IVC Filter Complications: Patients File Suit Over Filter Risks, Side Effects

IVC Filter Complications: Patients File Suit Over Filter Risks, Side Effects 2018-12-07T11:58:12+00:00
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IVC filters have been linked to a wide range of severe complications, including:

  • Filter fractures
  • Migration
  • Vein and internal organ perforation

Eligible patients may be able to file a product liability lawsuit. Learn more about your legal options in a free consultation.

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IVC filters have been linked to a wide range of severe complications, including:

  • Filter fractures
  • Migration
  • Vein and internal organ perforation

Eligible patients may be able to file a product liability lawsuit. Learn more about your legal options in a free consultation.

24/7 IVC Filter Consultations

866-521-0396

I have the utmost confidence in my clients. They deserve a strong advocate.

— Laurence Rosen, Esq.
"Thank you." Laurence is a compassionate and honest man.
Rosen Injury Lawyers Reviewed by Walter H. on .
Rating: 5.0 ★★★★★

Over the past two decades, IVC filters have been linked to a wide range of severe complications. Thousands of patients have filed product liability lawsuits over these complications, accusing major medical device manufacturers like Cook Medical and C.R. Bard of concealing the true risks of IVC filters from the public and the medical community.

Lawsuits: IVC Filters Fail, Fracture At Extraordinary Rates

Implanted in the body's largest artery, the inferior vena cava, IVC filters feature a small basket of metal wire struts designed to catch blood clots as they travel along with the flow of blood. IVC, or inferior vena cava, filters are usually implanted in patients who live at an increased risk for pulmonary embolism or deep vein thrombosis, though some doctors also use them in trauma patients, who live at an increased risk for developing blood clots.

Physicians Preparing For Surgery

At the same time, injury and complication reports have piled up. The US Food & Drug Administration ("FDA") has received hundreds of reports of severe IVC filter complications, including filter fracture, filter migration (movement out of position), vein and internal organ perforation and embolization, in which the implant or its fragmented components flow into the heart or lungs.

The FDA has advised surgeons to remove filters immediately after the risk for pulmonary embolism has passed, as complication rates seem to increase the longer an implant remains inside the body. But removal can be difficult, especially after IVC filter complications have been identified.

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Filter Tilt Increases Risk Of Pulmonary Embolism

Removal is especially hard after the filter has tilted to one side inside the vein. Filter tilt, defined as a tilt greater than 15º from the axis of the inferior vena cava, also increases the risk for pulmonary embolism, according to researchers in the Archives of Surgery. While newer, retrievable filters have been designed to reduce the risk of tilting, several models of IVC filter, including C.R. Bard's Recovery and G2 filters and Cook Medical's Günther Tulip, are still prone to this complication.

Once a filter has tilted, it becomes extremely difficult to remove. Filter tilt can result in perforations of the inferior vena cava, with the device becoming embedded in the vein wall. A number of plaintiffs, in recent IVC filter lawsuits, allege they were forced to undergo open surgical procedures after suffering this form of complication.

Vein & Organ Perforation

Several studies have suggested that up to half of all IVC filter patients experience complications, including perforation, in which one or several of the filter's metal struts pierce the walls of the inferior vena cava.

IVC filter perforations can lead to chronic problems. In some cases, the perforating strut can extend to pierce other internal organs, including the small intestines. Many patients are alerted to the complication by gastrointestinal distress, as a strut punctures the intestine, causing inflammation, pain and diarrhea. Abdominal and back pain, however, are the most common symptoms. In combination with the use of anticoagulants, a perforation can lead to potentially-fatal internal bleeding.

Cook Medical Filters Perforate At High Rate, Studies Conclude

Some IVC filter models appear to perforate the inferior vena cava in the majority of cases. Compared to Boston Scientific's Greenfield filter, for example, Cook Medical's Günther Tulip and Celect filters pierce the inferior vena cava at an extraordinary rate. A 2013 study from researchers at Ohio State University found, after an average of 277 days implantation, 49% of patients with a Celect filter were suffering from an IVC perforation. The rate for Günther Tulip patients was similarly high at 43%. Over the same time period, the Greenfield filter was associated with only 1 perforation.

Asymptomatic Complications

Unfortunately, identifying complications can be extremely difficult. Some patients don't experience symptoms, even when the IVC filter has punctured the vein or begun to tilt dangerously out of place. The absence of symptoms does not indicate the absence of a problem. As authors explained in Cardiovascular Diagnosis & Therapy, "patients are usually asymptomatic. However, when adjacent structures are perforated by the filter, potentially severe clinical consequences may occur."

Other plaintiffs describe experiencing horrific, chronic pain, only to learn later from radiologic examination that their filter's struts have penetrated the inferior vena cava to impinge on other internal organs. Since pain and discomfort are the clearest indicators of a problem, it's unclear how many IVC filter patients have experienced complications.

Embolization

Embolization may well be the greatest risk associated with IVC filters. Ever since the technology was introduced, researchers have noted how IVC filters, after their implantation, can move inside the vein. In cases where the filter has moved 2 centimeters or more, researchers refer to the complication as "migration."

IVC filter migration can be deadly. In severe cases, entire IVC filters have been discovered inside the chambers of a patient's heart, impacting blood flow and respiration. This is known as "embolization." For obvious reasons, a full embolization of this sort can be deadly. Tragically, many wrongful death claims have been filed against IVC filter manufacturers, alleging that filter side effects caused the death of a loved one.

Shocking though it may seem, the first indication of a serious embolization can be cardiac arrest, a heart attack. Embolizations and migration are thankfully rare, though the G2 filter, manufactured by C.R. Bard, is associated with a 4.5% migration rate, according to researchers in Cardiovascular Diagnosis & Therapy.

IVC Filter Fracture Reports

Surprisingly more common is filter fracture, when the IVC filter fails inside the vein and begins to break apart. In many cases, IVC filter fracture leads to another complication, embolization, as fragments of the broken filter make their way toward the heart and lungs. Even in cases where the broken filter's components do not embolize, surgeons generally recommend filter removal after a fracture has been identified.

A 2014 review of FDA adverse event reports found that filter fractures are most commonly reported in relation to C.R. Bard's G2 filter series. This finding has been confirmed through additional studies, including one report in which 13% of Bard Recovery and G2 filters were found to have fractured in at least one strut. In at least 5 of these patients, the fractured strut had embolized to the heart. In any event, filter fractures are far more common with newer, retrievable filters than their permanent counterparts.

IVC Filters May Increase Risk For Deep Vein Thrombosis

Perversely, IVC filters may even increase the risk for deep vein thrombosis, one of the very conditions they are meant to treat. To date, there has only been 1 randomized controlled trial to assess the safety and efficacy of IVC filters. The trial, referred to as PREPIC, compared medical outcomes in IVC filter patients to outcomes in patients who were treated for deep vein thrombosis via anticoagulants alone. After 8 years, a team of French researchers could find no difference in morality between both groups of patients. IVC filters, in other words, saved no more lives than traditional anticoagulants, according to these findings.

Worse yet, the use of IVC filters appeared to increase the risk for deep vein thrombosis. While the researchers noted a decreased incidence of pulmonary embolism in patients with IVC filters, they were forced to conclude that "systematic use in the general population with venous thromboembolism is not recommended."

Other studies have come to a similar result, finding that, paradoxically, IVC filters seem to increase the risk for deep vein thrombosis. While studies vary, the risk for deep vein thrombosis in IVC filter patients hover between 13% and 40%. In one study of trauma patients, published in the Journal of Trauma and Acute Care Surgery, an astounding 44% of 64 patients developed a deep vein thrombosis after filter placement. In their lawsuits, injured plaintiffs argue that this increased risk of deep vein thrombosis was not properly communicated to patients and health care providers.

IVC Filter Risks Increase Over Time

It's likely, say researchers in Seminars in Interventional Radiology, that this risk increases over time. As a rule of thumb, this is true for all IVC filter complications. As the FDA has repeatedly stressed, IVC filter risks increase the longer the filter is implanted. According to the published literature, FDA experts say, IVC filter complications, including fracture, embolization and perforation, increase both in incidence and severity the longer a filter remains inside a patient.

As a result of this finding, the FDA in 2014 announced new safety guidelines for physicians. According to the FDA, IVC filters should be removed from patients as soon as possible after the risk of pulmonary embolism has subsided.

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