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Soft Tissue Recall FAQs Why was a CryoLife recall issued?
Why did the FDA allow CryoLife heart valves to remain?
How many people have been affected by the CryoLife recall?
Why would someone choose to receive donated soft tissue?
Why is the SEC investigating CryoLife?
Are there alternate options to soft tissue implants
and heart valves?
What should I do if I have received CryoLife soft tissue
or heart valve?
Do I have any legal rights?
Why was a CryoLife recall issued?
After a November 7, 2001 death of a 23-year old patient that had
received a soft tissue implant for a reconstructive knee surgery
that was derived from CryoLife, the FDA continued receiving reports
of other infections in soft tissue implant patients and along with
the CDC realized the majority of them were due to CryoLife. The
two agencies determined that CryoLife failed to take necessary measures
to prevent or address the possibility of fungal and bacterial infections
due to their processing and testing methods.
Why did the FDA allow CryoLife heart valves
to remain?
Currently, the Centers for Disease Control and Prevention are investigating
cases of bacterial or fungal heart valve infections that have been
reported by both physicians and patients since March. Opposed to
soft tissue, heart valves are often necessary to save lives, especially
with babies, which is why the CDC is investigating heart valve infection
claims as it remains on the market. CryoLife supplies 70% of the
heart valves implanted in the U.S., making a CryoLife heart valve
recall especially impacting.
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How many people have been affected by the CryoLife
recall?
So far, the CDC has found 54 cases of infections after surgery with
half of them linked to CryoLife. This number is thought to be grossly
under the actual number due to the lack of recording in the past
and lack of federal regulation on soft tissue implants and heart
valves.
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Why would someone choose to receive donated
soft tissue?
A patient can have a much faster recovery time if a graft has been
taken from the patient's body. In addition, a surgeon is able to
more easily and less invasively replace knee ligaments that were
taken from a cadaver tissue than with part of a patient's own body
parts.
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Why is the SEC investigating CryoLife?
As CryoLife was receiving reports from doctors, laboratories, and
the CDC of infections occurring because of their soft tissue implants,
CryoLife continued to tell the investors that there was no contamination.
Although CryoLife has backed off of that statement since then, they
had continued to claim there were no problems for months. Records
show that CryoLife key corporate officers and directors stopped
buying and started to sell millions of dollars worth of stock when
health investigators were sending the company letters. The SEC is
now investigating this matter and shareholder are suing CryoLife,
in addition to the families of the infection victims and the infected.
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Are there alternate options to soft tissue implants
and heart valves?
When undergoing reconstructive knee surgery patients can opt to
use a piece of their hamstring to replace a damaged tendon. Heart
valves are a little trickier than knee surgery because while mechanical
heart valves are available, they can be too large to use for babies.
In addition, tissue is often a better and more effective option.
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What should I do if I have received CryoLife
soft tissue or heart valve?
Contact your physician to make sure an infection is not developing.
For
more information on the CryoLife recall contact us to speak with
a tissue implant attorney.
Do I have any legal rights?
The FDA was especially concerned with the soft tissue from a cadaver
CryoLife sent out despite it being confirmed that harmful germs
were present in tissue samples they had obtained from the same donor.
CryoLife is now being investigated for the contaminated soft tissue
implants and heart valves that were used.
Please
contact us for more information regarding the CryoLife recall from
a tissue implant attorney.
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