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1. Stevens WG, Calobrace MB, Alizadeh A, Zeidler KR, Harrington JL, d’Incelli RC. Ten-year core study data for Sientra’s Food and Drug Administration—approved round and shaped breast implants with cohesive silicone gel. Plast Reconstr Surg. 2018;141(4s):7S-195 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 bene ts of Sientra breast implants, please visit sientra.com/resources or call Sientra at 888.708.0808. Sientra breast implants with high-strength cohesive silicone gel are only available through board-certi ed 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 bene ts of this device in the form and manner speci ed in the approved labeling provided by Sientra, Inc. Sientra ® is a trademark of Sientra, Inc. © 2022 Sientra, Inc. All rights reserved. MDC-XXXX R0
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