W Grant Stevens1, Jennifer Harrington1, Kaveh Alizadeh1, David Broadway1, Kamakshi Zeidler1, Tess B Godinez1. 1. Dr Stevens is a Clinical Professor of Surgery in the Division of Plastic Surgery at the University of Southern California School of Medicine and Director of the University of Southern California-Marina del Rey Aesthetic Surgery Fellowship Program, Los Angeles. Dr Harrington is a plastic surgeon in private practice in Plymouth, MN. Dr Alizadeh is a plastic surgeon in private practice in Great Neck, NY. Dr Broadway is a plastic surgeon in private practice in Lone Tree, CO. Dr Zeidler is a plastic surgeon in private practice in Campbell, CA. Ms Godinez is the Director of Clinical Operations at Sientra, Inc., Santa Barbara, CA.
Abstract
BACKGROUND: On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States. OBJECTIVES: The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants. METHODS: The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant-related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size. RESULTS: Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment. CONCLUSIONS: Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped implants through 8 years. LEVEL OF EVIDENCE: 3 Therapeutic.
BACKGROUND: On March 9, 2012, the Food and Drug Administration (FDA) approved Sientra's premarket approval application for its portfolio of silicone gel breast implants based on their review of Sientra's 3-year study data from the largest pivotal silicone gel breast implant study to date. This included the first approval of shaped breast implants in the United States. OBJECTIVES: The authors provide an update to the 8-year safety and effectiveness of the Sientra High-Strength silicone gel breast implants. METHODS: The Sientra Core study is an ongoing 10 year open-label, prospective, multi-center clinical study, which includes 1788 patients implanted with 3506 Sientra implants across four indications (Primary Augmentation, Revision Augmentation, Primary Reconstruction, and Revision Reconstruction). For the safety analysis, the incidence of post-operative complications, including all breast implant-related adverse effects (eg, infection, asymmetry), was estimated based on Kaplan-Meier risk rates. The effectiveness analyses include surgeon and patient satisfaction and changes in bra/cup size. RESULTS: Through 8 years, the overall risk of rupture was 4.6%, the risk of capsular contracture was 11.8% (rates were lower when using True Texture™), and the risk of reoperation was 28.3%. Out of the 580 reoperations in 456 patients, over half of all reoperations were due to cosmetic reasons (n = 299). The most common reasons for reoperation were capsular contracture (19.0%), style and/or size change (18.4%), and asymmetry (8.8%). Patient satisfaction remains high through 8 years, with 87% indicating that their breast implants make them feel more feminine than prior to enrollment. CONCLUSIONS: Safety data from the FDA Core study continues to support a comprehensive safety and effectiveness profile of Sientra's portfolio of round and shaped implants through 8 years. LEVEL OF EVIDENCE: 3 Therapeutic.
Authors: Nima Khavanin; Mark W Clemens; Andrea L Pusic; Neil A Fine; Jennifer B Hamill; H Myra Kim; Ji Qi; Edwin G Wilkins; John Y S Kim Journal: Plast Reconstr Surg Date: 2017-05 Impact factor: 4.730