Removable IVC Filter Injuries

The inferior vena cava (IVC) is a large vein in the abdomen, which returns blood from the lower body to the heart. An IVC filter is placed about 1mm below the lowest arterial branch below the heart to prevent blood clots. The device is typically shaped like an octopus with a small head and then branching limbs. It is designed to catch and break apart potential blood clots. The device is intended for patients with recurrent pulmonary emboli (PE) despite adequate therapeutic anticoagulation (blood thinning medication). It is also indicated for patients with deep vein thrombosis (DVT) or PE when anticoagulation is not recommended.

Permanent IVC Filters

The first IVC filters were permanent devices for people who were unable to take blood thinners, such as Coumadin (generic warfarin), Pradaxa (dabigatran), Xarelto (rivaroxaban), or Eliquis (apixaban). The filters on the market had been found to be effective and without serious complication so no need was found for any further products for permanent use.

The permanent IVC filters are designed to be left in a patient’s body and there is long-term follow-up data (20 years and longer) supporting their use. Complications of IVC filters include: aaccess site thrombosis, IVC thrombosis, migration (rare, but catastrophic), structural failure, and IVC perforation.

Temporary IVC Filters

In 2003, some IVC filter manufacturers began marketing temporary filters known as optional or retrievable filters. These retrievable filters were designed to be surgically removed after the risk of PE subsided. Initially, the window for filter retrieval was two weeks, but the retrievable filters have been marketed as permanent with a retrieval option.

Retrievable IVC Filter Injuries

Retrievable IVC filter injuries fit into three main categories: migration of the filter, fracture of the struts of the filter, and perforation. These injuries may not have immediate recognizable symptoms for a patient.

Since 2002-2003 when these devices first came to market, there have been a significant number of deaths and adverse events reported among patients with retrievable IVC filters. For instance, a study from 2011 showed that 40% of the Bard Recovery Filter resulted in fracture after 5.5 years. Bard’s G2 filter fractured after 5 years in 37.5% of units. Of Cook’s Günther Tulip and Celect Retrievable Filters, 40% tilted and 100% perforated (a vessel, organ, spine, etc.) after 71 days.

Migration

Migration of the device is dangerous from several standpoints. When the device moves downward (caudal) or upward (cephalad) or tilts/shifts, the device becomes difficult or even impossible to remove. This can lead to fracture of the device struts and loss of efficiency against clotting.

Fracture

Fractures of device struts are also dangerous. When pieces of the device break off, it can lead to emboli in the heart, lung, liver, or kidneys. Such fractures may result in serious injury or death.

Perforation

Perforation of the device occurs when one or many of the struts push into adjacent organs, vessels, and even the spine. These perforations make removal of the filter very difficult or impossible. The increased stress this change places on the body, and in turn, the filter, leads to an increased risk of fracture.

Speak to a Medical Device Injury Lawyer

If you’ve had an IVC filter implanted, our personal injury attorneys are interested in speaking with you. Call toll-free (888) 662-1210 for a free consultation.

Our attorneys have experience representing patients in pharmaceutical and medical device litigation against major manufacturers for allegedly defective drugs and medical devices such as Actos, Yaz, Risperdal, the Mirena IUD, GranuFlo, Eon spinal stimulators, and Medtronic defibrillators.