PCO2H1

Indications, Safety, and WarningsParietex™ composite mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. 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.Warning

It is recommended that the reinforcement be used in the form in which it is provided without being cut. This will ensure that the film protecting the edge is left intact.

The effectiveness and safety related to the use of this device in pregnant women have not been established. For women planning future pregnancies, the surgeon should be aware that this product will not stretch significantly as the patient grows.

Adverse effectsThe complications arising from wall reconstruction with reinforcements can also be seen after Parietex™composite mesh has been used.These complications include, but may not be limited to, seroma, hematoma, recurrence, adhesions, chronic pains, infection, inflammation, and allergic reactions to the components of the product.ContraindicationsAll the usual contraindications for the use of wall reinforcements apply to the use of Parietex™ composite mesh.These include, but may not be limited to:

Patient in a period of growth: the limited extensibility may be insufficient for the growth of a child

Surgery in an infected or contaminated site

Please refer to the instructions for use for complete contraindication and risk information.

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