Advice to Patients Who Got Human Tissue

[Guest guest]

Advice to Patients Who Got Human Tissue

The Associated Press

By MARILYNN MARCHIONE

August 31, 2006

Although this is an extremely serious matter For the second time in a year,

people who received tendons, cartilage and other parts from donated cadavers

are being urged to get tested for hepatitis and the AIDS virus because of

scandals involving tissue suppliers.

How much risk do they face?

Answering that is tough right now because federal officials will not say how

many people around the country had already received tissue by the time

recalls were announced. Or which types of tissue were involved and how it

was treated.

Patients may not even be aware they received cadaver tissue, which is used

for everything from back surgery to dental implants. Not all doctors even

tell their patients they'll be getting donated human tissue. Doctors

themselves often don't know where the tissue came from _ especially since it

often is procured, tested and treated by different companies.

However, two steps can give patients a pretty good idea of their potential

risks, experts say:

_Pressing your doctor for details on the companies that supplied your tissue

and whether any are involved in the recalls.

_Getting the infectious disease tests that health officials recommend _ HIV,

hepatitis B and C, and syphilis.

'If they're six months out (from the transplant) and they test negative,

they don't have to worry,' said Dr. L. Clifford Mc, an infectious

disease specialist at the federal Centers for Disease Control and

Prevention.

Chances are good that an infection would have taken hold by then, or at

least shown up in blood tests, he said.

More than 1.3 million procedures each year _ ranging from knee repairs to

cornea transplants to spine surgeries _ use tissue from donated cadavers.

Most are supplied by reputable companies and do a lot of good, but the

industry is little regulated, a three-month Associated Press investigation

found earlier this year.

On Aug. 18, the U.S. Food and Drug Administration shut down Philip Guyett

Jr. and Donor Referral Services of Raleigh, N.C., citing 'serious

deficiencies' in manufacturing practices. In some cases, records did not

match what official death certificates showed, and left out details like a

donor's history of cancer or drug use that may have made the donor's tissue

ineligible for transplant, the FDA's order says.

On Wednesday, the FDA urged doctors to contact patients who received tissue

from the firm, saying that additional information from the ongoing

investigation 'has heightened our concern' about the situation.

Companies voluntarily recalling tissues supplied by the Raleigh firm are

Alamo Tissue Services of San , Texas; Lost Mountain Tissue Bank of

Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell of

Cincinnati, Ohio. (AlloSource of Centennial, Colo., which acquired some of

US Tissue's assets in March, is handling US Tissue's recall).

However, tissues typically are distributed nationwide, so patients anywhere

could be affected.

An industry group, the American Association of Tissue Banks, estimates that

fewer than 100 donors are involved in the Raleigh company's case. But each

donor can provide 100 or more tissues, and the company also operated in Las

Vegas from 2004 to 2005, the FDA notes.

'Although this is an extremely serious matter,' says an association

statement, this case appears much smaller in scope than one earlier this

year involving Biomedical Tissue Services, a now-defunct New Jersey company

that may have provided up to 20,000 potentially risky tissue products.

Good treatment and processing methods can make tissue safe 'even if it was

not screened properly or came from an infected donor,' said Dr. n

Kainer, a Tennessee Department of Health infectious disease expert who

formerly investigated tissue cases for the CDC.

Most risky, she said, is so-called 'fresh-frozen' tissue like cartilage,

which cannot be sterilized without ruining the tissue.

'The chances of that being contaminated are much greater' than with bone,

for instance, which can be treated with radiation to destroy germs, she

said.

No one knows whether someone can develop cancer if they receive tissue from

a cancer patient. That's why such donors are supposed to be rejected.

Still, specialists believe the chances of someone getting a disease from

these tissues is small.

'The fact is, we don't know the risk, but it's thought to be low,' Mc

said.

The current scandals involve 'a very small subset' of the total tissue

supply, said Areta Kupchyk, a former FDA attorney who helped write tissue

regulations.

If patients cannot get satisfactory answers from their doctors on all the

companies involved in supplying their tissue, 'that's when they should start

making more demands,' she said.

___

On the Net:

FDA public health alert: http://www.fda.gov/cber/safety/drs083006.htm

Tissue questions and CDC advice:

http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html

List of accredited businesses: http://www.aatb.org/aatbac.htm

Reporting tissue problems: http://www.fda.gov/cber/tissue/hctadverse.htm

and http://www.fda.gov/medwatch

http://www.topix.net/content/ap/2413379514428219202931099818930211537025

_________________________________________________________________

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[Guest guest]

Advice to Patients Who Got Human Tissue

The Associated Press

By MARILYNN MARCHIONE

August 31, 2006

Although this is an extremely serious matter For the second time in a year,

people who received tendons, cartilage and other parts from donated cadavers

are being urged to get tested for hepatitis and the AIDS virus because of

scandals involving tissue suppliers.

How much risk do they face?

Answering that is tough right now because federal officials will not say how

many people around the country had already received tissue by the time

recalls were announced. Or which types of tissue were involved and how it

was treated.

Patients may not even be aware they received cadaver tissue, which is used

for everything from back surgery to dental implants. Not all doctors even

tell their patients they'll be getting donated human tissue. Doctors

themselves often don't know where the tissue came from _ especially since it

often is procured, tested and treated by different companies.

However, two steps can give patients a pretty good idea of their potential

risks, experts say:

_Pressing your doctor for details on the companies that supplied your tissue

and whether any are involved in the recalls.

_Getting the infectious disease tests that health officials recommend _ HIV,

hepatitis B and C, and syphilis.

'If they're six months out (from the transplant) and they test negative,

they don't have to worry,' said Dr. L. Clifford Mc, an infectious

disease specialist at the federal Centers for Disease Control and

Prevention.

Chances are good that an infection would have taken hold by then, or at

least shown up in blood tests, he said.

More than 1.3 million procedures each year _ ranging from knee repairs to

cornea transplants to spine surgeries _ use tissue from donated cadavers.

Most are supplied by reputable companies and do a lot of good, but the

industry is little regulated, a three-month Associated Press investigation

found earlier this year.

On Aug. 18, the U.S. Food and Drug Administration shut down Philip Guyett

Jr. and Donor Referral Services of Raleigh, N.C., citing 'serious

deficiencies' in manufacturing practices. In some cases, records did not

match what official death certificates showed, and left out details like a

donor's history of cancer or drug use that may have made the donor's tissue

ineligible for transplant, the FDA's order says.

On Wednesday, the FDA urged doctors to contact patients who received tissue

from the firm, saying that additional information from the ongoing

investigation 'has heightened our concern' about the situation.

Companies voluntarily recalling tissues supplied by the Raleigh firm are

Alamo Tissue Services of San , Texas; Lost Mountain Tissue Bank of

Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell of

Cincinnati, Ohio. (AlloSource of Centennial, Colo., which acquired some of

US Tissue's assets in March, is handling US Tissue's recall).

However, tissues typically are distributed nationwide, so patients anywhere

could be affected.

An industry group, the American Association of Tissue Banks, estimates that

fewer than 100 donors are involved in the Raleigh company's case. But each

donor can provide 100 or more tissues, and the company also operated in Las

Vegas from 2004 to 2005, the FDA notes.

'Although this is an extremely serious matter,' says an association

statement, this case appears much smaller in scope than one earlier this

year involving Biomedical Tissue Services, a now-defunct New Jersey company

that may have provided up to 20,000 potentially risky tissue products.

Good treatment and processing methods can make tissue safe 'even if it was

not screened properly or came from an infected donor,' said Dr. n

Kainer, a Tennessee Department of Health infectious disease expert who

formerly investigated tissue cases for the CDC.

Most risky, she said, is so-called 'fresh-frozen' tissue like cartilage,

which cannot be sterilized without ruining the tissue.

'The chances of that being contaminated are much greater' than with bone,

for instance, which can be treated with radiation to destroy germs, she

said.

No one knows whether someone can develop cancer if they receive tissue from

a cancer patient. That's why such donors are supposed to be rejected.

Still, specialists believe the chances of someone getting a disease from

these tissues is small.

'The fact is, we don't know the risk, but it's thought to be low,' Mc

said.

The current scandals involve 'a very small subset' of the total tissue

supply, said Areta Kupchyk, a former FDA attorney who helped write tissue

regulations.

If patients cannot get satisfactory answers from their doctors on all the

companies involved in supplying their tissue, 'that's when they should start

making more demands,' she said.

___

On the Net:

FDA public health alert: http://www.fda.gov/cber/safety/drs083006.htm

Tissue questions and CDC advice:

http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html

List of accredited businesses: http://www.aatb.org/aatbac.htm

Reporting tissue problems: http://www.fda.gov/cber/tissue/hctadverse.htm

and http://www.fda.gov/medwatch

http://www.topix.net/content/ap/2413379514428219202931099818930211537025

_________________________________________________________________

Check the weather nationwide with MSN Search: Try it now!

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[Guest guest]

Advice to Patients Who Got Human Tissue

The Associated Press

By MARILYNN MARCHIONE

August 31, 2006

Although this is an extremely serious matter For the second time in a year,

people who received tendons, cartilage and other parts from donated cadavers

are being urged to get tested for hepatitis and the AIDS virus because of

scandals involving tissue suppliers.

How much risk do they face?

Answering that is tough right now because federal officials will not say how

many people around the country had already received tissue by the time

recalls were announced. Or which types of tissue were involved and how it

was treated.

Patients may not even be aware they received cadaver tissue, which is used

for everything from back surgery to dental implants. Not all doctors even

tell their patients they'll be getting donated human tissue. Doctors

themselves often don't know where the tissue came from _ especially since it

often is procured, tested and treated by different companies.

However, two steps can give patients a pretty good idea of their potential

risks, experts say:

_Pressing your doctor for details on the companies that supplied your tissue

and whether any are involved in the recalls.

_Getting the infectious disease tests that health officials recommend _ HIV,

hepatitis B and C, and syphilis.

'If they're six months out (from the transplant) and they test negative,

they don't have to worry,' said Dr. L. Clifford Mc, an infectious

disease specialist at the federal Centers for Disease Control and

Prevention.

Chances are good that an infection would have taken hold by then, or at

least shown up in blood tests, he said.

More than 1.3 million procedures each year _ ranging from knee repairs to

cornea transplants to spine surgeries _ use tissue from donated cadavers.

Most are supplied by reputable companies and do a lot of good, but the

industry is little regulated, a three-month Associated Press investigation

found earlier this year.

On Aug. 18, the U.S. Food and Drug Administration shut down Philip Guyett

Jr. and Donor Referral Services of Raleigh, N.C., citing 'serious

deficiencies' in manufacturing practices. In some cases, records did not

match what official death certificates showed, and left out details like a

donor's history of cancer or drug use that may have made the donor's tissue

ineligible for transplant, the FDA's order says.

On Wednesday, the FDA urged doctors to contact patients who received tissue

from the firm, saying that additional information from the ongoing

investigation 'has heightened our concern' about the situation.

Companies voluntarily recalling tissues supplied by the Raleigh firm are

Alamo Tissue Services of San , Texas; Lost Mountain Tissue Bank of

Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell of

Cincinnati, Ohio. (AlloSource of Centennial, Colo., which acquired some of

US Tissue's assets in March, is handling US Tissue's recall).

However, tissues typically are distributed nationwide, so patients anywhere

could be affected.

An industry group, the American Association of Tissue Banks, estimates that

fewer than 100 donors are involved in the Raleigh company's case. But each

donor can provide 100 or more tissues, and the company also operated in Las

Vegas from 2004 to 2005, the FDA notes.

'Although this is an extremely serious matter,' says an association

statement, this case appears much smaller in scope than one earlier this

year involving Biomedical Tissue Services, a now-defunct New Jersey company

that may have provided up to 20,000 potentially risky tissue products.

Good treatment and processing methods can make tissue safe 'even if it was

not screened properly or came from an infected donor,' said Dr. n

Kainer, a Tennessee Department of Health infectious disease expert who

formerly investigated tissue cases for the CDC.

Most risky, she said, is so-called 'fresh-frozen' tissue like cartilage,

which cannot be sterilized without ruining the tissue.

'The chances of that being contaminated are much greater' than with bone,

for instance, which can be treated with radiation to destroy germs, she

said.

No one knows whether someone can develop cancer if they receive tissue from

a cancer patient. That's why such donors are supposed to be rejected.

Still, specialists believe the chances of someone getting a disease from

these tissues is small.

'The fact is, we don't know the risk, but it's thought to be low,' Mc

said.

The current scandals involve 'a very small subset' of the total tissue

supply, said Areta Kupchyk, a former FDA attorney who helped write tissue

regulations.

If patients cannot get satisfactory answers from their doctors on all the

companies involved in supplying their tissue, 'that's when they should start

making more demands,' she said.

___

On the Net:

FDA public health alert: http://www.fda.gov/cber/safety/drs083006.htm

Tissue questions and CDC advice:

http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html

List of accredited businesses: http://www.aatb.org/aatbac.htm

Reporting tissue problems: http://www.fda.gov/cber/tissue/hctadverse.htm

and http://www.fda.gov/medwatch

http://www.topix.net/content/ap/2413379514428219202931099818930211537025

_________________________________________________________________

Check the weather nationwide with MSN Search: Try it now!

http://search.msn.com/results.aspx?q=weather & FORM=WLMTAG

[Guest guest]

Advice to Patients Who Got Human Tissue

The Associated Press

By MARILYNN MARCHIONE

August 31, 2006

Although this is an extremely serious matter For the second time in a year,

people who received tendons, cartilage and other parts from donated cadavers

are being urged to get tested for hepatitis and the AIDS virus because of

scandals involving tissue suppliers.

How much risk do they face?

Answering that is tough right now because federal officials will not say how

many people around the country had already received tissue by the time

recalls were announced. Or which types of tissue were involved and how it

was treated.

Patients may not even be aware they received cadaver tissue, which is used

for everything from back surgery to dental implants. Not all doctors even

tell their patients they'll be getting donated human tissue. Doctors

themselves often don't know where the tissue came from _ especially since it

often is procured, tested and treated by different companies.

However, two steps can give patients a pretty good idea of their potential

risks, experts say:

_Pressing your doctor for details on the companies that supplied your tissue

and whether any are involved in the recalls.

_Getting the infectious disease tests that health officials recommend _ HIV,

hepatitis B and C, and syphilis.

'If they're six months out (from the transplant) and they test negative,

they don't have to worry,' said Dr. L. Clifford Mc, an infectious

disease specialist at the federal Centers for Disease Control and

Prevention.

Chances are good that an infection would have taken hold by then, or at

least shown up in blood tests, he said.

More than 1.3 million procedures each year _ ranging from knee repairs to

cornea transplants to spine surgeries _ use tissue from donated cadavers.

Most are supplied by reputable companies and do a lot of good, but the

industry is little regulated, a three-month Associated Press investigation

found earlier this year.

On Aug. 18, the U.S. Food and Drug Administration shut down Philip Guyett

Jr. and Donor Referral Services of Raleigh, N.C., citing 'serious

deficiencies' in manufacturing practices. In some cases, records did not

match what official death certificates showed, and left out details like a

donor's history of cancer or drug use that may have made the donor's tissue

ineligible for transplant, the FDA's order says.

On Wednesday, the FDA urged doctors to contact patients who received tissue

from the firm, saying that additional information from the ongoing

investigation 'has heightened our concern' about the situation.

Companies voluntarily recalling tissues supplied by the Raleigh firm are

Alamo Tissue Services of San , Texas; Lost Mountain Tissue Bank of

Kennesaw, Ga.; TissueNet of Orlando, Fla.; and US Tissue and Cell of

Cincinnati, Ohio. (AlloSource of Centennial, Colo., which acquired some of

US Tissue's assets in March, is handling US Tissue's recall).

However, tissues typically are distributed nationwide, so patients anywhere

could be affected.

An industry group, the American Association of Tissue Banks, estimates that

fewer than 100 donors are involved in the Raleigh company's case. But each

donor can provide 100 or more tissues, and the company also operated in Las

Vegas from 2004 to 2005, the FDA notes.

'Although this is an extremely serious matter,' says an association

statement, this case appears much smaller in scope than one earlier this

year involving Biomedical Tissue Services, a now-defunct New Jersey company

that may have provided up to 20,000 potentially risky tissue products.

Good treatment and processing methods can make tissue safe 'even if it was

not screened properly or came from an infected donor,' said Dr. n

Kainer, a Tennessee Department of Health infectious disease expert who

formerly investigated tissue cases for the CDC.

Most risky, she said, is so-called 'fresh-frozen' tissue like cartilage,

which cannot be sterilized without ruining the tissue.

'The chances of that being contaminated are much greater' than with bone,

for instance, which can be treated with radiation to destroy germs, she

said.

No one knows whether someone can develop cancer if they receive tissue from

a cancer patient. That's why such donors are supposed to be rejected.

Still, specialists believe the chances of someone getting a disease from

these tissues is small.

'The fact is, we don't know the risk, but it's thought to be low,' Mc

said.

The current scandals involve 'a very small subset' of the total tissue

supply, said Areta Kupchyk, a former FDA attorney who helped write tissue

regulations.

If patients cannot get satisfactory answers from their doctors on all the

companies involved in supplying their tissue, 'that's when they should start

making more demands,' she said.

___

On the Net:

FDA public health alert: http://www.fda.gov/cber/safety/drs083006.htm

Tissue questions and CDC advice:

http://www.cdc.gov/ncidod/dhqp/tissueTransplantsFAQ.html

List of accredited businesses: http://www.aatb.org/aatbac.htm

Reporting tissue problems: http://www.fda.gov/cber/tissue/hctadverse.htm

and http://www.fda.gov/medwatch

http://www.topix.net/content/ap/2413379514428219202931099818930211537025

_________________________________________________________________

Check the weather nationwide with MSN Search: Try it now!

http://search.msn.com/results.aspx?q=weather & FORM=WLMTAG