Bard - 0115611 - Bard Modified Onflex Mesh Large 4.0 X 6.2 Inch 10.2 X 15.7 Cm

1. Brown C, Finch J. Which mesh for hernia repair? Annals of The Royal College of Surgeons of England 2010;92(4):272-278.

* Observed in preclinical model, which may not correlate to performance in humans.

Indications

The Modified Onflex Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

Contraindications

1. Use of this device is contraindicated for infants, children, or pregnant women, whereby future growth will be compromised by use of such mesh material.
2. Literature reports that there is a possibility for adhesion formation when polypropylene is placed in direct contact with the bowel or viscera.

Warnings

1. The use of any synthetic mesh or patch in a contaminated or infected wound can lead to fistula formation and/or extrusion of the mesh and is not recommended.
2. If an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. Unresolved infection may require removal of the mesh.
3. Do not cut or reshape the Modified Onflex Mesh, except for the positioning strap, as this could affect its effectiveness. Care should be taken not to cut or nick the SorbaFlex PDO monofilament
4. Excess positioning strap material above the fixation point must be cut off at the level of the fascia and discarded to eliminate excess material from remaining in the body.

Precautions

Care should be taken not to cut or nick the SorbaFlex PDO monofilament.

Adverse Reactions

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

DAV/OFLX/0917/0026