Medical Devices

Labeling for Approved Breast Implants

The links below contain the patient labeling at the time FDA approved the implant. For the current labeling, please go to the manufacturer's website, listed at Manufacturers of Approved U.S. Breast Implants.

Saline-Filled Breast Implants

Ideal Saline Breast Implants

Mentor Saline Breast Implants

Inamed (now Allergan) Saline Breast Implants

Silicone Gel-Filled Breast Implants

Mentor MemoryGel Silicone Gel-Filled Breast Implants

Allergan Natrelle Silicone Gel-Filled Breast Implants

Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Sientra Silicone Gel Breast Implants

Page Last Updated: 03/22/2019
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English