Examination of Witnesses (Questions 140
THURSDAY 22 MARCH 2001
STUART MP, DR
CBE AND DR
140. Can I press you on two points, one in relation
to the adverse incidents and the other on the Registry. You were
talking earlier about the need for more information, more research,
and Dr Stoate was referring to the current system really being
unrestricted clinical trials. I gather, Dr Ludgate, you are responsible
for management and use of data in the Registry. One of the criticisms
we have received is that the data supplied is supplied on a voluntary
(Dr Ludgate) Yes.
141. The first question is is that a valid criticism?
Secondly, could you give us any indication of the progress and
use of the Registry and what uptake there has been by surgeons
in relation to any research findings that have come out from that
(Dr Ludgate) Yes, it is voluntary. One of the recommendations
of the Independent Review Group in their review, which you have
seen, was that it should be compulsory. Legal advice is that we
cannot do this because it takes away freedom from the woman and
it almost amounts to coercion, so it has to remain voluntary.
142. I think the lawyer who we were listening
to earlier was saying that it would be anonymous data. Is your
legal advice still that it would contravene some human rights?
(Dr Ludgate) Yes, it is. That was our legal advice,
that you cannot force women to go on to the Registry if they do
not want to do so, and some do not want to do so.
(Ms Stuart) In terms of data there will come a stage
when we can properly encrypt data. For proper research to be done,
on the one hand you can get anonymised data but if you have an
adverse incident there must be a way in which you can trace it
back. At the moment there will be a consent form to make absolutely
sure there is always a right there. It is not right to say that
it will be totally anonymised. I think the whole debate at the
moment on consent is it has to be right, it has to be informed
consent. I do not think we could get to a position where we could
say a register is compulsory. The Chairman made the point earlier
himself that they may not want their own GP to know this. If a
woman was to say "I do not want to go on the register",
we would then be in a position to say "in that case you cannot
have the operation".
143. Let us move from the register to the adverse
incidents because it is obligatory, is it not, to notify adverse
outcomes to you?
(Dr Ludgate) There are a number of strands to this.
The regulations say that manufacturers must report serious adverse
incidents to the regulatory authority and what constitutes a serious
adverse incident is laid down in the regulation and in the guidance
documents that underpin it. In fact, we get as many reports directly
from clinicians and patients as we do via that system. It is a
bringing together, if you like, of information from all sources.
144. How do you react to Dr Myhill's evidence
given to us where she says in relation to a sub-group of over
100 patients with chronic fatigue syndrome following silicone
breast implants: "During the early years I reported these
cases individually to the medical Devices Agency, but when it
became clear to me that they took no action whatsoever to investigate
these cases further, I gave up reporting. More recently I have
simply told them the numbers of patients affected and the symptoms
from which they suffer. The Medical Devices Agency has not asked
for any further information nor investigated any of these either
as a group or singly"?
(Dr Ludgate) We do add all these to a body of evidence.
At one time we were not investigating each one individually. As
an Agency we were looking at the adverse incidents of the devices,
so we were not looking at each individual person and their ill-health,
we could not do that. What we were doing was compiling a document
that set this all out and, indeed, when the Independent Review
Group met this was evidence that we submitted to them as part
of the evidence. We felt it was very important that evidence directly
from women and their adverse events was, if you like, put to them
for their evaluation in terms of the conclusions that were drawn,
and we do this in an ongoing way. We now actually register each
woman individually if they are registered with us and then we
feed that information through to the Independent Review Group
as part of the evidence that they consider at each of their meetings.
145. Can I just follow this through. The evidence
we had this morning was that very rarely is this a single operation
and the likelihood of requiring further surgery and further intervention
is highly likely. I raised the issue earlier of a young woman
undergoing this kind of implant surgery and clearly the younger
they are the more likely a number of later interventions. I quoted
the example of a teenager getting a boob job for her birthday
present from her parents, which I think all of us would find quite
disturbing. Is the Department doing anything in terms of guidelines
and guidance to practitioners regarding the use of implant techniques
on young women who may not have fully developed?
(Ms Stuart) I think in the particular case you refer
to, which was in the press, when medical advice was given they
withdrew that. You will find that the vast majority of the Department's
professional recommendations to surgeons make quite clear the
clinician's responsibility also in that to give the appropriate
advice. Some people have suggested that we should say we should
outlaw it for under 16 year olds but with that harshness of the
law there may be a 15 year old with some congenital problems where
it may be appropriate. We do feel that in the professional guidelines,
particularly with the Royal College of Surgeons, we keep strengthening
them and we keep reminding them. Can I come back to something
that was said earlier when you were talking about the reporting
of adverse incidents and the impression that was given that the
women themselves could not do that.
146. That was their impression.
(Ms Stuart) When I looked at thisand I think
the Select Committee here can take credit for thatmy first
reaction was to say "the MDA is not on there". I can
assure you on the reprint it will be on there. I also looked at
the letters which the MDA send out to women in response to reporting
an adverse incident and it is quite clear that they have tried
to differentiate between a report of ill-health, which the Agency
could not take up and they urged them to have looked at further,
and what is an adverse incident. Looking at the figures of the
MDA, they have investigated 360 adverse incidents closely. What
was interesting to me was that 66 of those were referred by women,
68 of those were referred by GPs, and there was one GP who took
a very great interest, 68 from the hospital and then the rest,
something like 158, from manufacturers and other sources. I was
pleasantly surprised when I looked at the split that the largest
numbers came from the manufacturers, which I thought was right
and proper, but a very significant number came from the other
routes. I do take on board that we probably have to make it much
clearer that there is a direct line but at the same time I think
we also need to be clear as to what is an adverse incident of
the device and maybe something like ill-health. It would be equally
damaging if anybody got the impression that it may have been an
ill-health thing and by reporting it to the MDA that would resolve
it. It is a two-way valve.
147. I am still quite confused about the messages
we are getting in this inquiry this morning. We have heard from
the IRG that there is no statistical evidence that these implants
cause any great damage, particularly the silicone ones, and yet
we have heard from the support groups and patients that there
are hundreds of cases, if not thousands, that they have got on
their books of people who have complained of various reactions
which they at least attribute to their problems. There is clearly
a huge disparity here. I was concerned to hear in this post marketing
surveillance idea that the manufacturers themselves decide what
constitutes post marketing surveillance. If it is as loose as
that, how do manufacturers know what adverse reactions there are?
Who tells them? How do they get to find out? If they are only
carrying out a sort of vague postal survey every now and again,
how do they know what the true story is?
(Dr Ludgate) There are two things here. The first
is, yes, you are absolutely right, how do they know? The MDA have
prepared a booklet that sets out very clearly what should be reported
to us. This was written for manufacturers but we also promote
it to surgeons.
148. How do they know themselves? If they are
only carrying out fairly loose and weak surveys, how do they know
that is going on out there? They could be blissfully unaware of
(Dr Ludgate) Absolutely. The second strand that we
are pushing at the moment, along with our improvements in Europe,
is to promote a much better post market surveillance programme.
At the moment, as I have said, all it says is there must be a
post market surveillance programme. We are pushing to produce
guidance that lays out very specifically exactly what manufacturers
have to do in terms of getting information from surgeons, from
hospitals, etc. and, again, that is something that has been taken
up very favourably by other Member States.
149. I will continue to draw my parallel with
drugs because, as I say, I am a doctor and I see both sides of
the argument. If a new drug comes on to the market a little triangle
is put against that drug saying "special reporting required
by the CSM of any adverse reactions", a yellow card scheme
to openly criticise, and the yellow card scheme works at least
to a large extent. There is a special triangle, it comes up on
my computer on my desk, it is in Mimms, it is everywhere, "special
reporting required" and GPs are alerted to the fact that
they must report adverse incidents. Why can we not have a yellow
card scheme for devices where there is special reporting required,
where GPs and other health professionals are required to notify
possible adverse reactions, so at least they could be statistically
collated and patterns looked for and if there were a pattern developing
it would be picked up sooner rather than later in the same way
that many drugs have come on to the market in a huge blaze of
publicity, stuck around for a couple of years and then gone off
again very quickly when the yellow cards start dropping onto the
mat? Why do we not have the same level of proof for the safety
of these devices?
(Dr Troop) The Medical Devices Regulations are much
more recent than the drugs. There are the European regulations
within which the MDA are working. There is clear recognition from
us that the regulations around devices are not tight enough, as
you describe. So the MDA has been pushing more than any other
Member State for, first of all, these devices to be in the higher
risk category in which case they would have to have more clinical
data in the way that you have described before marketing and they
would gain support. That has been led by the MDA. Equally, the
whole issue of standards around Europe has been questionable and
we have been concerned about that, so again the MDA have led to
try to change the regulations across Europe. They are relatively
new regulations, not like the MCA. What has happened is the recognition
has come from us in the UK that they are not tight enough and
the MDA has been leading in Europe to try to change those regulations.
You are quite right, the situation is not there yet and, therefore,
there are a number of areas that we would consider unsatisfactory
but there are European regulations to which we are working.
150. I am very pleased indeed that the British
Government is taking the lead on this, that is obviously extremely
reassuring and all one can say is all power to your elbow in making
sure we do get the regulations tightened up across Europe because
clearly there are significant gaps at the moment.
(Dr Ludgate) We do have a system very similar to the
yellow card system for devices. Indeed, we have over 7,500 adverse
incidents of devices now reported annually to the Medical Devices
Agency for investigation.
151. This is a bit of a long question so I am
going to have to read it out to make sure I get it right, so forgive
me if I am a bit monotone. Women opting for Trilucent implants
might have assumed that they were safe on having them fitted.
They were then told in March 1999 that there were doubts about
the safety of these implants. The Advice Notice stated that "there
was no safety information to suggest that removal of Trilucent
breast implants was indicated but that women should be advised
to seek an immediate clinical consultation if they noticed unusual
breast swelling or inflammation associated with their Trilucent
breast implants". Finally, over a year later in June 2000
they were told to have them removed because of potential genotoxic
components and you, Dr Troop, said that the risk of cancer or
damage to an unborn baby "could not be ruled out". This
seems an extraordinary sequence of events. How can you justify
giving such contradictory advice and why were women not advised
to have the implants removed when you first became aware of the
(Dr Troop) I can pick that up but also Dr Ludgate
was very much directly involved with the work. It was a progression
of understanding about these. Each response was thought to be
proportionate to the evidence that was there at the time. So when
some evidence and information came that there were concerns there
was the advice that they should not be used. Further work was
done to investigate that a lot further to find out the extent
of that and then this further evidence came to light and, therefore,
they were recommended to be removed. It does go back to the whole
question that we have raised before, that at the moment these
are not in the high risk category and, therefore, this clinical
data was not required before manufacture to the same level. It
was in post market surveillance that this information was found
out. The MDA acted promptly on each occasion, I think. On the
first set of evidence they gave what was a proportionate response
to the evidence that they had. At that stage the evidence did
not justify recommending removal at the time but they continued
to investigate and after they found further evidence they recommended
removal. Dr Ludgate was directly involved in that.
(Dr Ludgate) I think this illustrates quite nicely
factors about the adverse incidents system and how things can
work quite positively. We first became aware of a possible problem
when a number of women reported to us that they were getting swelling
of the breast in association with rupture, which was something
152. Was it the women themselves who brought
it to your attention?
(Dr Ludgate) Absolutely. We got it from the women
This was something that had not been reported before, it was something
quite new. We then went and we discussed this because we did not
knowthere were only a fewwhether this was one or
two anecdotes or whether it was more general. We went to the professional
bodies who very helpfully contacted their surgeons and said "if
you have any problems of this kind could you bring it immediately
to the attention of the MDA". It was because of the numbers
that we had in that respect that we immediately said that we would
have to look at the safety here, there was something going on
we did not understand. We called for the dossier from the manufacturers,
we looked at all their safety data, and we were not happy that
they had carried out the full tests that we considered necessary
at that time, so immediately we said there should be no more implanted.
But there was nothing in that evidence from the manufacturer that
gave rise to any concerns at all at that time in terms of safety.
We immediately insisted that further toxicological tests were
carried out and the minute those came to light and we realised
that there was a small chance that the break down products of
the filler could result in genotoxic effects we recommended that
they were explanted. Why did we not recommend explant beforehand?
Firstly, because there were no safety issues at that time but,
more importantly, removal of an implant is not without risk so
you do not want to go in and be giving people anaesthetics without
risk. Also Trilucent implants are actually quite difficult to
remove, they get very stuck down to the surrounding tissue, and
it is a much bigger operation than just making a cut and whipping
them out. It is actually quite a long operation and there is often
a lot of bleeding and these patients need to stay in hospital
for several days with drains in, etc. That was the series of events.
We acted on adverse events immediately, we insisted on more toxicological
tests immediately and we acted promptly as each of these came
153. I am trying to flick through my notes to
find out the name of the other breast implant.
(Dr Ludgate) The Hydrogel.
154. Yes. We were told by a gentleman who gave
evidence previously, who was a solicitor, of women on his books
who had had one implant and then the information was that was
not safe, had it changed to another implant only to find out there
was a suggestion there might be a factor of that being unsafe
and had to have a third. So these women have gone through probably
(Dr Troop) When the women were advised to have the
first ones taken out there was information given on all of the
alternatives and on the Hydrogel it was stated at that stage that
the MDA did not have information about long-term safety. They
did not have information that suggested there was harm but neither
did they have information about long-term safety and they made
that quite clear in the information that went out at the time.
That is one of the problems of not having information but not
necessarily having information about harm. They did give that
information out at the time saying they could not say what the
long-term safety is of this implant. That was as honest an appraisal
of the implant that they could make at the time. They did not
say that these were a safe alternative.
155. You mentioned that it is a difficult operation
to remove a Trilucent implant, and I have heard exactly the same
thing, so it begs the question how do they get a CE stamp for
something that actually is quite a dodgy thing to remove? We have
know from the evidence that we have heard that women have to have
these implants removed for all sorts of reasons and yet it is
a technically very difficult procedure.
(Dr Ludgate) It comes back to the importance of having
pre-market clinical trials, which is what we are fighting for.
156. I hope that will be common in the future.
(Dr Ludgate) That is not something you can tell in
any other pre clinical studies.
157. Just on another point about this safety
issue. According to the evidence we have received, the MDA have
actually said that we should not use Trilucent breast implants
because there is no evidence as to their safety and yet the same
evidence we have received says we should not stop using silicone
implants because there is no evidence that they are unsafe. That
sounds contradictory and I think that is one of the reasons why
people are so confused and why we have had confusing evidence
this morning. It seems to me that there is a dual message: you
cannot use Trilucent because there is no evidence of safety and
you must not stop using silicone because there is no evidence
of their lack of safety.
(Dr Ludgate) The toxicological tests that were done
on the Trilucents and the Hydrogels were quite clear. In the Trilucent
case the toxicology has been looked at and there are question
marks over it. With the Hydrogels we have said do not use any
more because there are no safety issues over it but we do not
have the data. With silicone the toxicological safety data has
been assessed and there is no evidence based on that toxicological
assessment of it being unsafe. So we have, in fact, been quite
consistent across the three implants. The toxicology of each of
these has been looked at in turn. In one case it has come out
as safe, in one it is unsafe and let us take them out and in the
third we are doing it and we are awaiting further toxicological
158. There is a moratorium, or a ban, on the
use of silicone breast implants in the United States, Canada and
Australia. Do you think that women in this country ought to be
aware that those countries all ban the use of silicone breast
(Ms Stuart) At the same time in the whole of Europe
it is available. France banned it for a period but has now reintroduced
it. What has been happening over the last few years is that we
have tried in as public a way as possible to make information
available in a variety of ways. What is quite interesting, and
it takes us to what we are discussing here in terms of risk assessment
and almost takes us beyond the specific issue in the Committee,
is that in a sense we have got choices as a Government, as a society,
as individuals. We either say totally precautionary and until
something is proved to be absolutely safe we will not do anything
or, on the other hand, we say let us try it until it is unsafe.
What we have tried to do is have a continued progression and as
long as the benefits outweigh the risks we will continue the review.
We have got the adverse reporting, the reviews of the evidence,
and we make it absolutely public, and that includes the doubts.
159. If you were contemplating it and you knew
that it was banned in Australia, Canada and the United States,
would the fact that you knew it was banned in those countries
not make you think twice or find out the risks and why it had
been banned in those countries?
(Dr Ludgate) It is actually not banned in the United
States. They are allowed within clinical trial situations and
for reconstruction. Although there was a moratorium for a short
period of time, it has not been banned completely. I just make
160. I think the concern is perhaps if a person
within this country approached a surgeon in the private sector
for this operation and the same process happened in the States,
in the States that would not be able to go ahead. Is that correct?
(Dr Ludgate) That is correct.
Chairman: That qualifies the answer I think.
Any further questions? If not, can I thank you, Minister, and
your colleagues for a very helpful session, we are most grateful
66 Note by witness: Since 1997, each case reported
by Dr Myhill was logged by MDA and a copy of a specific reporting
form was sent to her for completion by the patient. Most of these
have been returned and thus included in the evidence considered
by the IRG. Back
Note by witness: Cases of swelling were predominantly
reported to MDA by the manufacturer, in line with statutory reporting
Note by witness: In the USA, silicone gel-filled implants
are available to women through two FDA-approved clinical studies,
one for women seeking breast reconstruction or the revision of
an existing breast implant, and a second study designed to meet
US regulatory requirements for pre-market clinical data. Back