Directions for use - Mentor Worldwide LLC

TUTOPLAST ® PROCESSED DERMIS
Directions for use
Description
Dehydrated Human Dermis
Tutoplast processed Dermis consists of human collagen. All tissues are selected in compliance with stringent specifications governing donor
selection and serological testing in order to minimize the risk of transmitting infectious diseases. Tutoplast processed Dermis is preserved
by a defined, proprietary process consisting of meticulous cleaning of the tissue and gentle solvent dehydration monitored by continuous
quality controls. The process does not result in chemical residues and reduces the antigenic properties of the original tissue. Preservation
also includes sterilization of the finished product by gamma irradiation.
Package
Bioimplant
The package contains a sterile section of human Tutoplast processed Dermis.
Indications
Tutoplast processed Dermis is indicated as a soft tissue graft for horizontal and vertical soft tissue augmentation of thickness and length,
such as breast reconstruction. Collagenous connective tissue with three-dimensional intertwined fibers retains the multidirectional and
mechanical properties of native Dermis, while providing the basic formative structure to support replacement by new endogenous tissue.
Contraindications
• Implantation in surgical sites with poor perfusion and in necrotic or infected sites is not advisable.
• Tutoplast processed Dermis should be used with particular caution for indications where the graft is under moderate to high
tension.
Precautions
• Tutoplast processed Dermis remains sterile as long as the package is not opened and/or damaged. The product must be used
before the expiration date.
• Before clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the graft.
Patients should be instructed in the limitations of the graft and should be taught to govern their activities accordingly.
• Appropriate placement and fixation are critical factors in the avoidance of potential adverse effects on graft service life.
Utilization/Implantation
● Open package by firmly grasping both sides of the pouch top and peeling outward. Dispense the tissue unit onto a sterile field
without touching the product. (Failure to observe sterile technique may contaminate the unit)
• It is recommended that NeoForm Tutoplast Processed Dermis be rehydrated prior to use for a minimum of 5 minutes (maximum
hydration is achieved in 30 minutes) in order to improve suppleness and handling properties. Thicker pieces may take longer than 5
minutes to rehydrate. The amount of time is to be determined by the implanting physician and is dependant upon the consistency
desired. Rehydration is accomplished by using sterile technique and soaking in sterile, endotoxin-free, room temperature 0.9%
saline solution. The entire piece of NeoForm must be submerged. Use promptly following rehydration. For bilateral cases it is
recommended that one piece be rehydrated at a time.
• It is recommended that a suitable antibiotic be included in the soaking solution as a precaution against incidental infection.
• The graft should be sized according to the tissue defect and securely placed to prevent displacement and aid incorporation. Implant
the graft so that free edges of the Dermis do not protrude.
• Either absorbable or non-absorbable suture material may be used, with a round trauma needle. Select the appropriate suture size
for the indication and operation. Place the stitches 2-3 mm from the edge of the implant where possible. Use Tutoplast processed
Dermis where the material is under minor to moderate tension. Better results are obtained by doubling the section at suture sites
that are under moderate to high stress.
• The process of absorption and tissue neogenesis begins after 1 to 2 days and may last for weeks or months, depending on the size
of the graft and reagibility of the host site.
Warnings
• Tutoplast processed tissues have been used for over 30 years in more than 1,500,000 surgical transplant cases with an
outstanding safety record. As with all biological products, it is not possible to give an absolute guarantee of freedom of transmitting
infectious diseases. Processing treatments shown to be capable of reducing the risk of any transmission as well as strict donor
screening and laboratory testing are used to decrease the risk.
• Discard all damaged or mishandled grafts or when possible contamination of the graft has occurred.
• Return all packages with flaws in the sterile barrier to the supplier. Do not re-sterilize.
• Unused Dermis should be properly discarded.
• Single use only (This product is NOT warranted for multiple uses or for use on multiple patients).
• Use on single occasion only (This product is NOT warranted for multiple use).
Adverse Effects
• As with any surgical procedure, the possibility of infection exists.
• Although the Tutoplast process is designed to eliminate antigenic properties of the graft, with no incidence of immunologic rejection
after over thirty years of use, the possibility of such rejection is present in any allograft procedure.
• Re-operation could be necessary to correct adverse effects.
• Adverse reactions should be immediately reported to Mentor.

Sterilization
• This graft has been sterilized by gamma radiation to provide sterility throughout the unit.
• The packaging of all sterile products should be inspected for flaws in the sterile barrier before opening. In the presence of such a
flaw, the product must be assumed non-sterile.
• Care should be taken to prevent contamination of the graft. In the event of such contamination, this product must be discarded.
• If the package has been opened, but the product is not used, the graft must not be re-sterilized and must therefore be discarded.
Storage
This product should be stored in a clean, dry place at controlled room temperature of 15° to 30°C (59° to 86°F) and protected from
direct sunlight.
Special Instructions
● The enclosed Transplant Utilization Record (TUR) should be promptly completed and returned to Tutogen Medical, Inc.
● Recipient records should be retained by the transplanting physician for the purpose of tracing tissue post- transplantation
● Tissue intended for transplantation must be maintained in appropriate storage conditions by the clinician prior to transplantation.
Product Evaluation
Mentor requests that any complications and/or explantation related to the use of this graft be brought to the immediate attention of the
Product Evaluation Department at Mentor. Please call Mentor Corporation at 866-250-5115 to report any complications and/or explantation
related to the use of this graft.
Product Returns
Customers within the United States may return product for credit directly to our Texas facility provided they include a copy of the packing slip
that came with the product. The product must be in its original package and in resalable condition. Product returned more than sixty (60)
days after the invoice date is subject to a restocking fee. Product returned more than six (6) months after the invoice date is not eligible for
credit. Product should be returned to our warehouse by a traceable method.
Returns address: Mentor Corporation
555 Airline Drive
Coppel, TX 75019
CAUTION: Federal law (U.S.A.) restricts this material for sale to or use by a licensed physician.
Tutogen Medical, Inc. distributes this tissue without any express or implied warranties. All statements or descriptions are informational only
and not made or given as a warranty of the tissues in any way. Tutogen Medical, Inc. makes no guarantee whatsoever concerning the
biologic or biomechanical properties of the tissue. The user shall be solely responsible for determining the adequacy and suitability of the
tissue for any and all uses to which the user shall apply the tissue.
Donor Screening and Suitability for Transplantation
Blood from the donor of the tissue used to produce this product was tested by a laboratory certified under the Clinical Laboratories
Improvement Amendment of 1988 (CLIA’88) using FDA licensed donor screening tests and found to be negative or non-reactive for the
following tests, among others: HIV-1&2, Hepatitis B Surface Antigen, Hepatitis C Antibody, HTLV-I&II, RPR (syphilis). Tissue recovered
after 5/25/05 and donor eligibility determination after 5/25/05 also includes non-reactive tests for Total Hepatitis B core (IgG+IgM), HIV NAT
and HCV NAT.
Tutogen Medical, Inc. asserts that the infectious disease test results, together with the consent documents, donor medical history and
behavior risk assessment according to current public health service guidelines, physical assessment, available relevant medical records
including previous medical history, laboratory and serological test results, existing autopsy or coroners reports if available, as well as
information from other sources or records which may pertain to donor suitability, along with tissue procurement test results, have been
evaluated by the Tutogen Medical, Inc. staff and Medical Director and are sufficient to indicate that the donor suitability criteria current at the
time of tissue recovery have been met, and the tissue is deemed suitable for transplantation. Tutogen Medical, Inc. further asserts that it
can positively trace the enclosed tissue to the specific donor.
Specific information on the names and addresses of testing laboratories, the specific listing and interpretation of all required infectious
disease testing, listing of documents reviewed as part of the relevant medical records, and the name of the person or establishment
determining the suitability of this donor are on file and are available upon request to: Tutogen Medical, Inc. at 800-698-4996 or in writing at
the following address: Tutogen Medical, Inc.
13709 Progress Blvd. Alachua, FL 32615-9989.
Tutoplast ® is a registered trademark of Tutogen Medical, Inc.
NeoForm is a Trademark of Mentor Corp.
Distributed in U.S.A. by:
Manufactured by:
Mentor Corporation Tutogen Medical, Inc.
13709 Progress Blvd.
Irving, TX 75038 USA Alachua, FL 32615
Phone: 800-235-5731 (USA) Phone: 800-698-4996 (USA)
Fax:805-967-7108 Fax: 386-462-1421
Document # PS.9.1.4
Effective Date: 02/01/2008