A few months ago, NBC News aired a scathing report on C.R. Bard and its IVC (inferior vena cava) filter, which is designed to catch blood clots coming from the legs before they can enter the lungs. A Dec. 31 follow-up report focuses an even harsher spotlight squarely on the pharmaceutical giant.
What is an IVC Filter?
An IVC filter is a metal device that has thin prongs, making it look somewhat like a spider. The filter is inserted in the inferior vena cava (one of the largest veins in the body), typically near the groin area. If someone is suffering from blood clots in his or her legs, an IVC filter can be implanted and is supposed to catch the clots before they can travel to the lungs and result in a pulmonary embolism.
The problem with the filters is that, in some cases, the metal prongs break off and impale major organs such as the liver, kidneys and even the heart. This has caused many surgeons to decide that a patient would be better off if the prong was left in the organ because it is too dangerous to remove the filter from the organ.
A Fatal Flaw
According to NBC’s follow-up report, Bard’s original IVC filter, known as the Recovery, was associated with nearly 30 deaths. The company then replaced the Recovery with newer versions known as the G2 and G2 Express. However, internal communications show that Bard was well aware that not only did the Recovery pose serious risks of failure, but the G2 did as well. NBC reported that 12 fatalities have been attributed to the G2 series.
Even though Bard is one of 11 manufacturers of IVC filters, the company’s devices have been linked to more problems than any of its competitors, according to the report. NBC interviewed a doctor who specializes in IVC filter removal surgeries and he said both the Recovery and G2 should have been pulled from the market.
A large clinical study into the safety and effectiveness of all IVC filters on the market has just begun. Eventually, it is expected to include more than 2,000 patients and last five years.
However, that will be far too late for either the families of people who have died due to malfunctioning filters or the thousands of others who have suffered severe injuries.