March 21, 2025- BD (Becton, Dickinson and Company) announced the first patient treated in an Investigational Device Exemption (IDE) clinical trial intended to advance BD’s efforts to achieve Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the use of GalaFLEX LITE™ Scaffold in decreasing capsular contracture (CC) recurrence during breast revision surgery.
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%. GalaFLEX LITE™ Scaffold is engineered to conform to the desired anatomical structure and provide immediate strength and stability throughout the wound healing period. It is made from P4HB, a fully absorbable, biologically-derived polymer with more than 10 years of clinical use supporting hernia repair and other plastic and reconstructive procedures where soft tissue weakness or deficiency exists.