The Wrong Kind of Heartbreak

May 24th, 2017

The FDA website has put up a notice that there have been numerous adverse events related to use of IVC filters. The IVC (Inferior Vena Cava) filter is an implanted device used for people who were in danger of developing recurrent blood clots. It was used on people who cannot take blood thinning medication or who were at risk for blood clots even when on blood thinning medication.


But they are not a permanent fix. They need to come out. The FDA has found that many of the side effects reported may have been because the IVC filter stayed in the body too long. That led to some serious complications such as filter breakage, infection, internal bleeding, embolization, perforated organs, the filter migrating to other areas, and death. The FDA warns that IVC filters need to be removed as soon as the risk of pulmonary embolism is gone.

 
Some of these devices have been recalled. Boston Scientific had a recall in 2005 and Cordis Corporation had a recall in 2013. IVC Manufacturer C.R. Bard had problems with the FDA for manufacturing a Recovery Cone Removal System (the Model RC-15) without marketing clearance and several of their filters have had a number of alleged safety issues.

In one study only less than 10% of patients that received and IVC filter had had the filter removed, even though having a filter stay past the recommended time in the body pushes the rate of complication significantly higher.

Did you or a loved one have an IVC filter implanted? Is it still in there? Do you even know? The answer could literally break your heart.

Comments

comments