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)

The History of Breast Implants and The Role of the FDA

Many assume that because silicone breast implants were on the market for a long time preceding the present controversy, they must have been safe and approved by the FDA. This assumption is incorrect. The regulatory framework for medical devices, which include silicone gel-filled and saline filled breast implants, did not play a role in the early development, marketing or labeling of this product. Because the use and sale of breast implants pre-existed regulations regarding other medical devices and prosthetics, breast implants were not subject to the rigorous regulatory process other medical devices are now put through.

In fact, in the mid-80's when questions began to arise with regard to the rupture rate of implants and the incidence of painful scar tissue development in the breast, the FDA requested that the industry provide safety data to support the continued use of their product in the market place. When the industry was unable to provide the requested information, some manufacturers took preemptive action removing their breast implants from the marketplace. The first such "voluntary" withdrawal from the marketplace involved polyurethane breast implants, such as, the Meme or Replicon implant.

In 1993, recognizing the vacuum that existed with regard to safety data for breast implants, the FDA proposed a moratorium on the use, sale and implantation of silicone gel-filled breast implants, except under very limited circumstances. This moratorium remains in place today, despite the efforts of the breast implant manufacturers to have the moratorium lifted. Significant questions remain today regarding whether breast implants cause autoimmune disease and a variety of other serious complications. The FDA maintains a World Wide Web site regarding the breast implant controversy located at The Food and Drug Administration's Breast Implant Home Page. http://www.fda.gov/cdrh/breastimplants/indexbip.html

If you believe you have been injured by breast implants please contact us at breastimplants@toxicdiscovery.com