Did IVC manufacturers know about the dangers?
C.R. Bard’s Recovery IVC Filter and the G2 IVC Filter System have reportedly fractured and migrated inside of patients’ bodies, leading to perforation of organs including the heart and lungs. Both of these devices were approved by the FDA 510(k) protocols, which is an approval system by which the medical device is cleared without human clinical trials if the device maker is able to prove that the proposed device is essentially equivalent to another product already approved for sale and on the market.
The Recovery filter was first introduced in 2003, but was soon replaced by the G2 in 2005. Prior to the removal of the Recovery IVC filter from the market, the FDA had received 300 reports of adverse effects linked to the device. Though the Bard G2 was expected to be more effective, the device still had a 12 percent failure rate, and was succeeded by the G2 Express in 2008. One study found that all of Bard’s devices experienced a combined 12 percent fracture rate.
A vast amount of these devices are still implanted in patients, and in fact, a 2013 study completed in the Journal of American Medical Association (JAMA) discovered that doctors had only effectively removed 18% of IVC filters in a population of 679 individuals.
If you, or a loved one, have suffered physical, emotional, and financial injury, or even death, as a result of IVC Filters, then contact us today at (877) 919-0830.