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FDA Warning on IVC Leg Stents/Filters–If You Have An Old One In Place Check With Your Doctor-Newer Designed Devices Not Po

Posted Aug 11 2010 5:32pm

A while back I did an interview with Cook Medical, another company that makes the leg stents and is NOT part of this recall and I learned quite a bit.  One other item image worth mentioning here too is the fact that sometimes getting the patients to come back and have them removed is a chore.  Doctors contact patients and knowing that is has not been urgent or brought to the attention of many until this FDA safety notice, many patients won’t or don’t go back to have them removed, even after several notices from their doctors. 

Their product used is a bit more advanced than the ones with the Bard technology as well, so that also comes into play here with their stents being medically impregnated too.  These stents can save your life too if you are having surgery and there are blood clots detected.  You can read more about the devices at the link below so age and technology with PAD makes a difference. 

If you have an old Bad device then it would be a good move to have it checked and some of the newer devices are meant to be permanent too, so check and see what you have before panicking over the warning from the FDA.  BD 

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The U.S. Food and Drug Administration warned Monday that certain devices used to keep blood clots from traveling to the lungs could fracture and migrate to other parts of the body.

Known as inferior vena cava, or IVC, filters, the small devices are inserted into the main vessel returning blood from the lower half of the body.

The devices can be used to treat patients with venous thromboembolism, or blood clots in the legs, in order to keep the clot from traveling to the lungs where the clot can sometimes be fatal.

Since 2005, the FDA said it has received 921 adverse-event reports associated with the devices, which are made by 10 companies, including a unit of Johnson & Johnson , Angiotech Pharmaceuticals Inc. and a unit of C.R. Bard Inc.

The reports included device migration, or movement within the body; detachment of device parts; filter fracture; and perforation of the inferior vena cava.

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