DXT1309AR

Indications, Safety, and WarningsDextile™ anatomical mesh is intended to be used for the reinforcement of soft tissues where weakness exists during repair of inguinal hernias by laparoscopic approach.Warnings

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.

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

It is recommended not to cut Dextile™ anatomical mesh as it may affect its effectiveness.

Adverse effectsThe possible complications associated with the use of the Dextile™ anatomical mesh are those typically associated with surgically implantable mesh: seroma, hematoma, recurrence, inflammation, infection, 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.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: approved for distribution

As Dextile™ anatomical mesh will not stretch significantly 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 Dextile™ anatomical 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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