IVC Filters Used for Blood Clots Come With Risks, Complications
For Americans suffering from blood clots, inferior vena cava (IVC) filters have been lifesavers. IVC filters are used in patients who cannot tolerate blood thinners for one reason or another. These filters are implanted into the inferior vena cava – the largest artery in the body – and are used to trap blood clots before they reach the lungs, where they can be fatal. Unfortunately, these metal, spider-like devices have done more harm than good, to some patients.
According to an investigation by NBC News, at least 27 people have died in the past decade, due to complications caused by IVC filters. The specific filter in question is called Recovery, and it’s made by C.R. Bard, a popular medical device manufacturer. Besides these 27 deaths, NBC News reports that the IVC filter is responsible for another 300 serious, non-fatal complications. In the United States, IVC filters are available from 12 manufacturers, including C.R. Bard. As reported by NBC News, the risk of complications and death appears to be much lower for devices manufactured by companies, other than C.R. Bard. The failure rate for the C.R. Bard Recovery IVC filter is 25 percent.
Despite the significant health risks involved with usage of the Recovery filter, Bard refused to issue a recall. The company kept the devices on the market for three years, and sold 34,000 additional units, before they were updated and renamed “G2.” The new “G2” filters have a 12 percent rate of failure.
Bard is not the only manufacturer under fire for faulty IVC filters. IVC filters from two other manufacturers, Cook and Gunther, have also exhibited high failure rates. Cook manufactures the Cook Celect filter, while Gunther manufactures the Gunther Tulip filter. Both of these filters have a high rate of venous puncture, within 71 days after implantation. In addition, 40 percent of patients implanted with the Cook or Gunther device, experienced filter migration.
The problem is that the inferior vena cava opens and closes, and this constant motion can cause the filter to come loose. It can then fall apart and lodge itself into the heart, lungs and other organs. In most cases where complications are involved, the filter migrates or comes apart. These situations can cause serious injury or death.
IVC filters have always been intended for short-term implantation. There are permanent ones available, but most doctors use retrievable ones, which are to be taken out after a certain amount of time. However, most of these filters are left in longer than recommended, according to a study by the Journal of American Medical Association (JAMA). Out of the 679 retrievable IVC filters tracked in the JAMA study, only 58 had been removed.
Many IVC filter patients or their families have decided to file an IVC filter lawsuit against the device manufacturer. On August 17, 2015, the U.S. Judicial Panel on Multidistrict Litigation ordered that all federal lawsuits for Bard IVC defect claims be transferred to the U.S. District of Arizona.