Safety Information
Breast Implants
Sientra breast implants are indicated for breast augmentation in women at least 22 years old and for breast reconstruction. Breast implant surgery is contraindicated in women with active infection anywhere in their body, with existing cancer or precancerous conditions who have not received adequate treatment for those conditions, and who are currently pregnant or nursing. Prior to use, plastic surgeons should review all risk information, which is found in the Directions for Use. Key complications associated with the use of silicone gel breast implants include capsular contracture, implant removal, rupture, and reoperation. The Directions for Use and detailed information regarding the risks and benefits of Sientra breast implants can be found at sientra.com.
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 Sientra, Inc.
Breast Tissue Expanders
Sientra breast tissue expanders are indicated for breast reconstruction. They are temporary expanders and are not intended for long-term or permanent implantation. Sientra breast tissue expanders are contraindicated in patients with active infection or existing carcinoma at the intended expansion site. Tissue Expanders with integral magnetic ports should not be used in patients who already have implanted devices subject to magnetic field interference or in patients where an MRI may be needed. Prior to use, plastic surgeons should review the Instructions for Use and detailed information regarding the risks and benefits of Sientra breast tissue expanders, located at sientra.com.
Scar Treatment
BIOCORNEUM is for external use only. Avoid direct contact with eyes, mucous membranes, third degree burns, and open wounds. BIOCORNEUM should not be used on damaged or broken skin. This product has not been shown to help prevent skin cancer or early skin aging.