Ventralex™ ST Hernia Patch

Please note, not all products, services or features of products and services may be available in your local area. Please check with your local BD representative.

Indications.

The Bard^® Ventralex^™ Hernia Patch is indicated for use in the reinforcement of soft tissue deficiencies in the repair of ventral, incisional and umbilical hernias.

Contraindications.

1. Do not use this mesh in infants, children or pregnant women, whereby future growth may be compromised by use of such mesh material.

2. The use of this mesh has not been studied in pregnant or breastfeeding women.

3. Do not use the Bard^® Ventralex^™ Hernia Patch for the reconstruction of cardiovascular defects.

4. Literature reports that there is a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.

Warnings.

1. The mesh is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use.

2. This mesh has been designed for single use only. Reuse, resterilization, reprocessing and/or repackaging may compromise the structural integrity and/or essential material and design characteristics that are critical to the overall performance of the mesh and may lead to mesh failure which may result in injury to the patient. Reuse, reprocessing, resterilization, or repackaging may also create a risk of contamination of the mesh and/or cause patient infection or cross infection, including, but not limited to, the transmission of infectious diseases from one patient to another Contamination of the mesh may lead to injury, illness, or death of the patient or end user.

3. Product should be used once exterior foil pouch has been opened. Do not store for later use. Unused portions of mesh should be discarded.

4. Do not cut or reshape the Bard ^® Ventralex^™ Hernia Patch as this could impact its effectiveness. Care should be taken not to cut or nick the SorbaFlex^™ PDO monofilament during insertion or fixation. If the SorbaFlex^™ PDO monofilament is cut or damaged, the mesh must be removed immediately. Additional complications may include, but are not limited to, bowel or skin perforation and infection.

5. Follow proper rolling techniques for all patches as described in these instructions for use as other rolling techniques may potentially compromise the SorbaFlex ^™ PDO Monofilament.

6. Ensure proper orientation; the solid white surface (ePTFE) must be oriented against the bowel or sensitive organs. Do not place the mesh surface against the bowel. There is a possibility for adhesion formation when mesh (including strap) is placed in direct contact with the bowel or viscera.

7. To ensure a strong repair, the mesh should be secured with tacks or sutures through the polypropylene mesh straps and/or positioning pocket. Suturing or tacking on the sealed edge of mesh alone is not recommended.

8. Excess positioning strap material above the fixation line and at the level of the fascia must be cut off and discarded to eliminate excess material from remaining in the body.

9. The use of any synthetic mesh or patch in a contaminated or infected wound could lead to fistula formation and/or extrusion of the mesh.

10. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the patch. An unresolved infection may require removal of the mesh.

11. To prevent recurrences when repairing hernias, the mesh should be sized with appropriate overlap for the size and location of the defect, taking into consideration any additional clinical factors applicable to the patient. Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue.

12. This mesh is not for the use of pelvic organ prolapse via transvaginal approach.

13. This mesh is not for the use of treatment of stress urinary incontinence.

Precautions.

1. Please read all instructions prior to use.

2. Only physicians qualified in the appropriate surgical techniques and use of this device should use this mesh.

3. Care should be taken not to cut or nick the SorbaFlex™ PDO Monofilament or the knitted polypropylene mesh tube during fixation.

4. The safety and effectiveness of Bard^® Ventralex™ Hernia Patch has not been evaluated in clinical studies in the presence of malignancies in the abdominopelvic cavity.

Adverse Reactions.

Possible complications include, but are not limited to, seroma, adhesions, hematoma, pain, inflammation, extrusion, erosion, migration, fistula formation, infection, allergic reaction, and recurrence of the hernia or soft tissue defect. If the SorbaFlex™ PDO Monofilament is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection

Disclaimers.

• Not all products, services, claims or features of products may be available or valid in your local area. Please check with your local BD representative.

• Please consult product labels and instructions for use for indications, contradictions, hazards, warnings, and precautions.

References.

1. Majercik, S. et al. “Strength of tissue attachment to mesh after ventral hernia repair with synthetic composite mesh in a porcine model.” Surg Endos. (2006) 20: 1671-1674.

2. Results may not correlate to performance in humans.

3. Pierce, Richard A. MD, PhD, et al. Surgical Innovation. March 2009; 16, 1:45-54.

4. Preclinical data on file at C. R. Bard. Results may not correlate to performance in humans.

5. These images are from a porcine study using the Ventrio™ Hernia Patch which contains the same SorbaFlex™ Memory Technology

6. Tinella A, Malvasi A, Manca C, Alemanno G, Bettocchi S, Benhidjeb T. “Post-laparoscopic mesh in post-menopausal umbilical hernia repair: a case series.” Minim Invasive Ther Allied Technol. 2011 Sep; 20(5):290-5.

7. Iversen E, Lykke A, Hensler M, Jorgensen LN. “Abdominal wall hernia repair with a composite ePTFE/polypropylene mesh: clinical outcome and quality of life in 152 patients.” Hernia. 2010 Dec;14(6): 555-60.

8. Vychnevskaia K, Mucci-Hennekinne S, Casa C, et al. “Intraperitoneal mesh repair of small ventral abdominal wall hernias with a Ventralex™ Hernia Patch.” Dig Surg. 2010; 27(5): 433-5.

9. D.F. Martin, R.F. Williams, T. Mulrooney, and G.R. Voeller. “Ventralex™ Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes and Complications.” Hernia. 2008 Aug 12(4) 379-83.

10. D.F. Martin, R.F. Williams, T. Mulrooney, and G.R. Voeller. “Ventralex™ Mesh in Umbilical/Epigastric Hernia Repairs: Clinical Outcomes and Complications.” Hernia. 2008 Aug 12(4) 379-83.