FDA Says IVC Filter Retrievers Are Unsafe
According to MassDevice, C.R. Bard Medical has announced that they have received an official warning from the U.S. Food and Drug Administration (FDA). The warning was in reference to their inferior vena cava (IVC) filter retrieval devices.
About the FDA’s Warning on IVC Retrieval Devices
The FDA conducted inspections at Bard plants in Glen Falls, New York, and Tempe, Arizona. The warning letter said that these plants had problems with “quality systems and medical device reporting observations”, according to Bard.
Two models of Bard’s recovery cone removal systems were affected by the FDA’s official warning. These models will not be able to receive FDA approval until Bard addresses the safety concerns.
About the IVC Filters
The inferior vena cava (IVC) is a major artery in the human body. IVC filters are small devices placed inside the artery. The filters serve to stop blood clots before they can reach the lungs.
These filters can be either permanent or retrievable. Most of the safety concerns are in reference to the retrievable ones.
IVC filters have been being used in increasing numbers for the past thirty years. In 2012, about 259,000 filters were used. This number is nearly 130 times higher than in 1979, when only 2,000 IVC filters were used.
Despite the fact that IVC filter usage has become much more popular, the FDA has received many adverse event reports in relation to the products. In fact, they received 921 such reports from 2005 to 2010. Most of these complaints involved device migration.
If the filter were to fracture inside the vein, open-heart surgery may be necessary. In addition, some patients have complained of difficulty breathing, fatigue, nausea, chest pain, and weakness.