Device Dossier

Symbotex Composite Mesh - Abdominal hernia surgical mesh, composite-polymer

Device Dossier for Symbotex Composite Mesh - Abdominal hernia surgical mesh, composite-polymer (Abdominal hernia surgical mesh, composite-polymer, Class…

Intended purpose

Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.

Functional description

SymbotexTM Composite Mesh is made of a three-dimensional (3D) monofilament polyester textile, which is covered with an absorbable, continuous and hydrophilic film on one of its sides. The non-absorbable three-dimensional polyester provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera. The collagen film is essentially degraded in less than 1 month.

TGA Public Summary