PPDS1510X3

Indications, Safety, and WarningsParietene™ DS composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists. It is indicated for the repair of ventral hernias.Warnings

Parietene™ DS composite 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.

Parietene™ DS composite mesh is not designed for repair of parastomal hernias.

Parietene™ DS composite mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

If the mesh is trimmed, the marking may no longer be centered and lose its functions.

The pre-placed sutures are necessary to guarantee sides differentiation when deploying the mesh. If it is required to trim the device, ensure that the pre-placed sutures remain on the device.

If the pre-placed sutures are not used for transparietal fixation, do not remove them until the placement of the mesh is secured.

Adverse effectsThe possible complications associated with the use of Parietene™ DS composite mesh are those typically associated with surgically implantable mesh: seroma, hematoma, recurrence, adhesions, bowel obstruction, fistula formation, infection, inflammation, acute and chronic pain, extrusion/erosion and/or allergic reaction to the components of the product.Other possible complications 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™ DS composite 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™ DS composite 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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