An Inferior Vena Cava (IVC) heart filter is a medical device designed to prevent blood clots in deep veins, also known as, deep venous thrombosis (DVT) from traveling to the heart or lungs, where they can interfere with organ function or cause sudden death. Since 2005, filters have been surgically implanted by radiologists or vascular surgeons into the Inferior Vena Cava, a large abdominal vein.
IVC filters seek to protect patients who can’t take blood- thinning drugs, or who develop clots despite medication and remain at risk for pulmonary embolism (PE). The filters are manufactured by medical device companies such as Bard and Cook, among others.
The filters can either be surgically placed for short term use or implanted permanently, depending on patient need. In general, the longer a filter is left in place, the more difficult it is to retrieve.
Are IVC Heart filter risks well understood?
In response to mounting consumer complaints, the FDA published a safety alert in 2010 that detailed the risks associated with IVC filters. Of the 921 adverse events reported between 2005 and 2010, 328 cases involved device migration, 202 embolizations were due to device fracture or breaking apart while in use, and 70 instances involved perforation of the IVC.
The FDA’s alert prompted the American College of Radiology (ACR) and Society of Interventional Radiology (SIR) to get involved. In 2006, they published medical guidelines for placement and retrieval of IVC filters, in an effort to increase patient safety and reduce the amount of adverse events.
From the time IVC filters were introduced in 2005, their use has increased dramatically, from 167,000 in 2007 to over 250,000 in 2012. And though they are credited with helping to save the lives of 1000s of patients, there have been numerous documented clinical problems.
Despite many patients benefiting from the use of IVC filters, the medical community and the FDA agree that further studies are needed to better understand the effectiveness and use of IVC filters. One such study was initiated this year, by the SIR and the Society for Vascular Surgery (SVS). Over the next five years, the study will evaluate the overall safety and efficacy of IVC filters and treatment. 2,100 patients from 60 different U.S. medical facilities were recruited to participate. Filters from 7 different manufacturers will be tested. Patients will be evaluated every 6 months post-procedure, and up to 24 months a filter was retrieved.
Known issues associated with IVC filters
Because the safety and effectiveness of IVC filters is not well established, they are generally recommended only in cases where patients cannot be sufficiently anti-coagulated by more conventional means. Here are a few issues commonly cited as potentially problematic:
- Device migration (the filter may shift following surgery, requiring recapture and re-positioning)
- Filter fracture and embolization, causing perforation of the vena cava
- Damage of veins (perforation) during procedure may lead to bypass surgery or repair
- Clots bypassing the filter may cause additional pulmonary embolism
- Injury to neck or groin where the catheter was inserted
- Failure of patient to follow prescribed self-care
- Although rare, the IVC filter itself may cause clots to form
Is there a legal case?
Understanding there is risk with every treatment or procedure does not necessarily mitigate the risks that are being associated with IVC Heart filters. One should always seek secondary medical opinions to ensure proper care. If you’ve been injured during the process of placement or retrieval of an IVC heart filter, or suspect device related problems you should consult a specializing lawyer to ensure your legal rights are protected. (link)