Inferior vena cava filters are used for some patients who are at risk for a pulmonary embolism, which is a life-threatening blood clot. This device is typically used for people who are contraindicated for anticoagulation therapy. Surgeons started using these filters in 2005. Since that time, over 900 reports have been received by the FDA about dangerous effects of IVC filters. These implanted products are small and made from metal. Their purpose is to filter out possible blood clots to prevent them from entering the heart, but many patients are suffering serious injuries due to these devices, prompting many to file IVC filter embolization cases.
The main complaint among patients who received these devices was that they broke off into fragments in the body and traveled to other parts of it. This essentially means that the filters themselves became the same type of danger that they were designed to prevent. In some cases, there were reports of veins being punctured by the fragmented pieces. When the pieces traveled to other organs, there were also reports of them puncturing the organs. Punctured organs can lead to internal bleeding, which may be fatal.
As the number of negative reports climbed after 2005, the FDA issued a warning against IVCs in 2010. They stated that the products posed risks of fracture, migration and organ perforation. Their suggestion was that most of them should be removed. In 2014, the FDA recommended that any of these implants be left in for no more than 54 days. For patients who already had their IVCs longer, it was too late for the warning to help.
The FDA now requires physicians to warn patients of their potential risks. Many of the lawsuits filed against device manufacturers were on the basis of the company failing to warn them of potential harmful effects. IVCs must always be removed as soon as symptoms diminish or before 54 days after initial implantation.
Since fragments of these products can perforate organs and blood vessels, the risks of permanent damage and internal bleeding are significant. From the 921 reports received by the FDA with harmful results after implantation, these were the amounts of different incidents:
- 56 device fractures
- 70 organ perforations
- 146 detachments or embolizations
- 328 device migrations
When manufacturers learned of the serious defects in 2005, they quickly worked to remedy the issue. The struts and radial arms were the parts that broke off. Bard’s redesigned filter was named “G2” and has been used in procedures since its release. The company estimates that about 65,000 patients have a G2 product.
More studies are surfacing with grim reports on the effects of IVC filters. As the devices continue to fail in considerable percentages, the number of lawsuits is rising. Victims of defective IVCs may need additional surgeries or may suffer from permanent debilitating effects of the device, and the manufacturer must compensate people who experience these life-threatening side effects.
If you had similar problems after having an IVC filter implanted, contact our law firm to find out if you are entitled to compensation.