BD, a leading global medical technology company, today 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%. At advanced stages, CC necessitates treatment through surgical intervention, and when performed using conventional techniques, the risk of recurrence may be as high as 54%. This multi-center Study of GalaFLEX LITE Poly-4-Hydroxybutyrate (P4HB) Scaffold in Treatment of Capsular Contracture after Breast Implant Augmentation (STANCE) is a pivotal study that aims to evaluate whether GalaFLEX LITE™ Scaffold, when used in breast revision surgery, decreases the likelihood of CC and or malposition. The trial further positions BD as a leader in advanced biomaterial science – driving transformative change in how tissue is reconstructed.
"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."
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.
"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."
Dr. Caroline Glicksman, the study's National Principal Investigator from Sea Girt, New Jersey added, "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."
The following five sites are currently enrolling patients:
- HKB Cosmetic Surgery (Various Locations, North Carolina) – Principal Investigator: Dr. Bill Kortesis; Sub-Investigators: Dr. Gaurav Bharti, Dr. Shawna Kleban, Dr. Brett Baker
- Billington Plastic Surgery (St. Petersburg, Florida) – Principal Investigator: Dr. Alicia Billington
- The Practice Plastic Surgery (Beverly Hills, California) – Principal Investigator: Dr. Kelly Killeen; Sub-Investigator: Dr. Lisa Cassileth
- Plastic Surgery Institute of New York (New York, New York) – Principal Investigator: Dr. Matthew DelMauro; Sub-Investigator: Dr. Adam Shaffner
- Newport Plastic and Reconstructive Surgery Associates (Newport Beach, California) – Principal Investigator: Dr. Hisham Seify
- Essential Medical Research (Tulsa, Oklahoma) – Principal Investigator: Dr. John Tedesco
The trial is expected to enroll at least 250 patients across 40 investigative sites and aims to demonstrate the device's safety and efficacy in breast implant revision surgery to treat capsular contracture. BD is committed to scientific rigor and patient safety and aims to continue proactive FDA engagement in developing products that enhance women's health care.
