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An IVC filter, which is inserted into the inferior vena cava to prevent blood clots, can actually cause more harm than good for many patients. Medical malpractice claims involving IVC filters are, sadly, not uncommon.
When a patient is at risk of developing a blood clot, either because of inactivity after surgery or for other medically necessary reasons, doctors will permit the use of an IVC filter. The IVC filter is a metal object with metal spider-like legs that splay outward in a vein to prevent a blood clot from traveling to the heart. In 2012, the FDA (Food and Drug Administration) believes about 259,000 people had an IVC filter inserted. This a dramatic increase from 2,000 people in 1979 and 67,000 in 2007.
When this filter was first designed, it was intended to be removed after the symptoms subsided. But studies have shown that many of these filters were never removed and in most instances, there was no indication to believe that there was any intention to remove them. There were also many indications showing that the filter was not properly tested by the manufacturers or the FDA. Additionally, although the devices were originally developed to save lives, it is not clear whether they have actually done this.
The risks involved with IVC filters seem to increase with time and the filters have increased the possibility of cardiac events by puncturing the vein where they were inserted, or fracturing and migrating throughout the body.
The FDA approved these filters under a fast-track process since they were substantially similar to products already on the market. But these filters, which hit the market around 2003, were marketed as devices which could be safely removed at any point after insertion. In reality, studies show that the products could embed themselves into patients’ veins very shortly after insertion, some as quickly as a few days. It was eventually discovered the product was most likely to be retrieved within nine days of insertion and after that time, the devices could not be easily removed.
Although medical devices can vastly improve people’s lives, if the device is defective, a patient can suffer significant injuries. If you or someone you know has been hurt by a defective medical device, contact our medical product liability lawyers in Philadelphia at Brookman, Rosenberg, Brown & Sandler to assist with your case. Call our Philadelphia medical device lawyers at 1-215-569-4000 or contact us online.