Device Dossier

4D Dome Semi Resorbable Mesh with Onlay patch - Abdominal hernia surgical mesh, composite-polymer

Device Dossier for 4D Dome Semi Resorbable Mesh with Onlay patch - Abdominal hernia surgical mesh, composite-polymer (Abdominal hernia surgical mesh,…

Intended purpose

The device is intended for abdominal reinforcement including inguinal and femoral hernias.

Functional description

The dome mesh and onlay patch are packaged together as a plug and patch technique. The dome mesh is a semiresorbable reinforcement parietal implant, constructed of 10% non-resorbable light polypropylene and 90% resorbable PLLA in which the PLLA component takes 6 months to resorb and the polypropylene is left to strengthen the fascia; whilst the onlay patch which is the anterior implant is 75% PLLA and 25% polypropylene.

TGA Public Summary