Larger Volume Silicone Breast Implants Are Safe In Breast Reconstruction: Data From The Athena Multicenter, Prospective Study Of 400 Patients

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 50.3±9.91 years) were enrolled. Average BMI was 35.8±6.37 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 71.6±19.25) and outcome (mean 79.9±22.33) with similar results in the other domains. CONCLUSION: 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.