Histomorphologic Outcomes of GalaFLEX Scaffold Used in Breast Surgery: Clinical Follow-up From 6 Weeks to 63 Months

Abstract Background The use of scaffolds in reconstructive and aesthetic breast surgeries for soft tissue reinforcement has increased over time. However, histomorphologic outcomes with the use of such materials are not typically reported. The present study describes the histologic findings associated with the use of the GalaFLEX Scaffold by BD (Franklin Lakes, NJ), an absorbable biosynthetic material, when used as soft tissue support in breast surgery. Objectives The present study evaluates the histomorphologic patterns of a 10-patient cohort that received GalaFLEX Scaffolds as soft tissue support in breast surgery, with and without breast implants. Methods Tissue biopsy specimens that included the implanted GalaFLEX Scaffold were collected during revision from 6 weeks to 63 months postimplantation. General staining and specific immunolabeling were used to determine cellular infiltration, tissue composition and organization, and vascularization. Results Biopsy specimens showed slow degradation of the GalaFLEX Scaffold, robust vascularization, mononuclear cell infiltration that decreased with time, and deposition of an organized collagenous connective tissue matrix in the interfiber space of the GalaFLEX Scaffold. There was no evidence for chronic inflammation or a foreign body response. The pattern of tissue remodeling around and within the fibers suggests a constructive tissue remodeling process rather than the formation of dense capsular tissue with contraction. Conclusions Implantation of the GalaFLEX Scaffold for reconstructive and cosmetic breast surgery appears to be safe and is associated with slow scaffold degradation, neovascularization, and mononuclear cell infiltration that diminishes with time, and a constructive remodeling response devoid of chronic inflammation or foreign body response. These conclusions are limited by the size of the 10-patient cohort. Level of Evidence: 4 (Therapeutic)