Product Description - Bard Phasix Mesh Mode D'emploi

P Mesh
™
Fully Resorbable Implant
for Soft Tissue Reconstruction

PRODUCT DESCRIPTION

P ™ Mesh is a fully resorbable synthetic mesh implant
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prepared from poly-4-hydroxybutyrate (P4HB). P4HB is
produced from a naturally occurring monomer and is
processed into monofilament fibers and then knitted into a
surgical mesh. P ™ Mesh degrades through a process
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of hydrolysis and a hydrolytic enzymatic digestive process.
It has been developed to enforce areas where weakness
exists while minimizing the variability of resorption rate (loss
of mass) and strength to provide support throughout the
expected period of healing.
Preclinical implantation studies indicate that P
retains approximately 70% of its strength at 12 weeks.
Absorption of the mesh material will be essentially complete
within 12 to 18 months.
INDICATIONS
P ™ Mesh is indicated to reinforce soft tissue where
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weakness exists in patients undergoing plastic and
reconstructive surgery, or for use in procedures involving
soft tissue repair, such as the repair of hernia or other fascial
defects that require the addition of a reinforcing or bridging
material to obtain the desired surgical result.
CONTRAINDICATIONS
Because P ™ Mesh is fully resorbable, it should not be
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used in repairs where permanent wound or organ support
from the mesh is required.
WARNINGS
1. P ™ Mesh must not be put in direct contact with
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bowel or viscera.
2. Device manufacture involves exposure to tetracycline
hydrochloride and kanamycin sulfate. The safety and
product use for patients with hypersensitivities to
these antibiotics is unknown. Use of this device in
susceptible patients with known allergies to
tetracycline hydrochloride or kanamycin sulfate
should be avoided.
3. The safety and effectiveness of P
following applications has not been evaluated or
established:
a. Pregnant women
b. Pediatric use
c. Neural and cardiovascular tissue
4. If an infection develops, treat the infection
aggressively. Consideration
regarding the need to remove the mesh. An
unresolved infection may require removal of the
device.
5. To prevent recurrences when repairing hernias, the
P ™ Mesh must be large enough to provide
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sufficient overlap beyond the margins of the defect.
Careful attention to mesh fixation placement and
spacing will help prevent excessive tension or gap
formation between the mesh and fascial tissue.
6. Prior to use, carefully examine package and product
to verify neither is damaged and that all seals are
intact. Do not use if the foil pouch or package is
damaged or open, or if the center of the temperature
indicator on the foil pouch is black.
7. This mesh has been designed for single use only.
Reuse, reprocessing, resterilization or repackaging
may compromise the structural integrity and/or
essential material and design characteristics that are
critical to the overall performance of the mesh and
may lead to mesh failure which may result in injury
to the patient.
Reuse, reprocessing, resterilization or repackaging
may also create a risk of contamination of the mesh
and/or cause patient infection or cross infection,
including, but not limited to, the transmission of
infectious diseases from one patient to another.
Contamination of the mesh may lead to injury, illness
or death of the patient or end user.
8.
PRECAUTIONS
1. Please read all instructions prior to use.
2. Only physicians qualified in the appropriate surgical
ADVERSE REACTIONS
™ Mesh
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In preclinical testing, P
reaction characteristic of foreign body response to a
substance. The tissue reaction resolved as the mesh was
resorbed. Possible complications may include, but are not
limited to infection, seroma, pain, mesh migration, wound
dehiscence,
inflammation, allergic reaction, extrusion, erosion, fistula
formation and recurrence of the hernia or soft tissue defect.
DIRECTIONS FOR USE
P
each specific application. To prevent recurrences when
repairing hernias, a mesh larger than the defect is required
to ensure adequate coverage. The mesh is to be positioned
so that its edges extend beyond the margins of the defect.
It is recommended that surgical fixation be performed using
absorbable or permanent sutures, or absorbable or
permanent tackers placed 6 to 12 mm (¼ to ½ inches) apart
at a distance approximately 6 mm (¼ inch) from the edge of
the mesh.
HOW SUPPLIED
P
mesh of varying widths and lengths.
STORAGE
Store at room temperature. Avoid prolonged exposure to
™ Mesh in the
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elevated temperatures. If the center of the temperature
indicator on the box is BLACK, check the temperature
indicator on the foil pouch. If the center of the temperature
indicator on the foil pouch is BLACK, DO NOT USE
PRODUCT.
TRACEABILITY
should be given
A traceability label that identifies the type, size, expiration
date and lot number of the device is attached to every
package. This label should be affixed to the patient's
permanent medical record to clearly identify the device that
was implanted.
If you experience a product failure, please contact Davol, Inc.
at 1-800-556-6275 for instructions on returning the product.
Copyright © 2010, 2013, 2014, 2015, 2016 C. R. Bard, Inc.
All Rights Reserved.
Bard, Davol and Phasix are trademarks and/or registered
trademarks of C. R. Bard, Inc.
If unused P
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instruments or supplies used on a patient or
contaminated with body fluids, handle and
dispose of in accordance with accepted medical
practice and applicable local, state, and federal laws
and regulations.
techniques should use this device. Users should be
familiar with mesh strength and size requirements.
Improper selection, placement, positioning and fixation of
the device can cause subsequent undesirable results.
™ Mesh elicited a minimal tissue
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hemorrhage,
™ Mesh may be cut to the shape or size desired for
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™ Mesh is available in sterile packages as a single flat
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only U. S. Federal law restricts this device to
sale by or on the order of a physician.
Do not use if package is damaged
Contents
Absorbable
Circle
Do not use if the center of the temperature
indicator is black.
™ has been in contact with
adhesions, hematoma,
Actual Size
Square
Rectangle