The Risks Associated with Recoverable IVC Filters can be Deadly

An IVC filter is a small strainer type of device used to filter out blood clots and to assist in preventing them from forming and becoming pulmonary embolisms (a blood clot that travels to the lungs). IVC stands for Inferior Vena Cava, which is the large vein that enters the upper right chamber of the heart and delivers oxygen depleted blood from the legs, pelvis and abdomen back to the heart. The filters were designed for people who cannot take anticoagulants (blood thinners) and are at risk for pulmonary embolisms.

In theory, these recoverable devices are good because preventing a pulmonary embolism (PE) can be life-saving. A PE can cause severe lung tissue or heart damage by preventing blood from flowing into the lungs or heart, diminishing blood oxygen levels and damaging other body organs, as well as pulmonary hypertension or even death. However, the IVC filter, which is a spider-like wire inserted into a vein, can cause more damage because it can break, tilt, migrate inside the body or puncture a vein and/or organ. This can occur when one of the metal spikes unknowingly releases into the body.

In 2014, the Food and Drug Administration (FDA) updated its previous warning, and expanded it to say that patients have an increased risk of a PE the longer the device remains in place, and recommends removal after 29-54 days from the date of implant. Due to the inadequate warnings from the manufacturers of the IVC devices, many doctors and hospitals do not know of the 29-54 day removal recommendation
and IVC implants are remaining in place longer than the FDA warning. The longer a device remains in place, the more difficult, and dangerous, it is to have it removed.

According to reports and discovery efforts, less than a year after New Jersey based C. R. Bard (1 of 11 manufacturers) launched its recoverable IVC filter, it received numerous complaints of device malfunction, indicating the legs of the device were prone to break
loose and travel to other parts of the body. Although Bard knew of the problem with the IVC filters, they chose to not inform the public or the FDA. Instead, Bard hired an independent consultant to prepare a report that compared the fracture and migration rate of the new filters to previous models in 2004. In 2015, an NBC News investigation revealed that Bard may have known of the IVC risks well before the complaints and the independent consultant’s report. See: https://www.nbcnews.com/health/health-news/why-did-firm-keep-selling-problem-blood-clot-filters-n488166

Injuries can be in the form of: chest pain, confusion, heart rhythm irregularities, hypotension, lightheadedness, nausea, neck pain, shortness of breath, hemorrhaging, internal bleeding, pulmonary embolism, stroke and even death.

The first IVC cases scheduled to go to trial under the Multidistrict Litigation will occur on October 23, 2017; April 30, 2018; and September 10, 2018. There are some cases which have settled and there is a class action filed as well.

If you or a loved one has suffered from complications due to IVC Filters, please call our office for more information