Annex 1
Statement of Russell Levy to the National
Academy of Sciences' Institute of Medicine, review of the safety
of silicone breast implants
I am a solicitor and partner with Leigh Day
& Co. We are specialist medical, environmental, product liability,
occupational health and industrial disease lawyers. I have acted
on behalf of women concerned about the safety of silicone breast
implants since 1992 and represent 450 women from all over the
United Kingdom (a few of our clients live in other European countries
or the United States) who have suffered illnesses or injuries
that they believe were caused by their silicone gel breast implants.
In this statement I will confine myself entirely to important
issues that I believe the panel needs to consider when evaluating
the contribution made to the debate by the recently published
report of the Independent Review Group (IRG) to the United Kingdom
Government's Chief Medical Officer.
Like other people interested in the field I
warmly welcomed the incoming Government's decision to set up a
group to review the possible health risks associated with silicone
gel breast implants. However, it became apparent from a very early
stage that the IRG's focus was to be largely upon consent issues
and that it was structured in such a way as to make an in-depth
review most unlikely. In the end, I regret to have to say that
the report is essentially nothing more than a glorified literature
review. The IRG took oral evidence from only 18 people of whom
I was one. The only specialist doctors or scientists who have
been concerned about the health risks associated with silicone
on behalf of patients who gave evidence were Professor Garry and
Professor Shanklin. Offers made by me and others to arrange for
other eminent experts from the United States to give evidence
to the IRG were not taken up. I am not aware of any steps taken
by the IRG or the Medical Devices Agency of the Department of
Health (the MDA) to seek out scientists or doctors from whom they
believed evidence should be obtained; the process, I believe,
was essentially a passive one, with the IRG only considering taking
evidence, on the whole, from those who offered.
What the panel should know is that contrary
to media reports and the way in which their conclusions have been
represented by the manufacturers of silicone implants and plastic
surgeons, the IRG did not conclude that silicone implants are
safe. It concluded that there is at present insufficient evidence
of a link and recommended further research.
Although the IRG states it considered written
evidence, again, so far as I am aware, no public appeal was made
for people to submit evidence to it. I provided the IRG with an
anonymised list setting out the symptoms each of our clients complains
of with an offer for the IRG to select for themselves those women
whose medical charts they wished to review or whom they might
wish to have examined and speak to. The offer was declined; instead
the IRG took evidence from only three representatives of silicone
support groups. The IRG did not solicit plaintiff and defence
submissions to the rule 706 panel appointed by Federal Judge Pointer—I
gave these to them.
The IRG comprised six doctors and one lawyer.
My understanding is that for all of the members this was a part-time
appointment carried out in conjunction with their other usual
appointments and duties. The report lists nine advisers who "were
asked to consider specific information". The IRG was also
assisted by a secretariat provided by the MDA. The extent to which
the members of the IRG themselves considered the evidence rather
than relying upon the interpretation of others is unclear. What
is clear, however, is that this was not an exhaustive investigation
carried out by the members of the IRG.
Limited literature reviews in relation to the
possible association between silicone gel implants and connective
tissue disease were carried out by the Medical Devices Directorate
which subsequently became the MDA. [12]The
1993 report was authored by Tinkler, Campbell, Senior and Ludgate
and the 1994 article by Tinkler, Gott and Ludgate based on a study
by Tinkler and Gott. They came to the conclusion that there was
insufficient evidence of an association between implants and connective
tissue disease which, crucially, became the basis for the United
Kingdom Government's decision not to take any steps to regulate
the use of silicone gel-implants.
Three of the four members of the secretariat
provided by the MDA to the IRG were Dr Gott, Dr Ludgate and Mr
Tinkler. There is no doubt that their minds were made up before
the IRG started its work—attached is a copy letter from
Mr Tinkler to one of my clients dated 5 August 1997. [13]In
particular I would draw your attention to the first paragraph
where Mr Tinkler states:
"Thank you for your letter.. enquiring about
the position of the Medical Devices Agency on silicone gel breast
implants. I enclose a copy of a summary of the Agency's views...
Unfortunately we have not had time to update this since April,
since when the Minister of Health has asked for a further review
of the subject. This will concentrate particularly on the issue
of the provision of appropriate advice to women contemplating
surgery, since conclusions about the health risks relating to
silicone are now fairly well established." (My emphasis)
When I was called to give evidence, the IRG
wanted to focus exclusively on consent issues. They were surprised
when I insisted that whilst consent issues were important, the
real issue that needed to be addressed was whether there is sufficient
evidence as to the safety of silicone implants. The evidence given
by the other plaintiff's lawyer who appeared before the IRG, Mr
Paul Balen, focused almost entirely on consent issues. If the
panel wishes copies of the transcripts of the evidence can be
submitted.
The IRG recognised the paucity of good evidence.
They failed to consider why that should be so given that the products
have been marketed for over 30 years and manufacturers have had
more than ample opportunity to obtain good evidence. Regrettably,
the IRG was only prepared to recommend limited research into the
true incidence of rupture and the aetiology of symptoms in particular
in relation to sub-clinical infection. It decided, effectively
on a cost benefit analysis, that it could not justify recommending
further epidemiological studies to investigate any link between
silicone implants and connective tissue diseases even though it
recognised that the majority of reported cohort studies were based
on a diagnosis reported by a doctor and referred only to specific
diagnostic groups. Although the IRG were not prepared to recommend
further research, on the checklist of issues they suggest plastic
surgeons must discuss with patients considering cosmetic breast
augmentation surgery the "possible association between silicone
and generalised illness such as connective tissue disease or autoimmune
effects or a new connective tissue disease like syndrome"
is included.
It is also regrettable that the IRG includes
only one specialist plastic surgeon who has himself continued
to use silicone breast implants throughout the period of the review
and only one epidemiologist who had himself previously published
summaries of epidemiological studies concluding that there was
insufficient evidence that silicone implants were unsafe. When
I gave evidence to the IRG the epidemiologist, Professor Silman,
stated "... one is always left with the anxiety is one dealing
with the complication of an implant or the complication of being
the kind of woman who subject herself to an implant."
My own major criticism is of the approach that
has characterised the United Kingdom Department of Health's view
in relation to silicone gel implants throughout this decade: there
is insufficient evidence that silicone implants are unsafe rather
than seeking sufficient evidence of safety. I was not successful
in persuading the IRG that if the manufacturers could not show
that their products were safe after more than 30 years, the public
interest demands a very cautious approach to the use of those
products. The IRG felt that..."...safety is not a simple
concept..." Essentially their report concluded no more than
the previous Medical Devices Directorate reports that there is
insufficient evidence of an association between silicone gel implants
and abnormal auto-immune responses and connective tissue diseases.
Media in the United Kingdom, including those who should know better[14]almost
universally reported the IRG conclusion as demonstrating that
silicone implants are safe. Most regrettably, the IRG took not
steps whatsoever to caution members of the public that this is
by no means necessarily so.
If there is any information that the panel would
like I would, of course, be more than happy to assist further.
27 August 1998
12 see for example MDD report/92/42 February 1993
and Health Trends Volume 26 No.1 1994 p25. Back
13
Not printed. Back
14
"UK review group gives silicone implants all clear"
The Lancet Volume 352 July 18 1998. Back
| 
