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Modified OnFlex™ Mesh

For Open Preperitoneal Inguinal Hernia Repair

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Modified-OnFlex
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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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Features and Benefits
Lightweight, Large Pore Mesh
Lightweight, Large Pore Mesh
  • Reduces the amount of foreign material implanted
  • Allows good tissue ingrowth1*
  • Results in a more flexible and compliant scar formation1
Positioning Pocket
  • Medial and lateral pockets aid in proper placement
  • Absorbable SorbaFlex ™ Memory
Technology
Allows the patch to open and conform to the anatomy
Positioning Strap
Facilitates placement, positioning and fixation of the patch
Optional Onlay
Lightweight, large pore mesh
Interrupted PDO Monofilament
Enables easy mesh insertion into the preperitoneal space
Inguinal Notch
Designed to conform to the iliac vessels
Reference

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 formation and/or extrusion of the mesh and is not recommended. 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.

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

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.

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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 formation and/or extrusion of the mesh and is not recommended. 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.

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

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.

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Resources
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 formation and/or extrusion of the mesh and is not recommended. 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.

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

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.

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Frequently Asked Questions
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