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2003-10-18 13:31:36 UTC

Minutes of IRG Meetings

What is silicone ?

History: the assessment of health effects attributed to silicone gel
breast implants

Regulatory requirements for breast implants

Infection: studies reviewed

Fate of Gel Bleed


Histopathology Review

Tests commissioned by the IRG

Immune responses to silicone gel breast implants

Statistical aspects and sample sizes

Survey of epidemiological studies from 1970 - 1998

Effects on children of implanted women

Toxicity of silicones

Consent to medical treatment

The National Breast Implant Registry

Mammography and
Breast Implants

Adverse incidents

Press Notice

Open Day

Information for Women Considering Breast Implants
The Department of Health has published an information booklet for
people considering breast implants. This can be downloaded from their
website - http://www.doh.gov.uk/bimplants.

PDF copy of Publication
A complete copy of the Silicone Gel Breast Implants review, published
to work alongside this web site, is available in Adobe pdf format by
clicking on the symbol on the left.
If you have not got the Adobe Acrobat reader software that is required
to view this document you can download it free of charge by clicking

Reference Database
A searchable database of published references available to the IRG
predominantly from literature searches on commercially provided

If you have any comments you wish to make about this publication
please send an email to the following address,
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2003-10-18 20:11:03 UTC
Post by User123
If you have any comments you wish to make about this publication
please send an email to the following address,
My opinion is that this "review" was just another bogus
"investigation" ... and all in all ... looks like an advertisement for
the Plastic Surgeons ..

Here are others opinions on this:

Silicone Gel Breast Implants: The UK IRG Report ~ Letters to the JNEM

Date: Fri, 23 Jun 2000 21:00:55 -0700

From: ilena rose ***@san.rr.com

~~~ Soon the IRG will be meeting again in Britain to look over what
they reported in June, 1998 on Silicone Gel Implants. Here are some
Letters to this Journal by several of us, that I never found before in
postable form. Our European and British activists are going to need
support to help ensure that this year's report is not the debacle that
the original was. ~~~


Letters to the editor

Journal of Nutritional & Environmental Medicine; Abingdon; Dec 1998;
Volume:8 Issue:4

Silicone Gel Breast Implants: The UK IRG Report


Sirs: The IRG Report claims a complete study of subject and literature
and many documents from American manufacturers. This claim seems
exaggerated compared to the rich scientific and clinical literature
establishing beyond doubt that silicone devices are dangerous

My meeting in May 1997 with Baroness Jay and the Medical Devices
Agency (MDA) started the review. I projected numerous color
photographs showing silicone spread and immunopathological reactions
to it.

In June 1997 Dr Ludgate and Professor Sturrock asked me to prepare a
brief on causation due to silicone: The Yellow Book (TYB, the cover
color) has 136 pages and a 38-page summary [1].

Cited were 284 specific references up to June 1997 for the summary.
Forty more were in three appendices; a fourth appendix had 189
important references not used in the summary. Our working reference
list contained over 1200 cites at the time. By contrast, the IRG
Report cites 10 papers, three more recent, and the 1994 MDA Report
(their website has a longer list).


The Report has no cites on device failure. They said, lacking a
precise figure for the prevalence of device rupture, they could not
recommend a moratorium.

Implantation of medical devices is clinical medicine, not analytic
chemistry. One does not need a precise figure, just an order of
magnitude or a reasonable estimate, for common-sense practice. The IRG
cannot say they had no data. They had much data, some in TB and more
from December 1997.

The prevalence of rupture is circa 30% at five years, 50% at 10 years,
and 70% at 17 years post implantation. These trends were confirmed in
July 1998 at the National Academy of Sciences (NAS) in Washington.

Robinson (1014 devices), Goldberg (5500 + ), and Feng (1619) confirmed
these trends. Dow Corning product return data (p. 20, TYB) fell into
this range with an annual rate of 6.37%.

There can be no excuse for keeping such a defective product on the


The Report said there was no abnormal reaction to silicone. This means
silicone is not inert since, when put affirmatively, there is
reaction! There is something abnormal about it, however; it can last
for three decades or more, unusual in human pathology. Little and
Baker [2] showed that healing of the operative wound is delayed
significantly by the silicone device. Fifty per cent healing for
ordinary surgical wounds of that size takes about six weeks [3];
half-healing around silicone implants takes nineteen weeks [2]. Thus,
the reaction is abnormal because it does not proceed on a normal
schedule. The immune system becomes thoroughly

engaged during this latent phase; regular healing does not leave an
immune memory state.

The pathological evidence for a reaction to silicone is overwhelming.
This was detailed in TYB; dozens of articles are available for this

Immune process

The IRG concluded that the method and results of the Smalley T cell
method [4] had not been confirmed. TYB contained many citations
showing the essence of the test for silicone and silicates going back
to 1980! The basis for this test was confirmed at the NAS by Fred
Miller of the Food and Drug Administration (FDA). He demonstrated
immunohistochemically that lymphocytes in or near the capsules are
memory T cells by expression of CD44. Immune cells coming into the
scar are responding to specific cellular signals. Recently we
identified 117 examples of immunopathic lymphoplasmacytic vasculitis
in 454 silicone patients (25.8%) [5]. This is the group most likely to
convert to chronic immunopathic or autoimmune processes.


The Report concluded that there was no epidemiological evidence for
traditional rheumatic diseases due to silicone. Not so. The American
claims office medical certifications show significant increases in
lupus and scleroderma. This summary was given to the IRG.

No published epidemiological study makes the distinction between
status and sequelae. Some, despite short time periods, reveal
important increases in classical rheumatic disorders [6]. Most women
have mixed rheumatic disease, new in human experience.

The IRG uncritically accepted poorly designed epidemiological reports
as proving a lack of causal connection and then said no further
studies are indicated. They accepted as definitive a Swedish study
based only on hospital records [7]. This ignores the fact that
rheumatic diagnosis is an outpatient exercise [8]. The IRG committed
the logical fallacy of equating absence of evidence as evidence of

Industry documents

Professor Sturrock found no evidence in industry documents. This would
have been formidable: public releases of Dow Corning documents run
well past 10,000 pages. An executive summary of internally recognized
problems runs for 384 pages. Short lists [9] of the most significant
were provided to the MDA/IRG in May 1997.

Silicone devices do not work as intended and carry grave risks of
harm. Even if one were to conclude that some points need more study,
logic suggests stopping implant use now to prevent putting more women
at risk and making use of past and current cohorts to assess the
situation, thus fulfilling the premise of primum non nocere.


University of Tennessee, Memphis, 134 Grove Park Circle, Memphis,
Tennessee 38117, USA REFERENCES

[1] Shanklin DR. Injury and disease due to implantation of silicone
devices. Gainesville FL, EEC Press, 1997, p. 136.

[2] Little G, Baker JL. Results of closed compression capsulotomy for
treatment of contracted breast implant capsules. Plast Reconstr Surg
1980; 65: 303.

[3] Carrel A, Hartmann A. Cicatrization of wounds. I. The relation
between the size of a wound and the rate of its cicatrization. J Exp
Med 1916; 24:429-50.

[4] Smalley DL, Shanklin DR, Hall MF, Stevens MV, Hanissian A.
Immunologic stimulation of T lymphocytes by silica after use of
silicone mammary implants. FASEB J 1995; 9: 424-7.

[5] Shanklin DR, Smalley DL. Lymphoplasmacytic vasculitis as a late
stage in siliconosis (unpublished data).

[6] Hennekens CH, Lee I-M, Cook NR, Hebert PR, Karlson EW, LaMotte F,
Manson JE, Buring JE. Self-reported breast implants and
connective-tissue diseases in female health professionals. J Amer Med
Assoc 1996; 275: 61621.

[7] Nyren O, Yin L, Josefsson S, McLaughlin JK, Blot WJ, Engqvist M,
Hakelius L, Boice JD, Adam H-O. Risk of connective tissue disease and
related disorders among women with breast implants: a nation-wide
retrospective cohort study in Sweden. BMJ 1998; 316: 16.

[8] Shanklin DR, Smalley DL. Study adds nothing to knowledge of
processes of tissue injury induced by silicone (letter). BMJ 1998;
317: 470.

[9] Shanklin DR, Smalley DL. Silicone immunopathology. Science &
Medicine (Sept.-Oct.) 1996; 5: 22-31.


Sirs: As one of the scientists invited to give testimony to the
Independent Review Group (IRG) on Silicone Gel Breast Implants (SBI),
I was extremely dismayed about many aspects of the report. One serious
deficiency of the IRG Report is the dismissal of the seriousness of
local complications that occur after SBI implantation. The report
implies that, because we do nothave precise numbers on their
incidence, they can be ignored. However, it is now well established

(a) About half of SBIs rupture in 7-10 years, and more than 95% of all
SBls will be ruptured by 20 years [1].

(b) SBIs induce a foreign body reaction. The process may be "natural",
but it is also often disfiguring and painful. The majority of SBI
recipients experience some degree of fibrous capsule formation,
capsular contracture and/or implant displacement.

(c) All SBIs bleed silicone through the silicone rubber shell which
can induce a local chronic inflammatory or granulomatous reaction.
Silicone which bleeds out of the implants or is released after rupture
can also migrate to various organs, including liver, ovaries, joints,
and spinal cord, where it can induce inflammatory or granulomatous
reactions. Release of cytokines, chemokines and other mediators from
these "local" lesions provides a plausible mechanism to partially
account for systemic silicone-related connective tissue disease.

(d) Resurgeries to replace ruptured implants or because of other
"local" complications are frequent. A study from the Mayo Clinic
showed that a fourth of SBI recipients required additional surgery
within 5 years [2]. Besides overt rupture and capsular contracture,
other local complications of SBI noted by the Mayo researchers were
chronic pain, calcification, skin rashes, tissue necrosis (nipple,
aureole, etc.), and infections (the only "local" complication admitted
by the IRG).

(e) Some SBI recipients experience a loss of breast sensation,
particularly in the nipple area, which can cause difficulties with or
prohibit breast feeding. A study from Texas Children's Hospital showed
that 64% of augmented women had insufficient lactation, compared with
fewer than 7% of nonaugmented women (p<0.001) [3].

British women with SBIs should have been encouraged by the IRG to have
regular mammograms from facilities experienced with SBI recipients,
not misled by the statement that "Breast screening arrangements are
not affected by the presence of an implant (IRG Report, p. 29)".
However, even with "diagnostic" mammography (the standard recommended
in the US for implanted women), which subjects the breast to
additional views and more radiation than "screening" mammography,
20-80% of breast tissue can be obscured by an SBI. Many SBI recipients
have had carcinomas undiagnosed or

mistaken for "silicone granulomas" during mammography. Some studies
have shown breast cancer in SBI recipients to be more advanced (more
invasive, more positive nodes) than in non-implanted patients [4].
Furthermore, implantation of SBI obscures and reduces the sensitivity
of breast tissue, making it more difficult to perform a proper breast
self-exam. Women should be advised of this risk when contemplating SBI
for cosmetic purposes.

Moreover, breast cancer survivors should be informed that the presence
of a radiopaque device makes it more difficult to detect cancer

The IRG Report seems intended more to placate the concerns of women's
advocacy groups than to truly address SBI safety issues. Why does the
Report refer to Dr D. Radford Shanklin and myself as "particularly
cited by patient groups?" It seems that we were invited to testify as
"straw men" to be deconstructed and to have our work dismissed. In
this regard, I am concerned that several members of the IRG had
already taken public positions on the "safety" of silicone breast
implants or related issues. The six original members of the IRG (all
male) seem to have been hand-picked to reach a conclusion consistent
with prior Medical Device

Agency reports.

In my IRG testimony I discussed results regarding a serological marker
for systemic silicone-related disease called the antipolymer antibody
(APA). Results of a blinded clinical trial using the APA assay were
reported in a respected international medical journal last year [5]. I
presented to the IRG a number of as yet unpublished studies confirming
and extending these esults. However, in the IRG Report it says that I
did not present any evidence on cross-reactivity of APA with
anti-silicone antibodies,

"although this should have been readily demonstrable (IRG Report, p.
19)". In fact, on p. 23 of the transcript of my IRG testimony, it is
shown clearly that data on cross-reactivity of APA with anti-silicone
antibodies were presented to the IRG. Indeed, I made every effort to
emphasize this point at the meeting. The cross-reactivity tissue was
mentioned again in a follow-up letter to the chair of the IRG. Why is
this inaccurate and misleading statement in the Report?

The IRG report on SBl is an opportunity lost for the United Kingdom.
The Report clearly gives the impression that, except for some minor
pain associated with surgery and inconsequential local effects,
silicone breast implants cause no harm. Nothing could be further from
the truth.


Department of Microbiology and Immunology SL-38,

Tulane University School of Medicine,

New Orleans, LA 70112, USA


[1] Brown SL, Silverman BG, and Berg WA. Rupture of silicone-gel
breast implants: causes, sequelae, and diagnosis. Lancet 1997; 350:

[2] Gabriel SE, Woods JE, O'Fallon WM, Beard CM, Kurland LT and Melton
L.l. Complications leading to surgery after breast implantation. N
Engl J Med 1997; 336: 677-82.

[3] Hurst NM. Lactation after augmentation mammoplasty. Obstet Gynecol
1996; 87:1, 30-4.

[4] Silverstein MJ, Handel N, Gamagami P, Gierson ED, Furmanski M,
Collins AR, Epstein M and Cohlan BF. Breast cancer diagnosis and
prognosis in women following augmentation with silicone gel-filled
prostheses. Eur J Cancer 1992; 28: 635-40.

[5] Tenenbaum SA, Rice JC, Espinoza LR, Cuellar ML, Plymale DR, Sander
DM, Williamson LL, Haislip AM, Gluck OS and Tesser JR. Use of
antipolymer antibody assay in recipients of silicone breast implants.
Lancet 1997; 349:449-54.


Sirs: In order to better understand the complexity of silicone
gel-filled breasts implant a short history is indicated.

Johann Berzelius, a Swedish chemist, isolated the element silicium or

silicon in 1824. The first organosilicon compound was made in 1863.
Frederick Kipping of England cast the term silicone by fusing silicium
and ketone. In 1963 plastic surgeons started to introduce this
man-made polymer in the form of a breast implant. At that time no laws
controlled the use of liquid silicone or any implantable devices. In
1965 the Food and Drug Administration (FDA) of the USA declared liquid
silicone a drug and forbade its parenteral use in humans. In 1976 a
public law 94-295 was passed that required classification of all
implantable devices. Because of pressure and intimidation by the
manufacturers, the FDA was negligent by failing to classify the
silicone gel-filled implants into Class III which required the
manufacturers to give clear and documentable proof of the safety and
efficacy of their product. The FDA did so only in 1992 after the
Courts found the manufacturers guilty of fraud. To this date the
manufacturers still have not given such required proof.

The silicone gel-filled breast implant is a heterogeneous combination
of polymers, mineral fillers, catalysts, accelerators, stabilizers,
lubricants, stripping agents, plasticizers, inhibitors, fillers and
solvent residuals. 52-95% of the silicone gel is liquid silicone,
contained within a three-dimensional network of cross-linked silicone
chains. It consists of a mixture of cyclic and linear chains of
various molecular weights with different cytotoxic and immunotoxic
effects. The elastomer envelope, fortified with 30-volume % amorphous,
fumed silica, is a lattice with microscopic openings. Thus, the 15
chemical precursors used in making a gel-filled breast implant are
released into the woman's body over a lifetime. The highly toxic
ethylenoxide is used for gas sterilization and is partially absorbed
by the silicone gel and later diffuses into mammary tissues. An
implant rupture simply accelerates and intensifies the

dispersion of its contents.

We are dealing with a drug delivery system, the drug being liquid
silicone. Injectable liquid silicone and liquid silicone from silicone
gel are identical. They diffuse into the human body in the form of
microdroplets measuring 0.1-10 microns. One cubic centimeter of liquid
silicone dispersed into billions of microdroplets has a tremendous
contact surface with human cells. The dissemination occurs through
phagocytosis by macrophages and

direct migration into the lymphatic and vascular system. Presently,
there is no proven method by which liquid silicone can be removed from
vital organs such as the brain, spleen, liver, bone marrow and the
heart muscle. This is an irreversible process!

The symptoms caused by silicone gel-filled breast implants are local,
regional and systemic. Plastic surgeons have removed several thousand
silicone gel-filled breast implants. Ninety percent of local symptoms
disappeared and in 70% of patients systemic symptoms improved. A
re-implantation of implants in 2 women, 4 months after explantation,
immediately brought back all symptoms, illustrating Robert Koch's
principle of cause and effect.

In the early 1970s the FDA permitted two well-controlled 7-year
studies of liquid silicone's clinical use. Because of a high rate of
complications the studies were stopped after 2 years and the
parenteral use of liquid silicone was forbidden. For years the
manufacturers have urged that ruptured implants should be removed.
They have warned that silicone breast implants should not be used in
any patients with signs of autoimmune disease.

In the Proceedings of the Royal Society of Medicine, Vol. 46, 647,
1953, Mr John T. Scales of the Plastic Research Unit, Institute of
Orthopaedics, University of London, described the necessary qualities
of synthetic material to be used as implants as follows:

(1) Not to be physically modified by tissue fluids.

(2) Be chemically inert.

(3) Not excite an inflammatory or foreign body cell response in the

(4) Be non-carcinogenic.

(5) Not produce a state of allergy or hypersensitivity.

(6) Be capable of standing up to mechanical strains imposed upon it.

(7) Be capable of being fabricated with reasonable ease at a
relatively low


(8) Be capable of being sterilized.

Only the last two requirements have been fulfilled. Number 4 is still

In view of the recent decision by the Independent Review Group that
silicone gel-filled breast implants are safe, it should be pointed out
that none of the six physician members has ever done any basic
silicone research or published any scientific papers on liquid
silicone. The Independent Review Group failed to consult with an
expert in biomaterials. All their conclusions were based on hearsay
information. Thus, the long-term effects of implanted silicone
material on the human body have never been addressed.

It is therefore my opinion that silicone gel-filled breast implants
are not safe and should not be used in women. Any continued use of
this unsafe drug delivery system is tantamount to unethical and
irresponsible experimentation on women.


PO Box 1112, Rancho Mirage, California 92270


Sirs: In the article recently published as "Syndromes Associated with
Silicone Breast Implants" there were several areas that were deleted,
by the author, and these sections deal directly with the issue of
causation [1]. At the core of the issue all the epidemiological
studies on silicone breast implants have one thing in common; they are
all designed either to investigate or to obfuscate the issue of
causation. Unfortunately, silicone does not fulfill any of the
scientific epidemiological criteria for either sufficient or necessary
cause of the disease that appears to be associated with silicone gel
implantation. While it is tempting to assert that there is a direct
risk from silicone there is little scientific evidence to support that
conclusion, although it may play a secondary role in the pathogenesis
of disease. There is considerable evidence to suggest that the
indirect (autoimmune) factor(s) is/are central to the development of a
disease from the presence of silicone. Moreover, the biochemical
activity of silicone has been well documented by Dow Corning Health
and Environmental Sciences 1997 as an internal animal study
#1997-100000-43454 [2]. Whether autoantibodies are merely associated
with the development of a silicone adjuvant disease or play a central
role in the cause of the illness is often difficult to determine.

Witebsky [3] has erected a set of postulates that are routinely used
to determine the relationship of immunology phenomena to the etiology
of a specific disease.

The autoimmune response must be regularly associated with the disease

There is convincing evidence that polyneuropathy (demyelinating) is
associated with patients complaining of symptoms after silicone gel
implantation. This may be associated with a variety of autoimmune
chemical phenomena. Less convincing, but an association of
demyelination of the central nervous system and anti-thyroid
antibodies may be found in approximately 2>25% of the patients with
symptoms following implantation. Furthermore, local immune responses
may be found in the capsule surrounding the silicone gel implants and
this includes activation of macrophages, B and T lymphocytes and
selected T cell receptor utilization and interleukin-2 antibodies.
Moreover, HLA typing has demonstrated that there is a significant
HLA-DR52-53 positivity in those symptomatic patients with silicone gel

(2) A replica of the disease must be inducible in animals

Peritoneal inflammatory granulomatosis, foamy conglomeration and,
finally, plasmacytomagenesis in genetically susceptible mice
(BALC/C.DBA/2-IHDI-PEP3) have been shown following intra-peritoneal
injection of silicone. In addition, experimental allergic
encephalopathy (EAE) and experimental allergic neuropathy (EAN) have
been extensively studied. Moreover, silicone gel and
octamethylcyclotetrasiloxane (D4) have been shown to potentiate
antibody production to bovine serum in A/J mice.

(3) Immunopathologic changes in the natural and experimental diseases
should parallel each other

EAN and EAE have been extensively studied and each of the adjuvant
dependent antigens has been identified. In the EAN disease, produced
in susceptible animals, the Po glycoprotein, P2 lipid binding protein
and the myelin associated protein (MAG) have been, etiologically,
associated with the development and progression of the disease which
parallels that found in silicone breast implant adjuvant disease
associated with peripheral neuropathy. The protein, PI, also named
myelin basic protein (MBP), is found only in the central nervous
system and is responsible for the animal model of EAE. In the model of
EAN, commonly produced in Lewis rats, a maximum histocompatibility
complex MHC II response regularly occurs which is medicated by T cells
and occurs in the following stages:

(A) Alteration of the blood-nerve barrier with the infiltration of T
cells within 72 hours after the challenge.

(B) Migration of the inflammatory T cells with the presence of edema
and it is associated with a decrease of nerve conduction. This occurs
within 45 days following the induction of EAN.

(C) CD4 (T) cells predominate with the production of cytokines, which,
in turn, increase the cell adhesion molecules by endothelial cells.

(D) Finally, there is accumulation of macrophages, T cells,

polymophonuclear leukocytes which when activated release free oxygen,
hydroxyl radicals, proteases and lipases. The damage appears to be
oxidative damage, while the protein and lipid enzymes are produced in
order to digest the damaged cells debris. These changes have been
observed in patients with Sural nerve biopsies.

Thus, the balance between the intensity of the initial inflammatory T
cell response and the antibody concentration may then determine the
clinical course of the disease.

(4) Transfer of the autoimmune illness should be possible by the
transfer of serum or lymphoid cells from the diseased individual to a
normal recipient

This study has not been performed to the knowledge of the author. The
only evidence is that of passive transfer of immunologic stimulation
of lymphocytes found in some children of silicone breast implant
mothers. All these children have complained of arthalgias, growth
disorder, abdominal pains, exhibited esophageal dysmobility on
endoscopy and demonstrated learning attention deficit disorders.

In conclusion, I do not believe that epidemiological studies alone and
the continuing rhetoric will be adequate either to prove or to
disprove if there is a definitive relationship between silicone breast
implants and disease and, furthermore, adequate biological and
biochemical studies will be required.


6560 Fannin, Suite 720, Houston, Texas 77030, USA


[1] Ericsson AD. Syndromes associated with silicone breast implants: a
clinical study and review. J Envir Med 1998; 8: 35-51.

[2] Varapath S, Salyers K and Plotzke K. Non-regulated study:
identification of major metabolites of octamethylcyclotetra-siloxane
(D4) in rat urine, Dow Coming Internal Memorandum (August 26, 1997),

[3] Barrett J. Textbook of Immunology. St Louis, MO: C. V. Mosby
Company 1988: 36>2.


Sirs: As a casualty of silicone gel leakage/disease who is conversant
with studies on both sides of the argument, as well as with the
accounts of many fellow sufferers, I offer my response to the full
Independent Review Group (IRG) Report in a lay capacity. I suggest
that the Report displays a general failure to weigh the data and
assess the evidence with proper scrutiny.

For example, in the website details of the Report, manufacturers'
information is described as sometimes 'patchy' and the exact nature
and source of materials being tested `was not always possible from
data provided'. Standards of processing had, therefore, to be
'assumed' to be adequate. Are these imprecisions compatible with
scientific rigour?

When the panel finds insufficient evidence from the slides provided by
Professor Shanklin, this is taken to detract from the credibility of
his silicone-unsafe opinion. When, on the other hand, the panel
receives insufficient data from the manufacturers, this is not taken
to detract from the silicone-safe opinion.

A point of great concern has been the dominant influence of the
Medical Devices Agency (MDA) during the review period. This is
manifestly apparent in the Report. An example can be seen in the
Histopathology section, website, page 1, para. 4, where Professor
Shanklin's work is interpreted with MDA aid. Another is seriously
evident in the Immune Response website section. This is introduced by
congratulations to the MDA from the IRG on

the methodology of the MDA's earlier Independent Expert Advisory Group
(IEAG) review. On the strength of this, the panel is content to
exclude from its assessment any studies which pre-date 1994 when the
IEAG review was published.

The MDA has been committed to the silicone-safe stance from the outset
of and throughout the review period. When this was questioned we were
told that the MDA was acting as secretariat; but should a partisan
body have been employed as secretariat? Has not the MDA by far
exceeded the secretariat role? Does this not block any fresh-eyed
approach essential to an independent review?

In the Summary Report, page 21, the Role of Epidemiological Studies to
Assess Risk, the drawbacks of cohort study, case study and
meta-analysis are honestly admitted. So where do we go from here?
Should not an

open-minded but skilful consultation with reported casualties be high
on the agenda?

In the Summary Report, pages 19 and 20, the studies of Ellis and Young
et al. are selected as worthy of further exploration. Elsewhere, the
sense of inconclusiveness with regard to the evidence of the disease
link is manifest. How can the panel feel at ease in allowing this to
be interpreted as safe-to-continue?

Professor Sturrock, the chairman of the IRG, and Baroness Jay prided
themselves on having invited written and oral accounts from patients.
During the review Professor Sturrock commented on the enormity of the
response. We know from our own feedback from helplines and the
representations we made to the panel on behalf of those who had
contacted us that substantial numbers submitted anecdotal evidence on
the silicone/disease link. Nowhere, in either the Summary Report or
the website details, were these patients' accounts given any analysis,
assessment or mention.


Action Against Silicone Gel (UK), 34 Haughton Drive, Northenden,

M22 4EQ


Sirs: American corporations have long been known to "dump" outdated,
faulty and dangerous medications and devices overseas. Silicone breast
implants fit well into this category.

After being marketed with no proof of safety for 30 years in America,
the Food and Drug Administration (FDA) finally removed these known
defective devices from the market in 1992 when no silicone
manufacturer could prove its product "safe". Today, over 150,000 ill
and injured women have written to the FDA with serious adverse
complications and others are too sick or too dead to voice their

The inappropriately named "Independent Review Group" came to
conclusions in July 1998 that read like a manufacturer's public
relations piece. Indeed, their slick brochure has become a marketing
tool for the British plastic surgeons who assure their patients that
silicone is "safe" and "inert." This is based on wishful thinking,
their pocketbooks, and the support of the Medical Devices Agency-not

Rupture, which is a devastating event often requiring multiple
invasive surgeries, is all but dismissed because these reviewers found
"little information on the overall rupture rate." The Lancet
(11/22/97) clearly detailed rupture of up to 95% within 20 years.
Other journals report similar high rates. Silicone has been located in
the brains, spinal cords, livers, uteri, lymph system and children of
implanted women. The Mayo Clinic describes 36% of postmastectomy
women-who ironically can still receive silicone gel in America-having
to have further surgery within just the first 5 years! What possible
definition of "safe" is described here?

British women describe being treated worse than lepers as their
medical doctors have no cure and cannot clearly define the illnesses.
This impotency appears to induce them to walk these women out of their
offices untreated, or worse, to mock them for their illnesses. Caring
doctors who try to report failed implants are left frustrated with no
means to record the damage to their patients. Because the cover-up of
the true dangers has been exported from America to Britain, implant
removal (explantation) is not properly done and women are left with
residual scar capsule and silicone free floating in their bodies.

In America, women don't fare much better, as the silicone wars rage on
in the courtrooms and science, medicine and the implanted women are
the victims.

Daily I communicate with thousands of implanted and explanted women
who are trying to deal with this human tragedy which is often tearing
their families apart. Autoimmune diseases are extremely prevalent in
this group of women, and many have experienced 1030 implant related
surgeries. Their viewpoints on "local complications" sound nothing
like the mild, minimized descriptions of the IRG.

Dow Coming commissioned a study and has known since 1975 that silicone
crossed the placenta yet chose to hide this important study. What
pediatrician ever asks the mother of a child with swallowing problems,
allergies, or autoimmune conditions whether or not she has implants?
This second generation issue must be rigorously explored.

We implore the British Government to re-visit this issue, away from
the political manipulations and the bottom lines of the plastic
surgeons, and protect its women and their offspring.


Director, The Humantics Foundation for Women

1380 Garnet #444, San Diego, CA 92109, USA