One-Year NBC Investigation Reveals Serious IVC Filter RisksJun 23, 2016
A recent three-part NBC News investigative report brought to light the various risks associated with C.R. Bard's Inferior Vena Cava (IVC) filters. The tiny filters are implanted into the inferior vena cava to help stop blood clots in individuals who have deep vein thrombosis (DVT) in their legs from traveling to the heart, lungs, and brain. C.R. Bard is a unit of Johnson & Johnson.
The human body has two vena cavas, which are the body's largest veins and that carry deoxygenated blood into the heart. The inferior vena cava, also known as the IVC, carries blood from the lower body.
Retrievable IVC filters, such as the C.R. Bard Recovery IVC filter and the C.R. Bard G2 IVC Filter System, have been associated with reports of fracturing and reports of the device migrating in patients' bodies. This defect may lead to significant and life-threatening injuries, including perforation of the IVC and other organs, including the heart and lungs. Migration is typically associated with severe pain, bleeding, and further embolus.
C.R. Bard removed the Recovery IVC from the market in 2005, but it is believed that there are still devices implanted in people. The G2, which was the replacement for the Recovery, is still in use.
Concerns are emerging over if J&J and Bard revealed all they knew about the devices and potentially deadly damage. In the past 10 years, some 27 deaths have been tied to the Recovery filter, a one and a-half-inch metal trap, “spider-shaped,” device inserted into the IVC to block blood clots from traveling. The defects associated with the device have lead to deadly and life-threatening consequences for patients.
Meanwhile, in 2010, the U.S. Food and Drug Administration (FDA) reported it had received over 900 adverse event reports involving IVC migration, fracturing, embolization, and perforation. Four years later, the agency recommended that IVC filters should be removed between 20 and 54 days after implantation. Yet, in April 2013 JAMA: Internal Medicine reported that less than 10 percent of patients implanted with IVC filters have undergone successful device removal.
IVC filters are now the focus of hundreds of lawsuits that allege the devices caused serious harm and, in some cases, death; claims have been brought against C.R. Bard and other IVC filter manufactures. Allegations also include that the filters may tilt or move from the original implantation site, making the devices ineffective for trapping blood clots. It is the spider-like nature of the device that involves pieces tilting or separating and traveling when the so-called “legs” of the filter break and migrate. In some cases, the filter's dislodged pieces become lodged within the body in areas where a surgeon is unable to safely remove the piece, or pieces.
In some cases, pending lawsuits were filed by patients who still have a filter embedded in their bodies because the filter is unable to be removed safely. These patients say they are in constant fear the IVC may cause some significant, life-threatening injuries that may occur at any time.
When pieces of the IVC filter breaks off and migrates, patients and survivors have alleged symptoms that include:
- Chest pain
- Heart rhythm problems
- Internal bleeding
- Low blood pressure
- Shortness of breath