On August 9, 2010, the FDA released a warning on the risks and adverse events associated with long-term use of IVC filters. The warning urged physicians to use increased discretion regarding the risks and benefits for each individual patient before advising the implantation of an IVC filter.
Hundreds Of Adverse Event Reports To The FDA
Between 2005 and 2010, the FDA received 921 reports of adverse events relating to IVC filters, including:
- 328 cases involving device migration (to the heart or pulmonary artery causing fluid buildup, rapid heartbeat or sudden death)
- 146 cases involving embolizations (blockage in the artery) after detachment of device components
- 70 cases involving filter perforation (damage to artery walls and other bodily organs)
- 56 cases involving filter fracture (leads to migration complications)
- 4 percent of cases involving death
The FDA recommends that retrievable IVC filters be removed immediately after the threat of pulmonary embolism has passed. Many studies have detailed the high rates of failure associated with these devices and the significant risks to patients when IVC filters are used or left in the patient for too long.
C.R. Bard IVC Filters FDA 510(k) Clearance Process
The Bard Recovery IVC Filter System was first granted FDA clearance as a permanent implant in late 2002. They remain on the market despite hundreds of adverse complication complaints along with several other filters that pose similar potential risks to patients, such as Cook Celect™ and Cook Günther Tulip™ vena cava filters.
C.R. Bard attempted to modify its IVC filter products to address consumer complaints and adverse events in 2005. That same year, the FDA granted clearance to market the Bard G2 Filter System, which required further improvements in the years following. The result was another enhanced product in 2008 — the G2 EXPRESS (G2 X) IVC Filter System. Still, hundreds of adverse event reports have followed the release of the G2 X IVC filters.
Cook Vena Cava Filters FDA 510(k) Clearance Process
In late 2003, the FDA granted clearance for the Cook Günther Tulip™ vena cava filter for permanent and temporary implantation, which was marketed as a saving grace type of solution for patients with need of close management and control over thromboembolic disease.
Cook, Inc., introduced the Cook Celect™ vena cava filter in 2008, with FDA 510(k) clearance following several years of trials in other countries. The Celect filter was implanted in patients to capture and prevent hazardous blood clots from reaching the lungs following trauma, surgery or other serious health conditions. It was intended to be a design improvement to allow easier retrievability, but Cook vena cava filters have also been the subject of many adverse event reports to the FDA.
If you or a loved one has experienced complications or health problems relating to an IVC filter implant, please contact us today to gain an understanding of your legal options for recovery. Our Houston IVC filter lawyers represent clients throughout the United States, including Texas, New York and California.