Natrelle® Breast Implants are indicated for women for the following:
Breast augmentation for women at least 22 years old for silicone-filled implants and breast augmentation for women at least 18 years old for saline-filled implants. This 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. This 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
CONTRAINDICATIONS
Breast implant surgery should not be performed in:
Women with active infection anywhere in their body
Women with existing cancer or precancer of their breast who have not received adequate treatment for those conditions
Women who are currently pregnant or nursing
ADDITIONAL WARNINGS
See Boxed Warning
Avoid damage during surgery: Care should be taken to avoid the use of excessive force and to minimize handling of the implant. Forcing of implants through too small an opening or applying concentrated localized pressure on the implants may result in localized weakening of the breast implant shell, potentially leading to shell damage and possible implant rupture. An incision should be of appropriate length to accommodate the style, size, and profile of the implants.