Plastic & Reconstructive Surgery: November 2015 - Volume 136 - Issue 5 - p 957–966
Doren, Erin L.
Background: Contoured cohesive gel breast implants have been recently approved in the United States. These implants have been available for premarket approval studies for selected surgeons. The purpose of this study was to assess a single surgeon’s outcomes in three specific clinical situations—breast augmentation, secondary augmentation, and breast reconstruction—using implants of all three contoured cohesive gel implant manufacturers (Allergan, Mentor, and Sientra) over a 10-year period.
Methods: The authors performed a prospective study of contoured cohesive silicone gel breast implants. Demographic and outcomes data were recorded. Complication rates were compared among the three implant manufacturers.
Results: From 2001 to 2013, 695 patients were included from U.S. Food and Drug Administration clinical trials......................