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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 Communication, Education, and Radiation Programs (OCER) 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 at http://www.fda.gov/cdrh/breastimplants/.

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 at http://www.fda.gov/cdrh/breastimplants/ 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.

Updated June 8, 2004

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Center for Devices and Radiological Health / CDRH