TMP4008G

Indications, Safety, and WarningsProGrip™ self-gripping polyester mesh is intended for use in reinforcement of abdominal wall soft tissues where a weakness exists in procedure involving inguinal and incisional hernias repair.Warnings

ProGrip™ self-gripping polyester 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.

ProGrip™ self-gripping polyester mesh is not designed for repair of parastomal hernias.

ProGrip™ self-gripping polyester mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

ProGrip™ self-gripping polyester mesh is not intended for 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 intraperitoneal 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.

If an anatomical mesh is trimmed, special care should be taken to preserve the sewing of the flap to limit the risk of recurrence.

If an anatomical mesh is trimmed, the blue marking should not be cut as it could detach from the base textile. If the mesh is trimmed, the blue marking may no longer be present, compromising its function.

Adverse effects
The possible complications associated with the use of ProGrip™ self-gripping polyester mesh are those typically associated with surgically implantable meshes: hematoma, seroma, infection, acute and chronic pain, extrusion/erosion, inflammation, recurrence, and/or allergic reaction to the components of the product. Other possible complications inherent to the surgical procedure may occur.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 ProGrip™ self-gripping polyester 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 ProGrip™ self-gripping polyester 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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