Bard™ Soft Mesh, Square, 12 in x 12 in (30.5 cm x 30.5 cm)

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

INDICATIONS

BARD^® Soft Mesh is indicated for the repair of incisional and inguinal hernias.

CONTRAINDICATIONS

Do not use Bard™ Soft Mesh in infants or children, in whom future growth will be compromised by use of such mesh material. Literature reports that there may be a possibility for adhesion formation when the polypropy

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.

This device is not for the use of repair of pelvic organ prolapse. This device is not for the use of treatment of stress urinary incontinence.

PRECAUTIONS

Intact Bard™ Soft Mesh 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 notch in the mesh, a V-shape with a radiused point will withstand more force than a V-shape which comes to a sharp point.

Davol™ 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 use in hernia repair. Care should be taken to ensure that the mesh is adequately fixated to the uncompromised tissue of the inguinal floor. If necessary, additional fasteners and/or sutures should be used.

ADVERSE REACTIONS

Possible complications include seroma, adhesions, hematoma, 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.