Bard ONFLEX Mesh Mode D'emploi page 2

O
™
Self-Expanding Lightweight Mesh
for Open Preperitoneal Inguinal Hernia Repair
DESCRIPTION:
The O ™ Mesh is a self-expanding, non-absorbable,
NFLEX
sterile prosthesis made from monofi lament polypropylene
mesh and has a lightweight large pore design. This
construction allows a prompt fi broblastic response through
the interstices of the mesh as observed in a preclinical
model, which may not correlate to performance in humans.
The O ™ Mesh has an anatomical shape designed
NFLEX
to cover potential defect areas. The O
contains a pocket on the larger medial apex of the mesh to
facilitate insertion and positioning of the device.
The device contains S
ORBA
provides memory and stability to the device, facilitating
ease of initial insertion and proper placement of the device.
The S F ™ Memory Technology is comprised of an
ORBA LEX
extruded polydioxanone (PDO) absorbable monofi lament
that is contained within a knitted polypropylene mesh tube.
The PDO monofi lament fully degrades in vivo by means
of hydrolysis and has been found to elicit an infl ammatory
response during absorption. Absorption is essentially
complete in 6-8 months. The PDO monofi lament is dyed
violet by adding D & C Violet No.2.
INDICATIONS:
The O ™ Mesh is indicated for use in the reinforcement
NFLEX
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 fi stula
formation and/or extrusion of the mesh and is not
recommended.
2. If an infection develops,
aggressively. Consideration
regarding the need to remove the mesh. Unresolved
infection may require removal of the mesh.
3. If unused mesh has been in contact with instruments
or supplies used on a patient or contaminated with
body fl uids, discard mesh with care to prevent risk of
transmission of viral infections.
4. To prevent recurrences when repairing hernias, the
mesh should be large enough to provide suffi cient
overlap beyond the margins of the defect. If fi xation
is used, careful attention to mesh fi xation placement
and spacing will help prevent excessive tension or
gap formation between the mesh and fascial tissue.
5. To avoid injury, careful attention is required if fi xating
the mesh in the presence of nerves, vessels, or
spermatic cord structures.
6. The mesh is supplied sterile. Inspect the packaging
to be sure it is intact and undamaged prior to use.
7. This device is for single use only. Do not resterilize
or reuse any portion of the O
8. Do not cut or reshape the O
at the opening in the interrupted S
PDO monofi lament, to accommodate the spermatic
cord and outside the blue limit line in the lateral
portion of the mesh, as this could affect its
effectiveness. Care should be taken not to cut or nick
the S F ™ PDO monofilament.
ORBA LEX
Mesh
™ Mesh also
NFLEX
F ™ Memory Technology which
LEX
treat the infection
should be
™ Mesh.
NFLEX
™ Mesh, except
NFLEX
ORBA
TRIM ONLY
OUTSIDE BLUE
LIMIT LINE
PRECAUTIONS:
1. Please read all instructions prior to use.
2. Only physicians qualifi ed in the appropriate surgical
techniques should use this prosthesis.
3. Care should be taken not to cut or nick the
S F
ORBA
4. If fi xation is used, care should be taken to ensure that
the mesh is adequately fi xated. 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, infl ammation,
extrusion, erosion, migration, fi stula formation and recurrence
of the hernia or soft tissue defect. If the S
monofi lament is cut or damaged, additional complications
may include, but are not limited to, bowel or skin perforation
and infection.
INSTRUCTIONS FOR USE:
Select the appropriate size of the O
hernia has been reduced, dissect the preperitoneal space
to accommodate the selected size of the mesh. Using the
pocket, roll the mesh along the long axis without folding the
PDO monofi lament and guide the medial apex of the mesh
into the preperitoneal space to adequately cover the defect.
The lateral apex of the mesh can be placed in either the
preperitoneal space or onlay position above the muscle layer
to adequately cover the defect. Based on surgeon preference
and surgical technique, a keyhole or slit may be cut into the
mesh at the area of the interrupted PDO monofi lament and
the tails of the mesh may be placed around the spermatic
cord. The tails can be brought together with sutures, while
ensuring adequate space to accommodate the spermatic
cord. Secure the mesh and close wound.
TRACEABILITY:
A traceability label which identifi es the type, size, expiration
date, and lot number of the prosthesis is attached to every
given
package. This label should be affi xed to the patient's
permanent medical record to clearly identify the device which
was implanted.
If you experience a product failure, please contact Davol, Inc.
at 1-800-556-6275 for instructions on returning the product.
Bard, Davol, Onfl ex and SorbaFlex are trademarks
and/or registered trademarks of C. R. Bard, Inc. or an
affi liate.
Copyright © 2014 C. R. Bard, Inc. All Rights Reserved.
Medium
Large
Contents
Do not use if package is damaged.
Actual Size
F ™ Partially Absorbable
LEX
U. S. Federal law restricts this device to sale
only
by or on the order of a physician
Peel Here
™ PDO monofilament.
LEX
NFLEX
F ™ PDO
ORBA LEX
™ Mesh. Once the