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Welcome Patients.
Your surgeon is recommending the use of a Tutoplast®
Processed Human Tissue Graft for your surgical procedure.
Due to today's concerns regarding disease transmission from
donor tissue and blood, we are aware that many people have
questions and concerns regarding their tissue transplant surgeries.
The information within this section of our site is designed
to anticipate questions and address concerns you may have
about these very important issues. It should also provide
you with an understanding of the origin, science and benefits
of Tutoplast®.
We'd like to start by familiarizing you with some of the
basic surgical terminology. An allograft is tissue obtained
from a human donor. An autograft is tissue obtained from your
own body through what surgeons' refer to as a "secondary
surgical site." For example, a surgeon may take tissue
from one part of the body and then transplant this tissue
to another part of the body. Many experts believe that "autografting"
has many disadvantages. These procedures can lengthen the
time you are under anesthesia, result in greater discomfort
and a longer recovery period. The use of an allograft is designed
to make the surgery easier for you. The purpose of Tutoplast®
is to provide you and your surgeon with the safest, strongest
allograft option available.
What Is Tutoplast®?
Tutoplast® is a patented, scientific and technology based
process of virally inactivating, preserving and sterilizing
human tissue for transplantation. The Tutoplast® Process
is recognized as the worldwide leader in preparing allografts
for surgery.
How long have surgeons used Tutoplast®?
Surgeons all over the world have used Tutoplast Allografts
for over 30 years. More than 1 million patients have received
Tutoplast tissues without a single known or documented case
of disease transmission.
Are the donors safe? What measures are employed
to insure safety?
Our focus with the Tutoplast® Process is to offer the
safest, strongest tissue possible. In order for us to do this,
the first step involves the screening of potential donors
(i.e. people who generously donate their organs and tissue
after passing away). Donors are screened based on a stringent
review process. All FDA-required protocols are followed.
Before being accepted for tissue donation, medical histories
of all potential donors are obtained and verified based on
a thorough review by independent sources. Donors whose medical
histories reveal viral infections or any form of communicable
disease such as HIV, AIDS, hepatitis or tuberculosis are immediately
rejected. Also excluded are those with histories of diseases
that spread (cancer), diseases of unknown origin (Alzheimer's),
or diseases known to be difficult to cure (those caused by
fungus or yeast). Donors are also screened to insure that
the tissue quality is not compromised due to age or gender-related
conditions (such as osteoporosis).
If the potential donor passes the initial screening of his/her
medical history, tissues and body fluids are then tested for
disease. Any unclear or questionable conditions at this point
will automatically exclude the donor. Tutoplast tissues are
selectively chosen and obtained from carefully screened and
accepted donors.
We insure complete donor-to-recipient traceability. Records
are kept of the tissue source and specifics related to the
donor's medical history. This information is assigned a code,
which is placed on all tissue packaging to insure the traceability
of each Tutoplast® Processed Allograft back to the donor's
medical record.
What happens to the tissue after passing
the donor screening process?
Following successful screening, each tissue is sent to the
next phase of the patented Tutoplast® process. The rest
of the process is performed over several days during which
the tissues are cleaned, disinfected and preserved. The tissues
are gently soaked and washed in a series of solutions and
solvents, which have been proven to be effective in destroying
potential diseases (like HIV) and antigens. This phase also
remove other cells in the tissue that might cause rejection,
allergic reactions or inflammation. You should also note that,
while these steps in the process are powerful, the strength
or "integrity" of the tissue is not compromised.
The tissue remains intact and strong.
Finally, the tissues are dehydrated and undergo a final sterilization
process. By the time the process is completed, each tissue
is clean, sterile, dry and ready for implantation.
How do you control the quality of the allografts?
The quality of the Tutoplast® Allografts is carefully
controlled. The process is performed entirely by specially
trained medical personnel using the latest technology and
equipment. Each piece of tissue receives repeat inspections
for consistency throughout initial processing to final packaging.
What part of the body does the donated tissue
come from?
The human body contains several different types protein frameworks
called collagen. One type of collagen is found in several
soft, connective tissues within the body. Many of these tissues
have been successfully used as allografts for many years.
Only clinically successful and proven tissues are put through
the Tutoplast® Process and provided to surgeons for surgery.
How will my body react to the tissue? What
happens to the tissue over time?
In your body, the Tutoplast® tissue will act as a support
or bridge for your new tissue growth. Over time, your own
living cells will begin to "re-populate" the donor
tissue. As your body undergoes its natural healing process,
the Tutoplast® Allograft gradually becomes part of your
healthy body.
Your surgeon is your best source of information.
Any questions or concerns you may have about your surgery
can be best answered by your surgeon. You can help insure
the best outcome for your procedure by carefully following
your surgeon's instructions.
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