Comparative double blind clinical study on round versus shaped cohesive gel implants

Abstract

Highly cohesive round or shaped implants are used today by most plastic surgeons performing breast augmentation outside North America. This study was conducted to (1) compare aesthetic outcomes of round versus shaped implants in breast augmentation by defining the preferences of the general female population and plastic surgeons towards two groups of augmented breasts (implanted with either round or shaped devices); and (2) to determine whether or not plastic surgeons could identify the type of implant used in each patient based on the postoperative appearance. The study surveyed 30 breast augmentation patients, 15 with shaped implants and 15 with round devices. Two cohort categories evaluated the postoperative photographs of the patients: the first group comprised 235 female lay respondents and the second group included 11 male plastic surgeons. The lay respondents were asked to score breast beauty and naturalness, and to assess the upper pole. The plastic surgeons were asked similar questions and were additionally asked to try to identify the implant type. With respect to "breast beauty," both respondent categories scored round and shaped implant patients similarly. With regard to "naturalness," both groups scored round implant patients significantly higher (P < .001). Concerning upper pole assessment, the round implant group was scored higher and better than the shaped implant group (P < .001). The plastic surgeons' correct identification rate was 64% for round implants, and 47% for shaped implants. We believe that in the hands of an experienced surgeon who takes all soft tissue variables into consideration, the aesthetic result may not be differentiable when using round versus shaped implants in well-selected patients.