ABOUT THE DEVICE
Retrievable inferior vena cava filters (IVC filters) are small, metal devices designed to stop a blood clot from traveling to the lungs. The device resembles a metal cage and is surgically inserted into a patient’s vein. Most patients take blood thinners to stop blood clots, but doctors use IVCs on patients who can’t use blood thinners.
The device was introduced in 1979, and its use increased continuously through the years. By 2012, doctors inserted approximately 259,000 filters in patients.
PURPOSE OF THE DEVICE
The inferior vena cava is the largest vein in the body, moving de-oxygenated blood from the lower legs to the heart and then the lungs. In order to prevent life-threatening pulmonary embolisms (PEs), blood clots from traveling through the vein into the lungs, doctors implant an IVC filter in the vein.
Retrievable filters are associated with potential risks, like damaging veins and failing to stop blood clots from bypassing the device.
A doctor inserts the device using a catheter into a patient’s inferior vena cava through a small incision in the neck or groin. The device’s metal wires capture and trap blood clots before they can reach the lungs.
Some filters are permanent, and some are retrievable or temporary. Doctors remove retrievable filters in a similar way that they implant them. Healthcare providers inject contrast or X-ray dye around the device to make sure it is safe to proceed with the removal. A catheter-like snare goes into the vein and grabs the hook located at the end of the filter. The filter is then covered by a sheath and pulled out of the vein.
Retrievable filters are associated with potential risks, like damaging veins and failing to stop blood clots from bypassing the device. Serious complications can occur because of the implanted filters, like when a device breaks apart and travels to another area of the body, otherwise known as device migration, the most common adverse reaction. The FDA listed embolization as the second most frequently reported complication.
Retrievable IVC filters are only intended for short-term placement, and the FDA reported concern about the devices staying in patients long after PE risks subsided. The FDA updated safety communication in 2014, recommending retrievable devices be removed between the 29th and 54th day after implantation in patients in which PE subsided.
Former recipients of retrievable IVC filters filed legal claims against manufacturers for poor design, manufacturing and failing to warn of risks. Faulty filters punctured veins, fractured and migrated to other parts of the body causing complications.
In a report released in 2010, the FDA received more than 900 reports of adverse events associated with IVC filters, including 70 filter perforations, 328 device migrations, 56 filter fractures, and 146 embolisms.
HOW BRAMZON & ASSOCIATES SPECIALTY LITIGATION LLC CAN HELP
Studies have revealed five retrievable IVC filters prone to failure – Bard’s Recovery, Bard’s G2, Bard’s G2 Express, Cook’s Gunther Tulip and Cook’s Celect.Studies have revealed five retrievable IVC filters prone to failure – Bard’s Recovery, Bard’s G2, Bard’s G2 Express, Cook’s Gunther Tulip and Cook’s Celect. If you or someone you know has received any of these IVC filters and experienced any adverse side effects, you should speak seek legal counsel immediately.
“By the time a patient has received an IVC filter, he has reached an emotional state of mind where he thinks his concerns are finally being addressed and has achieved long-awaited peace of mind, but that just isn’t the case,” says Lonny Bramzon. “The irresponsibility on the part of the manufacturers has been egregious, and patients and their families should understand the risks and how to protect themselves.”