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Medical Devices

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FDA Breast Implant Consumer Handbook - 2004

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Table of Contents

2004 Breast Implant Consumer Handbook Introductory Letter

Glossary

Introduction

Device Description

  • Saline-Filled Breast Implants
  • Silicone Gel-Filled Breast Implants
  • Alternative Breast Implants

Status / Availability of Implants

  • Saline-Filled Breast Implants
  • Silicone Gel-Filled Breast Implants
  • Alternative Breast Implants

Local Complications & Reoperations

  • Reoperation
  • Removal
  • Rupture/Deflation
  • Capsular Contracture
  • Breast Pain
  • Nipple and Breast Sensation Changes

Diseases

  • Connective Tissue Diseases (CTDs) and Related Disorders
  • Cancers
  • Neurological Symptoms/Diseases

Specific Issues to Consider

  • Mammography
  • Breast Feeding
  • Effects on Children
  • Suicide
  • Gel Bleed
  • Platinum
  • Silicone Sensitivity
  • Polyurethane Foam-Coated Breast Implants
  • Trilucentâ„¢ Breast Implants

Breast Implant Surgery & Related Issues

  • Choosing a Surgeon
  • Choosing an Implant
  • Choosing the Surgical Incision Site
  • Choosing the Type of Implant Placement
  • General Description of Breast Implant Surgery
  • After the Surgery
  • Choices in Reconstructive Procedures
  • Breast Reconstruction with Breast Implants
  • Breast Reconstruction with Tissue Flaps
  • Questions to Ask Your Surgeon about Breast Augmentation
  • Questions to Ask Your Surgeon about Breast Reconstruction

Resource Groups

Timeline of Breast Implant Activities

MedWatch

Freedom of Information

 

    
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