IVC Filter Complications?

An inferior vena cava filter (IVC filter) is a type of vascular filter, a medical device that is implanted by radiologists or vascular surgeons into the inferior vena cava in an attempt to prevent life threatening pulmonary embolisms.  The filters are small, spider-like devices that are inserted into the vein to “catch” blood clots traveling to the lungs.  The Bard Recovery IVC Filter was introduced in 2003, and then removed from the market in 2005 amid reports that the filter was prone to fail.  As a result of several reports of broken filters, Bard redesigned the device and released the Bard G2 filter in October 2005.  This device has been prone to similar problems where the struts may become embedded or fracture.

The FDA has been raising concerns about problems with IVC filters since August 2010.  They have repeatedly warned about the risks associated with the device.  Between 2005 and 2010, more than 921 adverse event reports were filed with the FDA involving IVC filter complications, including:

• Filter migration
• Filter embolization or detachment of device components
• Vena cava perforation
• Filter fractures

In September of this year, NBC News reported that at least 27 deaths and 300 injuries have been linked to flaws in IVC or “blood clot” filters.  Evidence suggested that medical device company, C.R. Bard, was aware the filter had higher rates of relative risk for death, filter fracture and movement than all of its competitors, yet did not recall nor replace the device for years.

The FDA issued a warning letter to C.R. Bard, Inc. and Bard Peripheral Vascular, Inc. for eight violations of federal law relating to the safety of its Inferior Vena Cava filter product line.  Among the number of violations, Bard illegally sold adulterated and misbranded IVC Filters and failed to report complications and adverse events.  The letter further cites Bard with violations for withholding critical information from the FDA and public.

The FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from pulmonary embolism is no longer needed.

If you or a loved one have experienced a medical complication related to an IVC filter, call us today at 1-866-327-2952 to discuss your legal options.