Implant-based breast surgery is among the most common plastic surgery procedures performed each year in the U.S., and capsular contracture, a condition where the scar tissue naturally forming around the implant becomes unusually hard, causing pain and anatomical displacement, is its most frequent complication, with overall incidence ranging from 10% to 20%1-5. At advanced stages, CC necessitates treatment through surgical intervention, and when performed using conventional techniques, the risk of recurrence may be as high as 54%6. This multi-center Study of GalaFLEX LITE™ Poly-4-Hydroxybutyrate (P4HB) Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation (STANCE) is a pivotal study that aims to evaluate whether GalaFLEX LITE™ Scaffold, when used in breast revision surgery, decreases the likelihood of CC and or malposition. The trial further positions BD as a leader in advanced biomaterial science – driving transformative change in how tissue is reconstructed
