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In Wake Of National Body Part Transplant Scandal, Schumer To Unveil Critical Legislation To Regulate Tissue Transplants

Senator Stands With Patricia Battisti Who May Have Been Exposed to Infected Tissue

FDA Response to Problem Inadequate

Last week, amid reports of the growing scope of an under regulated tissue transplant industry, Senator Schumer wrote to the Food and Drug Administration calling for stronger regulatory oversight for tissue transplants and an accounting of how exactly contaminated tissue was transplanted into otherwise healthy patients. Since the FDA has not adequately responded to this problem, today Schumer unveiled legislation to properly regulate the tissue transplant industry. Schumer stood with Patricia Battisti, a Long Island resident who may have been exposed to infected tissue.

In this reallife version of the body snatchers, healthy people are getting sick when they are supposed to be receiving life saving tissue transplants, Schumer said. Instead of getting better they are being implanted with contaminated tissue that was acquired illegally from corpses. And, to add insult to injury, there isnt any accountability. Its time for stronger regulations in the tissue transplant industry to become law.

Patricia Battisti underwent surgery in early 2005 to alleviate back pain from a prior car accident. Nearly a year later she found out that many body parts from a New Jersey Tissue bank, Biomedical Tissue Services of Fort Lee New Jersey, were used in surgeries between 2003 and 2005 and she subsequently received notification that body parts sold to tissue banks from a NJ company may not have been tested properly.

Upon further investigation, the FDA found the tissue that may have been used in Battistis surgery and others was originally from a funeral home in Brooklyn, where police allege that bodies were exhumed and bones were stolen. That tissue went to Biomedical Tissue Services in Fort Lee, where it seems that records were altered. The tissue was then sent to tissue banks where it may not have been tested for contamination and went to hospitals for transplant implant procedures.

Tissue transplantation is similar to organ transplantation, but the industry is regulated much more loosely. While organ donors are only identified by doctors in hospitals, tissue donations can come out of funeral homes or morgues. Although the companies that test and sterilize tissue must be registered with the FDA, they are not subject to any regular inspections or audits, but are only inspected when the FDA decides there has been a risk associated with the bank. And worst of all, tissue transplantation is used by some companies as a profitmaking machine, turning materials desperately needed by patients into money.

Under the current system, there are many links in the chain from donor to recipient, with each link creating another potential opening for improper behavior. First, a donor is identified. The cause of death must not be one, like cancer, that would make the tissues less strong or healthy. Donors can be identified at hospitals, morgues, crematoria, and funeral homes. From there, tissue is purchased by a tissue bank, which is responsible for retrieving, processing, storing, and distributing the tissue. These banks can be nonprofit or forprofit, and may receive alreadyprocessed tissue from one of 58 federallydesignated organ procurement organizations, which operate under the strictest standards in the business. Tissue banks may distribute their goods to other companies before they finally reach a hospital, which is not required to do any further testing of the tissue, but trusts the tissue bank to have been a proper gatekeeper.

Federallydesignated organ procurement organizations, such as the New York Organ Donor Network, receive a phone call every time there is a death in a nearby hospital. They apply several strict screening processes, including talking to the family of the donor, to ensure that the tissue is safe. They recover the tissue in a sterile operating room before selling it to a tissue bank, for a price determined by a federallyoverseen formula that determines how much money it cost them to recover the tissue. This keeps costs low and appropriate, but once the tissue is sold to a tissue bank, the strict regulations end.

In his letter to FDA Commissioner Eschenbach last week, Schumer wrote, On examining these particular cases, it appears that there were clear warning signs that stricter oversight could have picked up on. For example, BioMedical Tissue Services was registered with the FDA and had been cited for several violations in 2003, not by the FDA but by the New York State Department of Health. Was the FDA aware of these citations, did it follow up with its own inspection, and did it see the warning signs that BioMedical Tissue Services would act improperly? Schumer also asked the FDA to provide a full accounting of where the breakdown in the system occurred in each of these cases.

The FDA expanded its regulations in 2004 and does not appear to recognize the gaping holes that still remain. To combat this evergrowing problem from becoming larger, today Senator Schumer unveiled legislation to regulate the tissue transplant industry. His legislation would specifically:

" Make it illegal for tissue banks to buy tissue from funeral homes and morgues, with an exception for types of tissue deemed to be in short supply.
" Require the FDA to do surprise inspections of tissue banks every year.
" Require the FDA to conduct periodic audits of the documentation that shows where the tissue has come from. Identifying false phone numbers, medical information, or family consent information can help investigators reveal problems.
" Require FDA to define the term "reasonable processing fee." It is currently illegal to buy and sell tissue, but it is legal to charge "reasonable processing fees." This term has never been defined, and can be used by forprofit tissue banks to make money off of body parts.