In discussion with me regarding your orthopaedic condition, we have discussed the use of allograft tissue as an option in the treatment of your problem. This section was developed to educate you about allografts-what they are, their history, current guidelines and my experiences to help you make a well-informed decision in your care.
Information about Allografts
Where does the allograft come from?
Allograft tissue comes from the procurement or harvest of tissues from a human donor within 12-24 hours after the time of death. Harvest of these tissues is performed by surgeons or specially trained technicians under sterile conditions. These grafts are then tested, processed, packaged and distributed by tissue banks. I obtain all of my grafts from the Musculoskeletal Transplant Foundation (MTF), which is the largest non-profit tissue banks in the country.
How often are allografts used?
The use of allograft tissue increases every year in the United States with the advent of new technologies, improved operating techniques and more applications for the use of allograft tissue. Currently over one million grafting procedures are performed annually.
Why are allografts considered?
The patient may have an inadequate amount of their own tissue or their own tissue may be unsuitable due a medical problem. Sometimes there is so much going on from a surgical standpoint that harvesting the patient’s own tissue would be a further component of healing and recovery to overcome.
Are there any risks involved with using allografts?
As with any surgery there are some risks you need to be aware of. Infection and a theoretical risk of disease transmission are possible. There have been some instances in this country of inadequate testing, processing and distribution of allograft tissue but as will be explained in the sections below, the more stringent regulation of the Food and Drug Administration (FDA), the use of reputable tissue banks and compliance with the standards set by the American Association of Tissue Banks (AATB) has greatly minimized the risk. Being well informed regarding which tissue bank your graft comes from, the guidelines they follow, their safety record and the experience with allografts of the surgeon are simply your right as a patient.
Tissue banking and the FDA
Tissue banking has been regulated by the Food and Drug Administration (FDA) since 1993. Considering this, the FDA has lagged behind compared to regulation in other areas of the health care industry. As an example, for five years it has been required that a certain type of specific test for HIV and hepatitis be used in blood banking for blood transfusions. It was not until May 2005 that these same tests were required for tissue transplantations. Therefore, it is of paramount importance for the individual tissue bank and their affiliated associations to establish very high voluntary standards. I do believe the FDA is catching up, but most of the standards are based on expert panel recommendations in the industry.
What is the AATB?
The American Association of Tissue Banks (AATB) was established in 1976. The AATB sets standards regarding donor screening, allograft harvesting, the handling and processing of tissues, record keeping, as well as donor testing and tissue culturing. They offer inspection and accreditation of tissue banks and certification of personnel in tissue banks to ensure their high standards of quality are being met. It is important to note that this is not a requirement, but is strictly voluntary. It is generally accepted that accreditation or certification by the AATB is very significant achievement to those in the tissue banking industry. In general, the AATB sets the bar regarding the standards for handling and processing allografts in the United States. Their standards have exceeded those of the FDA. Currently 90% of tissue banks in the United States are accredited with the AATB.
What is the Musculoskeletal Transplant Foundation (MTF)?
The MTF is the largest non-profit tissue bank in the country. Since it was established in 1987, it has provided over 2.5 million allografts nationwide. It has an exemplary safety record and is currently accredited with the AATB. All technical staff at the MTF are AATB certified. The MTF is registered with the FDA (a federal requirement). All of their allograft tissues are registered with the FDA (a federal requirement). At MTF patient safety is of paramount importance. The battery of tests performed on each allograft exceeds what is required by the FDA. The MTF in some instances even surpass standards set forth by the AATB. On each donor and allograft tissue, the MTF performs the following tests: cultures for infection, HIV I AND II (detects HIV infection), hepatitis B and C, and RPR (syphilis). These are all FDA requirements. HTLV I and II (conditions relating to leukemia/lymphoma and related illnesses), HIV-I NAT AND HCV-NAT (tests that determine early exposure to HIV and hepatitis), HB Core (test to determine past immunity from the vaccine for hepatitis B) is additional testing required by the AATB and done by the MTF. Extensive screening for west nile virus, severe acute respiratory syndrome (SARS), Creutzfeldt-Jacob Disease (CJD or mad cow disease), avian flu, rabies and other septic conditions or cancer are carried out. This is done through careful analysis of the donor’s medical records and family history. At present there is no blood test to check for these illnesses.
Comparing blood donors vs. tissue donors
Blood donors tend to be healthy citizens who donate blood on a regular basis, and have very few risk factors for disease transmission. Tissue donors are deceased victims of violence, illness or trauma, who have signed organ donor cards. These donors may have life-saving measures, such as multiple blood transfusions, prior to their ultimate demise. Therefore, there is some increased exposure, such as multiple blood transfusions in the terminal phases of their life that would increase their risk of contamination or infection, as compared to a blood donor. This can fall within a window of exposure to the disease without conversion to a positive test. The window of exposure can vary from roughly 7 to 14 days when the viral disease is essentially undetectable.
Is special surgical training required for using allografts?
No. Any surgeon can implant allografts without special training or consent. However, there is detailed special knowledge that is of pre-imminent importance in using tissues and advising patients of the relative risks and benefits. I was a faculty speaker at the 2005 American Orthopaedic Society for Sports Medicine course on allograft transplantation in orthopaedic surgery, held in Atlanta, GA in January 2005. This course was intended to update orthopaedic sports medicine surgeons in the use of allograft tissue.
My experience with allograft tissue
I obtain all of my allograft tissue from the MTF or Allosource – the nation’s top two suppliers with the highest tissue banking standards. Requests for tissue are forwarded to one specific allograft consultant with the MTF who is well versed in my specific requirements. All allografts are specifically ordered with the patient’s needs in mind. Due to supply and demand for these grafts, your graft may not be immediately available for use. There may be a waiting period involved with doing your surgery until a graft becomes available. This is very dependent on the type of graft needed for your case. I have used a wide variety of allograft tissue for various orthopaedic/sports medicine conditions. I have never had a case of infection or disease transmission in the use of these grafts.
In summary, this information details what I believe are important issues when considering allograft tissue. It is intended to inform and educate and not to alarm you. The risks are small but can be serious. A clear understanding of the relative pros and cons of using this tissue, as well as the inherent risks of allograft tissue transplantation can help you as a patient to make decisions regarding use of this tissue. I may have specifically recommended this tissue, or only offered it as a treatment alternative that you are able to choose. Ultimately, it is up to you to decide what treatment you want to pursue, and which graft or surgery you prefer. It is my hope that this information gives you comprehensive information to assist you in your choice. Please write down any questions you may have and forward them to us so we can provide counseling.
You can obtain further information regarding allografts at:
Informed Consent Form
In the event that you choose to have allograft tissue implanted in your body, you will be asked to sign a special consent form detailing that you have been advised and feel you are well-informed prior to your decision.