IRG Report and deficiencies

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

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

From: ilena rose ilena@...

Recipient List Suppressed:;

~~~ 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. ~~~

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Letters to the editor

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

Silicone Gel Breast Implants: The UK IRG Report

INDEPENDENT REVIEW GROUP (IRG) MISSES THE POINT OF PRIMUM NON NOCERE

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 products.

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).

Rupture

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.

(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 market.

Lesions

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 statement.

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 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.

Epidemiology

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 absence.

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.

PROFESSOR D. RADFORD SHANKLIN, MD FRSM

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, s 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, fsson 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.

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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 that:

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

( 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.

© 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 regrowth.

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.

ROBERT F. GARRY PhD

Department of Microbiology and Immunology SL-38,

Tulane University School of Medicine,

New Orleans, LA 70112, USA

REFERENCES

[1] Brown SL, Silverman BG, and Berg WA. Rupture of silicone-gel breast implants: causes, sequelae, and diagnosis. Lancet 1997; 350: 1531-7.

[2] 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, 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, on LL, Haislip AM, Gluck OS and Tesser JR. Use of antipolymer antibody assay in recipients of silicone breast implants. Lancet 1997; 349:449-54.

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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 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 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 tissues.

(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

cost.

(8) Be capable of being sterilized.

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

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.

HENRY JENNY, MD

PO Box 1112, Rancho Mirage, California 92270

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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 implants.

(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 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.

( 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.

© 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.

ARTHUR DALE ERICSSON, MD

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

REFERENCES

[1] sson 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), 1-72.

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

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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.

ROSE IRWIN

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

M22 4EQ

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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 outrage.

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 facts.

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.

ILENA ROSENTHAL

Director, The Humantics Foundation for Women

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

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