Surgeons Face Difficulties in Safely Removing IVC Blood-Clot FiltersOct 11, 2016
Some patients who have received an IVC (inferior vena cava) blood-clot filter say the filter could not be safely removed. The failed failure was left in place, leaving the patients at risk for serious complications.
IVC filters are small, spider-like implantable devices intended to prevent blood clots from traveling from the lower body to the heart and lungs, where they can be life threatening. The filters are used in patients who cannot take blood-thinning drugs or for whom the drugs do not work well. C.R. Bard, Cook Medical, and Cordis are three major manufacturers of IVC filters.
Some IVC filters are designed to remain in place indefinitely but most are considered temporary and should be removed after the risk of blood clots has passed. The Food and Drug Administration (FDA) issued safety warnings about retrievable IVC filters in 2010 and again in 2014. The FDA recommends that retrievable IVC filters be removed between 29 and 54 days after insertion. Research indicates that IVC filters may become more dangerous than beneficial when they are left in the body longer than two months.
But complications can prevent removal. For instance, the filter can move from the original insertion site and lodge in a spot where the surgeon cannot retrieve it. The “legs” of the filter can break off and can become embedded in the vein or an organ. A clot can form around the filter fragment and that clot can travel to the heart or lungs. When the filter or a fragment becomes lodged elsewhere in the body it may be difficult or impossible to remove it.
A study in the Journal of the American Medical Association noted that more than 18 percent of attempts at removing IVC filters were unsuccessful. When the filter cannot safely be removed, the patient is at risk for future IVC filter complications.
At the time of the 2010 FDA safety communication, the FDA had received more than 900 adverse event reports involving IVC filters. Doctors and patients reported that filters had migrated out of proper position; had perforated surrounding tissue; or had broken into pieces. Patients had experienced blood clots, bleeding and pain.
The risks associated with these devices, and in particular how the manufacturers have dealt with those risks, have resulted in numerous product liability lawsuits. Manufacturers have been accused of negligence by patients who say their filter-removal complications were avoidable, according to Top Class Actions. One plaintiff says pieces of her fractured IVC filter migrated to her heart. When she was told that removal of the pieces would require open-heart surgery, she chose instead to take anticoagulant medications for the rest of her life. Other plaintiffs allege that filter pieces migrated throughout their bodies, and sometimes lodged in places where they could not be removed.
Researchers say that surgeons have greatest success when removing IVC filters within one year of insertion. The longer a filter remains in place, the harder it can be to remove. Because of the constant motion of blood within the vein, the filter can cause a local tissue reaction and the filter becomes embedded in the inferior vena cava lining.