Why are tissue banks so unregulated?
Unlike the tightly monitored organ donation network, tissue banks are less rigorously regulated. This is in part because, unlike organs that must be transplanted within hours of the donor’s death, tissue can be removed over a longer period, stored, and then in many cases processed. Human tissue is a $900 million to $1 billion industry involving both mom-and-pop and large companies. While most of the companies are non-profits about 20 percent are for profit including LifeCell Corp. of Branchburg, New Jersey, one of the current five tissue banks that the FDA pinpointed as having received questionable tissue from Biomedical Tissue Services.
