IMPORTANT SAFETY INFORMATIONSientra’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 Sientra 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 Sientra, Inc.
REFERENCES1. 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-19S.2. Kinney BM, Jeffers LLC, Ratliff GE, Carlisle DA. Silicone gel breast implants: science and testing. Plast Reconstr Surg. 2014;134(1S):47S-56S. 3. Calobrace MB, Schwartz MR, Zeidler KR, Pittman TA, Cohen R, Stevens WG. Long-term safety of textured and smooth breast implants. Aesth Surg. 2017;1-11.(4S):7S-19S. 4. https://www.plasticsurgery.org/patient-safety?sub=Accredited+Facilities 5. https://www.plasticsurgery.org/patient-safety/asps-member-qualifications 6. Clemens MW. Breast Implant Associated-ALCL: MD Anderson Cancer Center Experience. https://biaalcl.com/wp-content/uploads/BIA-ALCL-Dr-Clemens-March-2019.pdf Accessed April 3, 2019. 9S. 7. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplasticlarge-cell-lymphoma. 8. Caplin DA et al. MemoryGel breast implants: Final safety and efficacy results after 10 years of follow-up. Plast Reconstr Surg. 2021;147:556–566. 9. Spear SL et al. Allergan Silicone Breast Implant U.S. Core Clinical Study Group. Natrelle round silicone breast implants: Core Study results at 10 years. Plast Reconstr Surg. 2014 Jun;133(6):1354-1361. doi: 10.1097/PRS.0000000000000021. PMID: 24867717; PMCID: PMC4819531.