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

[BACKGROUND] 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.

[METHODS] 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.

[RESULTS] 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).

[CONCLUSION] 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.