Bard / Rochester Medical - 0123790 - Davol Mesh: E/X Polyprop & Epte Prosthesis Mesh For Ventral Hernia Repair Ellipse

INDICATIONS

BardComposix E/X Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

CONTRAINDICATIONS

1. Literature reports there may be a possibility for adhesion formation when the polypropylene is placed in direct contact with the bowel or viscera.
2. Do not use the BardComposix E/X Mesh, in infants or children whereby future growth will be compromised by use of such material.
3. Do not use BardComposix E/X Mesh, for the reconstruction of cardiovascular defects.

WARNINGS

1. 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 or sensitive organs. There may be a possibility for adhesion formation when polypropylene mesh is placed in direct contact with the bowel or viscera.
2. 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.

PRECAUTIONS

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.

Please consult package insert for more detailed safety information and instructions for use.

DAV/CPEX/0917/002