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Ventralight™ Synthetic mesh Ventralight™ ST Mesh

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

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Overview

Uncoated medium weight monofilament polypropylene mesh on the anterior side with an absorbable hydrogel barrier based on Sepra™ Technology on the posterior side for laparoscopic ventral hernia repair.

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Features and Benefits
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Specification

GTIN - Case

00801741031656

1

GTIN

GTIN - Case 00801741031656 1
Electronic Instructions for Use (eIFUs)
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References

* 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 in the repair of ventral, incisional and umbilical 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.
  4. This mesh is not for the use of repair of pelvic organ prolapse via transvaginal approach. This mesh is not for the use of treatment of stress urinary incontinence.

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.
  3. This mesh is not for the use of repair of pelvic organ prolapse via transvaginal approach.
  4. This mesh is not for the use of treatment of stress urinary incontinence.

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.

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