ask you
the question as to whether you think women who were undergoing
augmentation operations are fully aware of the risk now. Clearly
we are talking about experiences that go back some years, but
is the kind of experience we have just had recited still occurring?
(Ms Heasman) Yes. Unfortunately, only last week I
was speaking to a woman who had been told by the company that
the implants have a lifetime guarantee. We all know—and
this is fact—that that is not the case. Unfortunately, women
are not being informed.
53. So there is misinformation being given?
(Ms Heasman) There is a great deal of misinformation
and a great deal of misconceptions and myths as well.
54. What more do you feel should be done to
make them aware? Clearly we have this booklet that arose from
the Independent Review Group's work, but that presumably is a
small step in the right direction. What are the other areas that
you feel need to happen? You heard us in the first session asking
about the possibility of counselling so that people are made aware,
are asked to sit down and look at whether it is really want they
want or whether there are other reason why they have concerns
and to see whether there might be other steps taken to treat people
differently. What are your views on this?
(Ms Heasman) I think the problem lies in the very
first instance with the primary care sector. The General Medical
Council prefer a women to visit her GP in the first instance for
a referral to a surgeon. At the Society, I send out a questionnaire
to ladies who have implants—you have a copy of it there—and
this is how I get my facts, and a shocking 66 per cent of the
women said that their GP did not make any effort at all to find
out the reasons why they wanted the surgery. Unfortunately, there
is a general lack of knowledge amongst GPs and they tend to be
very judgmental and moralistic, which is what puts a number of
women off going to their GP.
55. Is that because primarily they are male?
(Ms Heasman) Yes, I would say so. I have also had
comments from female doctors. One doctor said to a patient, "What
do you want implants for? Can you not wear a padded bra?"
Now, ok, that is sensible advice but that is not what the patient
wants to hear and that kind of attitude then pushes the women
into the private sector where less questions are asked.
56. So you raise serious questions about the
role of the primary care sector in this?
(Ms Heasman) Yes, I do.
57. Are you basically not arguing that primary
care should have a role to play but are you saying that they are
not fulfilling that role in a proper way at the moment?
(Ms Heasman) No, not at all. If women are to be encouraged
to approach their GP, then GPs need to be educated and it is very
severely lacking.
Siobhain McDonagh
58. Earlier on, we had brief references to the
various forms of implant and I just want to ask a question about
what you think the effects have been of the various warning notices
to women about Trilucent and Hydrogel implants and what your views
are on the type and content of those notices.
(Ms Heasman) From my experience, unfortunately the
MDA announcements have had a terrible effect on the women concerned.
Nobody had any warning. I myself as an organiser had no warning
and I was suddenly inundated with calls and it was not until mid-morning
that I actually had the documentation through to explain what
was going on. I think it is difficult for the MDA because they
have to present the facts as they are and, as Professor Sturrock
said, the way the media get hold of it and translate it causes
a great deal of distress to women. What I did was produce my own
four page hot news bulletin which took the alert notice and put
it into plain English so that ladies could understand it and I
had many letters of thanks for doing that.
(Miss Livsey) I am concerned that they were put on
the market in the first place and a licence issued for them only
to be taken off again. Why should it only apply to Trilucent and
the Hydrogel and why not silicone?
(Ms Irwin) Could I come in on that because I think
we felt from where we were standing, or where we were lying at
the time, that it was in some ways possible to cope with the Hydrogel
and the soya problem, in being slightly cynical, in terms of taking
cautious measures by the MDA but really to evade the far larger
problem because, let us face it, far more people have silicone
gel implants than they do these others and, to some extent, in
spite of the difficulties which I think Maxine rightly states,
it could be contained in that there were 5,000 people in the UK
who had the soya implant and the manufacturers here did make some
attempt to pay for the operations and so on and we felt, that
is Brenda and I and others, that in some ways this could have
been used as a sort of way of masking the much greater problem
and appearing cautious and so on, but the very same principles
that applied to the Hydrogel, for instance, not enough evidence
and so on and warnings, applies to the silicone gel implants,
but that is such a big problem to deal with and we felt that in
some ways the withdrawal of these and the seemingly cautious actions
involved masked the greater problem of the silicone gel implants.
(Ms Heasman) Could I just say as well that, in my
own opinion, it is the misconceptions and the misinformation about
silicone, the very public misinformation, that was the main agent
in a number of these women going for the Trilucent and the Hydrogel.
(Mr Balen) I certainly have a large number of clients
who had the soya Trilucent implants put in instead of silicone,
so they have had silicone removed and Trilucent put in because
the soya was widely marketed as the safer alternative to silicone,
and I have clients who have then had to have them removed and
have had Hydrogel put in, only within a couple of weeks to be
met by the notice that came out in December. What is missing from
all these notices is a recognition that actually we are dealing
with, as you say, 80/85 per cent of women who are in the private
sector, exposed to the private sector, and there is not an agency
that has the ability to force co-ordination of how these women
will react. They will want medical counselling, they will want
medical advice and, in the private sector, that costs money. They
may require operations in the private sector and that costs money
and so, not only the health agencies but myself as a solicitor
known to represent these clients are in fact now involved and
virtually 100 per cent of my time is taken up with trying to organise
operations, payment for operations and payment for consultations
without anyone having any control over the sector that is supposed
to be providing it.
Dr Stoate
59. Obviously these devices are approved medical
devices and as such have a CE marking. Do you think that sends
out any sort of message to people, in that well it must be an
approved medical device, it must have been tested, it must have
been tried because it has a CE approval stamp on it? Do you think
that that possibly sends out a false sense of security?
(Mr Balen) I think it does and it is patently obvious
that it does because how can you have a CE marking for a device
that is then the subject of a hazard notice or a warning notice
which says the reason for this notice is concern at the lack of
safety data? That safety data must, in all logic, be supplied
before you have any Government authorised marking on it.
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