Franklin Lakes, N.J., May 25, 2025 — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology firm, has announced the start of a new clinical trial aimed at advancing the company’s efforts to gain U.S. Food and Drug Administration (FDA) approval for the GalaFLEX LITE™ stent. The device is designed to help reduce the recurrence of capsular contracture (CC) during breast revision surgery.
Breast implant surgery is one of the most common procedures in the U.S., but it often comes with the complication of capsular contracture. This occurs when the scar tissue around the implant hardens, leading to pain and displacement. In advanced stages, surgical intervention is required, and the risk of recurrence is high—up to 54% using traditional methods.
What Is Capsular Contracture and Why It Matters
Capsular contracture is a major complication following breast implant surgery, affecting 10-20% of patients. The condition results in the abnormal stiffening of the scar tissue around the implant, which can cause pain and misalignment. In some cases, it may require additional surgery for correction.
The GalaFLEX LITE™ Poly-4-Hydroxybutyrate (P4HB) Scaffold for Capsular Contracture Following Breast Implant Augmentation (STANCE) study is a pivotal clinical trial designed to evaluate whether the GalaFLEX LITE™ Scaffold can reduce the likelihood of capsular contracture and improve outcomes in breast revision surgery.
BD’s Commitment to Innovation
Rian Seger, Global President of BD Surgical, emphasized the significance of this milestone in the company’s ongoing effort to gain FDA premarket approval for the GalaFLEX LITE™ Scaffold. “This milestone is a significant step in our mission to improve patient outcomes by reducing surgical complications with innovative technologies,” Seger said.
The GalaFLEX LITE™ Scaffold is designed to conform to the anatomy and provide support during the wound healing process. Made from P4HB, a fully absorbable, bioderived polymer, the scaffold has been used in over 10 years of clinical applications for hernia repair and other reconstructive surgeries.
Expert Insights on the Clinical Trial
Dr. Shawna Kleban, a board-certified plastic surgeon who performed the first surgery in the trial, shared her thoughts on the importance of the study. “This trial offers new hope for patients with capsular contracture and provides evidence-based solutions that could transform treatment options,” Kleban said.
Caroline Glicksman, MD, the study’s national principal investigator, expressed excitement about the potential benefits of the GalaFLEX LITE™ Stent. “This study is critical to advancing solutions for patients undergoing breast revision surgery,” said Dr. Glicksman. “It will provide the necessary data for the FDA to approve specific breast indications for this technology.”
Trial Details and Patient Enrollment
The clinical trial is expected to enroll at least 250 patients across 40 sites in the U.S. Participants will be randomly assigned to receive either the GalaFLEX LITE™ Stent or traditional breast revision surgery with no implant or an acellular dermal matrix (ADM). The study aims to demonstrate the safety and effectiveness of the new stent in preventing capsular contracture recurrence and implant malposition.
The following centers are currently enrolling patients:
HKB Plastic Surgery (Multiple Locations, NC) – Dr. Bill Kortesis
Billington Plastic Surgery (St. Petersburg, FL) – Dr. Alicia Billington
The Plastic Surgery Clinic (Beverly Hills, CA) – Dr. Kelly Killeen
New York Institute of Plastic Surgery (New York, NY) – Dr. Matthew DelMauro
Newport Plastic and Reconstructive Surgery Associates (Newport Beach, CA) – Dr. Hisham Seify
Basic Medical Research (Tulsa, OK) – Dr. John Tedesco
About BD
BD is one of the world’s largest medical technology companies, dedicated to improving global health by advancing medical discovery, diagnostics, and care delivery. The company’s innovations support healthcare professionals on the front lines, helping them improve patient outcomes, reduce costs, and enhance safety.
With over 70,000 employees, BD is committed to addressing some of the world’s most pressing health challenges and expanding access to healthcare through collaboration and technology.
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