Labeling for Approved Breast Implants

The original labeling (at the time the FDA approved the implant) and the current labeling from the manufacturer are linked below.

The links below also include the Summary of Safety and Effectiveness Data (SSED), an FDA document that summarizes the key content of the premarket approval, such as the Device Description, Preclinical Evidence, and Clinical Evidence, as well as the FDA's analysis of the scientific evidence that served as the basis for the FDA's decision regarding the reasonable assurance of the safety and effectiveness of each implant.

Saline-Filled Breast Implants

Ideal Saline Breast Implants (P120011)

• Ideal patient labeling (current)
• Patient labeling for Ideal saline breast implants (2014) (PDF - 3.54MB)
• Physician labeling for Ideal saline breast implants (2014) (PDF - 683KB)
• Summary of Safety and Effectiveness Data (SSED) for Ideal saline breast implants (PDF - 346KB)

Mentor Saline Breast Implants (P990075)

• Mentor patient labeling (current)
• Patient labeling for Mentor saline breast implants (2009) (PDF - 1.63MB)
• Physician labeling for Mentor saline breast implants (2009) (PDF - 842KB)
• Summary of Safety and Effectiveness Data (SSED) for Mentor saline breast implants (PDF - 1.1MB)

Inamed (now Allergan) Saline Breast Implants (P020056)

In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Smooth surfaced implants are not affected by this recall.

• Allergan patient labeling (current)
• Patient labeling for Inamed (now Allergan) saline breast implants (2004) (PDF - 2.73MB)
• Physician labeling for Inamed (now Allergan) saline breast implants (2005) (PDF - 1.88MB)
• Summary of Safety and Effectiveness Data (SSED) for Inamed (now Allergan) saline breast implants (PDF - 263KB)

Silicone Gel-Filled Breast Implants

Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028)

• Mentor patient labeling (current)
• Mentor MemoryShape Silicone-Filled Breast Implant Labeling (2013)
• Summary of Safety and Effectiveness for Mentor MemoryShape (PDF - 522KB)

Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053)

• Mentor patient labeling (current)
• Mentor MemoryGel Silicone Gel-Filled Breast Implant Labeling (2006)
• Summary of Safety and Effectiveness for Mentor MemoryGel (PDF - 363KB)

Allergan Natrelle Silicone Gel-Filled Breast Implants (P020056)

In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Smooth surfaced implants are not affected by this recall.

• Allergan patient labeling (current)
• Allergan Natrelle Silicone Gel-Filled Breast Implant Labeling (2006)
• Summary of Safety and Effectiveness for Allergan Natrelle Silicone Gel-Filled (PDF - 263KB)

Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (P040046)

In July 2019, Allergan voluntarily recalled Natrelle BIOCELL textured breast implants and tissue expanders from the market to protect patients. Smooth surfaced implants are not affected by this recall.

• Allergan patient labeling (current)
• Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Labeling (2013)
• Summary of Safety and Effectiveness for Allergan Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled (PDF - 314KB)

Sientra Silicone Gel Breast Implants (P070004)

• Sientra patient labeling (current)
• Sientra's Silicone Gel Breast Implant Labeling (2012)
• Summary of Safety and Effectiveness for Sientra Silicone Gel (PDF - 1.16MB)