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<h2>Indications, Safety, and Warnings</h2> <h3><b>Indications</b><br /> </h3> <p><b>ProGrip™ self-gripping polypropylene mesh — pre-cut elliptic slit mesh</b>, is intended for use in reinforcement of abdominal wall soft tissue where weakness exists, in procedures involving inguinal hernia repair via anterior tension-free approach.</p> <h3><b>Contrandictions</b></h3> <ul> <li>As ProGrip™ self-gripping polypropylene mesh will not stretch 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 ProGrip™ self-gripping polypropylene 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> <li>ProGrip™ self-gripping polypropylene mesh is not intended to be used for laparoscopic hernia repair.</li> </ul> <h3><b>Possible complications</b><br /> </h3> <ul> <li>The possible complications associated with the use of ProGrip™ self-gripping polypropylene mesh are those typically associated with surgically implantable meshes: acute and chronic pain, allergic reaction to the components of the product, extrusion/erosion, hematoma, infection, inflammation, recurrence and/or seroma. Other possible complication inherent to the surgical procedure may occur.</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. Being a permanent implant designed to integrate into tissues, significant dissection may be required if the mesh needs to be removed, in part or in whole. It is important that patients are given complete information regarding possible complications.</li> <li>Any adverse event or serious incident that occurs in relation to the device should be reported to the manufacturer and/or the competent authority of the country in which the patient is established, as applicable per the federal, national or local regulations.</li> </ul> <h3><b>Warnings</b></h3> <ul> <li>Do not use the device past the labeled expiration date.</li> <li>The device is provided in a double sterile packaging. Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity. Do not use the device if the package is open or damaged or if the integrity of the packaging appears compromised.</li> <li>Open the last packaging only for the placement of the mesh and handle the latter using clean sterile gloves and instruments.</li> <li>The mesh is not designed for repair of parastomal hernias.</li> <li>The 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. When implanting in a pre-peritoneal site, the mesh shall be placed with the grips towards the muscle fascia with the mesh completely covered with peritoneum.</li> <li>For women planning future pregnancies, the surgeon should be aware that this product will not stretch enough as the patient grows.</li> <li>Ensure that the mesh is adequately fixated. To avoid injury, exercise caution if fixating the device in the presence of nerves or vessels.</li> <li>The mesh should not be overly stretched when it is being put in place in order to maintain the elasticity and the porosity of the reinforcement. A moderate and equal tension should be applied in all directions for fixation in order to account for wound shrinkage during the healing process.</li> <li>The mesh should assure necessary overlap beyond the margins of the defect according to the surgeon’s practice.</li> <li>If a pre-cut mesh is trimmed, special care should be taken to preserve the sewing to limit the risk of recurrence.</li> <li>If a pre-cut mesh is trimmed, the green marking should not be cut as it could detach from the base textile. If the mesh is trimmed, the green marking may no longer be present, compromising its function.</li> <li>Unused product, explant, and packaging may be a potential biohazard. Handle and dispose them with the necessary precautionary measures in accordance with accepted medical practices and with applicable local, state, and federal laws and regulations on disposal of packaging and medical waste</li> </ul> <p> </p> <h3><b>Indications</b></h3> <p><b>ProGrip™ self-gripping polypropylene mesh — square and rectangular</b>, is intended for use in reinforcement of abdominal wall soft tissue where weakness exists, in procedures involving inguinal and ventral hernia repair by open approach.</p> <h3><b>Contraindictions</b></h3> <ul> <li>As ProGrip™ self-gripping polypropylene mesh will not stretch 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 ProGrip™ self-gripping polypropylene 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> <h3><b>Possible complications</b><br /> </h3> <ul> <li>The possible complications associated with the use of ProGrip™ self-gripping polypropylene mesh are those typically associated with surgically implantable meshes: acute and chronic pain, allergic reaction to the components of the product, extrusion/erosion, hematoma, infection, inflammation, recurrence and/or seroma. Other possible complication inherent to the surgical procedure may occur.</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. Being a permanent implant designed to integrate into tissues, significant dissection may be required if the mesh needs to be removed, in part or in whole. It is important that patients are given complete information regarding possible complications.</li> <li>Any adverse event or serious incident that occurs in relation to the device should be reported to the manufacturer and/or the competent authority of the country in which the patient is established, as applicable per the federal, national or local regulations.</li> </ul> <h3><b>Warnings</b></h3> <ul> <li>Do not use the device past the labeled expiration date.</li> <li>The device is provided in a double sterile packaging. Upon receipt of shipment, ensure that the packaging is not open or damaged and retains its sealed integrity. Do not use the device if the package is open or damaged or if the integrity of the packaging appears compromised.</li> <li>Open the last packaging only for the placement of the mesh and handle the latter using clean sterile gloves and instruments.</li> <li>The compatibility of ProGrip™ self-gripping polypropylene mesh with trocars and laparoscopic instruments has not been established.</li> <li>The 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>The mesh is not designed for repair of parastomal hernias.</li> <li>The mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.</li> <li>The mesh is not intended for repair of chest wall defects.</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.</li> <li>When implanting in a pre-peritoneal site, the mesh shall be placed with the grips towards the muscle fascia with the mesh completely covered with peritoneum. The self-gripping side of the mesh can be differentiated from the smooth non-gripping side visually or through tactile feel.</li> <li>For women planning future pregnancies, the surgeon should be aware that this product will not stretch enough as the patient grows.</li> <li>Ensure that the mesh is adequately fixated. To avoid injury, exercise caution if fixating the device in the presence of nerves or vessels.</li> <li>The mesh should not be overly stretched when it is being put in place in order to maintain the elasticity and the porosity of the reinforcement. A moderate and equal tension should be applied in all directions for fixation in order to account for wound shrinkage during the healing process.</li> <li>The placement of the mesh should assure necessary overlap beyond the margins of the defect according to the surgeon’s practice. When possible, a minimum of 5 cm overlap over the edges of the defect is recommended for ventral hernia repair.</li> <li>Unused product, explant, and packaging may be a potential biohazard. Handle and dispose them with the necessary precautionary measures in accordance with accepted medical practices and with applicable local, state, and federal laws and regulations on disposal of packaging and medical waste.</li> </ul>

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