TSB3030

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Indications, Safety, and WarningsRisk statementMesh complications may include but are not limited to hematoma, seroma, infection, acute and chronic pain, extrusion/erosion, inflammation, recurrence.

The use of any synthetic mesh in a contaminated or infected site could lead to additional complications and it is not recommended. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the mesh. The placement of Transorb™ self-gripping resorbable mesh as a bridging device is not recommended. When using Transorb™ self-gripping resorbable mesh, the defect shall be closed.

The use of additional suture fixation is recommended to limit the risk of hernia recurrence.

When implanting in a pre-peritoneal site, the mesh shall not be placed with the grips towards the peritoneum, adhesion may develop if grips are in contact with bowels. The self-gripping side of the mesh can be differentiated from the smooth non-gripping side visually or through tactile feel.

When implanting in a preperitoneal site, complete coverage of the mesh with peritoneum should be achieved to minimize the risks of adhesion.

The compatibility of Transorb™ self-gripping resorbable mesh with trocars and laparoscopic instruments has not been established. Transorb™ self-gripping resorbable mesh is not recommended for passage through a trocar; product damage may occur.

Please refer to the instructions for use (IFU) for complete contraindications and risk information.

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