Indications
Bard™ Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.
Contraindications
Literature reports there may be a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera.
Do not use the Bard™ Composix™ L/P Mesh in infants or children whereby future growth will be compromised by use of such material.
Do not use Bard™ Composix™ L/P Mesh for the reconstruction of cardiovascular defects.
Warnings
This device is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use.
This device is for single use only. Do not resterilize. After opening, discard unused portions of the prosthesis.
Ensure proper orientation; the solid white surface (ePTFE) must be oriented against the bowel or sensitive organs. Do not place the polypropylene mesh surface against the
bowel. There may be a possibility for adhesion formation when polypropylene mesh is placed in direct contact with the bowel or viscera.The use of any permanent mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the prosthesis.
If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device.
To prevent recurrences when repairing hernias, the prosthesis should be large enough to extend beyond the margins of the defect.
Discard Introducer Tool after use. This product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
Precautions
Please read all instructions prior to use.
Only physicians qualified in the appropriate surgical techniques should use this prosthesis.
Davol™ fixation devices or nonabsorbable monofilament sutures are recommended to properly secure the prosthesis. If other fixation devices are used, they must be indicated for use in hernia repair. Care should be taken to ensure that the prosthesis is adequately fixated to the abdominal wall. If necessary additional fasteners and/or sutures should be used.
Adverse Reactions
Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect.
