There is PROOF of negative immunoloic consequences!

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Plaintiffs' Supplemental Submission in Response to Manufacturers' Submission and in Response to the November 10 and 11 Panel Meeting(dated 01/22/1998)

Section

Page No.

I.

INTRODUCTION

1

II.

SILICONES FROM SILICONE GEL FILLED BREAST IMPLANTS ARE NOT INERT BUT ARE, INSTEAD, BIOACTIVE

7

III.

SILICONES MIGRATE FROM INTACT AND FAILED BREAST IMPLANTS, AND ARE TRANSPORTED THROUGH THE LYMPHATIC SYSTEM TO MAJOR ORGANS AND TISSUE

8

A.

Silicones Are Released Into The Body Through Implant Failure

8

B.

Silicone Gel Bleed Contains Significant Amounts Of Low Molecular Weight Silicones And Heavy Metals Such As Platinum

11

C.

Silicones Migrate Extracellulary And Intercellularly To Major Organs And Tissue

16

1.

The Reaction To Silicones In The Breast Implant Capsule Creates A Biologically Active, Pseudo-Synovial-Like Transport Mechanism

20

2.

Macrophages And Lymphocytes Transport Silicones To Regional Lymph Nodes Where They Are Then Distributed Throughout The Body

25

3.

Studies Using Radio-Labeled Silicone (The Same Silicone In Breast Implants) Consistently Report That Silicones Migrate To The Brain, Liver, Kidneys, Spleen, Bone Marrow, Thymus, And All Organs And Areas Of The Body

28

IV.

SILICONES ARE NOT STABLE IN VIVO. THEY DEGRADE CHEMICALLY AND ARE METABOLIZED

39

V.

SILICONES ARE IMMUNOTOXIC

46

A.

The National Toxicology Program Studies On Silicone Gel, Fluid And Elastomer Found Immunotoxic Effects

46

B.

Additional Toxicity Studies Also Report Toxic Effects From Silicones

59

C.

Silicones Can Be Toxic To Nerves

63

D.

The Animal Studies Report Positive Findings Of Disease And Immune System Dysfunction

65

VI.

SILICONES CAN CAUSE IMMUNE SYSTEM DYSFUNCTION AND DISEASE

88

A.

Existing Studies And Reports Consistently Find That Silicones Cause Chronic Inflammation, Granulomatous Inflammation, Granulomas, Massive Fibrosis, Lymphadenopathy, And The Activation Of Macrophages With Pro-Inflammatory Cytokine Production

88

B.

Studies On Silicone Injections Report Similar Findings

99

C.

The Effects of Inflammation And Granulomas Are Systemic And Provide A Pathologic Basis For Immune System Dysfunction And Disease Symptoms

103

D.

Silicones Can Cause A Delayed Hypersensitivity Reaction

111

E.

Studies Have Consistently Concluded That Silicones Are Adjuvants That Have Potent Biological Activity

119

F.

Continued Exposure To Adjuvants Can Cause Immune System Dysfunction

125

VII.

SILICONES AND SILICONE-BOUND PROTEINS CAN PROMOTE THE PRODUCTION OF ANTIBODIES AND AUTOANTIBODIES

131

A.

The Studies Demonstrate That The Administration Of Silicones In Vivo Results In The Production Of Antibodies

131

B.

Proteins Bind To Silicones In Vivo And Silicone-Bound Proteins Are Antigenic

140

VIII.

CLINICAL STUDIES AND REPORTS ESTABLISH IMMUNOTOXICITY AND IMMUNOGENICITY OF SILICONE IN THE BODY

144

A.

Silicones Exert Many Different Effects to Genetically Different People

144

B.

HLA Studies Report A Statistically Significant Correlation Between HLA Genotype And Symptomatic Women With Silicone Breast Implants

150

C.

Overwhelmingly, Studies And Reports Consistently Show That Symptomatic Women Who Are Explanted Improve Or Experience Remission And Symptomatic Women Who Remain Implanted Remain Unchanged Or Worsened

161

IX.

THE EPIDEMIOLOGY STUDIES, VIEWED IN THE APPROPRIATE CONTEXT, PROVIDE FURTHER SUPPORT OF AN ASSOCIATION BETWEEN SILICONE GEL BREAST IMPLANTS AND SYMPTOMS OF DISEASE

167

A.

The Prevalence Rates For Breast Implants And Diseases Are Overstated By The Manufacturers

169

B.

The Medical Community Generally Accepts Relative Risks of Greater Than 1.0 But Less Than 2.0 When Determining Health Decisions

177

C.

Studies On Breast Implants Have Reported Statistically Significant Associations With Symptoms Of Disease

179

D.

The Manufacturers Mischaracterize The Epidemiologic Evidence

185

E.

The Bradford Hill Criteria Have Been Misinterpreted And Misapplied By The Manufacturers

190

X.

THE MANUFACTURERS' SUGGESTION THAT THIS PANEL RELY UPON SO-CALLED "POSITION STATEMENTS" OF CERTAIN ORGANIZATIONS AND INTEREST GROUPS IS IRRESPONSIBLE AND NOT ALLOWED UNDER GENERAL SCIENTIFIC PRINCIPLES NOR THE CHARGE BY THE COURT TO THIS PANEL

197

XI.

CONCLUSION

199

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