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  6. Labeling for Approved Breast Implants
  1. Breast Implants

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)

Mentor Saline Breast Implants (P990075)

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.

Silicone Gel-Filled Breast Implants

Mentor MemoryShape Silicone Gel-Filled Breast Implants (P060028)

Mentor MemoryGel Silicone Gel-Filled Breast Implants (P030053)

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 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.

Sientra Silicone Gel Breast Implants (P070004)