of Silimed Brand Shaped Implants with High - Strength Silicone Gel : A 5 - Year Primary Augmentation Clinical Study Experience and a Postapproval Experience — Results from a Single - Surgeon 108 - Patient Series COSMETIC

38S Since the first breast implants were introduced in the early 1960s,1 there have been various design improvements to the round implant, which had been the only shape commercially available for over 50 years. As breast implant surgery became more popular across a larger demographic and patients requested a more “natural” shape, the need for an anatomically shaped silicone implant became apparent. Although widely available and popular in Europe,1 anatomically shaped implants were only available in the United States through clinical studies until Sientra’s recent approval. On March 9, 2012, the Food and Drug Administration approved Sientra’s portfolio of its Silimed brand silicone gel breast implants based on the clinical study data from its large pivotal study. This approval also marked the introduction of the first shaped silicone gel implant in the United States. The following data present a summary of the results from Sientra’s Core Gel and Continued Access Study of its shaped implants through