W Grant Stevens1,2, M Bradley Calobrace1,2, Kaveh Alizadeh1,2, Kamakshi R Zeidler1,2, Jennifer L Harrington1,2, Rosalyn C d'Incelli1,2. 1. Marina del Rey, CA; Louisville, KY; New York, NY; Campbell, CA; Minneapolis, MN; and Santa Barbara, CA. 2. From the Division of Plastic Surgery, University of Southern California School of Medicine; Division of Plastic Surgery, University of Louisville, and Division of Plastic Surgery, University of Kentucky; Division of Plastic and Reconstructive Surgery, Westchester Medical Center and New York Medical College; Private Practice; Division of Plastic and Reconstructive Surgery, University of Minnesota, and North Memorial Hospital; and Clinical and Medical Affairs, Sientra, Inc.
Abstract
BACKGROUND: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years. METHODS: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction. RESULTS: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons. CONCLUSION: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.
BACKGROUND: In March 2012, the United States Food and Drug Administration approved Sientra's application for premarket approval of its portfolio of round and shaped silicone gel breast implants based on data from the largest silicone gel breast implant study to date. This article presents the results of Sientra's Core Study at the conclusion of 10 years. METHODS: The Sientra Core Study was a 10-year, open-label, prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra's breast implants in augmentation and reconstruction. A total of 1,788 patients (3,506 implants) were enrolled, including 1,116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction, and 84 revision-reconstruction. RESULTS: Across all cohorts, the rate of rupture by patient was 8.6%, the rate of Baker grade III/IV capsular contracture was 13.5%, and the rate of reoperation was 31.5%. The rate of capsular contracture was statistically significantly lower for textured devices [9.0%; 95% confidence interval (CI), 7.0-11.5%] compared with smooth devices (17.5%; 95% CI, 14.9-20.4%). There were no cases of breast implant-associated anaplastic large cell lymphoma. Primary reasons for reoperations included capsular contracture (18.8%), and style/size change (19.3%), with over 50% of the reoperations due to cosmetic reasons. CONCLUSION: The 10-year results of Sientra's Core Study support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped breast implants.
Authors: Mimi R Borrelli; Dre Irizzary; Ronak A Patel; Dung Nguyen; Arash Momeni; Michael T Longaker; Derrick C Wan Journal: Aesthet Surg J Date: 2020-03-23 Impact factor: 4.283
Authors: Evan B Lynch; Ryan C DeCoster; Krishna S Vyas; Brian D Rinker; Mei Yang; Henry C Vasconez; Mark W Clemens Journal: Ann Breast Surg Date: 2021-09-30