FDA Home Page | CDRH Home Page | Search | A-Z Index

New Device Approval

Allergan Inamed® Silicone-Filled Breast Implants - P020056

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Inamed® Silicone-Filled Breast Implants
Manufacturer: Allergan (formerly Inamed Corporation)
Address: 5540 Ekwill Street, Santa Barbara, California 93111
Approval Date: November 17, 2006
Approval Letter: http://www.fda.gov/cdrh/pdf2/p020056a.pdf

What is it? The Inamed® Silicone-Filled Breast Implant is a silicone shell filled with silicone gel. The implants are available with textured and smooth surfaces and with various profiles and sizes.

How does it work? The breast implant is surgically implanted either under breast tissue or under the chest muscle.

When is it used? Inamed® Silicone-Filled Breast Implants are indicated for females for the following uses (procedures):

• Breast augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.
• Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.

What will it accomplish? Refer to the patient labeling for a summary of the clinical data for this product at http://www.fda.gov/cdrh/pdf2/P020056d.pdf (for breast augmentation) and at http://www.fda.gov/cdrh/pdf2/P020056e.pdf (for breast reconstruction).

When should it not be used? Breast implant surgery should not be performed in:

• Women with active infection anywhere in their body.
• Women with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions.
• Women who are currently pregnant or nursing.

Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.fda.gov/cdrh/pdf2/p020056.html

Other:

FDA’s breast implant website: http://www.fda.gov/cdrh/breastimplants/ (includes links to Panel transcripts, approved labeling, consumer handbook, breast implant guidance document, etc.)

Article, “Making an Informed Decision About Breast Implants:” http://www.fda.gov/fdac/features/2004/504_implants.html

Updated November 17, 2006

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH