Bard® Soft Mesh Pre-shaped

* As compared to other traditional polypropylene mesh, such as Classic Bard^® Mesh

INDICATIONS

Bard^® Soft Mesh Pre-shaped is indicated for the repair of inguinal hernia 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 Bard^® Soft Mesh Pre-shaped in infants or children, in whom future growth will be compromised by use of such material.

WARNINGS

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

1. Intact Bard^® Soft Mesh Pre-shaped exhibits high burst and tensile strength. However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful:
   • When cutting a notice in the mesh, a V-shape with a radiused point will withstand more force than a V-shaped which comes to a sharp point.
2. Bard^® permanent or absorbable fixation devices or nonabsorbable monofilament sutures are recommended to properly secure the prosthesis. If absorbable fixation devices are used, they must be indicated for hernia repair. Care should be taken to ensure that the mesh is adequately fixated to the abdominal wall. If necessary, additional fasteners and/or sutures should be used.

ADVERSE REACTIONS

Possible complications include seroma, pain, mesh migration, infection, adhesions, hematoma, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect. Erosion and migration of the mesh have been reported in gastric banding procedures.

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