PCO15FX

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<h2>Indications, Safety, and Warnings</h2> <p>Parietex™ optimized composite mesh is intended for the reinforcement of abdominal wall soft tissues where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.</p> <h3>Warning</h3> <ul> <li>Parietex™ optimized 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.</li> <li>Parietex™ optimized composite mesh is not designed for repair of parastomal hernias.</li> <li>Parietex™ optimized composite mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.</li> <li>The mesh should be used in the form in which it is provided without being cut.</li> <li>Parietex™ optimized composite mesh <b>with open skirt: </b>Do not use by laparoscopic approach. The device is designed for placement by open surgery only.</li> <li>Parietex™ optimized composite mesh <b>with open skirt: </b>Ensure that no tissue is trapped between the device and the abdominal wall to avoid bowel entrapment</li> </ul> <h3>Adverse effects</h3> <p>The possible complications associated with the use of Parietex™ optimized composite mesh are those typically associated with surgically implantable mesh: seroma, hematoma, recurrence, fistula formation, adhesions, infection, inflammation, acute and chronic pain, bowel obstruction, extrusion/erosion, and/or allergic reactions to the components of the product.</p> <ul> <li>Parietex™ optimized composite mesh <b>with open skirt: </b>Other possible complications inherent to the surgical procedure may occur, including but not limited to: trocar site herniation and organ injury.</li> <li>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.</li> <li>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.</li> </ul> <h3>Contraindications</h3> <ul> <li>As Parietex™ optimized composite mesh will not stretch enough to accommodate growth, its use is not appropriate in patients in a period of growth or pregnancy.</li> <li>Any foreign material may potentiate or prolong infection in the presence of bacterial contamination, and as such, the use of Parietex™ optimized 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.</li> </ul> <p>Please refer to the instructions for use for complete contraindication and risk information.</p>

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