anyone w/silicone or saline implant prior 1993..eligible for class action

[Guest guest]

IN MEMORY OF WALT MONGER

All these articles were sent via " SBI Talk "

Digest Number 171

Date: Thu, 8 Jun 2000 19:39:13 -0600

From: " Gofer " gofer@...

Topics in this digest:

1. USSW: SILICONE IN LIVER

2. USSW: Testing for Monoclonal Gammopathy

3. USSW: Clinical And Laboratory Features Of 30 Patients

4. USSW: Monoclonal Gammopathy of Undetermined Significance

5. USSW: Abstract: Regional Silicone-Gel Migration In Patients With

ruptured Implants

6. USSW: Study of Silicone Injections in Mice

7. USSW: MULTIPLE SCLEROSIS-LIKE SYNDROME

8. USSW: Multiple Myeloma

9. USSW: Article by Betsy Lambert

10. USSW: SILICONE BREAST IMPLANTS AND LONG-TERM HEALTH

11. 1995 article The Truth About Breast Implants

12. 1995 NY Times

13. USSW: Peptide Growth factors and Myofibroblasts In Capsules

Around Human Breast Implants

14. USSW: Elevated Prolactin Levels In Women With Silicone Gel

Breast Implants And With Mineral Mixed Injections

15. USSW: Dow Corning---NEW PRODUCT INFORMATION SHEET

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Message: 1

SILICONE IN LIVER

SILICONE IN LIVER From Medline Migration and accumulation of

silicone in the liver of women with silicone gel-filled breast

implants.

Abstract: 1H NMR localized spectroscopy (STEAM), combined with

echocardiography (ECG), respiratory gating, and water and fat

suppression, was used to quantify silicone concentrations in the

liver of women with silicone gel-filled breast implants. Localized

spectroscopy was performed on 15 patients with silicone gel-filled

breast prostheses and on eight volunteers with no implants.

The 1H spectra in the liver of patients showed silicone resonances

from 0.3 to -0.8 ppm, attributable to protons in the methyl groups

of silicone. The presence of silicone in the liver could first be

detected 3-4 years after breast prostheses implantation.

No correlation between silicone concentrations and implantation

times was observed.

However, our results indicated that silicone concentrations may

reflect implant integrity: detectable silicone concentrations in the

liver appeared to be higher when the implants were ruptured than

when the implants appeared intact.

Moreover, new resonances in the range of -2.6 to -4 ppm were

observed in most patients after long-term implantation. As these

species increase with implantation time, the new resonances may

reflect chemically changed silicone (paramagnetically shifted

silicon complexes bound to iron) accumulated over time. The

sensitivity of 1H NMR localized spectroscopy is sufficient to detect

silicon concentrations as low as 0.20 mM.

Results from one patient whose implants had been removed 14 months

prior to the NMR examination showed no detectable silicone in the

liver, indicating that it may have been excreted via bile or

degraded to silica and high coordinated silicon complexes.

Quantitative 1H localized spectroscopy of the liver in women with

silicone gel-filled breast implants may provide valuable information

concerning silicone accumulation and degradation in vivo, as well as

about the kinetics of its elimination from the body after implant

removal.

Author:

Pfleiderer B

Garrido L

Address: NMR Center, Department of Radiology,

Massachusetts General Hospital, town 02129.

Abbreviated Journal Title: Magn Reson Med

Date Of Publication: 1995 Jan .Vol. 33, Pg. 8-17

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Message: 2

Testing for Monoclonal Gammopathy

LABS:Testing for Monoclonal Gammopathy is showing up some

interesting results. 2% have the usual results for multiple myeloma,

but 60% have abnormal patches of serum electrophoresis,which are

abnormal bands. This is an atypical result. These results are from

Immunosciences Lab. They have done 200 tests. The test is $75. Be

careful who you have do your tests, because most labs are not

looking at the abnormal results,and they will report only results

which are typical for monoclonal gammopathy. We need to keep

documenting our problems in case we again have to show documentation

to the Claims Office for the MDL.

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Message: 3

Clinical And Laboratory Features Of 30 Patients

Abstract: Clinical And Laboratory Features Of 30 Patients With

Systemic Lupus Erythematosus and Silicone Breast Implants.

Authors: Basbug,Schwartz,Wallace,Nessim,Klinenberg. Cedars-Sinai

Medical Center/UCLA School of Medicine Los Angeles,CA.

Source: American College of Rheumatology Sept.1995 Vol.38,No.9

Abstract: 30 patients were treated by our office for SLE between

1980 and 1994 who had undergone augmentation mammoplasty with

silicone gel implants prior to developing the disease. 125

clinical,laboratory and treatment parameters were compared with

those of 331age-matched(ages22-47) non-implanted females in our

lupus cohort(Semin Arth Rheum 21: 55-64,1991) Signigicant levels(p

less than 0.05) for implant-SLE vs. idiopathic SLE comparisons

included greater prevalence for fibromyalgia, family history of

rheumatoid arthritis, mucous membrane lesions, sun sensitivity,

cognitive impairment and Caucasian race.idiopathic SLE patients had

significantly lower white blooe counts, higher sedimentation rates,

and more organ threatening disease.C3 complement values and those of

8 autoantibodies did not demonstrate any differences.nevertheless,

77% of the implant-SLE patients were treated with a trial of

hydroxychloroquine, 50% corticosteroids,and 14% cytotoxic agents. In

summary,implant patients with SLE tended to have milder disease from

an organ-threatening standpoint, but more fibromyalgia,

cutaneous,and neurocognitive manifestations. These findings could

represent " siliconosis " superimposed upon an unrelated SLE, silicone

amelioration of SLE, or silicone-mediated SLE.

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Message: 4

Monoclonal Gammopathy of Undetermined Significance

The term monoclonal gammopathy of undetermined significance (MGUS)

denotes the presence of a monoclonal protein in persons without

evidence of multiple myeloma, macroglobulinemia, amyloidosis, or

other related disease. The term benign monoclonal gammopathv is

misleading because it is not known at the time of diagnosis whether

a monoclonal protein will remain stable and benign or will develop

into symptomatic, multiple myeloma, macroglobutinemia or amyloidosis.

A monoclonal protein level 3 g/dl or more usually indicates overt

multiple myeloma or macroglobulinemia, but some exceptions, such as

smoldering myeloma, do exist.

The presence of more than 5 % plasma cells in the bone marrow is

suggestive of myeloma, but in some patients who have a more

pronounced plasmacytosis, the process has remained stable for long

periods.

The most reliable means of distinguishing a benign course from a

malignant course is the serial measurement of the monoclonal

protein. If the serum monoclonal protein is less than 2.0 g/dI,

electrophoresis should be repeated 6 months after its discovery; if

the concentration has not increased, electrophoresis should be

repeated annually thereafter. If the monoclonal protein is 2.0 g/dl

or more and there is no evidence of myeloma or macroglobulinemia

after appropriate laboratory tests, electrophoresis should be

repeated 3 months after the recognition of the monoclonal protein.

Patients with silicone implants should be examined annually by

immunofixation tests for possible detection of monoclonal

immunoglobulins.

Measurement of immunoglobulin levels bv immunofixation test for

Kappa and lambda chains of IgG, IgM and IgA. Requirements: Two rml.

of serum, spinal fluid or 20 ml. Of urine.

There has been an excessive reported numbers of multiple myeloma

cases among patients with silicone breast implants. All cases should

be reported to the National Cancer Institute.

This information was obtained from Inununosciences Lab.Inc. Dr.

Aristo Vojdani, Ph.D. - 1-800-950-4686

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Message: 5

Abstract: Regional Silicone-Gel Migration In Patients With Ruptured

Implants

Authors: Ahn, Shaw Division of Plastic and Reconstructive Surgery,

University of California, LA.

Journal: Ann Plast Surg. Aug.1994, Vol.33, Pgs.201-208

Abstract: The current literature is reviewed, and four clinical

cases of silicone-gel migration are reported. All 4 patients

reported here had histories of closed capsulotomy,and all were

symptomatic. Preoperative magnetic resonance imaging demonstrated

the anatomical locations of silicone-gel migration into the chest

wall muscles, axillae, and upper extremity. Intraoperative and

pathological findings correlated with the presence of silicone-gel

migration and granulomas in various anatomical regions.With the

recent advances in diagnostic breast imaging of silicone-implant

patients,intracapsular rupture can be identified. Implant removal

may be indicated for intracapsular ruptures to prevent silicone-gel

migration into parenchyma, chest wall muscles, axillae, and the

upper extremity.

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Message: 6

Study of Silicone Injections in Mice

SILICONE GELS, INDUCTION OF PLASMA CELL TUMORS, AND GENETIC

SUSCEPTIBILITY IN MICE: A CALL FOR EPIDEMIOLOGIC INVESTIGATION OF

WOMEN WITH SILICONE BREAST IMPLANTS

In this issue of the Journal, Potter et al. (1) provide experimental

evidence that plasma cell tumors can be induced in genetically

susceptible substrains of BALB/c mice by the injection of silicone

gels from mammary implants. Depending on the protocol and the

specific lot of silicone gel used, plasmacytomas developed in up to

80% of genetically susceptible mice.Using intraperitoneal mineral

oils or related adjuvants in BALB/c mice, Potter and Boyce (2) first

described the murine model for plasma cell tumors more than three

decades ago. Most other genetically inbred strains tested were

resistant, but there are sub-strains of BALB/c that are more

susceptible (1).

Murine plasmacytomas have some features in common with human plasma

cell neoplasms, including monoclonal gammopathy of undetermined

significance (MGUS), solitary plasmacytoma, multiple myeloma,

macroglobulinemia, and primary amyloidosis (3). All of these

entities are monoclonal gammopathies, having in common the

production of monoclonal immunoglobulins by neoplastic plasma cells;

these immunoglobulins are easily detected in the serum and/or urine

of afflicted individuals. Unlike multiple myeloma, marine

plasmacytomas are usually extramedullary and rarely spread to bone.

Extramedullary plasmacytomas are rare in humans and are generally

lessaggressive neoplasms than is multiple myeloma (4).

Recognition that silicone gels from mammary implants can induce

plasma cell neoplasms in genetically susceptible mice provides the

basis for epidemiologic studies to determine whether plasma cell

neoplasms occur more frequently than would be expected by chance

alone in women who have received silicone breast implants. The SEER

group[1] at the National Cancer Institute (NCI) has estimated that

in 1990 multiple myeloma occurred in at least three of 100 000

individuals in the population per year and that the sex-specific

rates of multiple myeloma were 2.5 cases per 100 000 women and 3.8

cases per 100 000 men (5). Multiple myeloma thus represents

approximately 1% of all cancer cases. MGUS without evidence of

multiple myeloma is far more common (6). Given the fact that at

least several million women have received silicone breast implants

during the past few decades (7), it is to be expected that, by

chance alone, some women who have these implants will be discovered

to have MGUS, and smaller proportions will be found to have multiple

myeloma or other related monoclonal gammopathies. Silicone is known

to leak from some breast prostheses (7,8) and is immunogenic (9,10),

and it has been claimed that silicone may be involved in the

etiology of various immune disorders (11-14). However, a recently

reported case-control study of 749 women who had received a breast

implant and 1498 age-matched female community controls found no

evidence for increased risk of connective tissue disorders (15,16).

The challenge will be to determine whether the incidence of MGUS or

multiple myeloma in women with breast implants will be greater than

that expected in age-matched women who have not received silicone

breast implants.

It is important to emphasize that " the plural of anecdotes is not

data " and that careful epidemiologic studies will be required before

any conclusions can be reached. Inasmuch as serum electrophoresis

will detect most monoclonal gammopathies, this test should be

applied in screening breast implant recipients before more extensive

testing is undertaken. We would recommend that all detected

monoclonal gammopathies undergo further work-up and that all

identified cases of MGUS, multiple myeloma, or other monoclonal

gammopathies specifically diagnosed in silicone breast implant

patients and in patients with other types of silicone implants in

the United States be reported to the Food and Drug Administration (1-

800-FDA-1088 MED-WATCH) to provide the basis for further

epidemiologic investigation. Perhaps some reassurance can be gotten

from the fact that experimental plasmacytomas can be induced only

under special conditions in genetically susceptible mice. If the

same is true for humans, then most women with implants are probably

not at increased risk for MGUS or multiple myeloma.

Notes

1 Editor's note: SEER is a set of geographically defined, population-

based central tumor registries in the United States, operated by

local nonprofit organizations under contract to the NCI. Each

registry annually submits its cases to the NCI on a computer tape.

These computer tapes are then edited by the NCI and made available

for analysis.

Manuscript received June 10, 1994; accepted June 10, 1994.

References

(1) Potter M, on S, Wiener F, et al: Induction of

plasmacytomas with silicone gel in genetically susceptible strains

of mice. J Natl Cancer Inst 86:1058-1065, 1994

(2) Potter M, Boyce C: Induction of plasma cell neoplasms in strain

BALB/c mice with mineral oil and mineral oil adjuvants. Nature 193:

1086-1087, 1962

(3) Salmon SE, Cassady JR: Plasma cell neoplasms. In Cancer:

Principles and Practice of Oncology, 4th ed (DeVita VT Jr, Hellman

S, Rosenberg SA, eds).Philadelphia: Lippincott, 1993, pp 1984-2025

(4) Wiltshaw E: The natural history of extramedullary plasmacytoma

and its relation to solitary myeloma of bone and myelomatosis.

Medicine (Baltimore) 55:217-238, 1976

(5) BA, Ries LA, Hankey BF, et al, eds: SEER Cancer

Statistics Review 1973-1990. NIH Publ No. 93-2789, Bethesda, Md:

NCI, 1993

(6) RA, Lust JA: Monoclonal gammopathies of undetermined

significance. Semin Hematol 26: 176-200, 1989

(7) Shons AR, Schubert W: Silicone breast implants and immune

disease. Ann Plast Surg 28:491-499; discussion 499-501, 1992

(8) Silicone gel breast implants. Council on Scientific Affairs,

American Medical Association [see comment citation in Medline]. JAMA

270:2602-2606, 1993

(9) Pfleiderer B, Ackerman JL, Garrido L: Migration and

biodegradation of free silicone from silicone gel-filled implants

after long-term implantation. Magn Reson Med 30:534-543, 1993

(10) Wolf LE, Lappe M, RD, et al: Human immune response to

polydimethylsiloxane (silicone): screening studies in a breast

implant population. FASEB J 7:1265-1268, 1993

(11) Kossovsky N, Heggers JP, Robson MC: Experimental demonstration

of the immunogenicity of silicone-protein complexes. J Biomed Mater

Res 21:1125-1133, 1987

(12) Bridges AJ, Conley C, Wang G, et al: A clinical and immunologic

evaluation of women with silicone breast implants and symptoms of

rheumatic disease [see comment citations in Medline]. Ann Intern Med

118:929-936, 1993

(13) Teuber SS, Rowley MJ, Yoshida SH, et al: Anti-collagen

autoantibodies are found in women with silicone breast implants. J

Autoimmun 6:367-377, 1993

(14) Press RI, Peebles CL, Yumagai Y, et al: Antinuclear

autoantibodies in women with silicone breast implants. Lancet

340:1304-1307, 1992

(15) SE, O'Fallon WM, Kurland LT, et al: Risk of connective

tissue diseases or other disorders after breast implantation. N Engl

J Mod 330:1697-1702, 1994

(16) Angell M: Do breast implants cause systemic disease? N Engl J

Med 330:1748-1749, 1994

By Sydney E. Salmon, A. Affiliations of authors: S. E.

Salmon, Arizona Cancer Center, University of Arizona College of

Medicine, Tucson. R. A. , Hematology and Internal Medicine, Mayo

Clinic, Rochester, Minn Correspondence to: Sydney E. Salmon, M.D.,

Arizona Cancer Center, University of Arizona College of Medicine,

Tucson, AZ 85724.

******

Journal of the National Cancer Institute is published by National

Cancer Institute and is not copyrighted.

Copyright 1994 by National Cancer Institute. Text may not be copied

without the express written permission of National Cancer Institute.

ÆSalmon, Sydney-, , Silicon gels, induction of plasma cell

tumors, and genetic susceptibilityin mice: A call for..., Vol. 86,

Journal of the National Cancer Institute, 07-20-1994, pp. 1040.

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Message: 7

MULTIPLE SCLEROSIS-LIKE SYNDROME

MULTIPLE SCLEROSIS-LIKE SYNDROME IN WOMEN WITH SILICONE BREAST

IMPLANTS: A NOVEL NEUROLOGICAL DISEASE WITH RHEUMATOLOGICAL SYMPTOMS.

Britta Ostermeyer Shoaib and Bernard M. Patten. Houston, Tex 77030.

Twenty-six women developed a systemic disease with central nervous

system involvement at a mean age of 38 years (range 21-64 years)

after receiving silicone breast implants (n=25) or fluid injections

into breasts (n=1). The medium latency period between breast surgery

and onset of symptoms was 5 years (range 3 months - 15 years). All

patients had evidence of disseminated central nervous system

lesions. Twenty patients also had evidence for peripheral

neruopathy. Additional problems included myalgia (=24), joint s

(n=23), arthralgia (n=22), Sicca complex (dry eyes and dry mouth)

(n=19), headache (n=16), skin rash (15), joint swelling (n = 14),

Raynaud's phenomena (n=14), fever (n=13), hair loss (n=12),

allergies (n=11), sensitivity to sunlight (n=10) and lymphadenapathy

(n=9). MRI of the brain was abnormal in 22/26 (21 white matter

lesions,1 ischemic lesions, 4 cerebral atrophy). Spinal tap revealed

oligoclonal bands in 18/23. Visual evoked responses were delayed in

14/23. Autodirected antibodies were detected in 16/26. Sural nerve

biopsy showed loss of myelinated fibers in 15/15. Seventeen of 24

patients (71 %) who underwent implant removal were found to have

grossly ruptured implants. We believe our patients developed a new

syndrome triggered by the foreign material in their body. This

syndrome presents as a systemic inflammatory autoimmune with central

nervous system involvement resembling February 9, 1996multiple

sclerosis.

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Message: 8

Multiple Myeloma

Dr. Lewy, of Breast Implant Research, sent information on two

large studies to determine the risk of developing multiple myeloma

or monoclonal gammopathy of undetermined signifcance (MGUS) in women

with silicone exposure. An FDA funded study, in collaboration with

Dr.Fred and several other national authorities will be done.

It is entitled " A Study of Immunogenetic Risk Factors for Silicone-

Associated Multiple Myeloma and Monoclonal Gammopathy of

Undeterminded Significance.

" Patients will be enrolled in this study through the H.Lee Moffitt

Cancer Center in Tampa, FL the Mayo Clinic; Medical Group in Kansas

City, KS; Washington, DC (NIH); the Arizona Cancer Center in Tucson,

and the University of Arkansas at Little Rock. Patient consent forms

will be requested.

In the second study, Dr.Lewy is lead Investigator, together with

several epidemiologists with the Texas Dept.of Health Cancer

Registry in a study to determine the rate of myeloma in silicone

exposed women in Texas, as well as other silicone-induced

cancers.The study has been approved, and funding from the ACS and

NIH is under consideration.

If you have been seen at BIR, you will be automatically enrolled.

There is some concern about cancer risk, since animal studies have

indicated that some cancers do occur from exposure to silicones.

Hematologists nationwide are reporting some concerns about cancer

risks. This project will help build a baseline laboratory profile

which will be helpful to both women and their children.

For more information and a summary of the protocols, call(713) 791-

9311 or fax (713) 791-9236. Dr. Lewy will consult with your

attorney, if necessary, to see if you have any legal reasons not to

participate. You may write to Dr.Lewy at: Breast Implant Research,

Inc. 8181 N. Stadium Dr., Houston, Tx, 77054

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Message: 9

Article by Betsy Lambert

Breast Implant Update:

Based on an article in the Journal of the National Cancer Institute

by Betsy Lambert

Unlike the usual scientific meeting where name and affiliation

suffice, researchers who met recently for a workshop on the effects

of silicones on the immune system, introduced themselves by

disclosing the source of their research funding, and if they had

ever been involved in breast implant litigation.

Silicones, once thought to be inert, have been found in laboratory

studies to induce chronic inflammation, and augment certain immune

responses. Some evidence indicates that such immune responses may be

occurring in humans, too. According to the FDA, some studies suggest

that implants may cause auto-immune-like disorders, but a connection

has not been proven, and the workshop did not seek to resolve this

issue.

Three years ago, the FDA removed silicone gel implants from the

market following reports of adverse effects, and after concluding

that insufficient evidence was available on their safety and

effectiveness. Silicone gel implants are now available only in

controlled clinical trials while research on them continues.

An increased risk of cancer has not been associated with the

implants in published scientific studies. However, there are some

recent anecdotal reports of multiple myeloma in persons exposed to

silicones. NCI's Rabkin, M.D., said that he will establish a

registry to collect information on cases among women with the

implants.

Some researchers at the workshop contended that the implants are

causing a new auto-immune disease. " There is an atypical rheumatoid

disease out there, and that's what is not being picked up by

epidemiologists, " said , M.D., Hospital for Joint

Diseases Orthopaedic Institute, NYC. " You look at these [rheumatoid]

diseases and try to get them to fit the criteria, but they don't. "

He also said that silicone-related disease can encompass

biomechanical problems, sleep disturbances, neuralgia, and

connective tissue disorders. Other researchers agreed, and added it

to the list of health problems and symptoms.

Anyone having a silicone or saline implant prior to June 1, 1993, is

eligible for inclusion in a class action. After registration, claims

can be made if there is a diagnosis of an auto-immune disease (for

example: lupus or mixed connective tissue disease), a rupture,

removal, and associated medical expenses. The cut-off for

registration was March 1, 1995, but the class has not been closed.

Anyone interested in registering should call 1-800-887-6828 for

information and forms.

Judge Pointer, the judge presiding over the settlement of these

claims, decided, on the basis of a preliminary examination, that the

total amount of current claims, if approved, will exceed the $1.2

billion dollar payment. The court is now involved in negotiations

with the plaintiffs and defendants about the options that are

available to maintain the class settlement. The options are: to

obtain more contributions from the defendants, and/or to reduce the

amount to be paid to the claimants. If the projected benefits are

reduced, each claimant will be afforded a " second opt-out period. "

This means that the individual is then free to proceed with a

lawsuit, if possible. All participants must know the name of the

manufacturer of the implant to file a lawsuit. Dow Corning filed for

bankruptcy, but class counsel does not believe that this will

destroy the class action.

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Message: 10

USSW: SILICONE BREAST IMPLANTS AND LONG-TERM HEALTH

ABSTRACT: SILICONE BREAST IMPLANTS AND LONG-TERM HEALTH

EFFECTS: WHEN ARE DATA ADEQUATE?

AUTHOR: LAMM SH

ADDRESS:Consultants in Epidemiology and Occupational Health, Inc.

Washington, D.C.

Date: April, 1995

JOURNAL VOL. 48 page numbers: 507-511

ABSTRACT: The epidemiological literature examining, the possible

association between silicone br. implants and br.cancer or

rheumatological conditions or diseases is far greater today than it

was when, in early 1992, FDA determined that the data were not

adequate for the assessment of their safety. A literature data base

exists for assessing the magnitude of risk for certain diseases that

might be associated with silicone br. implantation and for narrowing

the uncertainty in those estimates. The studies reported in this

series make a major contribution to that database. As for future

research needs, some general observations can be made. First, it is

likely that completed, ongoing and planned studies will prove more

than adequate in accurately delineating any cancer risks that might

be associated with br.implantation. Second, the risks of developing

scleroderma will also be reasonably well established. Further study

may be desirable for other specific connective tissue diseases and

for connective tissue disease considered as a whole.

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Message: 11

1995 article The Truth About Breast Implants

" The Truth About Breast Implants " Part One (of Three) Genuine

Article #1 (1995):4.

Wallis frankw@...

The safety of silicone breast implants was called into question in

1992 by the FDA (Food & Drug Administration). In January 1992 the

FDA ordered a moratorium on silicone breast implants, asking

manufacturers to suspend production, and plastic surgeons to cease

inserting them into their patients. In April the agency forbade

their use, except for clinical studies and for reconstruction

surgery following mastectomy. In March, Dow Corning (largest maker

of silicone implants) withdrew their product from the market.

The FDA cited consumer concerns about several medical problems

associated with implants: cancer, immune system diseases, connective

tissue disorders, interference with accurate mammography, and

capsular contraction (formation and shrinking of scar tissue around

the implant, causing painful hardening of the breast).

Silicone was developed during WWII, and has been used in surgical

procedures since then, because this man- made inorganic substance

feels like human flesh. Silicone breast implants were introduced to

the market in the mid- 1960s, but the FDA did not have

responsibility or authority to regulate these devices until 1976, by

act of congress.

Because this product had already been on the market for ten years,

it was grandfathered into a list of approved medical devices without

clinical testing. The practice of injecting pure silicone into

humans was banned by the FDA in 1965.

Thousands of women complained for over a decade about medical

problems associated with their breast implants. In Denver, stripper

Tammy McCartney testified that only weeks after her first

augmentation in 1987 she noticed abnormal deflation in one breast,

indicating rupture. In three subsequent operations, her plastic

surgeon replaced ruptured silicone implants, and adjusted implant

position to relieve painful pressure from scar tissue build-up.

After a total of six operations McCartney's breasts were disfigured,

and she was forced to end her exotic dancing career. Although she

elected for a seventh implant operation, this time it was saline

filled. Two more operations removed various glands from her breasts,

in which pathologists discovered silicone.

Cecy Doykos, a 42 year old Sacramento woman with two children,

suffers from autoimmune diseases such as lupus and systemic

sclerosis (scleroderma). The latter affliction causes hardening and

scarring to skin, lungs, heart, and kidneys. She and her doctors

think her silicone implants have generated this immune system

disease. Greatly disappointed, Doykos opined that when she was in

her early twenties it was enjoyable to sit on the beach and

have " these pert breasts " , but admitted that as she aged, they began

to sag as much as natural breasts, only worse because they were much

bigger.

Both manufacturers and surgeons knew that silicone implants could

split open, releasing silicone gel into surrounding tissue. Problems

related to implant rupture and gel migration include chest pain,

breast pain, triggerpoints (small areas that are very painful to the

touch), buildup of gel blobs in the armpit, elbow, or abdominal

wall, and addiction to prescription pain killers. An implant made by

now defunct Surgitek as known to crack in four years, show

perforations in six, and virtually disintegrate in ten years.

Surgitek also made an implant with a " Meme " cover, made from the

same type of foam used in furniture pholstery.

Thousands of women with silicone implants report fatigue, joint

pain, swelling of lymph nodes, and other symptoms of autoimmune

diseases. These are maladies in which the immune system attacks the

body's own cells. Silicone has been shown to cause immune reactions

in two ways: 1) local, where cells around the implant become

inflamed, causing fibrous tissue to form, walling off the entire

object; 2) systemic, where silicone leaks out into the rest of the

body.

Thus far, clinical studies indicate that silicone breast implants

may cause autoimmune diseases and damage the health of children born

to women with such implants. However, earlier concerns over cancer

links and connective tissue diseases have been allayed. Researchers

at UC School of Medicine found in 1993 that silicone implants

may induce autoimmune diseases, but not in all women. At least a

third of tested women in a study by the Chicago Academy of Allergy

and Immunology had elevated levels of anti-nuclear antibodies in

their blood, a finding associated with lupus.

The Journal of the American Medical Association reported that

infants breast-fed by mothers with silicone implants may absorb

silicone because the small intestine barrier is immature and unable

to fight off alien molecules. Women with such implants were urged

not to breast-feed their children. A Memphis study showed evidence

of silicone dioxide in women whose implants had been removed up to

eight years earlier. In addition, small breast tumors are not easily

detected by mammograms in women who have breast implants.

_____________

1. Phil Mintz, " New Fear: Studies on Breast Implants, " New York

Newsday (May 5, 1993):6; Doug Podolsky, " A Ban on Silicone, " US News

& World Report (Jan. 20, 1992):61; Ginny McKibben, " Ex-topless

Dancer Relates Deformed Implants Terror, " Denver Post (May 13,

1993):1B.

2. Sugg, " Breast Implants, Illness Linked, UCD Study Hints, "

Sacramento Bee (March 15, 1993):A1.

3. Sharon Roan, " Time Not on Their Side, Say Women With Implants, "

Los Angeles Times (May 18, 1993):E1; Tinker Ready, " The Doctor and

His Implants, " News & Observer (March 31, 1994):A1.

4. McKibben, " Ex-Topless. "

5. Sugg, " Breast Implants. "

6. Bor, " Medical Scanners Help Find Leaks in Implants, " The

Sun [baltimore] (Dec. 4, 1992):8A; Ready, " The Doctor " ;

Regush, " Toxic Breasts, " Mother 17 (Jan/Feb 1992):24.

7. Laurie Loscocco, " OSU Scientists are on Trail of Breast Implant

Dangers, " Columbus Dispatch (Nov 6, 1993):2C.

8. Sugg, " Breast Implants " ; A. Flick, " Silicone Implants

and Esophageal Dysmotility: Are Breast-fed Infants at Risk? " JAMA

271 (Jan. 19, 1994):240; " Breast Feeding and Implants, " FDA Consumer

28 (April 1994):3; Garibaldi, " Breast Implants Said to Threaten

Health of Children, " Reuters (March 25, 1994); Powers, " Memphis

Study Finds Implant Tie to Illness, " The Commercial Appeal [Memphis]

(July 14, 1994):B1; Kathy A. Fackelmann, " Implants Block X-ray View

of the Breast, " Science News 142 (Oct. 17, 1992):262.

Dow Corning released its own study of silicone implants in March

1993, which indicated that silicone may cause immune system diseases

in laboratory rats. So much for " safe " silicone. Some health

problems originally linked to silicone implants have been partly

resolved. One study showed implants " may not increase " a woman's

risk of developing breast cancer. Other studies indicate that

connective tissue diseases are not caused by silicone implants.

Legal Implications

With so many women in pain from their breast implants, it is

understandable that they sought legal redress. Almost two million

women in the United States had breast implants over the past quarter

century, 80% of whom chose to do so for cosmetic reasons. About one

million women have silicone implants. Dow Corning offered $1200 to

women wishing removal of their silicone implants, but

such " explants " cost at least $3500, and health insurance often

fails to pay for it, because insurers use the loophole of, " medical

necessity. "

In September 1994, US Federal District Judge Sam C. Pointer, Jr., in

Birmingham, AL, approved a $4.25 billion settlement in a class

action lawsuit filed against the manufacturers of silicone breast

implants on behalf of millions of women across the globe who had

been implanted. It is without doubt the largest product liability

settlement in US history. Major defendants included Dow Corning,

Baxter Intl., and Bristol-Myers Squibb. This followed judgments

already awarded to plaintiffs in similar cases: $25 million to a

Houston woman, and $24 million to a California woman, against

Mentor, Inc., another silicone implant maker.

Thousands of women ill from silicone poisoning had to make legal

decisions. Under a complex formula, women with symptoms would get

from $100,000 to $1,400,000, based on the seriousness of their

symptoms. The settlement was open to more than just the 20,000

plaintiffs who filed suit before and during global negotiations. It

was open to any woman unable to determine the manufacturer of her

implants, or whose implants were made by a company like Surgitek

that went bankrupt. Even women without symptoms of silicone induced

disease could file a claim, but their awards could be less. There

were time limits for women to opt out of the settlement and pursue

individual suits, a major deadline being June 1994.

What Next?

Due to adverse publicity and events outlined above, silicone

implants are rarely used now. However, the mania for bigger breasts

has not subsided. American industry immediately filled the void left

by the excision of silicone gel implants from the market: new types

of breast inflators became available.

In the mid-1980s about 150,000 women were opting for implant surgery

every year. In 1992 that figure fell to 62,000, 80% of whom did so

for cosmetic reasons, according to figures from the American Society

of Plastic and Reconstructive Surgeons. In that same year more than

25,000 had explant operations and half of them chose to have

replacement implants. The implant of choice has been the saline

type, a silicone bag filled with salt water.

One 45 year old woman remarked that she decided to have replacements

for fear that her chest would look unattractive, with sagging skin

where once implants had been. Yet, women with money have been flying

to Mexico or the Caribbean islands to receive silicone implants,

despite the well known health risks associated with them.

Of course, plastic surgeons have voiced strong disapproval of the

way silicone implants were portrayed in the news media. Many still

maintain that it was " blown out of proportion, " or that it was " all

media hype. " The silicone scandal hit their implant line hard, and

they had to make up lost revenue via other procedures such as

chemical skin peels and liposuction. Some are beginning to advertise

breast reduction surgery for men " suffering " from gynecomastia,

buildup of fatty tissue under the male breast.

There is no national database on exactly how many women had implant

surgery each year since the first silicone bags came on the market

almost thirty years ago. It seems most women have recently been

opting for saline implants, but many are apprehensive about them due

to reports that they may harbor bacteria and/or fungi in the saline

solution, and that this is communicated into the body via leaking

containment bags. A Canadian study reports that bacteria do live and

grow in the saline implants. Besides this, the silicone-rubber bags

which contain the saline solution may shed tiny fragments of

silicone and cause autoimmune diseases.

9. Roan, " Time Not on Their Side. "

10. Hans Berkel, et al., " Breast Augmentation: a risk factor for

breast cancer? " New England Journal of Medicine 326 (June 18,

1992):1649; Sherine E. , et al., " Risk of connective tissue

diseases and other disorders after breast implantation, " New England

Journal of Medicine 330 (June 16, 1994):1697.

11. Shapiro, " What is it with Women and Breasts? " Newsweek 119

(Jan. 20, 1992):57; Roan, " Time Not on Their Side. "

12. Reuters (Oct 25, 1994); Roan, " Time Not on Their Side. "

13. Cornett, " Here Are Legal Options for Women with Breast

Implants, " Daily Camera (April 29, 1994).

14. Judy Foreman, " Breast Implant Field Altered by FDA Edict, "

Boston Globe (March 13, 1994):1.

15. Ibid.

16. Corrigan, " Breast Implants, " St. Louis Post-Dispatch

(March 3, 1994):1A; Vreeland, " Saline Breast Implants May Not

be So Safe, " American Health 13 (July/Aug 1994):11.

Science to the rescue! Women anxious to have bigger breasts can look

hopefully to modern chemistry and big business to provide them

with " safe " replacements for the discredited silicone gel. Already,

clinical trials have been underway for implants filled with peanut

oil. Another experimental implant is derived from soybean oil. This

latter product is called the Trilucent implant, made by LipoMatrix,

of Palo Alto, CA. The leader of the project seems to be Dr. Leroy

Young, a plastic surgeon from St. Louis, who thought silicone should

be replaced with a fatty substance similar to the fat already

present in women's breasts. His new implants use a silicone shell,

but they are filled with unsaturated triglyceride extracted from

soybean oil. If the implant cracked or leaked for any reason, the

oil would be absorbed into the body like any other fat.

The Culture of Boobs

Some social critics look at the implant scandal as evidence of a

fairly recent cultural trend which pressures women to look more

like...women. Others regard the whole affair as an issue not of

health, but of choice and control of one's body. One woman thought

the subject of breasts had been made a political issue only during

the past few decades. Young thought small breasts were

fashionable in the 1960s, but in the supercharged 1980s, the gilded

years of greed, women began having implant operations for the same

reason they wore enstein shoulder pads: they wanted to make

a " power statement. "

Another writer echoed this sentiment, and wrote women like boob jobs

because they provide self-confidence. Yet, only with the advent of

implants has the female quest to look more feminine threatened

women's health.

Well, yes and no. The subject of women's looks have not been a

concern of human culture since the 1960s, but from time immemorial.

Small boobs may have pleased some media types, but are we not

forgetting torpedo-tip bras, push-up bras, and Jayne Mansfield, not

to mention Marilyn Monroe and Jane ? Also, recall that

Playboy rose to prominence in the 1960s on a wave of centerfold

models with hourglass figures and large breasts. As for health

concerns, women's preference for tight-laced corsets in the 19th

century caused alarm among some social critics and physicians.

One does not really have to take seriously the opinion of a Forbes

magazine editor who wrote that the FDA has no right to interfere in

the choices made by women about their own bodies, in consultation

with a (usually male) plastic surgeon. And, after being told by

their doctor about the health risks, women should have the right to

chose implants. This argument neglects the likelihood that cosmetic

and plastic surgeons have a vested interest in convincing women that

bigger breasts are normal and will make women feel better.

In fact, the ASPRS (American Society of Plastic and Reconstructive

Surgeons, Inc.) has categorized small breasts as a treatable disease

called micromastia! At least one critic has called into question

this madness, and points out how the medical community tries to

exploit not only abnormalities, but women's perceptions of

abnormality to increase profits.

17. Isadore Rosenfeld, " The Latest on Breast Implants, " Vogue 182

(Sept 1992):414; Corrigan, " Breast Implant Developed at WU

Gets National Trial, " St. Louis Post-Dispatch (Aug. 2, 1994):1B.

18. Young, " A Few (More) Words About Breasts, " Esquire 118

(Sept 1992):141; Shapiro, " What is it... "

19. Huber, " A Woman's Right to Chose, " Forbes 149 (Feb 17,

1992):138; Barbara Ehrenreich, " Stamping Out a Dread Scourge, " Time

139 (Feb 17, 1992):88.

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Message: 12

1995 NY Times

Breast Implant Update

During the summer of 1995 some interesting, if not unanticipated,

legal maneuvers threatened to severely delay and perhaps eliminate

440,000 lawsuits against implant manufacturers. In May 1995, Dow

Corning filed for protection under Chapter 11 of the federal

bankruptcy code in a Bay City, MI, federal district court. This move

put a halt to new lawsuits and stymied pending claims. Only the

bankruptcy court can decide how much money Dow Corning will pay to

19,000 women who are suing the company. The Chapter 11 tactic has

been used to good effect (for corporations) by companies such as

asbestos maker s-Manville Corp. (1982), after workers sued it

for health claims; and by A.H. Robbins Co. (1985), maker of the

Dalkon Shield intra-uterine device, after suits by women claiming

birth defects.

The breast implant claims processing center in Houston, TX, affirmed

that new claim forms against implant makers would require women to

prove which manufacturer made the implants they were complaining

about. The original $4.2 billion settlement did not require this.

Other defendants are Bristol-Myers-Squibb, Baxter International, 3M,

and Union Carbide, but they settled with plaintiffs on 11-13-95.

Silicone Implants Declared Safe in Europe

Yes, despite the ban on silicone breast implants in the USA, both

France and Britain allowed their unrestricted use in the winter of

1995. A temporary restraint on silicone implants went into effect

after the FDA in America essentially banned them in 1992. Will

hordes of self-hating American girls flock to Europe for a silicone

uplift? Stay tuned.

Source: New York Times (5-16-95):1, D6; (9-1-95):D3; (11-14-95):A22.

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Message: 13

Abstract: Peptide Growth factors and Myofibroblasts In Capsules

Around Human Breast Implants.

Authors: Lossing, Hansson Department of Histology, University of

Goteborg, Sweden. Journal:Plast.Reconstr.Surg. June 1993, Vol.91

Pg.1277-1286

Abstract: Peptide growth factors were mapped immunohistochemically

for assessment of their presumed relation to the cells in capsules

enveloping gel-filled, smooth-surfaced silicone mammary implants (12

capsules from 11 women). The implant capsules were dominated by

fibroblast-like cells, but there were as well macrophages,

inflammatory cells, and vascular cells. These cells expressed

immunoreactivity for TGF-bets,iGF-II,IGF-I,and, to a lesser

extent,PDGFB,NGF,and TNf-alpha. The numerous spindle-shaped cells in

the contracted capsules displayed several distinct cytoplasmic actin

bundles and fulfilled ultrastructural criteria for myofibroblasts.

In contrast, myofibroblasts were recognized in low frequencies in

the noncontracted capsules. Mature skin scar tissue did not show any

peptide growth factor immunoreactivity, and myofibroblasts were

absent. It is postulated that the low-grade chronic inflammatory

foreign-body reaction, aggravated by mechanical stress and possible

leakage of irritants, stimulates capsule cells to form peptide

growth factors, reflecting that extended healing processes prevail

in both noncontracted and contracted capsules. We propose that the

local enrichment of peptide growth factors, beneficial for acute

wound healing, in the chronically irritated tissue around implants

provides trophic support for the contractile cells in the implant

capsules.

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Message: 14

Abstract: Elevated Prolactin Levels In Women With Silicone Gel

Breast Implants And With Mineral Mixed Injections.

Authors: Medina, Vera, Jara, Miranda, Fraga. Rheumatic Diseases Unit

Mexico

Source: American College of Rheumatology Sept.1995 Vol.38, No.9

Abstract: Diverse immunologic abnormalities have been described in

women who received silicone breast implants(SBI). Prolactin (PRL) is

an immunostimulatory hormone that appears to play a role on Reiter's

syndrome, SLE, adjuvant arthritis and other autoimmune disorders.

Mixed-mineral oil injections (MMOI) have been associated with the

presence of similar autoimmune alterations and with rheumatic

manifestations, but with a shorter time for the onset of symptoms.

Our purpose was to assess the prevalence of hyperprolactinemia in 29

consecutive female patients with breast MMOI and rheumatic

manifestations, as well as in 12 patients with history of SBI more

than 5 yrs.before. Methods: Blood was drawn at 8:00 AM after a one

hour rest. PRL was measured in serum by RIA controlled twice and the

high levels were confirmed. No patient was taking any medication

potentially influencing PrL levels (e.g. tricyclic

antidepressants,hormones). To rule out a possible prolactinoma, all

the patients underwent x-ray and CT scan which were normal in all

cases. Results: 17 of the 29 MMOI patients (58%) showed abnormally

high PrL levels that ranged from 21-49ug/l (normal <20 ug/l), and in

5/12 patients with SBI(41%,range 22-46). Conclusion: We found a high

incidence of basal hyperprolactinemia in patients with MMOI and SBI.

As PRL has the mammary glad as target organ, this finding may

disclose a potential role of PrL in the pathogenesis of " atypical "

connective tissue disease, or as a consequence of chronic tissue

gland stress.

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Message: 15

Dow Corning---NEW PRODUCT INFORMATION SHEET

From: Dow Corning---NEW PRODUCT INFORMATION SHEET

SILASTIC (Reg Trademark) Q7-2213

Medical Grade Dispersion

Bulletin 51-419A Date © 1980

Medical Products Dow Corning Corporation, Midland, Michagan

" Silastic Q7-2213 Medical Grade Dispersion is a fully componded

dimethylsiloxane elastomer dispersed in 1,1,1,Trichloroethane

(trademark *See below). The unique one-compound vulcanization system

is heat cured. Important characteristics of Silastic Q7-2213 Medical

Grade Dispersion include:

a.. -Fully Formulated System

b.. -Nonflammable Solvent

c.. -Excellant Physical Properties

The dispersion is used for making silicone rubber parts by dipping,

brushing or spraying onto molds or mandrels of the desired shape. It

may also be used to make membranes or cast films. "

d.. " *Manufactured by The Dow Chemical Company, also known a

Chlorothene NU(trademark) or Methyichloraform. " e.. " *Chlarothene

NU is a registere trademark of The Dow Chemical Company. " On page 2

of the Product sheet and I quote:

" Siliastic Q7-2213 Medical Grade Dispersion is an elastomer

dispersed in 1.1.1 Trichloroethane. This solvent is non-flammable

but prolonged breathing of the vapors should be avoided. The user is

urged to be familiar with the properties, hazards and chemistry of

this solvent. Information is obtaniable from the manufacture, The

Dow Chemical Company, Inorganic Chemicals Dept, Midland, Mich. "

" Product Availabilty This product is undergoing final evaluation.

Future availability in its present form depends upon market

acceptance. Dow Corning disclaims expressed or implaied warranty

against the infringment of any patent by the use of this product. "

" If this product is to be used in humans or animals, it is the

user's responsibility to employ it in accordance with any applicable

laws concerning subjects. "

" Shelf Life When stored under normal conditions in a sealed

container, Siliastic Q7-2213 Medical Grade Dispersion has a shelf

life of two months from date of shipment. "

End of Quote from Product Sheet from Dow Corning Corporation

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