LPG1510X2

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<h2>Indications, Safety, and Warnings</h2> <p>ProGrip™ laparoscopic self-fixating mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.</p> <h3>Warnings</h3> <ul> <li>Do not use product if the temperature dot on the package is black. ProGrip™ laparoscopic self-fixating mesh should not be exposed to elevated temperatures (i.e., above 111 F/44 C).</li> <li>ProGrip™ laparoscopic self-fixating mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.</li> <li>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. The mesh shall be placed with the grips towards the muscle fascia with the mesh completely covered with peritoneum.</li> <li>To limit the risk of recurrence, if the mesh is trimmed, the use of additional fixation should be considered depending on size and type of hernia and the patient’s condition.</li> <li>If an anatomical mesh is trimmed, special care should be taken to preserve the sewing of the flap to limit the risk of recurrence.</li> </ul> <h3>Adverse effects</h3> <p>The possible complications associated with the use of ProGrip™ laparoscopic self-fixating mesh are those typically associated with surgically implantable mesh: seroma, hematoma, recurrence, infection, inflammation, acute and chronic pain, extrusion/erosion, and/or allergic reactions 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.</p> <p>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.</p> <h3>Contraindications</h3> <p>As ProGrip™ laparoscopic self-fixating mesh will not stretch to accommodate growth, its use is not appropriate in patients in a period of growth or pregnancy.</p> <p>Any foreign material may potentiate or prolong infection in the presence of bacterial contamination, and as such, the use of ProGrip™ laparoscopic self-fixating 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.</p> <p>The collagen film is not intended to minimize tissue attachment, and thus this product cannot be used intraperitoneally.</p> <p>Please refer to instructions for use for complete contraindication and risk information.</p>

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