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As the name implies,
Ancure (as in "ANeurysm CURE") was presented to the FDA and the public
as an appropriate treatment for abdominal aortic aneurysm. However,
problems arose in patients who received an Ancure procedure. The FDA
notified hospitals and health care professionals that "Problems
associated with placement of the device within the blood vessels have
been reported. When this problem occurred, it was found to be associated
with damage to the artery wall." In the same statement, the FDA also
noted that the product was somewhat unpredictable. " Some patients have
had problems, and some have not," says the letter from the FDA. "But
these devices are new, and there is no way to predict who will develop
problems in the future."
Within 19 months of being released to the public, one out of every three
Ancure devices used in patients had malfunctioned, for a total of about
2500 units that did not perform as expected. At least 12 deaths have
been associated with malfunctioning Ancure units. These adverse
reactions led the FDA to issue this warning to patients: "If you have
one of these implanted grafts, it is very important that you have
regularly scheduled follow-up appointments with your physician, who will
prescribe periodic medical imaging examinations, such as x rays or CT
scans. You should continue to have these checkups as long as you have
the graft."
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