Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant - P040046
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: Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant
PMA Applicant: Allergan, Inc.
Address: 71 South Los Carneros Road
Goleta, California 93117
Approval Date: February 20, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040046a.pdf
What is it? The Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant (Natrelle 410 Breast Implant) is a silicone shell filled with clear silicone gel. The silicone gel is firmer (more cohesive) than Allergan’s previously approved implant (P020056). The Natrelle 410 Breast Implant is available in different shapes and sizes.
How does it work? The Natrelle 410 Breast Implant is intended to make the breast larger (breast augmentation) or to restore or replace breast tissue (breast reconstruction). It is surgically implanted beneath the breast tissue, either on top of the chest muscle or underneath part or all of the chest muscle.
When is it used? The Natrelle 410 Breast Implant is indicated for women 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? The implant increases the size of the breast. A majority of subjects in the clinical study reported favorable satisfaction and Quality of Life results.
Common adverse effects identified in the clinical study include:
- Uneven appearance (asymmetry)
- Breast pain
- Tightening of the area around the implant (capsular contracture)
- Delayed wound healing
- Collection of blood within a space (hematoma)
- Enlarged scar remaining after the wound heals (hypertrophic scarring/scarring)
- Implant removal with or without replacement
- Implant placed incorrectly or has moved/shifted from the original position (implant malposition)
- Implant rupture
- Additional surgeries, including those to change style or size (reoperation)
- Watery portion of the blood collects around the surgical incision or around the breast implant (seroma).
- Bulging on upper part of breast (upper pole fullness)
- Wrinkling/irregular wavy look or feel to breast (rippling)
Refer to the labeling for the clinical study.
When should it not be used? Breast implant surgery should not be performed in:
- Women with active infection anywhere in the 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: The Summary of Safety and Effectiveness Data and labeling are available online.