American Association of Plastic Surgeons

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Larger Volume Silicone Breast Implants Are Safe In Breast Reconstruction: Data From The Athena Multicenter, Prospective Study Of 400 Patients
Patrick B. Garvey, M.D.1, Alan Larsen, MD2, Roman Skoracki, MD3, Risal Djohan, MD4, Mark R. Migliori, MD5, Marissa M. Tenenbaum, MD6, Jeffrey D. Friedman, MD7, Joseph M. Serletti, MD8, Alanna M. Rebecca, MD9, William Kane, MD10;
1The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA, 2Buckhead Plastic Surgery, Atlanta, GA, USA, 3The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA, 4Cleveland Clinic, Cleveland, OH, USA, 5Muldowney, Migliori, and Witzke Plastic Surgery, Edina, MN, USA, 6Washington University School of Medicine in St. Louis, St. Louis, MO, USA, 7Houston Methodist, Houston, TX, USA, 8University of Pennsylvania School of Medicine, Philadelphia, PA, USA, 9Mayo Clinic, Phoenix, AZ, USA, 10Mentor Worldwide LLC, Irvine, CA, USA

PURPOSE - The maximum volume of commercially available silicone breast implants (SBIs) in the United States for women desiring implant-based breast reconstruction (IBBR) is 800cc. This prospective, multicenter study aimed to evaluate the safety of a prototype of larger SBIs ranging from 750cc to 1445cc in IBBR patients.
METHODS - A multicenter, open-label, ten-year prospective, pre-market investigational study was initiated in 2016 to demonstrate the safety and effectiveness of larger-volume Mentor UHP-L SBIs in women who underwent post-mastectomy two-stage primary or revision IBBR. Three-year Kaplan-Meier curves, Cox, and multivariable logistic regression analyzed the association between patient/treatment characteristics and surgical outcomes. Breast-Q was used to assess effectiveness at three years.
RESULTS - 400 women (mean age 50.39.91 years) were enrolled. Average BMI was 35.86.37 and mean mastectomy weight was 1056.9g (range 44-3348g). Bilateral reconstructions occurred in 79.3% of subjects, and 83.0% had submuscular implants. The 1030cc implant was used most frequently. The most common complications were Baker III/IV capsular contracture (CC)(6.4%), delayed wound healing (5.2%), and infection (4.7%). The explantation rate was 15.8%. Independent predictors of complications included radiation therapy for Baker III/IV CC (HR 3.03,p=0.0038) and past smoking for delayed wound healing (HR 2.22,p=0.0354). Implant volume was not associated with complications. Breast-Q demonstrated satisfaction with breasts (mean 71.619.25) and outcome (mean 79.922.33) with similar results in the other domains.
CONCLUSIONS -These three-year results from the largest prospective, ten-year breast reconstruction trial demonstrate that larger-volume SBIs are safe, effective, and a viable option for patients with larger breasts requesting post-mastectomy IBBR.
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