Sientra portfolio 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.

Background: The Sientra portfolio of silicone gel breast implants was approved by the Food and Drug Administration on March 9, 2012, and included the first approved shaped implants in the United States. The 5-year results from Sientra's Core Gel and Continued Access Study and the results of a single surgeon are presented.

Methods: This analysis used the data of 640 shaped implants in 321 primary augmentation patients implanted by 16 study surgeons through 5 years.