IVC Safety Concerns Lead to Decline in Use, Says Study
According to a recent study in the medical journal JAMA Internal Medicine, use of IVC filters is declining after the FDA warned about risks associated with the devices. Physicians are becoming increasingly selective about when to use the filters due to IVC safety concerns, say researchers. The decreased use of the inferior vena cava filters or IVC filters is likely due to Food and Drug Administration warnings about serious risks associated with the devices issued in recent years.
“Prior studies documented an increase in the rates of IVC filter placement from 1979 to 2005,” noted the researchers. “Our analysis shows that this trend continued until 2010 when, in a reversal of a 31-year trend, the rates declined from 2011 through 2014.”
The FDA has issued warnings about IVC safety concerns including:
- Perforation of major organs
- Cardiac or Pericardial tamponade
- Chest pain
- Shortness of breath
- Ventrical Tachycardia
Retrievable IVC filters were meant to be implanted in patients at risk of suffering pulmonary embolism and then removed once the risk had passed. However, after a steady increase of use of IVC filters from 1979 until 2009, rates of IVC filter use started declining in 2010.
The researchers pinpointed that in August of 2010, the Food and Drug Administration reported nearly 1,000 adverse event reports. At that point, the FDA recommended that doctors consider removing the filters over IVC safety concerns – previously, IVC filters, although designed to be retrievable, were often left implanted.
According to the letter published in JAMA, this correlates with the decline in use of the filters. Researchers also note that in 2014, the agency issued a stronger warning, asking doctors to remove IVC filters when patients were past the risk of pulmonary embolism.
It appears that physicians are becoming more selective in their use of the device, according to the researchers.
While there were 412 IVC filter placements per 100,000 hospitalizations in 2010, according to the report, that number was down to 321.8 by 2014.
Researchers also looked at the reasons why IVC filters were placed in patients during this time, including venous thromboembolism, deep vein thrombosis, pulmonary embolism, and filter placement by contraindication to anticoagulation.
According to the results of the study, physicians began using filters less for preventative reasons from 2005 until 2014.
Lawsuits Over IVC Safety Concerns
While the FDA has issued warnings over IVC safety concerns, medical device makers failed to warn the medical community, according to IVC filter lawsuits.
Currently, there are thousands of lawsuits filed against Bard, Cook, and other IVC filter manufacturers that allege patients suffered adverse medical effects after being implanted with the devices.
Additional claims are being filed. IVC filter lawsuits are generally centralized into multidistrict litigation (MDL) cases that are heard by one judge.
“Bellwether” cases will be heard to anticipate how litigation will proceed over IVC safety concerns. After these cases are heard, it is possible that the medical device manufacturers will proceed with settlements in a number of the cases.
The number of lawsuits over IVC safety concerns is expected to grow. If you or a loved one suffered from side effects from an IVC filter, contact the attorneys at McDonald Worley.