Risk Factor Analysis for Capsular Contracture: A 10-Year Sientra Study Using Round, Smooth, and Textured Implants for Breast Augmentation.

Abstract

Despite the increased understanding of surgical best practices, capsular contracture remains the most commonly reported complication and reason for reoperation following breast implant surgery. This study provides a long-term update to a previous investigation of potential contributing risk factors for capsular contracture in primary augmentation patients. The data used for this analysis include 5,122 implants in 2,565 primary augmentation patients implanted by 34 surgeons based on long-term results from Sientra's clinical study. Potential risk factors, including patient and implant attributes, surgery characteristics, pocket irrigation, and postsurgery characteristics, were analyzed using frequency and multivariate models. A total of 333 capsular contracture events in 224 patients were reported. The overall Kaplan-Meier rate for capsular contracture was 10.8% by device through 10 years. Results from the multivariate analysis found 8 factors to be independently associated with capsular contracture (implant placement, implant surface, incision site, hematoma or seroma development, device size, surgical bra, steroid, and antibiotic pocket irrigation; all P values < 0.05). Results from correlation analysis found 2 of the 8 factors to be more strongly associated with early onset capsular contracture events, compared with those occurring after 2 and 5 years of implantation (implant surface and steroid pocket irrigation). The results of this large-scale, multivariate analysis identified several significant risk factors for capsular contracture, including device features (smooth surface, smaller size), surgical factors (periareolar incision, subglandular placement, antibiotic irrigation), the development of hematoma/seroma, and the use of a surgical bra.