C.R. Bard’s G2® Vena Cava Filter was linked to a 38% 5-year fracture risk in recent studies. It was pulled off the market in 2010, soon after the FDA issued safety warnings and another study found “high rates of fracture and embolization.”
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently evaluating IVC filter cases in all 50 states, regardless of whether you have been injured or not. If you or somebody you know was implanted with an IVC filter, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the Bard G2 IVC Filter?
The Bard G2® IVC Filter is a cage-like wire device that is implanted into a vein called the inferior vena cava. This vein carries “used” blood from the body to the heart and lungs.
How Does It Work?
The G2 is designed to catch blood clots before they enter the lungs and cause a pulmonary embolism. IVC filters are often used in patients who are contraindicated for a blood-thinning medication.
Bard G2 vs. Bard Recovery
The G2 is the 2nd-generation of the Recovery filter line of implants. Bard voluntarily withdrew the Recovery filter in 2005, and the G2 was designed with improvements. Bard claimed that the G2 provided greater resistance to migration, improved centering of the device, and enhanced fracture resistance, which allowed for extended time until retrieval was necessary.
Study Finds 38% 5-Year Fracture Risk
In 2014, a study of 684 patients who were implanted with the G2 filter estimated that 38% would fracture within 5 years. Broken pieces of the filter were discovered embedded in patients’ lungs, heart, pericardium, iliac vein, and kidney. The risk increased over time.
Early Studies Find 12% Fracture Risk
In 2012, a study found a 12% rate of filter fracture associated with the Bard G2 IVC filter. The rate of fractures also increased over time. Only 53.4% of fractured IVC filter struts could be successfully removed.
In 2010, a study of 80 patients with the Bard G2 or Bard Recovery IVC filters estimated found that 12% of G2 filters fractured. The broken pieces traveled to the patient’s heart in 30% of patients. The study concluded:
The Bard Recovery and Bard G2 filters had high prevalences of fracture and embolization, with potentially life-threatening sequelae.
Temporary vs. Permanent IVC Filters
The Bard G2 IVC filter is a retrievable filter, instead of a permanent implant. It is supposed to be temporary, implanted only as long as the patient is at risk of a pulmonary embolism. Unfortunately, the FDA has warned that serious injury can occur when removable IVC filters are not removed after the risk of pulmonary embolism subsides.
FDA Safety Warning
In a Safety Communication in 2010, the FDA announced that they received 921 reports of adverse events linked to IVC filters. The agency was concerned that short-term filters were not being removed.
“Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.”
Side Effects of Bard G2 IVC Filter
Serious side effects of the Bard G2 IVC filter can cause life-threatening complications, which may include:
- Filter fracture (pieces can injure the heart, lungs, or inferior vena cava)
- Device migration (device may become ineffective, or erode into the body)
- Device erosion into the inferior vena cava
- Cardiac tamponade (a condition where fluid builds up in the space around the heart and interferes with heart function)
- Perforation of the inferior vena cava, heart, lungs
- Deep Vein Thrombosis
- Blood clots may clog the filter, slowing blood flow into the lungs
- A doctor may be unable to remove a fractured IVC filter
- Death
Do I have an IVC Filter Lawsuit?
The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.
Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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