Becton, Dickinson and Company (BD) announced that the first patient has been treated in its clinical trial for the GalaFLEX LITE™ Scaffold, an investigational device aimed at reducing the recurrence of capsular contracture in breast implant revision surgery. The trial is a key step toward Premarket Approval from the U.S. Food and Drug Administration.

Capsular contracture is a common complication of implant-based breast surgery, occurring in 10 to 20 percent of cases and requiring surgical intervention in advanced stages. The recurrence rate after surgery can be as high as 54 percent. The BD STANCE Study (NCT05945329) is a multi-center, randomized controlled trial designed to assess the effectiveness of GalaFLEX LITE™ Scaffold, a bioabsorbable polymer implant made of Poly-4-Hydroxybutyrate (P4HB), in reducing capsular contracture recurrence and improving implant positioning.

The trial, which will enroll at least 250 patients across 40 sites, is being conducted with the FDA’s collaboration and will compare GalaFLEX LITE™ with conventional revision surgery. Patients will be randomized 2:1, receiving either the scaffold or standard care without additional supportive materials.

BD aims to establish GalaFLEX LITE™ as a transformative biomaterial for soft tissue reconstruction. The company is committed to scientific rigor and patient safety, with continued FDA engagement to expand women’s healthcare solutions.

For more details, visit www.galateasurgical.com.