PNP6 | Medtronic

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<h2>Indications, Safety, and Warnings</h2> <p>The Parietex™ plug and patch system is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.</p> <h3>Warning</h3> <ul> <li>The disk must be adequately fixated in order to minimize the risk of migration. We recommend the use of nonabsorbable fixation.</li> <li>The size of the disk must be chosen depending on the defect size and the patient’s health conditions.</li> <li>The patch can be reshaped with scissors; the patch dimensions must be adapted to the size of the hernia defect. If the disk is reshaped, special care must be taken to preserve sewing stitch.</li> <li>The effectiveness and safety related to the use of this kit in pregnant women have not been established.</li> </ul> <h3>Adverse effects</h3> <p>The possible complications associated with the use of Parietex™ plug and patch system are those typically associated with surgically implantable materials: seroma, hematoma, recurrence, adhesions, chronic pains, infection, inflammation, migration, fistula formation, and allergic reactions to the components of the product.</p> <h3>Contraindications</h3> <ul> <li>As the Parietex™ plug and patch system will not stretch to accommodate growth, its use is not appropriate in patients in a period of growth.</li> <li>Any foreign material may potentiate or prolong infection in the presence of bacterial contamination, and as such, the use of the Parietex™ plug and patch system may not be appropriate in infected or contaminated sites. Furthermore, this product should be used with the understanding that infection may require removal of the device.</li> </ul> <p>Please refer to the instructions for use for complete contraindication and risk information.</p>

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