Franklin Lakes, N.J., March 20, 2025 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced today that investigators have treated the first patient in an investigational device exemption (IDE) clinical trial. The trial aims to support BD’s efforts to obtain premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its GalaFlex Lite scaffold in reducing capsular contracture (CC) recurrence during breast revision surgery.
Implant-based breast surgery is one of the most common plastic surgery procedures in the U.S. each year. Capsular contracture, where the scar tissue around the implant hardens abnormally, causing pain and anatomical displacement, is its most frequent complication. The overall incidence ranges from 10% to 20%. At advanced stages, CC requires surgical intervention, and when using conventional techniques, the recurrence risk can be as high as 54%.
This multi-center study of the GalaFlex Lite poly-4-hydroxybutyrate (P4HB) scaffold in the treatment of capsular contracture after breast implant augmentation (the STANCE study) is pivotal. It will evaluate whether the GalaFlex Lite scaffold, when used in breast revision surgery, can decrease the likelihood of CC and malposition. The trial further positions BD as a leader in advanced biomaterial science, driving change in tissue reconstruction.
“This milestone is a big step forward in our efforts to get FDA premarket approval for GalaFlex Lite scaffold’s first breast indication,” said Rian Seger, worldwide president of the BD Surgery business. “Our team has worked closely with the FDA to address a major medical complication from implant-based breast surgery. Treating the first patient brings us closer to providing a much-needed solution.”
The GalaFlex Lite scaffold is engineered to match the desired anatomical structure. It offers immediate strength and stability throughout the wound healing period. Made from P4HB, a fully absorbable, biologically-derived polymer with over 10 years of clinical use, it has been used in hernia repair and other plastic and reconstructive procedures where soft tissue weakness or deficiency exists.
“Participating in this trial shows our commitment to innovation and providing the best evidence-based care for patients with capsular contracture,” said Dr. Shawna Kleban, a board-certified plastic surgeon who performed the first procedure. “This trial helps participants find solutions for themselves and future patients.”
Dr. Caroline Glicksman, the study’s national principal investigator from Sea Girt, New Jersey, added, “As an early adopter of P4HB technology, we’re excited about the potential of GalaFlex Lite scaffold to improve patient outcomes in breast revision surgeries. This study is crucial for providing the data the FDA needs for a specific breast indication, so we can offer better solutions for breast surgery 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;
Plastic Surgery Institute of New York (New York, New York) – Principal Investigator: Dr. Matthew Del Mauro; 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. It aims to prove the device’s safety and efficacy in breast implant revision surgery for treating capsular contracture. BD is committed to scientific rigor and patient safety and will continue to engage with the FDA to develop products that enhance women’s healthcare.
The STANCE (NCT 05945329) study is a prospective, randomized, controlled, multi-center study. It will assess the safety and efficacy of the GalaFlex Lite scaffold in revision surgery to reduce capsular contracture recurrence and malposition in implant-based breast augmentation patients compared to those undergoing conventional revision surgery without a supportive matrix or acellular dermal matrix (ADM). Patients will be randomized 2:1 to receive either GalaFlex Lite scaffold or standard care (no ADM or matrix placement).
BD is one of the world’s largest global medical technology companies, advancing healthcare by improving medical discovery, diagnostics, and care delivery. The company develops innovative technology, services, and solutions to support healthcare providers and improve patient clinical therapy.
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