A Multicenter Prospective Study of Enhanced Viability Fat Transfer for Cosmetic Augmentation and Reconstruction of the Breast

Background . Autologous fat transfer (AFT) is a well-established technique for cosmetic breast augmentation and reconstructive breast procedures. Historically, however, graft retention has been highly variable. The Viality™ system (Tiger Aesthetics Medical, Conshohocken, PA) is an FDA-cleared, in-line fat processing device designed to concentrate viable adipocytes, improving retention. Methods . In this prospective, 14-center study (NCT05258305), 190 patients underwent AFT for cosmetic (n=85) or reconstructive (n=105) breast procedures. Harvested fat was processed with Viality and AuraClens™ surfactant wash. Volumetric analysis, based on 3D imaging, was performed at baseline and 1, 3, 6, and 12 months. Percentage retention and impact of patient factors on retention at 12 months were assessed. Results . Mean (95% CI) retention was 86.6% (85.4 to 87.7) at month 1, 83.1% (81.8 to 84.4) at month 3, 84.1% (82.8 to 85.5) at month 6, and 84.8% (83.2 to 86.5) at month 12. Mean retention was significantly greater at all timepoints than the historical benchmark of 70% ( P <.0001) with no significant changes in retention over time. Similar trends were observed for reconstruction and cosmetic cohorts. Retention was affected by fat transfer volume ( P<. 0001), weight change ( P<. 0001), and graft-to-recipient breast volume ratio ( P =.0187). Conclusions . Early graft steady state, sustained high-percentage volume retention, and consistent results suggest that the Viality system is an effective, predictable modality for processing fat for cosmetic and reconstructive breast surgery, setting a new standard for sustained volume retention.