BTS stolen body parts scandal generating gruesome headlines, fears of infection; NY grand jury meeting.

A stolen body parts scandal involving a New Jersey tissue recovery company continues to generate gruesome headlines featuring bodies allegedly snatched from funeral homes, their tissues sold to tissue processing companies, and fears of tainted tissues unwittingly implanted by unsuspecting hospital surgeons.

A New York State grand jury is currently hearing evidence against at least six Brooklyn funeral homes and Fort Lee, NJ-based Biomedical Tissue Services (BTS) to determine if they illegally profited by conspiring to sell the stolen body parts and tissues.

A snapshot of some recent press reports:

*The body of Alistair Cooke, the genteel British broadcaster who is best known for his PBS television series Masterpiece Theater, was among those that were "surgically plundered," according to the New York Daily News, which broke the original story.

*The corpse of a Queens grandmother that investigators exhumed in November had nearly all the bones removed below the waist and replaced with PVC pipes, the AP reported.

*Health authorities in Canada have determined that about 300 potentially tainted products purchased from BTS were imported there and used for dental surgery in at least two patients. No infections have been reported since the FDA ordered a recall of the products produced by BTS.

After being notified by the district attorney's office of what had happened to her father's body, Cooke's daughter, Susan Cooke Kittredge said, "At this point we're just reeling. It's so horrific on so many fronts."

Two of the companies that received tissues from BTS - Regeneration Technologies, Inc., and Tutogen Medical, both based in Alachua, FL - acknowledged they purchased parts of Cooke's bones after being given paperwork falsely listing his cause of death as a heart attack and his age as 85. Cooke was 95 when he died in March of 2004 of lung cancer that had metastasized to his bones, Ms. Kittredge said, according to the New York Times.

The investigation, led by Brooklyn District Attorney Charles J. Hynes, is the result of a deal struck between Michael Mastromarino, the Fort Lee dentist who started BTS, and Joseph Nicelli, an embalmer and funeral parlor operator from Staten Island, the Associated Press reported.

Investigators suspect Nicelli helped secure access to tissue and bone from funeral directors for $500 to $1,000 a body. Mastromarino then allegedly procured the body parts, shipped them to processors who paid for the tissues.

While the investigation proceeds - authorities say indictments could be handed up early this year, the AP said - fallout over the allegations include reports that hundreds of bodies were secretly carved up in the back rooms of several funeral parlors to fears that patients had unwittingly received tainted tissues which could cause infectious diseases such as AIDS or HCV.

"Statements have appeared in the press that recipients may have received diseased implants but to date we have received no confirmed reports of any adverse events related to tissue that was retrieved by BTS and processed by AATB banks," Bob Rigney, CEO of the American Association of Tissue Banks (AATB), told Transplant News. "Because of our screening, testing and processing standards, we believe that any risk to patients is extremely low."

AATB's testing standards are particularly rigorous and all the banks receiving tissues employed them, Rigney explained. There are multiple layers of screening, testing, quality assurance and quality control measures to ensure that the tissue is safe to transplant.

"To the best of our knowledge, this is the first time in the 29-year history of the AATB where allegations have been made of possible widespread falsification of donor consent forms and medical records," Rigney added.

Rigney said that the AATB and all of the banks that were involved in getting tissue are cooperating with the Food and Drug Administration and the district attorney's investigations.

The AATB reported that all the tissue that was retrieved by BTS and subsequently processed and distributed by AATB-accredited banks were tested for all the required communicable diseases and determined to be negative and acceptable.

However, Rigney said that all AATB-accredited tissue banks have quarantined tissue from BTS that is still in their inventories. They have also recalled tissue grafts that have been distributed.

"Even thought the risk is believed to be minimal, to ensure the safety and the well-being of transplant patients, hospitals have been notified to recommend that recipients of BTS-associated allografts be tested for HIV-1 and 2, HBV, HCV and syphilis," Rigney added.

The AATB has formed a task force to determine if any changes in Standards are needed to help guard against the falsification of donor and medical records.

Here are the screening procedures required to be used by AATB-accredited banks.

"Following recovery, the tissue is quarantined until a donor suitability determination is made. The tissue is tested for communicable diseases (HIV 1 and 2, HBV, HCV, HTLV I and II, and Syphilis), in some instances using multiple tests and methodologies (antibody tests and NAT). A medical doctor reviews all available medical records and donor medical and social (behavioral risk assessment) histories. The physician (tissue bank medical director) makes the final determination on the donor's suitability.

Once the donor is accepted, the tissue is processed in controlled environments to prevent contamination and cross-contamination. Processing methods are validated, which is required by FDA regulations and AATB Standards. Most musculoskeletal tissues are highly processed, meaning that they are cleansed, treated with antibacterial and virucidal agents, and subjected to gamma irradiation and/or another method of viral inactivation or sterilization."