Puros® Allografts Patient Guide
Puros® Accugraft®, Symmetry ® and Traditional Allografts
The purpose of Tutoplast® is to provide you and your surgeon with a safe, strong allograft option.
Your surgeon is recommending the use of a Tutoplast® Processed Human Tissue Graft for your surgical procedure.
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This brochure provides you with an understanding of the origin,
science and benefits of Tutoplast® processed tissue. 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 in this brochure is designed to anticipate questions and address concerns you may have about these very important issues. |
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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. Experience shows that autografting has many disadvantages. These procedures can lengthen the time you are under anesthesia, and result in greater discomfort and a longer recovery period.
The intent for using our allograft is to make the surgery easier for you.
The purpose of processed tissue is to provide you and your surgeon with the
safest, strongest allograft option possible.
What is Tutoplast®?
Tutoplast processed tissue is a proprietary, scientific and technology based process of virally inactivating, preserving and sterilizing human tissue for transplantation. The Tutoplast Process is recognized as one of the safest methods in preparing allografts for surgery.
How long have surgeons used Tutoplast® Allografts?
Surgeons all over the world have used Tutoplast® Allografts for over 30 years. More than 1 million patients have received Tutoplast processed tissues.
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). Donors are screened based on a stringent review process
that meets or exceeds current standards. Before being accepted for tissue
donation, medical histories of all potential donors are obtained and
verified based on a thorough review by medical directors. 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 malignant cancers,
neurological diseases of unknown origin (Alzheimer’s), or active infections
(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 meets the
initial screening criteria through 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 processed
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 ensure the traceability of each Tutoplast Processed
Allograft back to the donor’s medical record.
Tutoplast® processed tissues are selectively chosen and obtained from carefully screened and accepted donors
What happens to the tissue after the donor screening process?
Following successful screening, each tissue is sent to the next phase of the
proprietary Tutoplast process. The rest of the process is performed over
several weeks 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 removes 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 matrix 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, dry, sterile and ready for implantation.
How is the quality of the allografts controlled?
The quality of the Tutoplast®
Allografts is carefully controlled. The process is performed
entirely by specially trained personnel using the latest technology and
equipment. Each piece of tissue receives repeat inspections for consistency
throughout initial processing to
final packaging.
By the time the process is completed, each tissue is clean, dry, sterile and ready for implantation.
What part of the body does the donor tissue come from?
The human body contains several different types of 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 safe and effective 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 processed tissue will act as a support or bridge for your new tissue growth. Over time, your own living cells will began to "repopulate" the donor tissue. As your body undergoes its natural healing process, the Tutoplast Allograft gradually becomes a healthy part of your 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.
Tutoplast® is a registered Trademark of Tutogen Medical GmbH.
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