BD (Becton, Dickinson and Company) has announced the treatment of the first patient in a pivotal clinical trial evaluating its GalaFLEX LITE Scaffold for reducing capsular contracture recurrence during breast implant revision surgery. The Investigational Device Exemption (IDE) trial represents a significant step toward obtaining Premarket Approval (PMA) from the U.S. Food and Drug Administration for this specific breast indication.
Capsular contracture, where scar tissue around breast implants becomes abnormally hard and causes pain and anatomical displacement, affects between 10% and 20% of patients who undergo implant-based breast surgery. When conventional revision techniques are used, recurrence rates can reach as high as 54%, highlighting the significant clinical challenge this condition presents.
The STANCE (Study of GalaFLEX LITE Poly-4-Hydroxybutyrate Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation) trial is designed as a prospective, randomized, controlled, multi-center study that will assess both safety and efficacy outcomes. The study will compare the GalaFLEX LITE Scaffold against conventional revision surgery without supportive matrix or acellular dermal matrix (ADM).
Technology and Clinical Application
GalaFLEX LITE Scaffold is engineered from P4HB (Poly-4-Hydroxybutyrate), a fully absorbable, biologically-derived polymer with over a decade of clinical use in hernia repair and other reconstructive procedures. The scaffold is designed to conform to anatomical structures while providing immediate strength and stability throughout the wound healing period.
"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.
Dr. Shawna Kleban, the board-certified plastic surgeon who performed the inaugural procedure, emphasized the potential impact: "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."
Trial Design and Scope
The STANCE trial (NCT05945329) will enroll at least 250 patients across 40 investigative sites throughout the United States. Patients will be randomized in a 2:1 ratio to receive either the GalaFLEX LITE Scaffold or standard care without supportive matrix. The primary objective is to demonstrate whether the scaffold decreases the likelihood of capsular contracture recurrence and/or malposition when used in breast revision surgery.
Dr. Caroline Glicksman, the study's National Principal Investigator from Sea Girt, New Jersey, noted: "As an early adopter of the P4HB technology, we are excited to see the potential benefits of GalaFLEX LITE Scaffold in improving patient outcomes in breast revision surgeries. This study is crucial in providing the data FDA requires for a specific breast indication that will advance our ability to deliver better solutions for breast surgery patients."
Current Enrollment Sites
The trial is currently enrolling patients at six clinical sites:
- HKB Cosmetic Surgery (North Carolina) – Principal Investigator: Dr. Bill Kortesis; Sub-Investigators: Dr. Gaurav Bharti, Dr. Shawna Kleban, Dr. Brett Baker
- Billington Plastic Surgery (Florida) – Principal Investigator: Dr. Alicia Billington
- The Practice Plastic Surgery (California) – Principal Investigator: Dr. Kelly Killeen; Sub-Investigator: Dr. Lisa Cassileth
- Plastic Surgery Institute of New York (New York) – Principal Investigator: Dr. Matthew DelMauro; Sub-Investigator: Dr. Adam Schaffner
- Newport Plastic and Reconstructive Surgery Associates (California) – Principal Investigator: Dr. Hisham Seify
- Essential Medical Research (Oklahoma) – Principal Investigator: Dr. John Tedesco
Clinical Significance and Market Impact
Implant-based breast surgery ranks among the most common plastic surgery procedures performed annually in the United States. With capsular contracture being the most frequent complication, a solution that effectively reduces recurrence rates could significantly improve patient outcomes and reduce the need for multiple revision surgeries.
The GalaFLEX LITE Scaffold represents an innovative approach to addressing this persistent clinical challenge. If successful, the trial could establish a new standard of care for revision surgeries in patients with capsular contracture.
"This trial further positions BD as a leader in advanced biomaterial science – driving transformative change in how tissue is reconstructed," noted a company spokesperson. The company has emphasized its commitment to scientific rigor and patient safety throughout the development process.
About BD
BD is one of the largest global medical technology companies, with more than 70,000 employees worldwide. The company focuses on improving medical discovery, diagnostics, and care delivery through innovative technologies and solutions. BD maintains a presence in virtually every country and partners with organizations globally to address challenging health issues.
The STANCE trial represents BD's continued commitment to developing products that enhance women's healthcare through proactive engagement with regulatory authorities and rigorous clinical evaluation.
