APPENDIX 7
Memorandum by Professor David T. Sharpe
O.B.E. (B 11)
I am writing on behalf of the British Association
of Aesthetic Plastic Surgeons regarding the Health Committee enquiry
into the provision of information by the Government into the safety
of breast implants. I also represent EQUAM (European Committee
on Quality Assurance of Medical Devices in Plastic Surgery), am
Chairman of The Breast Special Interest Group of The British Association
of Plastic Surgeons and the Past President of The British Association
of Aesthetic Plastic Surgeons.
While I recognise that the issue of the safety
of breast implants is not under discussion I feel it is necessary
to summarise current orthodox medical opinion on silicone gel
breast implants. As I realise that the Committee will have been
petitioned by Anti Silicone Group Campaigners I wish to deal with
their concerns over local complications of breast implants.
It is quite true that in 1991 the FDA imposed
a moratorium on silicone gel implants for cosmetic purposes but
continued to allow them for breast reconstruction. This was because
there was insufficient information to refute the allegations that
they were a health hazard. Time has moved on and an enormous number
of independent reports have been produced by scientists and physicians,
including the Report of the Silicone Gel Breasts Implants Independent
Review Group (Department of Health, United Kingdom), who can find
no link with systemic disease.
Statements from the American College of Rheumatologists,
American Medical Association and the American Academy of Neurologists
and even the FDA themselves confirm the absence of evidence in
favour of health hazards. Recent epidemiological studies including
the women's cohort health study of 425,000 medical workers and
numerous other studies throughout America and Europe have shown
that despite some theoretical evidence of a mechanism which could
cause illness none has been demonstrated, in other words women
with breast implants within a single cohort have no significant
difference in illness to those without them. The complex scientific
evidence associated with the controversy has been reviewed by
a number of independent review groups. Judge Pointer set up a
scientific panel of independent experts and most recently the
Institute of Medicine in America consisting of 13 physicians all
established an absence of systemic illness. This is indeed fortunate
as silicone is widespread throughout society being used in products
which can be inhaled and in direct contact with the body, such
as lubrication for all needles and syringes (a diabetic would
accumulate more silicone in a life time at injection sites than
would leak from breast implants), an anti-foaming agent in food
stuff, for example Infacol which is anti-flatulence remedy given
to infants orally, is 100 per cent silicone and cosmetics, floor
polish, aerosols etc all contain it.
The FDA has not yet lifted its moratorium although
experts in the States feel that is about to do so. It is, of course,
being targeted by lawyers who wish to maintain the confusion and
controversy as the lifting of an embargo would deprive them of
large sums of litigation revenue.
Controversy now centres on the integrity of
implants themselves and the complications that might occur locally
following their rupture. There is no question that breast implants
even though very effective do have a down side which must be properly
evaluated by the clinician and patient before their use but I
am passionate in my belief that inaccurate poorly controlled studies
and junk science should not prevent the use of these valuable
devices by creating an aura of unscientific mistrust and prejudice.
Briefly there are three generations of implants.
The first manufactured from 1963 to 1975 had
a thick wall and contained silicone gel, few of these ruptured
and many are still in place today without problems.
The second-generation implant from 1975-86 was
fundamentally flawed, had a thin wall and 50 per cent of these
ruptured within 15 years. I have personally dealt with a large
number of them and recently published a paper in the American
Journal of Plastic and Reconstructive Surgery of 482 the largest
personal series in the World. The consequences of rupture were
in every case insignificant and easily dealt with although one
or two of these cases required some resection of breast tissue.
The third generation implants from 1986 onwards
have much thicker shells and have very much lower rupture rates.
I have used 1,500 in the last ten years of which I have operated
on 150 of these for reasons of capsular contracture, concern regarding
the silicone controversy and for change of size. In only two of
these were there any rupture, none of which entered the breast
tissue.
Many of the anti-silicone breast implant campaigners
rely on the study by Lori Brown previously of the FDA. This study
is fundamentally flawed because it discusses only second generation
implants and completely ignores the first generation and excludes
third generation implants for non-scientific reasons. The Editor
of the Lancet agreed with my condemnation of the paper
and refused to publish it, and it may be very interesting to you
to see a review in the Washington Times which speaks for
itself of which I enclose. [6]It
was of great interest to the Editor of the Lancet that publication
was expected as he would like to think he presides over a journal
which is subject to scientific scrutiny and is not a forum for
political intrigue.
The limitations and potential hazards of implants
have been well set out in the Department of Health leaflet, Breast
Implants, information for Women considering breast implants, which
will be familiar to you and I believe this to be an authoritative
analysis of the pros and cons of the use of breast implants which
was compiled with the main breast implant protest groups, and
I myself was on the panel. Armed with this leaflet and with the
advice of a properly qualified plastic surgeon, I believe women
are able to make an informed decision on the suitability of implants.
6 Not printed. Back
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