http://www.yourlawyer.com/topics/overview/tutogen_medical_tissue_scandal Sat, 21 Nov 2009 21:26:08 -0800 pixel-app en http://www.yourlawyer.com/articles/read/11803 Thu, 02 Mar 2006 00:00:00 -0800 http://www.yourlawyer.com/articles/read/11803
Last October, Jeffrey had a bone implanted in his jaw because a rotted tooth had damaged his jawbone. The bone came from a cadaver, and in November, his dentist told him he'd learned the bone was stolen and was never checked for disease.

"I actually had a consultation with my dentist. He sat me down, closed the doors, and said, 'I have something I need to talk to you about,' " Jeffrey recalled. "I'll tell you what, I didn't know what to think. I was totally shocked. I mean my jaw dropped, I was beside myself, I didn't even know what to ask him after that. I just sat there and went"

The implanted bone now in Jeffrey's jaw was allegedly stolen from a corpse by men working with Biomedical Tissue Services of Fort Lee, New Jersey. As we first reported earlier this week, the company's owner, Michael Mastromarino who happens to be a former dental surgeon has been indicted, along with an embalmer and two others who allegedly did the actual cutting.

Hundreds of people across the country could be walking around with HIV, syphilis, or hepatitis. But the 46-year-old businessman and longtime Tampa resident is the first potential victim we know of from the bay area.

Jeffrey contacted Action News after seeing Matthew's report Tuesday night, and he says his dentist told him there are three other patients who also have stolen body parts implanted.


"There are victims right here in the Tampa Bay area. And god only knows how many more victims there are in the Tampa Bay area," he continued.

Jeffrey's dentist apparently had no idea the bone was stolen until notified by Tutogen Medical, a tissue and bone processing plant near Gainesville. Tutogen got the bone from the now-closed Biomedical.

Meanwhile, Jeffrey King has not been tested for disease; the blood kit sent to him remains unopened.

"It's been sitting on my dresser for a month. And I'd look at it every day and I'd think, 'Do I really wanna know?' " he explained. "Since your interview two days ago, the show I watched, I've since scheduled my appointment with my doctor to have it done."

Meanwhile, sources in New York City say more arrests are expected in this ghoulish scandal.
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While no adverse reactions related to these tissues have been reported to FDA at this time, because of the potential lack of proper screening of the tissue donors, some recipients of the tissues may be at increased risk of infections that could potentially be transmitted through tissues. FDA and the Centers for Disease Control and Prevention (CDC) believe the risks from these tissues are low because the tissues were routinely processed using methods that help to reduce the risk of infectious disease; however, the actual infectious risk is unknown.

FDA's requirements to determine donor eligibility include important steps to ensure that donors do not harbor infections that could be transmitted to recipients. These steps include reviewing the donor's medical history and other factors, physically assessing the donor, and testing for relevant communicable diseases that may place the donor at an increased risk of infections that could then unintentionally be transmitted to recipients through the tissues.

The following tissue processors received tissue from BTS:

• LifeCell Corporation of Branchburg, NJ
• Lost Mountain Tissue Bank of Kennesaw, GA
• Blood and Tissue Center of Central Texas in Austin, TX
• Tutogen Medical, Inc., of Alachua, FL
• Regeneration Technologies, Inc., of Alachua, FL

These firms already have voluntarily recalled all unused tissue remaining in inventory and are working cooperatively with FDA to ensure that the implanting physicians whose patients may have received the products are properly notified. Physicians who implanted tissue from BTS should have been contacted at this time by the receiving health care facility.

FDA and CDC recommend that implanting physicians inform their patients that they may have received tissue from a donor for whom an adequate donor eligibility determination was not performed. While the overall infectious risk is likely low, FDA and CDC recommend that physicians offer to provide patients access to appropriate infectious disease testing. The relevant communicable diseases for which a tissue donor is required to be tested are HIV-1 and 2 (the viruses that cause AIDS), hepatitis B virus, hepatitis C virus, and syphilis. Physicians who still have concerns or questions about the source of the tissue should contact the health care facility where the procedure was performed. FDA will continue its investigation into this matter and will issue further public health updates, as needed.

Patients and physicians should report any infectious disease possibly related to a tissue transplant to the processing firms, who then should notify FDA. Patients and physicians who wish to notify FDA directly of such infectious disease should report via FDA’s MedWatch reporting program at http://www.fda.gov/medwatch.

Additional information is available on FDA’s web site at http://www.fda.gov/cber/recalls.htm and by calling 1-800-835-4709.]]> http://www.yourlawyer.com/topics/overview/tutogen_medical_tissue_scandal Wed, 26 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/tutogen_medical_tissue_scandal Tutogen Medical Tissue Scandal The gruesome tale of stolen body parts, missing persons, contaminated human tissue grafts, and the possibility that thousands of innocent patients are currently in danger of developing everything from HIV/AIDS and syphilis to hepatitis B and C has turned into a scandal of national magnitude that has health officials in numerous states as well as the Centers for Disease Control and Prevention (CDC) and the Food & Drug Administration (FDA) tremendously worried.

On October 12, 2005 Tutogen Medical, Inc. announced a voluntary recall of all materials that were manufactured utilizing BioMedical Tissue Services (BTS) donor tissue. This action is being implemented because Tutogen was unable to satisfactorily verify that BioMedical Tissue Services (BTS) had properly obtained donor eligibility. Tutogen informed transfusion services, physicians and other medical facilities that there is a lack of guarantee that proper donor identification, donor screening, and medical history data collection was carried out and, for that reason, a risk of contagious disease exists.

The untested body parts and tissue scandal centers around Biomedical Tissue Services (BTS), which allegedly acquired body parts without donor permission and sold them for use in transplants performed at hospitals and other medical facilities throughout the United States. The owner and three other employees of Biomedical Tissue Services (BTS) 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 Biomedical Tissue Services (BTS) 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 (BTS) sold these illegal body parts to several large companies including Lifecell Corp., Regeneration Technologies, Inc., and 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.

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