Food and Drug Administration

General and Plastic Surgery Panel

October 14, 2003

Briefing Information

McGhan Silicone-Filled Breast Inplants

Disclaimer

The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document

Summary Panel Memorandum (PDF)

Inamed Clinical Summary Memorandum (PDF)

Panel Member Package (PDF)

Amendment to Panel Package (PDF)

Summary of Safety & Effectiveness Data (SSED) (PDF)

Inamed Corporation Table of Contents (PDF)

Chemistry

Bibliography (PDF)

Extractables Testing (PDF)

Presence or Absence of Silica (PDF)

Sililcone Elastomer Biodurability Study (1993) (PDF)

Biodurability Study (1995) (PDF)

Catalyst Metal Concentration (PDF)

Analysis of Peroxide Catalyzed Silicone Sheeting (1993) (PDF)

Toxicology

Acute Systemic Toxicity (PDF)

Chemical Characterization (PDF)

Chronic Toxicity and Carcinogenicity Testing 1 (PDF)

Chronic Toxicity and Carcinogenicity Testing 2 (PDF)

Chronic Toxicity and Carcinogenicity Testing 3 (PDF)

Cytotoxicity (PDF)

Dermal Sensitization Testing (PDF)

GC & GC-MS Analyses of Silicones (PDF)

Genetic Toxicity Testing 1 (PDF)

Genetic Toxicity Testing 2 (PDF)

Genetic Toxicity Testing 3 (PDF)

Genetic Toxicity Testing 4 (PDF)

Genetic Toxicity Testing 5 (PDF)

Genetic Toxicity Testing 6 (PDF)

Genetic Toxicity Testing 7 (PDF)

Genetic Toxicity Testing 8 (PDF)

Genetic Toxicity Testing 9 (PDF)

Hemocompatibility (PDF)

Immunotoxicity Testing 1 (PDF)

Immunotoxicity Testing 2 (PDF)

Immunotoxicity Testing 3 (PDF)

Immunotoxicity Testing 4 (PDF)

Immunotoxicity Testing 5 (PDF)

Immunotoxicity Testing 6 (PDF)

Implantation Tests (PDF)

Pharmacokinetics (PDF)

Pharmacokinetics - Literature With Bibliography (PDF)

Pyrogencity (PDF)

Reproduction - Literature With Bibliography (PDF)

Reproductive Testing - Female Fertility and Developmental Testing (PDF)

Reproductive Toxicity Testing - Extended F1 Generation (PDF)

Reproductive Toxicity Testing (Toxicology Review) (PDF)

Subchronic Toxicity Testing (PDF)

Teratology (PDF)

Physical/Mechanical Testing

Gel Cohesion and Gel Penetration Testing (PDF)

Gel Bleed Testing and GPC Analysis (PDF)

Fatigue Testing (PDF)

Retrieval Study

Retrieval Study Report (PDF)

Clinical Studies

Core Clinical Study

Original

Core Augmentation (Analysis & Data Tables) (PDF)

Core Reconstruction (Analysis & Data Tables) (PDF)

Core Revision (Analysis & Data Table) (PDF)

Revised

Narrative (PDF)

Core Augmentation (Data Tables only) (PDF)

Core Reconstruction (Data Tables only) (PDF)

Core Revision (Data Tables only) (PDF)

Analysis of A95-R95 Studies (PDF)

Rupture Information (PDF)

Core Augmentation - Removal Without Replacement (PDF)

Core Reconstruction - Removal Without Replacement (PDF)

Core Revision - Removal Without Replacement (PDF)

Core Augmentation - Breast Disease (PDF)

Core Reconstruction - Breast Disease (PDF)

Informal Core Study Emails (PDF)

Adjunct Clinical Study

Original

Adjunct Reconstruction (Analysis & Data Tables) (PDF)

Adjunct Revision (Analysis & Data Tables) (PDF)

Revised

Narative (PDF)

A95-R95 & Adjunct Revision Comparison (PDF)

Adjunct Reconstruction (KM Data Tables) (PDF)

Adjunct Revision (KM Data Tables) (PDF)

Informal Adjunct Study Emails (PDF)

AR90 Clinical Study

Original

AR90 Augmentation (Analysis & Data Tables) (PDF)

AR90 Reconstruction (Analysis Data TAbles) (PDF)

Revised

Narative (PDF)

AR90 Augmentation (KM Data Tables) (PDF)

AR90 Reconstruction (KM Data Tables) (PDF)

Clinical Studies

Supplemental Clinical Information

SEER Study Report (PDF)

Clinical Literature Summary & Bibliography (PDF)

Clinical Literature Narrative (PDF)

Clinical Narrative Bibliography (PDF)

Postapproval Plan for Core Study (PDF)

Comprehensive Bibliography

Narrative to Comprehensive Bibliography (PDF)

Comprehensive Bibliography (PDF)

Labeling

Draft Package Insert (3-14-03) (PDF)

Draft Patient Labeling (3-14-03) (PDF)