Sientra’s Silicone Gel Breast Implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of primary breast augmentation surgery. 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 results of a primary breast reconstruction surgery. Breast implant surgery is contraindicated in women with active infection anywhere in their bodies, with existing cancer or pre-cancer of their breast who have not received adequate treatment for those conditions and, who are pregnant or nursing. Key complications include capsular contracture, implant removal, rupture and reoperation. For more detailed information about the risks and benefits of Sientra breast implants, please visit sientra.com/resources or call Tiger Aesthetics at 888.708.0808. Sientra breast implants with high-strength cohesive silicone gel are only available through board-certified or board-eligible plastic surgeons.
The sale and distribution of this device is restricted to users and/or user facilities that provide information to patients about the risks and benefits of this device in the form and manner specified in the approved labeling provided by Tiger Aesthetics Medical, LLC.
