William P Adams, Jr, MD; Richard Baxter, MD; Caroline Glicksman, MD; Bruce A Mast, MD; Michael Tantillo, MD; Bruce W Van Natta, MD
Aesthetic Surgery Journal
Background: Mastopexy and reduction mammoplasty are often limited by the patient’s poor native soft tissue quality, resulting in ptosis recurrence and loss of rejuvenated surgical results. Surgical scaffolds and acellular dermal matrices are used in these procedures to provide physical and mechanical stabilization of weakened or compromised tissue. GalaFLEX scaffold, made from poly-4-hydroxybutyrate (P4HB), is a next-generation product for soft tissue reinforcement that resorbs gradually while aiding tissue regeneration to achieve excellent outcomes.
Objective: To assess the clinical performance of GalaFLEX scaffold in soft tissue reinforcement during elective mastopexy and reduction mammoplasty.
Methods: This multicenter, single-arm, observational study assessed product performance and outcomes of GalaFLEX scaffold when used in breast surgery. Outcomes included ptosis correction and maintenance, associated adverse events, patient and surgeon satisfaction, and mammographic and ultrasound imaging evaluation.
Results: At 6 centers in the US, 62 of 69 enrolled subjects were treated. Of this population, 89.7% had successful ptosis correction and maintenance at 1 year, with high patient and surgeon satisfaction for breast shape, droop/sag of the breast, and maintenance of results at 1 year. There were 5 adverse events deemed related to the device (8.0%), including nerve pain, breast swelling, ptosis, and 2 instances of asymmetry.
Conclusions: GalaFLEX scaffold safely and successfully supports and elevates breast tissue in mastopexy and reduction mammoplasty, with maintained support at 1 year. Surgeon and patient satisfaction were high. No mammogram or ultrasound interference was detected.
Level of Evidence: Therapeutic, 4
Device: GalaFLEX Scaffold
Use: The FDA does not consider the use of the manufacturer’s device as described in this Publication to be within the cleared indications for use statement.
Authors and Funding: Galatea Surgical, Inc., a wholly owned subsidiary of Tepha, Inc., provided the funding for the study clinical operations, data management, biostatistics and medical writing. Dr. Williams P. Adams, Jr. owns Tepha, Inc. stock options. Dr. Caroline Glicksman is a consultant and speaker with Galatea Surgical, Inc. Dr. Bruce Van Natta is a consultant and speaker with Galatea Surgical, Inc. and owns Tepha, Inc. stock options.
Risk: Significant risks or safety concerns associated with the use of GalaFLEX Scaffold known to the manufacturer are described in the Instructions for Use.