en
9. To prevent recurrences when repairing hernias, the prosthesis should be large enough to extend
beyond the margins of the defect.
PRECAUTIONS
1. Please read all instructions prior to use.
2. Only physicians quali
fi
ed in the appropriate surgical techniques should use this prosthesis.
3.
Care should be taken not to cut or nick the S
ORBA
F
LEX
™ PDO mono
fi
lament during
fi
xation.
4. The safety and effectiveness of V
ENTRIO
™ ST Hernia Patch has not been evaluated in clinical studies in the
presence of malignancies in the abdominopelvic cavity.
ADVERSE REACTIONS
Possible complications include seroma, adhesions, hematomas, in
fl
ammation, extrusion,
fi
stula formation,
infection, allergic reaction, and recurrence of the hernia or soft tissue defect. If the S
ORBA
F
LEX
™ PDO
mono
fi
lament is cut or damaged during insertion or
fi
xation, additional complications may include bowel or skin
perforation and infection.
INSTRUCTIONS FOR USE
Preparation
It is recommended that the V
ENTRIO
™ ST Hernia Patch be completely immersed in sterile saline for 1-3 seconds
immediately prior to placement in order to maximize the
fl
exibility of the prosthesis. The safety and effectiveness
of the V
ENTRIO
™ ST Hernia Patch in combination with solutions other than saline have not been tested.
Surface Orientation
It is extremely important that this product be oriented correctly to function as intended. The visceral side of the
V
ENTRIO
™ ST Hernia Patch is designed to temporarily separate tissue surfaces and minimize tissue attachment
to the mesh. Place the bioresorbable coated side of the prosthesis against those surfaces where minimal tissue
attachment is desired, i.e., against bowel or other visceral structures. The uncoated polypropylene mesh side
should face the surface where tissue ingrowth is desired. The uncoated polypropylene mesh surface should
never be placed against the bowel or other visceral structures.
Patch Folding Technique
The V
ENTRIO
™ ST Hernia Patch should overlap
the defect 3-5 cm on all sides. For larger defects,
the overlap should be at least 5 cm. For open
procedures, after hydration for 1-3 seconds,
the smaller size patches (5.4” x 7.0” or smaller)
should be rolled, bioresorbable coated side out,
around the surgeon’s
fi
ngers for insertion. All
other patches, after hydration for 1-3 seconds,
should be rolled into thirds along the long axis,
bioresorbable coated side out, and inserted into
the intra-abdominal space (
see Figure 2
).
For laparoscopic procedures, after hydration for 1-3 seconds, patches indicated in the table below should be
rolled into thirds along the long axis, bioresorbable coated side out, and inserted through a minimum trocar site
of 12 mm (remove trocar, insert patch, and reinsert trocar). If the patch is hydrated for longer than 3 seconds
and/or does not easily deploy through the trocar site, a larger trocar site may be required.
Prosthesis Size
Trocar Site (minimum)
5.4” x 7.0” (13.8 cm x 17.8 cm) or smaller
12 mm
6.1” x 10.1” (15.5 cm x 25.7 cm) or greater
Not Tested / Not Recommended
Insert the prosthesis through the trocar site using a rigid instrument, such as a non-serrated 5 mm forceps; do
not force prosthesis through the trocar site.
Fixation
Bard permanent or absorbable
fi
xation devices or nonabsorbable mono
fi
lament sutures are recommended
to properly secure the prosthesis. If other
fi
xation devices are used, they must be indicated for use in hernia
repair. The method of securing the prosthesis should be determined by surgeon preference and the nature of
the reconstruction to provide for adequate tissue
fi
xation and to prevent reherniation.
TRACEABILITY
A traceability label which identi
fi
es the type, size and lot number of the prosthesis is attached to every package.
This label should be af
fi
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, SorbaFlex and Ventrio are trademarks and/or registered trademarks of
C. R. Bard, Inc. or an af
fi
liate.
Sepramesh is a trademark and/or registered trademark of Genzyme Corporation licensed to
C. R. Bard, Inc. or an af
fi
liate.
Copyright © 2010, 2011 C. R. Bard, Inc. All Rights Reserved.
Figure 2
PK3794572 BAW-9.indd 3
PK3794572 BAW-9.indd 3
6/3/2011 8:48:10 AM
6/3/2011 8:48:10 AM
