Capsular contracture remains the most frequent complication in implant-based breast surgery, with recurrence rates after conventional treatment reaching as high as 54%. The ongoing prospective, randomized, controlled study aims to determine if the GalaFLEX LITE™ Scaffold—composed of poly-4-hydroxybutyrate (P4HB)—can improve outcomes compared to standard surgical revision.

Art Stephen, global R&D Leader of Surgery at BD, noted that the data generated through this trial will support a potential new indication for the company’s P4HB technology platform. National principal investigator Dr. Caroline Glicksman stated that the consistent enrollment across sites reflects the urgent need for robust clinical evidence to address this persistent challenge in reconstructive surgery. The study continues to monitor participants to provide the necessary data for an FDA Premarket Approval application.