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OnFlex™ Synthetic mesh Modified OnFlex™ Mesh

Modified OnFlex Mesh with Pocket, Strap, and Onlay, Medium, 8.6 cm x 14.2 cm

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Overview
Same proven technique with improved mesh

Bard© Modified OnFlex ™ Mesh was specifically designed to fit the inguinal anatomy during preperitoneal placement. It offers extended medial and inferior coverage for direct and femoral hernia spaces.

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References

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

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

Warnings

The use of any synthetic mesh or patch in a contaminated or infected wound can lead to fistula.

If unused mesh has been in contact with instruments or supplies used on a patient or contaminated with body fluids, discard mesh with care to prevent risk of transmission of viral infections.

To prevent recurrences when repairing hernias, the mesh should be large enough to provide sufficient overlap beyond the margins of the defect. If fixation is used, careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue. 

To avoid injury, careful attention is required if fixating the mesh in the presence of nerves, vessels, or spermatic cord structures. The mesh is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to use. This device is for single use only. Do not resterilize or reuse any portion of the Modified Onflex Mesh.

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

Please read all instructions prior to use. Only physicians qualified in the appropriate surgical techniques should use this prosthesis.

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

If fixation is used, care should be taken to ensure that the mesh is adequately fixated. If necessary, additional fasteners and/or sutures should be used.

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.

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Specification

GTIN - Case

00801741095399

1


Quantity

1/cs.


Dimensions

Medium with pocket, strap & onlay 3.4" x 5.6" (8.6cm x 14.2cm)

GTIN

GTIN - Case 00801741095399 1

Packaging

Quantity 1/cs.

Product Basic Specification

Dimensions Medium with pocket, strap & onlay 3.4" x 5.6" (8.6cm x 14.2cm)
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