IMPORTANT SAFETY INFORMATION 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 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.
REFERENCES 1. 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. 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. 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. 4. Jordan SW, Khavanin N, Kim JYS. Seroma in prosthetic breast reconstruction. Plast Reconstr Surg. 2016;137:1104-1116. 5. Hales CM, Carroll MD, Fryar CD, et al. Prevalence of obesity among adults and youth: United States, 2015-2016. National Center for Health Statistics, Data Brief 288, 2017. https://cdc.gov/nchs/products/databriefs/db288.htm (accessed May 1, 2018). 6. Sheina A Macadam, Peter A Lennox. Acellular dermal matrices: Use in reconstructive and aesthetic breast surgery, Can J Plast Surg. 2012 Summer; 20(2): 75–89. 7. Macario A. What does one minute of operating room time cost? Journal of Clinical Anesthesia. 2010;22, 233-236. 8. https://jamanetwork.com/journals/jamasurgery/fullarticle/1730490. 9. https:// www.trustedchoice.com/insurance-articles/life-health/cost-night-hospital/. 10. Fairchild B, Ellsworth W, Selber JC, Bogue DP, Zavlin D, Nemir S, Checka CM, Clemens MW. Safety and Efficacy of Smooth Surface Tissue Expander Breast Reconstruction. Aesth Surg. Volume 40, Issue 1, January 2020, Pages 53-62, https://doi.org/10.1093/asj/sjy199. 11. Zeidler K, Capizzi P, Pittman T. (2018). Sientra AlloX2 Short Term Case Study, Surgical Pearls & Roundtable Discussion. Manuscript submitted for publication. 12. 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. 13. https://www.fda. gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma.