BD treats first patient in bioabsorbable breast scaffold study

March 20, 2025 By Sean Whooley

The FDA investigational device exemption (IDE) trial evaluates GalaFlex Lite in decreasing capsular contracture (CC) recurrence during breast revision surgery. BD aims to use findings to advance its efforts to pick up FDA premarket approval (PMA) for the system.

Franklin Lakes, New Jersey–based BD said the pivotal study aims to evaluate if the scaffold decreases CC and/or malposition likelihood. The company said its trial further positions it as a leader in advanced biomaterial science.

BD designed GalaFlex Lite to conform to the desired anatomical structure and provide immediate strength and stability through the wound healing period. Made from P4HB, the fully absorbable, biologically-derived polymer has more than 10 years of clinical use. Other applications include hernia repair and other plastic and reconstructive procedures. In these cases, soft tissue weakness or deficiency exists.

The company expects its trial to enroll at least 250 patients across 40 sites. It plans to evaluate safety and efficacy in breast plant revision surgery to treat CC.

“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.”

Filed Under: Clinical Trials, Featured, Implants, Women's Health Tagged With: BD