Will the FDA Recall IVC Filters for Blood Clots?
In recent years, a growing number of product liability lawsuits have been filed against the manufacturers of IVC filters, which are small devices designed to prevent blood clots from traveling to the lungs.
The filters are often implanted into the inferior vena cava (IVC) as an alternative treatment for patients at risk of a pulmonary embolism, when an anticoagulant is contraindicated or has been ineffective. They contain a number of legs or struts that extend out and “catch” blood clots.
Amid the widespread use of IVC filters in recent years, concerns have emerged about the risk of severe and sometimes fatal injuries, where the wire struts or legs may fracture, break, move out of position or otherwise fail. This may cause fragments to enter the heart or lungs, or potentially puncture internal organs or arteries.
A number of studies have raised concerns over the safety of IVC filters and questioned the benefits provided for most patients.
While some have called for an IVC filter recall to be issued for some designs, and several manufacturers may be forced to pay substantial compensation through IVC filter settlements, there is no indication that the FDA currently plans to remove IVC filters from the market.
Rather, it appears that the safety of IVC filters may be improved through stronger warnings and tighter regulation of the devices.
IVC Filter Warnings
In August 2010, the FDA voiced concerns about the growing number of IVC filter problems reported by individuals throughout the U.S., indicating that more than 921 adverse events had been submitted between 2005 and the date of the warning.
Among the reports submitted to federal regulators:
- 35% involved IVC filter migration (328 Reports)
- 15% involved detacthment of IVC filter components, or embolizations (146 reports)
- 7.5% involved perforation of the vena cava (70 reports)
- 6% involved IVC filter fractures (56 reports)
If the IVC filter fractures or fails, components may travel to the heart or lungs, causing severe and potentially fatal injuries. It appears that many of the problems stem from warnings and instructions provided with the devices, which are often left in place for long periods of time, potentially increasing the risk of problems.
In May 2014, the FDA issued a safety communication urging doctors to remove IVC filters about one to two months after the risk of pulmonary embolism has passed. It appears that many severe injuries could have been avoided if the manufacturers had recommended earlier that the IVC filter should be removed once the risk has passed.
IVC Filter Recall Lawsuits
The two leading manufacturers of IVC filters in the U.S. are C.R. Bard, which manufactures the Bard Recovery and Bard G2 IVC filters; and Cook Medical, which makes the Cook Celect and Gunther Tulip IVC filters. Both company’s filters have been linked to large number of reports involving fracturing, migration, and health complications.
The lawyers at Saiontz & Kirk, P.A. are reviewing potential Bard G2 filter lawsuits, Bard Recovery filter lawsuits and Cook Select and Gunther Tulip filter lawsuits for individuals throughout the United States.
Even without a recall to remove IVC filters from the market, manufacturers still had a duty to provide sufficient warnings for patients and the medical community, to design IVC filters that stayed in place and did not fracture into fragments inside the body, and to advise doctors properly on when the devices should be removed.
To review a potential claim for yourself, a friend or family member with our IVC filter recall lawyers, call our office toll free at (800) 522-0102 or request a free consultation and claim evaluation.