LAWSUITS NEWS & LEGAL INFORMATIONHome Page >> Hot Legal Issues >> Long Term Use with Inferior Vena Cava Filters >> FAQ / Info
Inferior Vena Cava (IVC) Filter Side Effects FAQWhat is an IVC filter?
An IVC (Inferior Vena Cava) filter is a small, metal device implanted by vascular surgeons or interventional radiologists into a patients inferior vena cava vein to prevent blood clots from moving to the lungs - a health condition known as pulmonary embolism or PE. The inferior vena cava is the main vessel returning blood from the lower half of the body to the heart.
When is an IVC filter used?
IVC filters are designed to help people recovering from accidents and surgeries who are at risk for pulmonary embolism (a blood clot in the lungs) when blood-thinning drugs cannot be used or are ineffective. IVC filters are used in patients who cannot take anticoagulants.
As well, trauma patients, neurosurgical patients before surgery and super-obese patients are implanted with IVC filters for prophylaxis (to prevent a disease).
Is there a risk involved with an IVC filter?
The devices are linked to a number of complications like vein and organ perforation, and migration and breakage that can injure patients. The FDA now warns doctors and patients that the Bard IVC filter is only safe for short-term use. In as little as 4-6 weeks, the FDA says the risks of complications begin to outweigh the devices benefit.
What does the FDA say about IVC filter complications?
The FDA believes that the longer a filter remains in place, the higher the risk of complications, such as device fracture, perforation, migration or extrusion. According to the FDA report, Bard IVC filter complications become a serious risk in as little as four weeks following implantation.
2010: The FDA releases the first warning to medical professionals and patients.
Of the 921 reports of IVC filter adverse events and product problems, there are 328 reports of device migration, 56 reports of filter fracture, 146 reports of device embolization (where the entire filter or parts of the filter move to the lungs or heart) and 56 reports of perforation of the IVC.
The FDA also notes that some reports involved difficulty removing the device.
2014: The FDA releases a second warning, mainly providing information about the life span of Bard IVC filters. Research shows that Bard IVC filters should be removed starting 29 to 54 days after implantation. After that window of time, the high risk for complications outweighs any benefits of the device.
2015: The FDA learns that Bard manufactures the Recovery Cone Removal System, Model RC-15 in the United States without marketing clearance or approval. In a warning letter to Bard, the FDA requests that Bard Peripheral Vascular immediately cease activities that result in the misbranding or adulteration of the Recovery Cone Removal System, Model RC-15 and the Recovery Cone Removal System, Model FBRC, such as the commercial distribution of the devices
Have any clinical trials shown that risk outweighs benefit?
Only two clinical trials have assessed the efficacy of IVC filters compared with an established alternative. One small study of patients with hip fractures reports short-term outcomes only. A larger study comparing IVC filters with no filters found a short-term decrease in pulmonary embolism, but a longer-term increase in deep vein thrombosis (DVT) and no overall reduction in mortality.
Have any studies reported complications with IVC filters?
A study published in JAMA (4/8/13) found that, although the retrievable IVC filters are designed to offer temporary protection, many are left implanted indefinitely.
A decision analysis (Decision Analysis of Retrievable Inferior Vena Cava Filters in Patients without Pulmonary Embolism) was published in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (October 2013). The authors suggested that if the patients transient risk for PE has passed, the risk/benefit profile begins to favor removal of the IVC filter between 29 and 54 days after implantation.
What does retrievable IVC filter mean?
Retrievable means that it is designed to be taken out, but there is no time limit given by manufacturers. The FDA says the IVC filter should be removed once it is no longer medically necessary (e.g., no risk of PE). The manufacturers have always stated that although it is retrievable, it can also be left in as a permanent device.
When filters were first developed, they were permanently placed in the IVC. More recently, filters are designed to be potentially retrievable, but removal can be difficult.
When should the retrievable IVC filter be removed?
Manufacturers have different recommendations about how long a filter should stay in. But the FDA says that, for patients with retrievable filters, some complications may be avoided if the filter can be removed once the risk of pulmonary embolism has subsided. The FDA is concerned that retrievable IVC filters, when placed for a short-term risk of pulmonary embolism, are not always removed once the risk subsides.
What are IVC filter side effects?
According to the FDA report, these complications could lead to the following serious health problems:
Perforation of the vena cava
Recurrent Deep Vein Thrombosis
Recurrent Pulmonary Embolism
Vena cava thrombosis
Why are there IVC Filter lawsuits?
Plaintiffs allege they suffered serious IVC filter complications because the filters were defectively designed and not properly tested to ensure safety (see clinical trials, above).
Although the FDA reported the first IVC filter warning in 2010, court documents state that Bard, one of the IVC filter manufacturers, has been aware of potential complications since 2004. Bard also received FDA warning letters threatening regulatory action in 2014 and again in 2015 (see above) for failing to report injuries and deaths related to IVC filters and therefore violated federal regulations.
Bards market share of its IVC filter devices increased from 12 percent in 2002 to 42 percent in 2012. By 2014, it made more than $3.3 billion in annual profits.
What models are involved in IVC filter lawsuits?
The following manufacturers and devices are associated with serious IVC filter complications:
Bard Recovery Filter
Bard G2 Filter (2005)
Bard G2 Express Filter (2008)
Bard Eclipse (2010)
Bard Meridian (2011)
Bard Denali (2013)
Cook Gunther Tulip
Is there a statute of limitations?
Most states have IVC filter lawsuit time limits. If you have suffered from a defective IVC filter, you will likely be within those time limits, but it is advisable that you contact an attorney sooner than later.
Have any IVC filter lawsuits been filed?
Yes. The first lawsuits against C.R. Bard were filed in California and Pennsylvania state courts in 2012. In October 2014, the U.S. Judicial Panel on Multidistrict Litigation consolidated multiple actions from 11 districts into Multidistrict Litigation No. 2570 in the Southern District of Indiana. Many more IVC filter lawsuits are pending in federal and state courts, and new cases continue to be filed against the manufacturers.
|Please click here for a
free evaluation of your IVC Filter case
|Please click here for more
IVC Filter info and legal news
Last updated on Jun-8-16