Natrelle round silicone breast implants: Core Study results at 10 years.

ABSTRACT:

Background

Allergan's Natrelle round silicone-filled breast implants were approved by the U.S. Food and Drug Administration in 2006 based on interim results from the Core Study; final 10-year study results are now available.

Methods

Seven hundred fifteen subjects were implanted with smooth and Biocell textured Natrelle round silicone implants and attended clinic visits at 0 to 4 weeks, 6 months, 1 year, and annually through 10 years. Approximately one-third of subjects underwent magnetic resonance imaging at years 1, 3, 5, 7, and 9 to assess rupture.

Results

Complication rates showed modest increases over the previously published 6-year rates. The Kaplan-Meier capsular contracture rate was 18.9 percent for augmentation, 28.7 percent for revision-augmentation, and 24.6

SUBMITTER: Spear SL 

PROVIDER: S-EPMC4819531 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature