Ventralight™ ST Mesh, Ellipse, 6" x 8" (15.2 cm x 20.3 cm)

* Preclinical data on file at BD. Results may not correlate to performance in humans.

** Based on a preclinical study of a composite polypropylene/ePTFE hernia repair mesh.

INDICATIONS

Ventralight™ ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

CONTRAINDICATIONS

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

WARNINGS

1. Ensure proper orientation; the coated side of the prosthesis should be oriented against the bowel or sensitive organs. Do not place the polypropylene side against the bowel. There may be a possibility for adhesion formation when the polypropylene side 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 prosthesis. An unresolved infection may require removal of the prosthesis. Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect.

ADVERSE REACTIONS

Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation, infection, allergic reaction, and recurrence of the hernia or soft tissue defect.

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