GalaFORM 3D (Galatea Surgical; Lexington, Mass.) was approved by the FDA in February 2017 for use as a bioresorbable scaffold in surgery for soft tissue support and to repair and reinforce deficiencies where weakness or voids exist.
“This includes reinforcement of soft tissue in plastic and reconstructive surgery, and for general soft tissue support,” says Ashley Gordon, M.D., a plastic Surgeon at Restora âAustin âPlastic Surgery âCentre âin Austin, Texas.
The three-dimensional product, which also heals tissue for strength, acts as an insurance policy against breast sagging, which occurs due to natural aging and gravity.
GalaFORM 3D is constructed from the company’s proprietary biomaterial: P4HB, for strength retention and biocompatibility.
“Once implanted, the scaffold resorbs through hydrolysis over an 18- to 24-month period,” Dr. Gordon tells The Aesthetic Channel. “The scaffold is monofilament and designed to reduce the risk of infection, offer strength and support during the critical healing phase, and results in tissue that is three to five times stronger than native tissue.”
For reductions and lifts, Dr. Gordon shapes the ideal breast first and then uses tacking sutures to secure the GalaFORM 3D. “I also place my sutures in the periosteum over the ribs and pectoralis fascia,” she says.
Dr. Gordon says the key is to place the sutures in strong tissues rather than in the breast parenchyma.
Importantly, Dr. Gordon does not attempt to create the breast shape with the mesh. “It is important to create the perfect breast mound first and then use the mesh to support it,” she notes.
Symmetry must also be confirmed, “and it must look perfect on the table because the tissues will not settle as they do with traditional reductions and lifts,” Dr. Gordon says. “Overtightening the skin envelope should be avoided because this can lead to flattening of the lower pole.”
Dr. Gordon states that GalaFORM 3D scaffold has revolutionized her breast practice and her results. “I now use it in most of my primary mastopexies, mastopexy/augmentations and breast reductions,” she says.
Because all patients have some degree of compromised tissue, “it just makes sense to provide soft tissue support with GalaFORM 3D and offload the skin,” Dr. Gordon says. “The 3D mesh is super easy to place and the results are very predictable.”