Ventralex™ ST Hernia Patch

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Indications.

Ventralex™ ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving 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 the use of such mesh materials.
2. The use of this mesh has not been studied in breastfeeding or pregnant women.
3. Do not use this mesh for the reconstruction of cardiovascular defects.
4. Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed in contact with the bowel or viscera.

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 mesh.
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 the removal of the mesh.
3. If the unused mesh has been in contact with instruments or supplies used on a patient or contaminated with bodily fluids, discard with care to prevent the risk of transmission of viral infections.
4. 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.
5. This mesh is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use.
6. 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 device may lead to injury, illness, or death of the patient or end user.
7. This mesh should be used once the exterior foil pouch has been opened. Do not store for later use. Unused portions of the mesh should be discarded.
8. Ensure proper orientation; the bioresorbable coated side of the mesh 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 mesh is placed in direct contact with the bowel or viscera.
9. Do not cut or reshape any portion of the Ventralex™ ST Hernia Patch, except for the polypropylene positioning strap, as this could impact its effectiveness. Care should be taken not to cut or nick the SorbaFlex™ PDO monofilament. If the SorbaFlex™ PDO monofilament is cut or damaged during insertion or fixation, additional complications may include but are not limited to, bowel or skin perforation and infection.
10. Follow proper folding techniques for all patches as described in these Instructions for Use as other folding techniques may potentially compromise the SorbaFlex™ PDO monofilament.
11. To ensure a strong repair, the mesh should be secured with tacks or sutures through the polypropylene mesh straps or positioning pocket.
12. Excess positioning strap material above the fixation line must be cut off and discarded to eliminate excess material from remaining in the body.
13. When used to repair deficiencies caused by trocars, the mesh should be used under endoscopic guidance or direct visualization.
14. This mesh is not for the use of repair of pelvic organ prolapse via transvaginal approach. 15. 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 should use this mesh.
3. Care should be taken not to cut or nick the SorbaFlex™ PDO monofilament during fixation.
4. The safety and effectiveness of Ventralex™ ST Hernia Patch has not been evaluated in clinical studies in the presence of malignancies in the abdominopelvic cavity.

Adverse Reactions.

Possible complications may include, but are not limited to, seroma, adhesions, hematomas, pain, infection, inflammation, extrusion, erosion, migration, fistula formation, 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.  Please consult package insert for more detailed safety information and instructions for use.

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.