PCOPM15H50

Parietex™ composite (PCO) parastomal mesh

Indications, Safety, and WarningsParietex™ composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair and specifically for the repair of parastomal hernias. The nonabsorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.WarningsUsers should be familiar with surgical procedures and techniques involving the use of surgical mesh before employing Parietex™ composite parastomal mesh for parastomal hernia repair. Adverse effectsThe possible complications and adverse events associated with the use of Parietex™ composite parastomal mesh are those typically associated with surgically implantable materials and include, but are not limited to, seroma, hematoma, recurrence, adhesions, chronic pains, infection, inflammation, erosion, fistula, occlusion, allergic reactions to the components of the product.ContraindicationsAs Parietex™ composite parastomal mesh will not stretch to accommodate growth, its use may not be appropriate in infants, children, and patients in a period of growth. Any foreign material may potentiate or prolong infection in the presence of bacterial contamination, and as such, the use of Parietex™ composite parastomal mesh may not be appropriate in infected sites. Furthermore, this product should be used with the understanding that infection may require removal of the device.Please refer to instructions for use for complete contraindications and risks.

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