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

Calobrace, M. Bradley, MD; Stevens, W. Grant, MD; Capizzi, Peter J., MD; Cohen, Robert, MD; Godinez, Tess, BS; Beckstrand, Maggi, PhD

Plastic and Reconstructive Surgery: April 2018 - Volume 141 - Issue 4S - p 20S-28S
doi: 10.1097/PRS.0000000000004351
Original Articles
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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.

Louisville and Lexington, KY; Marina Del Ray, CA; Charlotte, NC; Santa Monica, CA; and Santa Barbara, CA

From the Division of Plastic Surgery, University of Louisville, and Division of Plastic Surgery, University of Kentucky; Division of Plastic Surgery, University of Southern California School of Medicine, University of Southern California; Department of Plastic Surgery, Presbyterian Hospitals; private practice; Clinical Operations and Medical Affairs, Sientra, Inc.; and MB Statistical Consulting.

Received for publication June 23, 2017; accepted November 7, 2017.

Disclosure:Drs. Calobrace, Stevens, Capizzi, and Cohen are clinical study investigators for Sientra and receive standard research support for conducting their studies. The authors have no financial interest to declare in relation to the content of this article and received no financial support in the preparation of this article. Ms. Godinez is a Sientra employee. Dr. Beckstrand is a Sientra consultant.

M. Bradley Calobrace, MD, CaloAesthetics, 2341 Lime Kiln Lane, Louisville, KY 40222, drbrad@calobrace.com

Copyright © 2018 by the American Society of Plastic Surgeons