What is an IVC filter?
IVC filters are tiny, metal cage-like devices that are implanted – either temporarily or permanently – into the inferior vena cava (IVC), a large vein in the body that delivers deoxygenated blood from the lower extremities to the heart. The filters are intended to capture blood clots that form in the legs – called deep vein thrombosis – and stop them from reaching the lungs and causing potentially fatal pulmonary embolism. Ideally, the clots remain trapped in the filter until they dissolve.
IVC filters are typically implanted in patients who are at risk for pulmonary embolism, such as patients recovering from accidents or surgeries, and those for whom blood thinners are ineffective or not an option. IVC filter candidates include bariatric patients, trauma patients (car accidents, or gunshot or stabbing injuries), and orthopedic patients.
IVC filters have been on the market since the 1960s for the prevention of injuries from thrombosis, or blood clots. The first retrievable filters were approved by the Food and Drug Administration (FDA) in 2003 and 2004. Since then, the use of these blood clot-catching devices has increased dramatically. Today, about a quarter-million people receive IVC filter implants each year.
IVC filter complications
Shortly after IVC filters hit the market in 2003 and 2004, reports of adverse events started flooding into the FDA’s MedWatch Adverse Event Reporting System. This prompted the FDA on Aug. 9, 2010, to issue its first Safety Communication warning of serious complications associated with the devices. On May 6, 2014, the FDA reiterated the warning in a second Safety Communication.
The FDA alerts reported that from 2005 to 2010, the agency had received 921 reports of adverse events with IVC filters, some of which resulted in adverse clinical outcomes for patients. Problems included 328 device migrations, 146 embolizations (movement of the entire filter or fracture fragments to the heart or lungs), 70 of perforations of the inferior vena cava, and 56 filter fractures. There were also reports of surgeons having difficulty removing the device.
The Safety Communication also cautioned that some adverse events may be related to how long the filter had been implanted, and that long-term risks of IVC filters included lower limb deep vein thrombosis and IVC occlusion. As a result, the FDA’s second Advisory recommended that retrievable IVC filters be removed as soon as the patient’s risk for pulmonary embolism subsided. One model suggested the risk/benefit profile for removal of the IVC filter at being between 29 days and 54 days after implantation.
Types of IVC filters
There are several manufacturers of IVC filters, but the country’s top IVC filter manufacturers are Cook Medical and C.R. Bard. Here is a list of medical device makers and their brands of IVC filters.
- Bard Recovery IVC Filter (withdrawn in 2005)
- Bard G2 IVC filter
- Bard G2 Express/G2x Filter
- Simon Nitinol Vena Cava Filter
- Gunther Tip Vena Cava Filter
- Gunther Tip Mreye
- Cook Celect Vena Cava Filter
- Cook Celect Platinum
- Bird’s Nest Vena Cava Filter
Other IVC Filters
- Johnson & Johnson’s Cordis OptEase
- ALN’s ALN Filter
- Rex Medical’s Option Vena Cava Filter
- Rafael (RTM) Medical’s Option Vena Cava Filter
- B. Braun Medical Convertible’s Vena Tech
- Boston Scientific’s Greenfield Vena Cava Filter
IVC Filter lawsuits
More than 6,000 lawsuits have been filed against C.R. Bard and Cook Medical alleging their IVC filters are defectively designed, which makes them prone to migration, fracture, tilting or perforating the inferior vena cava, causing severe injury or death. Those suing these medical device companies claim they knew their products could cause complications but failed to adequately warn doctors or patients of the dangers they posed.
In October 2014, the Judicial Panel on Multidistrict Litigation consolidated all federal cases against Cook Medical into a multidistrict litigation (MDL) in the Southern District of Indiana. Currently, there are about 4,000 cases pending in that MDL.
In August 2015, all federal cases against C.R. Bard and Bard Peripheral Vascular were consolidated into a MDL in the District of Arizona. More than 3,600 cases are currently pending in that MDL.