Retrievable inferior vena cava (IVC) filters are a type of vascular filter that is implanted in the heart in order to help prevent life threatening pulmonary embolisms and can be removed when they are no longer necessary. According to the FDA, approximately 200,000 of these devices are implanted into patients each year – many of which – were either most likely not medically necessary in the first place or should have been removed when they were no longer necessary.
And these devices were approved under the FDA’s 510(k) process, which as you may know, is approved under much less scrutiny than pre-market approved devices. Unfortunately, it has been reported that perhaps as many as one out of four of these filters may fracture and migrate to other parts of the body – causing serious injury and death. These IVC filters include C.R. Bard’s Recovery® and G2®.
Almost two years ago, on August 9, 2010, the FDA issued an initial advisory communication regarding all retrievable IVC filters, due to risk of perforation, fracture, and migration within the human body. If the IVC filter does travel, these fragments can cause severe pain, disruption in heart rate, hemorrhaging, puncturing of internal organs, veins and arteries and possible death. The FDA believes these issues could be related to the retrievable filter remaining in the place, long after the risk of pulmonary embolisms have passed and recommends removal as soon as doctors feel it is safe to do so.
According to a study by the Archives of Internal Medicine, the Recovery® IVC filter was reported to have a 25% fracture rate whereas the second generation the G2® IVC filter only had a 12% fracture rate. While the G2® IVC filter had a lower fracture rate, according to researchers, the G2® IVC filter failed after just 717 days whereas the Recovery® IVC filter averaged 1498 days before failure.
If you or a loved one has experienced injuries resulting from a Retrievable IVC Filter, please contact Pogust Braslow & Millrood for a free consultation to make sure that you rights are protected.