FDA Issues Medwatch Safety Communication Regarding IVC Filter Complication
In August of 2010, The U.S. Food and Drug Administration (FDA) released a Medwatch Safety Communication that discussed issues with inferior vena cava filters. The release was intended for doctors, interventional radiologists and cardiologists, vascular surgeons, and other medical professionals who deal with vena cava filters.
Initially, the update discussed the purpose for these filters, which is to capture blood clots rising from the lower extremities and progressing to the heart and lungs. It continued to mention the proliferation of these filters, as it progressed from being implanted in only hundreds of patients during the 1970’s to hundreds of thousands expected by 2012.
The core of the update appeared to be about the problems associated with these medical devices, as it stated, “Since 2005, the FDA has received 921 device adverse event reports involving IVC filters, of which 328 involved device migration, 146 involved embolizations (detachment of device components), 70 involved perforation of the IVC, and 56 involved filter fracture. Some of these events led to adverse clinical outcomes in patients. These types of events may be related to a retrievable filter remaining in the body for long periods of time, beyond the time when the risk of PE has subsided.”
In addition, the update mentioned the FDA’s worry about the fact that these devices were “intended for short-term placement, are not always removed once a patient’s risk for PE subsides” and that “Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
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If you or a loved one has been implanted with an IVC Filter, call Martin Baughman at (214) 761-6614, or contact us for a free initial consultation. We are a small firm that offers immediate answers and big results, all with no obligation. Call today.