Dear Reader: The Food and Drug Administration (FDA) is pleased to provide you the newly revised “FDA Breast Implant Consumer Handbook – 2004.” This replaces the previous version of the handbook entitled, “Breast Implants – An Information Update – 2000.”

This handbook contains the latest information about breast implants to assist you in making an informed decision about whether or not to have breast implants. It includes topics such as the status of breast implants, potential complications, issues to consider, timeline of FDA activities related to breast implants, and breast implant resource groups.

The Consumer Affairs Staff of FDA’s Office of Health and Industry Programs (OHIP) is a consumer resource to answer breast implant calls and distribute this handbook. For specific information on how to obtain a copy of this handbook or to talk to a Consumer Affairs Specialist, refer to the Resource Groups section.

This handbook, along with other breast implant information, may also be obtained by visiting FDA’s website at http://www.fda.gov/cdrh/breastimplants/.

You may also be interested in joining the Breast Implant Listserv to receive emails about upcoming events, panel meetings, frequently asked questions, etc. associated with breast implants. You may join the Breast Implant Listserv by visiting FDA’s website.

We hope the information in this handbook will be helpful to you. You may duplicate the information for further distribution. If you have any comments regarding this handbook, please email us through the link at the bottom of FDA’s website or write to us at FDA, Office of Device Evaluation, Division of General, Restorative, and Neurological Devices, 9200 Corporate Boulevard, HFZ-410, Rockville, MD 20850.

Sincerely yours,
Samie Allen
FDA Breast Implant Team Leader
Division of General, Restorative, and Neurological Devices
Office of Device Evaluation Center for Devices and Radiological Health

INTRODUCTION

The three basic types of breast implants are saline-filled, silicone gel-filled, and alternative (e.g., soybean oil) implants. Breast implants are designed for treatment of augmentation, reconstruction, and revision patients. While many women believe breast implants cause illnesses, such as autoimmune disease, this is not proven at this time.

However, most women with breast implants will experience local complications, such as pain, capsular contracture, and rupture/deflation. You may need to have nonsurgical treatments or reoperations to treat local complications. Breast implants do NOT last a lifetime. You should be prepared for long-term follow-up, reoperations to treat complications, and personal financial costs.

Before you make your decision whether or not to get breast implants, it is very important that you:

• read the information in this handbook
• read the patient labeling for the approved saline-filled breast implants at FDA’s website to learn about the types and rates of complications seen with breast implants
• read the specific patient labeling or informed consent documents for the breast implants for which you are gathering information
• collect specific information from your insurance company and your doctor to estimate personal financial costs (see below)
• have a realistic expectation of the outcome (see below).

Download FDA Breast Implant Consumer Handbook

PDF format, 1MB, 80Pages. FDA.gov

TABLE OF CONTENTS
GLOSSARY ................................................................................................................... 1
INTRODUCTION .............................................................................................................7
DEVICE DESCRIPTION...............................................................................................10
Saline-Filled Breast Implants .........................................................................................11
Silicone Gel-Filled Breast Implants ...............................................................................12
Alternative Breast Implants............................................................................................13
STATUS / AVAILABILITY...........................................................................................14
Saline-Filled Breast Implants .........................................................................................14
Silicone Gel-Filled Breast Implants ...............................................................................15
Alternative Breast Implants............................................................................................16
LOCAL COMPLICATIONS & REOPERATIONS....................................................17
Reoperation....................................................................................................................19
Removal.........................................................................................................................20
Rupture/Deflation ...........................................................................................................22
Capsular Contracture......................................................................................................28
Breast Pain......................................................................................................................29
Nipple and Breast Sensation Changes............................................................................30
DISEASES.......................................................................................................................32
Connective Tissue Diseases (CTDs) and Related Disorders .........................................32
Cancers ...........................................................................................................................35
Neurological Symptoms/Diseases..................................................................................36
SPECIFIC ISSUES TO CONSIDER.............................................................................37
Mammography ...............................................................................................................37
Breast Feeding ................................................................................................................39
Effects on Children.........................................................................................................39
Suicide ............................................................................................................................40
Gel Bleed ........................................................................................................................41
Platinum.........................................................................................................................41
Silicone Sensitivity.........................................................................................................42
Polyurethane Foam-Coated Breast Implants..................................................................43
Trilucent Breast Implants ............................................................................................44

BREAST IMPLANT SURGERY & RELATED ISSUES...........................................46
Choosing a Surgeon........................................................................................................46
Choosing an Implant.......................................................................................................47
Choosing the Surgical Incision Site ...............................................................................48
Choosing the Type of Implant Placement ......................................................................49
General Description of Breast Implant Surgery .............................................................50
After the Surgery ............................................................................................................51
Choices in Reconstructive Procedures ...........................................................................52
Breast Reconstruction with Breast Implants ..................................................................53
Breast Reconstruction with Tissue Flaps .......................................................................55
Questions to Ask Your Surgeon about Breast Augmentation........................................57
Questions to Ask Your Surgeon about Breast Reconstruction ......................................58
RESOURCE GROUPS ...................................................................................................59
TIMELINE OF BREAST IMPLANT ACTIVITIES...................................................62
MEDWATCH ..................................................................................................................75
FREEDOM OF INFORMATION .................................................................................76

Comments (0)

Show/Hide comments

Name

Email

Website

Title

Comment

smaller | bigger

Add Comment