Device Dossier

Phasix Mesh - Mesh, polymeric, biodegradable

Device Dossier for Phasix Mesh - Mesh, polymeric, biodegradable (Mesh, polymeric, biodegradable, Class III, sponsor Bard). ARTG record, intended purpose,…

Intended purpose

Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists, in patients undergoing abdominal, plastic, and reconstructive surgery in ventral hernia repair and other abdominal fascial defect procedures.

Functional description

PHASIX™ Mesh is a fully resorbable synthetic mesh implant prepared from poly-4-hydroxybutyrate. PHASIX™ Mesh degrades through a process of hydrolysis and a hydrolytic enzymatic digestive process. It has been developed to enforce areas where weakness exists while minimizing the variability of resorption rate (loss of mass) and strength to provide support throughout the expected period of healing. Absorption of the mesh material will be complete within 12-18 months.

TGA Public Summary