http://www.yourlawyer.com/topics/overview/lost_mountain_tissue_bank_scandal Sat, 21 Nov 2009 20:59:59 -0800 pixel-app en http://www.yourlawyer.com/articles/read/11777 Wed, 26 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/11777
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/lost_mountain_tissue_bank_scandal Wed, 26 Oct 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/lost_mountain_tissue_bank_scandal Lost Mountain Tissue Bank Scandal On October 10, 2005 Lost Mountain Tissue Bank, Inc. initiated warnings for all tissue products processed and/or distributed from donors attained in the New York area by Biomedical Tissue Services (BTS). Lost Mountain Tissue Bank, Inc. took this action after learning of perhaps fraudulent information in donor documentation. All related hospitals and medical professionals are being notified of the market withdrawal.

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 within 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 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.

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. If you or a loved one has received any bone, organ, or tissue transplant contact our attorneys today for an immediate lawsuit case consultation.

Biomedical Tissue Services (BTS) sold these illegal body parts to several large companies including Medtronic Inc., Lifecell Corp., Regeneration Technologies, Inc., Tutogen Medical, Inc., SpinalGraft Technologies, LLC, 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. However, Medtronic said it received 13,000 tainted pieces from Regeneration Technologies, of which 8,000 were actually implanted.

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 reveals it received 13,000 tainted samples 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.

If you or a loved one has received any bone, organ, or tissue transplant, please fill out the form to the right for a free case evaluation by a qualified attorney.]]>