Memorandum by Rose Irwin (B 4)
I submit my evidence as a casualty of silicone
gel implants and as a campaigning partner with Brenda Livsey of
AASG, UK. Ms Livsey and I have been in communication with, and
read reports of a large number of silicone implant casualties.
Our concerns lie primarily with the silicone implants involving
silicone gel. These are the implants which by far outnumber any
other breast implant used in the UK. It is from this type of implant
that we receive the largest number of reports of adverse effects.
We confer with fellow campaigners on the whole breast implant
subject. We also try to consult with medical bodies. We have become
conversant with the conflicting clinical studies and the many
aspects-including the problematical area of patient information-which
continue to surround this complex issue.
EXECUTIVE SUMMARY
As a casualty and campaigner for a moratorium
on silicone gel implants it will be impossible for me to avoid
any mention whatsoever of the disease aspects. I will strive to
keep this aspect within the terms of reference of the inquiry.
It will also be necessary for me to allude to my personal experience,
but only in the light of its relevance to the general points which
this, along with reports from fellow casualties, endorses.
The overwhelming factor which has emerged for
us has been the need for radical moves away from the didactic
to the consultative approach in relation to medical bodies and
many health professionals. This is integral to the best means
of information based on a combination of professional expertise
and patient feedback.
A large part of this most welcome inquiry surrounds
the issue of the dissemination of information—particularly
with reference to risks involved. It is necessary to say here
that the dissemination of information is crucially bound up with
the ways in which that information is gathered, assessed and compiled.
Much of our frustration in trying to represent silicone casualties
lies in the great shortcomings in these components, as well as
in the actual dissemination of the received information.
Our aims for the outcome of this inquiry are as
follows:
1. Some form of moratorium on silicone gel
implants, at least until the risks over benefits equation is more
clearly established, along with a firmer policy on patient awareness
of risk factors, this in line with the USA, Australia and Canada,
Japan and France.
2. Failing the above, a binding obligation
to patients contemplating silicone breast implantation (and possibly
other types of breast implant), to read and sign to say they have
read and understood the full list of risks drawn up from peer-reviewed
evidence on both sides of the argument, as well as from anecdotal
evidence. This would tally with the procedure used in New Zealand.
3. A method of take-up from patients' reports
of ill advised procedures by surgeons, (for example closed capsulotomy)
in terms of inspection and checks on such surgeons. At present
there appears to be no body which is equipped for this purpose.
It is outside the remit of the MDA. The GMC, which we thought
might encompass this area, has proved to be far too generalised,
bureaucratic and ineffective to fulfil such a role.
4. A more honest admission in PR information
on the inconclusive results of clinical research to date. At present,
for example, a careful reading of Independent Review Group (IRG)
report's website detail shows many areas of "don't know"
"further research needed" in terms of disease links.
This is not sufficiently reflected in the message of the IRG Summary
Report which comes across rather as: "silicone-gel-implants-safe".
This, in turn, has been re-interpreted by many plastic surgeons
as "proof positive of safety by the IRG".
5. Directives which will encourage medical
professionals to take a consultative rather than a defensive approach
with silicone implant casualties. This aim is linked to the need
for appropriate therapy and continuing research take-up from existing
peer-reviewed clinical studies indicating disease links.
6. An improved reportage system from the
MDA on adverse incidents, including both medical professionals
and patients. A proper take-up and investigation of all reports
of adverse incidence as stated in the principles of the MDA Framework
document. A change from the didactic to the consultative approach
from the MDA towards patients and other members of the public
concerned.
7. An improved method of arbitration in
terms of consultative skills from the Parliamentary Ombudsman.
I submit my evidence in order of the "Terms
of Reference" of the Health Committee Press Notice:
THE ROLE
OF THE
MEDICAL DEVICES
AGENCY
The Medical Devices Agency was formed as a whole
agency absorbing the pre-existing Adverse Incidence Centre in
1963. It reviewed the evidence on disease links and silicone gel
implants and recommended that the implants should remain in use
in the UK, all this in advance of its official opening. When flesh
and blood casualties attempted report in their/our problems, therefore,
the MDA had acquired a closed-door attitude. Officials were scrupulous
in replying to correspondence which, in my own case was prolific
for I was, in part, attempting to convince them of the progression
of disease with implant rupture and leakage; but the replies were
politely didactic rather than in any way consultative. There were
inconsistencies from different officials in replies to queries.
(Letters of evidence of this on file). Sometimes I was given deliberate
misinformation as, for example, when I enquired about the policy
in other page countries on the use of silicone gel implants. The
MDA official said that only the US had any restrictions. This,
I found, through the efforts on Ann Clywd, MP, to be not the case.
Most seriously of all, the MDA failed to confirm and investigate
my persistent efforts over almost two years to report bi-lateral
rupture and leakage of my implants. This technical failure constitutes
an adverse incident. The MDA Framework Document states that reported
adverse incidents with a medical device will be "taken up
and properly investigated". When I reported my implant rupture
I was simply thanked very much for the information and told how
useful it would be, this without any initiatives by the MDA to
confirm my report in any way! I put together my points of criticism
of the MDA and sent them by letter to the then Chief Executive,
Alan Kent. I sent a copy to the then CMO, Kenneth Calman. I asked
the CMO about questions of accountability. I received, in reply,
a solicitor's letter from the CMO's office forbidding further
correspondence. I received no replies to my points of criticism.
Later, communications with the MDA were resumed, but the attitude
had not improved.
Subsequently, I found through the SOS helpline
(Elaine Coomber), six other women who had all tried without success
to report implant rupture involving varying degrees of complexity
of complications. In the summer of 1997, we applied to the Adverse
Incident area of the MDA to confirm that implant rupture was indeed
classified as an adverse incident. At last, our reports, in the
context of the vigilance of the new Health Minister, Baroness
Jay, were taken up, confirmed and taken through a form of investigation.
We are aware that other people had tried to make reports by phone
without success. We wrote around to some twenty plastic surgeons
to discover a) whether or not they were aware of the MDA and b)
whether they regarded and would report implant rupture as an adverse
incident. The replies we received were varied. A letter from the
Chair of BAAPS (which I have on file) told us that plastic surgeons
would not regard or be likely to report implant rupture as an
adverse incident to the MDA. Meantime, the MDA in a 1996 publication
gave a figure of seven reported adverse incidents for silicone
gel implants. This did not, for a start, include the reports which
we and other women had attempted, in vain, to submit. It must
be admitted that a number of casualties who rang the helpline
said they would not report to the MDA after having heard of the
futile attempts by other casualites.
The MDA/Parliamentary Ombudsman
Seven women including myself complained against
the MDA through our MPs to the Parliamentary Ombudsman about a)
misleading letters from the MDA and b) failure to take up reports
of adverse incidents. A couple of these women gave up this pursuit
owing to failing health and the amount of paperwork involved.
In the end our individual complaints were, in part, upheld by
the Ombudsman and we received a form of apology from the Permanent
Secretary. However, the most crucial aspect of our complaint-and
that most pertinent to the compilation of information—that
of the weakness of the MDA's ad hoc reportage system, was not
solved or thoroughly examined by the Ombudsman. The MDA said they
had "lost" the early letters of all seven of us in which
we gave details of the rupture/leakage of our implants. I still
had copies of mine. All referred to implant rupture and leakage.
My first letter to the MDA, following my attempt to report by
phone, I had, in fact, submitted along with my complaint to the
Ombudsman. It was a one-page letter (on file) which clearly described
details of implant rupture and leakage. Yet the ombudsman seemed
satisfied with this "explanation" from the MDA. When
asked by the Ombudsman about future policy on adverse incident
reports, the MDA gave a vague and, we felt, under the circumstances
arrogant reply. I attach the extract on this from the Ombudman's
report. [48]
In the interests of the research which is crucial to the gathering
of information, I ask the Health Committee to compare this situation
with that of FDA in the US which positively invites reports from
patients with adverse effects from breast implants.
At no point did any official from the Ombudsman's
office come back to me following my written submission of my complaint
until I received the written Report. There was, therefore, none
of the dialogue necessary to a genuine process of arbitration.
I mention this because the process of compliant and its outcome
plays an important role in the continuing improvement of relevant
information and its circulation.
The MDA/National Breast Implant Registry (NBIR)/Ombudsman
The NBIR has played a confusing role so far
in its relationship to research and information. It was hoped
that it would help with information on the numbers of implant
operations and on rupture rates etc. However, since the registry
can only exist as a voluntary rather than compulsory facility,
its effectiveness is considerably impaired. Casualties who tried
to tell the MDA officials of their problems were told that the
NBIR would act as the research facility to determine a) local
problems and b) possible links with systemic illness, this latter
after some ten years or so, to allow for to systemic disease latency
period. The research on local problems was promised for 1997.
It did not happen. In 1999, I took on further extensive correspondence
with the MDA on this failure. One official assured us that an
epidemiologist and statistician had been consulted in 1997 for
the registry research project. I wrote for confirmation and contacts
on this to another MDA official and was told that no such experts
had at any stage been involved. Again, via the Ombudsman, I was
eventually given the correct information on this. The MDA justified
its own untruthfulness in terms of my prolific correspondence.
The Permanent Secretary seemed to accept this without any sense
of irony that here was an example of a situation that had required
prolific correspondence, and, in addition application to the Ombudsman
in order to obtain a small but telling detail of information to
which I was entitled. (Letters on file)
The MDA/Biosil/Checks on Manufacturing Standards
On 28 August 2000, a Scottish journalist, James
Moncur published a number of serious allegations of negligence
by the firm Biosil, manufacturers of saline implants which are
sold to the USA. These were quoted from complaints on the firm's
standards by the FDA. Biosil is the same firm as Nagor which also
manufacturers breast implants for sale in the UK. This lack vigilance
gave us great cause for concern with regard to the MDA's role
in the Biosil case and in its role in checking manufacturing standards
of other UK firms. We have written to the MDA as well as to the
Health Ministers, asking for a point for point answer to the allegations.
All we have received are letters telling us that the public health
was not put at risk by this Biosil's procedures. I attach a list
of some of the points of complaint made by the FDA from the newspaper
extract. (Subsequent letters of ours with Ministers on file).
During correspondence on this with MDA and Health
Minister, Philip Hunt I was greatly supported by my MEP, Brian
Simpson. Brian Simpson wrote to ask the MDA Chief Executive, David
Jeffreys, about the accountability of the MDA. He was told that
the MDA is accountable to a "notified body" and in this
instance the notified body is the MDA itself. (Letter on file)
Here, then, we have in the MDA a powerful, self regulating agency.
This is an unsatisfactory situation, but one in which it is doubly
imperative to ensure that the MDA gives detailed and honest information
in reply to questions from patients, moreover, that it cultivate
a genuinely consultative approach if it is to achieve credibility
with the general public which it serves. It is true that, a few
campaigners, as a result of an unrelenting persistence, have received
the literature we applied for to the MDA and, recently, were sent
an advance press statement on the withdrawal of hydrogel implants,
but this does not relfect the general attitude of the MDA.
The MDA/IRG
The MDA, employed as a secretariat to the IRG,
proved to have an overwhelmingly strong influence on this purportedly
independent panel. Letters, Reports from interviewees, website
detail in the IRG report, confusion even now in perception about
the two bodies all testify to this. (Substantial evidence on file)
Thus, the final message/information on the assessment of clinical
evidence was passed from one body to another. During the review
period, the IRG did not include a patient representative. We were
unhappy about this omission. Two years later, Claire Rayner for
a short time took on this role with the IRG. I received a letter
recently from Claire Rayner to say that the pressure of her other
commitments meant that she would have to stand down "from
the MDA"! This confusion is symptomatic of the way in which
these two bodies are inextricably bound. Information from each
body is similarly bound, we feel by these links. Entirely due
to the timing of the various reviews, the IRG became a kind of
parent review body and, in turn, strongly influenced the final
message of "inconclusive-means-safe" to subsequent review
bodies such as the US IoM, and EU STOA review. The PR from advertisers
and a number of cosmetic clinics has re-phased and hyped this
message to the extent that we now have, at one end, an epidemic
of young people undergoing cosmetic breast implantation, and at
the other end, increasing queues for explantation operations.
The mandate for the IRG was 1) to assess the
clinical evidence for disease links with silicone gel implants
and 2) examine the aspect of pre-operative patient information.
The PR put out by the MDA, at times, misinterpreted this in information
to the public (letter on file) giving the impression that the
mandate consisted only of "patient information" aspect.
Efforts were made to open up the review system
with the IRG. For example, patients were invited to send in accounts.
There was a large response from casualties (this was confirmed
to us by the IRG Chair, Professor Sturrock) giving accounts of
the disease damage they attributed to their implants. Representatives
of groups, including Elaine Coomber and myself (SOS UK) were granted
oral interviews with the panel. Elaine Coomber reported to the
IRG some of the 2,500 calls she had received and logged from people
with implant problems. In the IRG report these numbers were not
given, nor was there any assessment or space given to the anecdotal
evidence on health problems. I do not mention this in the expectation
that the Health Committee will make clinical judgements, but as
an example of the lack of balance of information. More recently,
in response to our questions on new clinical evidence etc., the
IRG reponded by holding an Open Day Meeting. Our questions were
submitted in writing by the required deadline. In advance of the
meeting I requested and was granted by the Chairman, Professor
Sturrock undertakings that there could be a feedback take-up from
questions arising from the meeting. At the meeting several vital
questions were not sufficiently explored. After the meeting, I
conferred with fellow casualties and submitted a carefully set
out feedback letter from points arising (or having been missed)
at the Meeting. I sent a short addendum, giving chapter and verse
after having belatedly received a transcript of the meeting. Professor
Sturrock now informs me that he does not intend to take up the
feedback points after all. At the meeting the press were invited,
but allowed to stay only until the end of Chairman's opening remarks.
Clearly there was less than met the eye in this PR exercise.
THE PROCESS
WHEREBY INFORMATION
RELATING TO
RISKS IS
DISSEMINATED
Most of my points relating to this heading have
been covered under my previous headings. However, it is appropriate
here to mention the DH booklet entitled, "Breast Implants—Information
for women considering breast implants" as a member of the
Patients Association, I was included in the Breast Implant Patient
Information Group (BIPIG). Two other campaigners against silicone
gel implants, as well as a campaigner in favour of them were included
in the whole group which otherwise comprised plastic surgeons,
a private clinic representative, breast care nurses, NHS and Bupa
representatives etc. The booklet had been recommended in the IRG
Report. In terms of numbers casualties were fairly represented,
though, justifiably, in accordance with the conclusions of the
IRG Report, anti silicone gel implant campaigners were vastly
outnumbered by parties which approved of these devices. My personal
Everest was the struggle and eventual achievement to have included
(p6), a short paragraph on risks as reported by silicone casualties,
surrounded thought it is by "reassuring" caveats from
the DH. We feel that the booklet does not go far enough, particularly
in the light of high profile current advertisements promoting
cosmetic breast implantation. For example: there is no mention
of the situation in the US with regard to its form of moratorium
on silicone gel implants and the category iii (need for proof
of safety) into which these have been placed by the FDA nor of
those other countries which do not use silicone gel implants and
never used trilucent or hydrogel implants. Point 8, Consent for
Operation does not make it clear to the patient that although
Patient Consent is legally binding Information to Patients in
itself is not. There is absolutely no reference to the MDA as
a body to whom one should report if things go wrong. I fought
hard but unsuccessfully to have these last two items in the booklet.
The omission of access to the MDA is nothing less than disgraceful.
The heading "if things go wrong" on page 13 is printed
as a question the patient must ask her surgeon. This is quite
cruel because we know from experience that many surgeons would
respond very defensively to such a question and it simply leaves
the reader hanging in the air. It does not tell her where she
should go or to whom she herself could report under such circumstances.
The fact that the bodies to whom we should be able to report are
not up to the job is no excuse. It is early days yet to say how
effectively or otherwise the booklet has been distributed. But
we must remember that there is at present in the UK no binding
obligation for any medical body or individual surgeon to give
out the booklet to the patient.
THE INFORMATION
PROVIDED BY
THE DEPARTMENT
OF HEALTH
DIRECTLY TO
THE PUBLIC
AND ACTION
TAKEN IN
RESPONSE TO
CONCERNS RAISED.
Most of my points on this are covered under
previous headings. However, I wish to stress the point that where
there is massive inconvenience, involving interests of finance,
status, and even the humanely based unwillingness for medical
professionals to believe they may have harmed large numbers of
patients, the forces against genuinely responding to concerns
raised on safety are, likewise, massive. A most telling example
of this occurred during the IRG review period in 1997, when on
22 August BBC "Newsnight" in drawing the publics attention
to the review, the following statement was made: "A Department
spokesman said no evidence emerged (then ie earlier MDA reviews)
to support a ban and no new evidence is expected this time. At
best this review will demand women are better informed about the
operation they planned to undertake". This statement was
highly prejudicial in relation to the IRG mandate. I rang the
CMO press office and spoke to a Denise Shaw who confirmed that
this precise statement had indeed been given by the CMO's office.
I complained to her. She wrote to give me a revised statement
for some hypothetical future reference. I complained to the then
junior Health Minister, Margaret Jay. She replied personally by
letter saying she, too, had been perturbed by the statement and
had questioned CMO press staff, but that "no one in the Department
of Health, CMO's office or MDA or press office had delivered any
such quotation for this programme" I pursued the matter with
Naomi Goldman, producer of the programme. She confirmed that this
was a direct quote from a telephone conversation with an official
of the Department of Health. I went back to Margaret Jay. Some
time later I received a letter of apology from the MDA. One could
not afford the stamina to follow up all misinformation in this
way. This is just one of too many examples of behaviour which
is symptomatic. One does not have the stamina to insist upon the
true facts in this way in every case. But we are presented with
a problem in trusting the information from official bodies on
this issue. Going to Health Ministers, even through our MPs &
MEPs, has been unproductive. Clearly Health Ministers have simply
referred back to and supported their civil servants, endorsing
a closed ranks system, particularly in relation to the MDA.
GUIDANCE TO
HEALTH CARE
PROFESSIONALS
My main point on this has been addressed in
the Executive Summary of this letter, but it is worth emphasising
the need for a more centralised circulation in terms method and
approach. Occasionally, in response to a query, one suddenly hears
of some new organisation intended to bring about reform. Some
time later it seems to have disappeared into thin air. Such was
the case with the "Interdisciplinary Group for the Supervision
of Breast Implant Operations". This was mentioned to a member
of staff from "Health Which" in response to some expressed
misgiving by her to a DH official—and passed on by her to
me. I tried through the Royal College of Surgeons, BAAPS, MDA,
GMC etc, to follow this up. Nobody by this time had heard of it.
I queried it several times over a period of a year in letters
to Philip Hunt. Eventually, he gave me, through my MEP, the name
Mr Michael Brough. I wrote to Mr Brough to ask about the remit
of this group. He replied to my letter, but, to be honest, it
was quite clear that there was no remit over and above any normal
requirements for any operation—and certainly no clear plan
in sight. At least, this and other aspects which have emerged,
show lip service to the need for concerns on this problem to be
taken seriously in terms of both information and action. I hope
that the outcome of this inquiry will aid the direction of some
positive steps towards this goal.
February 2001
48 Attachments not printed. Back
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