3DMax™ Light Mesh, Large Right, 4.1 in x 6.2 in (10.3 cm x 15.7 cm)

¹ Data on file. Results may not correlate to performance in humans.

Consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.

Indications

The 3DMax™ Light Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.

Contraindications

Literature reports that there may be a possibility for adhesion formation when polypropylene mesh is placed in direct contact with the bowel or viscera. Do not use polypropylene mesh in infants and children, whereby future growth will be compromised by use of such material.

Warnings

1. 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.

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

1. Do not cut or reshape the Bard 3DMax™ Light mesh as this may affect its effectiveness.

2. If sutures are used to secure the mesh in place, nonabsorbable monofilament sutures are recommended.

Adverse Reactions

Possible complications include seromas, 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.

BD-14716