Illegal Sale Of Untested Body Parts & Tissue
Thousands of patients who underwent tissue, bone and organ transplants are at risk of developing serious diseases due to the use of untested body parts. Recent criminal charges detailed the illegal sale of untested body parts and tissue to hospitals, distributors and medical device manufacturers. The FDA is concerned that the recipients of untested body parts and tissues are potentially at risk of developing HIV, Hepatitis B, Hepatitis C, Syphilis and other infectious diseases.
The untested body parts and tissue scandal centers around Biomedical Tissue Services, which allegedly acquired body parts without donor permission and sold them for use in transplants performed at hospitals and other medical facilities within the United States. The owner and three other employees of Biomedical Tissue Services have been indicted in Brooklyn, New York for taking body parts without legal consent and without proper screening. It is believed that funeral home operators accepted money from the company in exchange for ignoring obviously forged death certificates and consent forms. The body parts and tissue in question have been distributed throughout the country and used in thousands of operations.
Biomedical Tissue Services sold these illegal body parts to several large companies including Lifecell Corp., Regeneration Technologies, Inc., Tutogen Medical, Inc., Lost Mountain Tissue Bank and Blood & Tissue Center of Central Texas. The FDA and most of the companies involved have not disclosed the number of patients that received the untested parts and tissue.
Untested Body Parts Scandal – Timeline
2001 — Former dental surgeon Michael Mastromarino of Fort Lee teams up with embalmer Joseph Nicelli in a tissue-harvesting business.
Early 2002 — The pair allegedly begin more than three years of harvesting tissue without consent.
November 2004 — Following a complaint, an NYPD detective begins investigating a Brooklyn funeral home that Nicelli had recently sold.
Oct. 7, 2005 — News of the investigation breaks.
Oct. 13, 2005 — The Food and Drug Administration orders a recall of any unused tissue procured by BioMedical Tissue Services.
November 2005 — Medtronic revported that it received approximately 13,000 allografts from Regeneration Technologies, Inc that originated from BioMedical Tissue Services and implanted 8,000 of them.
Feb. 3, 2006 — The FDA shuts down BTS.
Feb. 23, 2006 — A 122-count indictment is unsealed in Brooklyn against Mastromarino, Nicelli and two others
March 8, 2006 — Brooklyn authorities are preparing indictments against funeral home employees, a law enforcement source tells The Record.
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