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Indications, Safety, and WarningsThe Parietex™ composite ventral patch mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary ventral hernia repair.Warnings

The Parietex™ composite ventral patch 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 Parietex™ composite ventral patch is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

Do not use by laparoscopic approach. The device is designed for placement by open surgery only.

The mesh should be used in the form in which it is provided without being cut. This will ensure the integrity of the mesh.

Ensure that no tissue is trapped between the device and the abdominal wall to avoid bowel entrapment.

The two handles (tubes and yarns) have to be removed and discarded after mesh implantation.

Adverse effectsPotential adverse effects with Parietex™ composite ventral patches are those typically associated with surgically implantable mesh: seroma, hematoma, fistula formation, mesh migration, recurrence, infection, acute and chronic pain, inflammation, visceral adhesion, bowel obstruction, extrusion/erosion, and/or allergic reactions to the components of the product. Other possible complications inherent to the surgical procedure may occur.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 the Parietex™ composite ventral patch will not stretch enough 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 Parietex™ composite ventral patch 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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