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Tissue Recall

Recent recalls by the Food and Drug Administration of tissue to be used for transplantation has called into question the safety of all tissue.

Human tissue is used as an important resource in certain medical treatments. Any tissue recall can affect any number of areas. Physicians and dentists use tissue from human cadevers for a variety of medical purposes. Donated skin is used in healing burn victims and in reconstructive surgery. Donated bone is implanted to replace cancerous bone, for knee and hip replacements and for spinal surgery; it can be processed into powder for use in dental surgery.

When families agree to donate their loved one’s tissue they expect it to be used in meeting important medical needs. A tissue recall can have a chilling effect on those families.

Tissue recalls are usually due to suspicion that the tissue has not been through proper screening methods, including physical examination, comprehensive medical history and social risk review of the donor. Criteria established by the U.S. Public Health Service should be used as a means of lowering the risk of a tissue recall. This criteria identifies donors with high-risk behavior and excludes them from the transplant list.

The American Association of Tissue Banks (AATB) and the FDA require all donated tissue be analyzed for infectious diseases including HIV, hepatitis B and C, and syphilis. Doing so, they maintain, will lower the risk of tissue recalls.

In addition, all data on the tissue is evaluated by a team of infectious disease and tissue banking specialists to further limit any hint of a tissue recall. Tissue is not released from the tissue bank until the medical director determines its safety. Although these safeguards are credited with decreasing the number of tissue recalls, anyone receiving a recall notice is advised to contact an experienced law firm to ensure the protection of their rights.