IVC Filters – Risks May Outweigh Benefits

IVC Filters – Risks May Outweigh Device's Benefits
IVC Filters – Risks May Outweigh Device's Benefits

A patient who has had surgery or is recovering from a serious accident, there is the possibility of blood clots forming in the body. If a blood clot migrates or travels to the heart or lungs, it can be a life-threatening occurrence. Patients who are unable to take blood thinning medications for a variety of reasons, may receive an inferior vena cava (IVC) filter.

How an IVC Filter Works

An IVC filter is a small cage-like device that is placed in the inferior vena cava vein (the largest vein in the body), and acts somewhat like a catcher’s mitt. It traps a blood clot in the spider like-appendages and prevents the clot from travelling to vital organs where it could allegedly cause death. When a blood clot is trapped, it normally dissolves back into the body.

Early versions of the IVC filter were designed to be a permanent implantation, but proved to be problematic for some patients when left in the body for a long period of time. The longer the filter was left inside the body, the more difficult it proved to be to extract the filter as it became more deeply embedded in tissue.

The next and most significant development was the introduction of the retrievable IVC filter, specifically designed as a temporary measure to be removed as soon as the threat of blood clots forming has passed.

IVC Filter Complications

There have been criticisms that retrievable IVC filters are not as strong as the permanent devices and may be prone to fracture. There have been numerous IVC filter lawsuits that allege failure of the IVC filter, either due to the fracture of struts that may migrate through the bloodstream to vital organs, or the migration of the filter itself to the lungs or heart.

Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in lawsuits regarding allegedly defective medical devices, including IVC filters.

The U.S. Food and Drug Administration (FDA) has received at least 900 reports of problems filed with the agency’s Adverse Events Reporting System (AERS). Most of these reports involved device fracture, migration, or failure. The FDA responded in May 2014 by determining that the risk for adverse events linked to the IVC filter increased the longer the device is left in the body. The FDA released a statement indicating that IVC filters should be removed recommending the window for removal between 29 and 54 days, following initial implantation.

Some delayed complications of IVC filters, aside from migration to another part of the vein or body include, device infection, deep vein thrombosis, blockage or swelling in the legs, filter breakage, and perforated organs.

In April 2015, a study published in JAMA (Journal of the American Medical Association), seemed to verify the FDA’s concern. The agency suggested the IVC filters were not as effective in the prevention of blood clots as blood thinners, considering that IVC filter patients may be twice as likely to experience blood clot migration, as those on anticoagulants.

Complications of IVC Retrieval

When the IVC filter is removed, complications may include blood vessel perforation, large clots in the filter that may prevent removal, difficult removal that may require long surgery times, and scars in the vein that may prevent removal.

Taking into account the FDA’s claim that IVC filter complications increase the longer the filter is left in place, some reports imply that in the majority of cases, retrievable filters are not removed, and no doubt, not within the recommended retrieval time. In numerous cases, an attempt to remove an IVC filter has failed because the device became embedded in tissue, or migrated so close to vital organs, removal is considered too great a risk.

IVC Filter Legal Issues

A study published in the Journal of Vascular and Interventional Radiology concerning a study conducted by researchers in 2015 at the University of Colorado, suggested that all models of the Cook Celect filter made by Cook Medical showed a higher risk for perforation than all other IVC filters manufactured by competitors.

C.R. Bard is one of the competing manufacturers and makes the Bard IVC filter. The Bard Recovery filter was available in 2003, but soon proved to be failure-prone. Some years later, the Bard G2 IVC filter was introduced with allegedly numerous improvements with reduced tendency to fracture.

IVC Filters – Risks May Outweigh Device's Benefits
IVC Filters – Risks May Outweigh Device’s Benefits

However, plaintiffs associated with many IVC filter lawsuits, claim the Bard G2 filter is no better than the Recovery filter it was meant to replace. Both IVC filters allegedly have equally high rates of failure.

For some individuals, the IVC filter may be a life-saving device. However, the complications with the use of IVC filters have made the FDA, patients, and doctors question if the benefits outweigh the problems.

Legal Advice and Information for Recipients of an IVC Filter

If you or someone you know suffered injuries associated with the use of an IVC filter, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please contact Parker Waichman medical device attorneys at 1-800-YOURLAWYER (1-800-968-7529).