SYM15F

Indications, Safety, and WarningsSymbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries.Warnings

Symbotex™ 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.

Symbotex™ composite mesh is not designed for repair of parastomal hernias.

Symbotex™ composite mesh is not intended for repair of pelvic organ prolapse and treatment of stress urinary incontinence.

[For SYM and SYM-F references only] Particular attention should be paid not to cut the green marking as it may detach from the mesh. If the mesh is trimmed, the marking may no longer be centered and lose its functions.

[For SYM-OS references only] Symbotex™ composite mesh is designed to be used in open approach only.

[For SYM-OS references only] Ensure that no tissue is trapped between the device and the abdominal wall to avoid bowel entrapment.

[For SYM-OS references only] The mesh should be used in the form in which it is provided without being cut.

Adverse effectsThe possible complications associated with the use of Symbotex™ 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.[For SYM and SYM-F references only] Other possible complications inherent to the surgical procedure may occur, including but not limited to trocar site herniation and organ injury.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 Symbotex™ composite mesh will not stretch enough 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 Symbotex™ 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.

Please refer to instructions for use for complete contraindication and risk information.

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