Narayanan M. Nair, MD ; and Daniel C. Mills, MD, FACS
Aesthetic Surgery Journal
Background: The GalaFLEX scaffold is a mesh composed of resorbable poly-4-hydroxybutyrate (P4HB) monofilament fibers that aids in providing
immediate internal soft tissue support, similar to that offered by an underwire bra, after breast reduction, lift, or augmentation.
Objectives: Our goal was to explore the possibility of using GalaFLEX as an internal support to prevent future sagging, predominantly in the lower pole of the breast. This preliminary study investigated GalaFLEX as a direct alternative to implants in a variety of complex revisional breast cases. Our intention was to establish a safety and efficacy profile in an effort to promote further investigation.
Methods: A retrospective case series of 5 patients over 2 years were evaluated. Inclusion criteria were capsular contracture with concerns over soft tissue coverage and future ptosis, along with complicated muscle coverage deficits secondary to plane switching.
Results: A retrospective review of photographs taken at the most recent follow-up consistently showed retention of implant position and soft implants. Additionally, patients presented with a mean ± SD Baker Grade Contraction score of 2.8 ± 0.9189 preoperatively compared with a score of 1 ± 0 postoperatively.
Conclusions: This preliminary study shows the initial safety of GalaFLEX but indicates the need for a multicenter, exhaustive study. Its versatility for complex revisional cases combined with acceptable aesthetic outcomes makes GalaFLEX an invaluable tool for plastic surgeons to consider.
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., did not provide the funding for the study clinical operations, data management, biostatistics and medical writing. Dr. Daniel C. Mills 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.