PPM1106X3

Indications, Safety, and WarningsParietene™ macroporous mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernia repair.Warnings

The mesh is not designed for “bridging” repair technique with the mesh placed in an “inlay” position. The inlay repair technique is defined as cutting mesh to the size of the defect, positioning the mesh in the abdominal wall defect and then suturing the edges of the mesh to the edges of the defect. In any case, every effort should be made to close the defect.

The mesh is not designed for repair of parastomal hernias.

The mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

Do not place the mesh in direct contact with the viscera. Direct contact with the viscera may lead to risks of adhesions, fistula formation, and bowel obstruction. Do not implant the mesh in an intra-peritoneal position.

Adverse effectsThe possible complications associated with the use of Parietene™ macroporous mesh are those typically associated with surgically implantable mesh, including acute and chronic pain, allergic reaction to the components of the product, extrusion/erosion, hematoma, infection, inflammation, recurrence and/or seroma. Other possible complication inherent to the surgical procedure may occur, including but not limited to trocar site herniation and organ injury.The incidence and severity of complications may depend on numerous factors, including but not limited to the type and size of the defect, the mesh fixation, the surgical technique and patient-related factors (e.g., comorbidities). A thorough assessment of each patient’s medical history and condition should be made to determine the suitability for implantation of this device. The treatment of complications may require one or more revision surgeries that may not necessarily resolve the complications and may pose risks of subsequent complications. Being a permanent implant designed to integrate into tissues, significant dissection may be required in case it needs to be removed, in part or in whole. It is important that patients are given complete information regarding possible complications.Contraindications

As Parietene™ macroporous mesh will not stretch to accommodate growth, its use is not appropriate in patients in a period of growth or pregnancy.

Any foreign material may potentiate or prolong infection in the presence of bacterial contamination and, as such, the use of Parietene™ macroporous mesh is not appropriate in an infected or contaminated site. Furthermore, this product should be used with the understanding that infection may require removal of the mesh.

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

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