FAQs|Common Myths|Questions to Ask Before Your Surgery

Common Myths

Myth: I could get a disease such as HIV or cancer from donated tissue.
Allografts have been used successfully in various medical procedures for more than 150 years. About one million allografts are transplanted each year in the United States. The risk of disease transmission through tissue transplantation is believed to be very low and with an increased demand for allograft tissue, the availability of safe allografts has become a focus of the tissue industry, surgeons and patients alike. Tissue processing is highly regulated by organizations such as the Food and Drug Administration (FDA) and the American Association of Tissue Banks (AATB) to ensure that tissue meets regulatory requirements.

The safety of any tissue is contingent upon three stages: donor screening, laboratory testing and tissue preparation validated to address potential disease transmission.

The donor-screening process includes a family/next-of-kin interview, medical record/hospital record review, a behavioral/lifestyle risk assessment, the medical examiner/coroner’s report (autopsy report, when available), and laboratory, pathology and radiology reports.

Laboratory testing includes an extensive panel of serological (blood) and microbiological testing to screen for potential contamination and to provide confirmation of tissue suitability for transplant. These results are subject to stringent acceptance criteria in order to release the donor tissue for implantation.

To better protect recipients from the risk of donor-to-recipient disease transmission, many tissue processors have advanced beyond the use of aseptic processing, which does not ensure the removal or inactivation of microorganisms inherent to the donor or tissue. When receiving an allograft implant, be sure to ask your surgeon about tissue preparation and sterilization.

Myth: Allograft tissue wouldn’t work as well as my own tissue (autograft).
Surgeons have the choice of autograft, which takes tissue from one part of the body for transplantation to another part.

Allograft tendons present certain advantages over autografts for some procedures. For example, they can eliminate the need for a second surgery site, avoiding additional pain, risk and possibly a longer hospital stay. Additionally, the main benefit of using allograft in surgery is its ability to remodel with the patient's own tissue. Allograft implants act as a scaffold; the patient's body recognizes the implant as human tissue and begins laying the patient's own new tissue cells over it.

Myth: I’m really young, and tissue from someone much older might not work as well for me.
While tissue processors will often establish a set of age criteria for donors, there are many published reports showing that the age of a donor is not a relevant factor in establishing suitability for transplantation.

Myth: Metals and synthetics are better than allografts.
Allografts are a natural alternative to synthetic or metal implants. Human tissue is favored by many surgeons over metals or synthetics, which sometimes weaken and stress adjoining bone. Additionally, the body usually adapts to the transplanted tissue as if it were its own.

Myth: Tissue is taken from a human donor without the donor’s consent or donor family’s authorization.
Legal authorization is required before recovery takes place. The standards by which tissue banks operate require staff to give each family the opportunity to ask for more information throughout the interview process and to give a phone number and contact person should the family want additional information at a later date.

In the case of consent, an individual has made a decision during his or her lifetime to donate organs and/or tissues, and it is the organ and tissue-recovery organization’s role to ensure his or her wishes are carried out.

Tissue banks should respect the family's decision to donate or not donate tissue and are committed to be responsible stewards of the gift of donation. These organizations have standards and protocols in place that are meant to protect donor families, recipients and the integrity of the entire process.

Myth: The tissue banking industry is unregulated.
Under federal law, all establishments dealing with recovery, processing and distribution of human donated tissue operating in the United States must be registered with the Food and Drug Administration (FDA) and must adhere to applicable FDA regulations, including the Current Good Tissue Practices (cGTPs). Registered tissue banks are subject to periodic inspections by the FDA.

Some tissue banks have voluntarily submitted to an accreditation process through the American Association of Tissue Banks (AATB), which also includes periodic inspections.

Tissue banks also must comply with the applicable laws of the states in which they operate. For a list of current state requirements for licensure, visit the AATB website at www.aatb.org

Myth: There is no way to trace which allograft implants came from which human donor.
Each tissue donor is assigned a unique identifier that is used to trace the tissue and associated laboratory specimens through every stage of screening, testing and processing. All medical and manufacturing records associated with the donor also refer to this unique identifier. Each allograft package label contains the donor number as well as a unique identifier or serial number that allows tracking of individual grafts. Records are maintained showing the transfer of the graft to the implanting health care facility.

The health care facility may use the labels to transfer graft identification information to the patient’s medical chart. Return of the record to the tissue processor completes the tissue traceability from donor to recipient. The information provided is entered into a confidential database that may be used by the tissue processor or the health care facility to ensure patient safety.

Myth: Tissue banks sell human tissue, which is illegal.
The sale of human organs or tissue is illegal in the United States. The cost associated with an allograft implant includes the expense to prepare the donated tissue before it can be used for transplantation.

Myth: Using allograft is experimental and not very common.
Second only to blood, musculoskeletal (allograft) tissue is the most commonly transplanted tissue, with more than one million grafts surgically implanted annually in the U.S. alone. The use of allograft tissue has seen significant advances in the last few years as a direct result of the development of precision processing technologies.

Myth: My body might reject allograft tissue since it’s not my own.
Most processors take steps to remove all blood and other organisms from the tissue, so there is nothing left that would cause rejection. The allograft is a clean, natural scaffold that allows for remodeling with the patient’s own tissue. If you want to know more about possible rejection, you can speak with your surgeon about how the tissue they use is processed and whether it is sterilized.