GalaFLEX, GalaFLEX 3D and GalaFLEX 3DR scaffolds are indicated for use as bioresorbable scaffolds for soft tissue support and to repair, elevate, and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue reconstruction. These products, referred to as Galatea scaffolds, are also indicated for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Possible complications following implantation of Galatea scaffolds include infection, seroma, pain, scaffold migration, wound dehiscence, hemorrhage, adhesions, hematoma, inflammation, extrusion and recurrence of the soft tissue defect. The safety and product use of Galatea scaffolds for patients with hypersensitivities to the antibiotics kanamycin sulfate and tetracycline hydrochloride is unknown. Galatea scaffolds have not been studied for use in breast reconstructive surgeries. The safety and effectiveness of Galatea scaffolds in neural tissue and in cardiovascular tissue has not been established. The safety and effectiveness of Galatea scaffolds in pediatric use has not been established. Consult the specific Galatea scaffold Instructions for Use for complete prescribing information, including its indications for use, warnings and precautions.
