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Instructions for Use – ENGLISH
DEVICE DESCRIPTION
TIGR® Matrix Surgical Mesh is knitted from two different synthetic
resorbable fibers, possessing different degradation characteristics. The fast-
resorbing fiber, making up approximately 40% of the matrix by weight, is
a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-
resorbing fiber, making up approximately 60% of the matrix by weight, is
a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by
bulk hydrolysis once implanted, resulting in a decreasing strength retention
followed by mass loss of the fibers. In vitro testing showed that the fast-
resorbing fiber (glycolide, lactide, and trimethylene carbonate) loses its
mechanical strength after 2 weeks and in vivo studies in the abdominal
wall of sheep showed that the fast-resorbing fiber is fully absorbed after
4 months. The same in vitro testing showed that the slow-resorbing fiber
(lactide, and trimethylene carbonate) maintains its mechanical strength for
6 months and in vivo studies in the abdominal wall of sheep indicated that
the slow-resorbing fiber is absorbed after approximately 36 months.
INDICATIONS FOR USE
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue
where weakness exists in procedures involving repair of indirect inguinal
hernias and ventral hernias, in prophylactic use to reinforce the midline
suture, and in reconstructive breast surgery for both prepectoral and
submuscular surgical procedures.
CONTRAINDICATIONS
Not suitable for reconstruction of cardiovascular defects. TIGR®Matrix
Surgical Mesh must always be separated from the abdominal cavity by
peritoneum. Not suitable for the repair of direct inguinal hernias.
WARNINGS
1. Do not use if the outer or inner package has been damaged and/or any
sterile or moisture barrier is not intact.
2. Do not use after the expiration date – the biodegradable components
may not perform adequately.
3. The use of any synthetic mesh or patch in a contaminated or infected
wound could lead to fistula formation and/or extrusion of the mesh and
it is not recommended.
4. For single use only. Do not use if outer or inner package has been
opened prior to initial intended use. Discard all unused portions of the
device. Do not resterilize. The device might not perform adequately due
to degradation.
5. The safety and effectiveness of TIGR® Matrix Surgical Mesh have not
been established for use with resorbable fixation devices.
6. The safety and effectiveness of TIGR® Matrix Surgical Mesh have not been
established for urogynecological use. Refer to safety communications
from the FDA and from UK's National Institute for Health and Clinical
Excellence (NICE) for guidance.
7. The safety and effectiveness of TIGR® Matrix Surgical Mesh have not
been established for use in tendon repair.
8. Because TIGR® Matrix Surgical Mesh is fully resorbable, it should not be
used in repairs where permanent support from the mesh is required.
PRECAUTIONS
device is restricted for use by or on the order of a physician.
1. This
2. Carefully check that the packaging is undamaged and unopened and
that the sterile barrier is intact before use.
3. The mesh should be large enough to extend beyond the margin of the
defect.
4. Infections should be treated according to acceptable surgical practice to
minimize the need for removal of the mesh.
ADVERSE REACTIONS
Possible adverse reactions with the mesh are those typically associated
with any implantable prosthesis, including, but not limited to, infection,
inflammation, extrusion, erosion, adhesion, fistula formation, seroma
formation, hematoma, and recurrence of the hernia or tissue defect.
Known adverse reactions following breast reconstructive surgery with or
without mesh includes, but not limited to, implant displacement, infection,
inflammation, hematoma, seroma formation, necrosis, capsular contraction
and implant rupture and in rare cases breast Implant associated anaplastic
large cell lymphoma (BIA-ALCL).
CLINICAL BENEFITS
Depending on the indication for use, the following clinical benefits can be
expected:
•
Freedom from hernia-related symptoms.
•
Prevention of surgery-related incisional hernia.
•
Short- and long-term successful subpectoral and prepectoral breast
reconstruction.
The magnitude of the clinical benefits related to TIGR® Matrix Surgical Mesh
is comparable with that of other commercially available surgical meshes.
PREPARATION FOR USE
1. Open the outer aluminum foil and remove the inner pouch containing
the product. Be aware that the inner pouch is non-sterile on the outside.
2. Carefully open the inner pouch containing the mesh.
3. Aseptically remove the mesh from the inner pouch using sterile, gloved
hands or sterile forceps, and place the mesh in the sterile field.
EN
DIRECTIONS FOR USE
1. Prepare the implantation site using standard surgical techniques.
2. Trim TIGR® Matrix Surgical Mesh to allow an adequate overlap of
the defect area or to fit the size of the implant when used for breast
reconstruction.
3. Implant TIGR® Matrix Surgical Mesh according to currently accepted
surgical mesh procedures. Device may be used in a dry state.
4. Fixate TIGR® Matrix Surgical Mesh with sutures according to currently
accepted surgical practices.
5. Affix the traceability label in the patient's medical record and provide the
implant card to the patient.
6. If a serious incident should occur in relation to the device it shall be
reported to the manufacturer and the competent authority of the
Member State in which the user and/or the patient is established.
STORAGE, PACKAGING AND DISPOSAL
1. Store in a cold dry place away from moisture and direct heat inside
the product box with unopened and undamaged aluminum pouch,
instruction for use and implant card.
2. Sterile in unopened and undamaged package with sterile barrier intact.
3. A traceability label which identifies the lot number of the product is
enclosed in every package for placement in the patient's medical record.
4. An implant card which identifies the product is enclosed in every
package.
5. Dispose of contaminated units, components, and packaging materials in
accordance with standard hospital procedures, universal precautions for
biohazardous waste, and applicable local, state, and federal laws.
DISCLAIMER OF WARRANTY
Although TIGR® Matrix Surgical Mesh (hereinafter referred to as
"product")
has
been
conditions; Novus Scientific AB (hereinafter called Novus) has
no control over the conditions under which the product is used.
Novus, therefore, disclaims all warranties, both expressed and implied,
with respect to the product, including, but not limited to, any implied
warranty of merchantability or fitness for a particular purpose.
Novus shall not be liable to any person or entity for any medical expenses
or any direct, indirect, incidental or consequential damages caused by any
use, defect, failure or malfunction of the product, whether a claim for such
damages is based upon warranty, contract, tort or otherwise.
No person has any authority to bind Novus to any representation or
warranty with respect to the product. The exclusions and limitations
set out above are not intended to, and should not be construed so as to
contravene mandatory provisions of applicable law, including the Federal
Drug, and Cosmetic Act. If any part or term of this Disclaimer of Warranty is
held to be illegal, unenforceable or in conflict with applicable law by court
of competent jurisdiction, the validity of the remaining portions of this
Disclaimer of Warranty shall not be affected, and all rights and obligations
shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.
EXPLANATION OF SYMBOLS
1.
Caution:
This device is restricted for use by or on the order of a physician.
2.
Consult Instructions for Use.
3.
Use before date.
4.
Sterilized using ethylene oxide.
5.
Single sterile barrier system with protective packaging outside. (Used
on the aluminum pouch.)
6.
For single use only.
7.
Catalogue number.
8.
Lot number.
9.
Date and country of manufacture.
10. Quantity.
11. Storage conditions.
12. Manufacturer.
13. Complies with the Medical Device Regulation 2017/745.
14. Do not resterilize.
15. Do not use if package is damaged.
16. Medical device.
17. Unique device identifier.
18. Patient information website.
19. Person identification.
20. Date.
21. Health care center or doctor.
22. Single sterile barrier. (Used on the Tyvek pouch.)
manufactured
under
carefully
controlled
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