BD Treats 1st Patient in Bioabsorbable Scaffold Study for Breast Revision Surgery

BD (Becton, Dickinson and Company) announced the first patient treated in its investigational device exemption (IDE) trial for use of its GalaFLEX LITE scaffold to decrease capsular contracture (CC) recurrence during breast revision surgery.

The study of GalaFLEX LITE Poly-4-Hydroxybutyrate (P4HB) Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation (STANCE) is evaluating whether the scaffold reduces the chance of CC and/or malposition when used in breast revision surgery. The scaffold is designed to conform to the desired anatomical structure and offer immediate strength and stability throughout wound healing.

It’s composed of P4HB, a fully absorbable, biologically-derived polymer with over ten years of clinical use in hernia repair and other plastic and reconstructive procedures where soft tissue weakness or deficiency is present.

“This milestone marks a significant advancement in our efforts to achieve FDA Premarket Approval for our first breast indication for GalaFLEX LITE Scaffold and reinforces the company’s commitment to improving patient outcomes through innovative technologies that reduce surgical complications,” said Rian Seger, worldwide president of the BD Surgery business. “Our team has worked closely with the FDA to help address a critical medical complication arising from implant-based breast surgery, and the first patient treated brings us closer to delivering a much-needed solution.”

The trial is anticipated to enroll a minimum of 250 patients across 40 investigative sites.

“Participating in this trial underscores our commitment to innovation and providing the best evidence-based care for patients suffering from capsular contracture, offering them hope and solutions for the future,” said Dr. Shawna Kleban, the board-certified plastic surgeon who performed the inaugural procedure. “This trial allows participants to help identify a solution for themselves and for future patients.”