Safety and Efficacy of the Sientra Silicone Gel Round and Shaped Breast Implants: 6-Year Results of the U.S. Postapproval Study.

ABSTRACT:

Background

After approval of Sientra silicone gel breast implants in March of 2012, the U.S. Food and Drug Administration required completion of a 10-year U.S. postapproval study. The authors present results from the first 6 years of this study.

Methods

An ongoing, open-label, prospective, multicenter study is being conducted to evaluate the long-term clinical performance of Sientra implants in patients undergoing breast augmentation, reconstruction, and revision in the postmarket environment. Enrollment of 5197 patients (10,327 implants) was completed on March 6, 2015 (4046 primary augmentation, 895 revision-augmentation, 149 primary reconstruction, and 107 revision-reconstruction). Analyses were conducted at year 6 (database lock: January 24, 2022).

Results

Across a

SUBMITTER: Calobrace MB 

PROVIDER: S-EPMC11195925 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature