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Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel.
[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 b…
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Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel.
[BACKGROUND] Since approval in March 2012, data on Sientra's (Santa Barbara, CA) silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The 9…
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Risk factor analysis for capsular contracture: a 5-year Sientra study analysis using round, smooth, and textured implants for breast augmentation.
[BACKGROUND] Although there are a few broadly agreed on contributory factors, the multifaceted causes of capsular contracture have remained unresolved for decades. This study investigates a variety of potential risk factors that contribute …