Allofill is an allograft derived from donated human adipose tissue intended for transplantation. Allofill is intended for use in situations where autologous fat grafting is appropriate. It should be restricted to homologous use of adipose tissue.
The allograft tissue used in Allofill is obtained from donors who are screened and tested before being considered for donation per standards put forth by the U.S. Food and Drug Administration (FDA). The tissue is then prepared and sterilized through a proprietary process and is measured against rigorous quality control standards to ensure patient safety. Each year in the United States more than two million allografts are used.
Donor screening and testing in accordance with Food and Drug Administration (FDA) regulations and American Association of Tissue Banks (AATB) standards is performed on all donors. Donors are assessed at the time of donation according to U.S. Public Health Service guidelines, including discussions with physicians and/or family members, to identify circumstances which may lead to the exclusion of the deceased from the donor population. All tissue is recovered using aseptic techniques in a hospital operating room. An appropriate blood sample from the donor is tested by a laboratory registered with the FDA to perform donor testing and certified to perform such testing on human specimens under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 using, when available, FDA-licensed test kits. Only accredited tissue banks are authorized to release tissue for transplantation that has negative or non-reactive results for:
- HIV-1 & HIV-2 antibodies
- Hepatitis B surface antigen
- Hepatitis C antibody
- Hepatitis B Core total antibody
- HIV-1/HCV NAT by TMA
In some instances, postmortem autopsies and/or biopsies are performed as a screen for nonspecific infectious or malignant conditions. Tissue is carefully examined at the time of recovery, and again during processing to ensure that it is suitable for a variety of transplantation applications. Infectious disease test results, medical history, physical assessment, available relevant medical records including previous medical history, laboratory test results, existing autopsy or coroner reports, 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 an accredited tissue bank and a licensed physician Medical Director. The results are sufficient to indicate that the donor suitability criteria current at the time of tissue recovery have been met and that this allograft has been determined to be suitable for transplant. The names and addresses of the testing laboratories, the interpretation of all required infectious disease tests, and a listing of the documents reviewed as part of the relevant medical records are kept on file at the tissue bank and are available upon request.
- Allofill is contraindicated for use in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies.
- Allofill is contraindicated for patients with bleeding disorders.
- Allofill should not be used on patients with a tendency to develop keloid formations or hypertrophic scars.
- Allofill should not be used on patients with a known sensitivity or allergies to any of the processing agents listed under the “Warnings and Precautions” section of this document
Warnings & Precautions
- Allofill must not be implanted into blood vessels. Implantation into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena.
- Do not use Allofill in any person with active skin inflammation (skin eruptions such as cysts, pimples, rashes, or hives) or infection near the treatment area until the inflammatory or infectious process has been controlled.
- Single patient, single use only.
- Do not re-sterilize.
- Do not use if packaging is damaged compromising sterile integrity.
- Do not use product after expiration date noted on the label.
- Recommended storage conditions and the maintenance of the tissue for transplantation are the responsibility of the hospital or surgeon. Do not use if tissue has not been stored according to the recommended storage instructions.
- Prior to clinical use, the surgeon should thoroughly understand all aspects of the surgical procedure and the limitations of the product.
- This tissue was processed using some of the following agents: phosphate buffered saline (PBS), Triton X-100, hydrogen peroxide, gentamycin, vancomycin, amphotericin B. Allofill should not be used in patients who exhibit sensitivities or allergies to these agents.
Complications and Possible Adverse Events
Inherent uncertainties exist in medical and social histories and lab testing which may not detect known or unknown pathogens. Therefore the following complications may occur with tissue transplantation:
- Transmission of disease of unknown etiology
- Transmission of known infectious agents including, but not limited to, viruses, bacteria and fungi
- Immune rejection of implanted human cells, tissues, and cellular and tissue-based products (HCT/P)
- Loss of function and/or integrity of implanted HCT/P due to resorption, fragmentation, and/or disintegration