The U.S. Food and Drug Administration (FDA) has issued a recent public safety statement regarding IVC filters and potential health risks connected to their use. The FDA approved IVC filters in 1979. At that time, only 2,000 devices were implanted. By 2007, those number rose to 167,000. The IVC filter is meant to protect those people who are at risk of blood clots, but are unable to use traditional anticoagulant drugs.
The IVC filter is a small cage-like device that is implanted into the patient’s inferior vena cava vein with the purpose of capturing blood clots before they reach the lungs or heart, thereby reducing the threat of pulmonary embolism, reports the State Journal.
In its public statement, the FDA stated that the implants have the potential to fracture while inside the body. When this happens, the pieces can travel through the bloodstream to other, more sensitive, areas of the body such as veins and organs, possibly puncturing them. The pieces can also lodge in the intestines and other high-risk areas where it is impossible to surgically remove them. Any migration of pieces of the IVC filter could potentially cause serious health issues, reports NBC News.
As a result of the increasing number of incidences of fracturing of the filter, many patients have filed lawsuits against the numerous manufacturers of the IVC filters, such as Cook Medical and C.R. Bard, with the allegation that the filters had a defective design. As people await their day in court, more news is emerging about IVC filters that seem to add to the controversy and the debate over whether the devices are safe to use or not, according to the State Journal.