Tag: IVC Filters

ivc filter symptoms

IVC Filter Symptoms FAQ

What Is An Inferior Vena Cava Filter?

The inferior vena cava filter (IVC filter) is an umbrella-shaped medical device with legs intended to prevent blood clots from migrating from the lower ranges of the body to the heart or lungs. IVC filters are inserted into the largest vein in the body, the inferior vena cava, where the legs of the device attach themselves into the walls of the inferior vena cava via small hooks on the end of each leg. The umbrella portion of the device then “catches” any blood clot and prevents it from traveling to the heart or lungs.

Who Receives IVC Filters?

IVC filters are designed for patients who are unable to take blood thinners to reduce the threat of blood clots. This includes patients who have sustained extreme trauma like puncture wounds or patients who have undergone surgery.

What Are Side Effects of Receiving an IVC Filter?

Some of the most common side effects of an IVC filter include bleeding, fever or chills, shortness of breath, chest pain, dizziness, nausea, and vomiting. If you experience one or more of these symptoms after having an IVC filter implanted, immediately seek medical attention.

What Happens When An IVC Filter Fractures?

Some IVC filters are now known to have an increased risk of fracturing while in the body. As an IVC filter remains in the body, it can be slowly worn down, causing the device to fracture. IVC filter fracture can be life threatening for the patient if the fractured pieces travel through the body.

What Is An IVC Filter Embolization?

When an IVC filter fractures, the broken pieces can sometimes travel through the blood stream, called embolization, and puncture internal organs like the heart or lungs. When this occurs, it can cause permanent damage and removal of the fractured pieces may be impossible.

Can An IVC Filter Move Throughout the Body?

While IVC filters are intended to be stationary inside the body, they can sometimes become detached and migrate through the body. The device’s migration can cause it to get attached to other organs and it may not be possible to remove once this occurs.

Do IVC Filters Damage the Inferior Vena Cava Walls?

IVC filters are designed to only attach themselves to the outer layers of the inferior vena cava wall; however, some IVC filters completely puncture the inferior vena cava wall, which can cause internal bleeding in addition to other serious side effects.

What Are Complications That Can Occur After An IVC Filter Fails?

When an IVC filter fails, it can cause permanent and life threatening injuries. A failed IVC filter can cause internal bleeding, chronic chest pain, hemorrhaging, lacerations in the heart, deep vein thrombosis, permanent damage to critical organs, and even death. For many patients who suffer from a failed IVC filter, removal of the device requires open surgery, or may not be possible at all.

What Has The FDA Said About the Safety of IVC Filters?

In 2010, the Food and Drug Administration (FDA) reported that between 2005 and 2010, they received over 900 reports of device failure from IVC filters. The FDA recommended removing the device immediately after the threat of blood clots had passed. In 2014, the FDA updated their initial safety statement from 2010 to advise doctors to remove IVC filters between 29 and 54 days after insertion. The FDA also warned that the risks of device failure greatly increased the longer the IVC filter remained in the body.

Are There Any Alternatives To IVC Filters?

Some patients might be prescribed anticoagulants like Pradaxa and Xarelto that work to prevent the blood from clotting, thereby reducing the risk of blood clots traveling into the heart and lungs. However, these medications have been shown to cause their own set of complications.

IVC Filter Lawyers

If you or someone you know suffered serious complications or death after the implantation of an IVC filter, you may be eligible to receive compensation. Let the experienced medical device litigation attorneys at Raizner Slania evaluate your claim and fight for the compensation you deserve in an IVC filter lawsuit. Contact Raizner Slania today for a free and confidential consultation.

Bard IVC Filters

Bard IVC Filters – Problems With The FDA

Inferior vena cava (IVC) filters are medical devices implanted to eliminate or catch blood clots before they travel through the bloodstream to the lungs or the heart. The Food and Drug Administration (FDA) issued a safety communication in 2010 after receiving nearly 1,000 reports of significant complications caused by implanted IVC filters.

An IVC filter should be removed after a set period of time; however, in many cases, the devices stay in the vein for too long and dangerous side effects occur.

If an IVC filter is left in place for too long, the following can happen:

  • IVC filters may move, migrate, and/or change position, causing damage to internal organs
  • IVC filters may perforate or erode into other veins, damaging them
  • Parts of IVC filters can break off, travel through the bloodstream and damage the heart or lungs
  • IVC filters can become clogged with clots that impede blood flow to the heart
  • A doctor may be unable to remove IVC filters at all

Medical Research and The FDA Find Fault With Bard IVC Filters

In one study that took place between 2004 and 2009, 80 people who had been implanted with Bard IVC filters were given a fluoroscopy check up on the status of their filters. The fracture rates for the filters were found to be 25 percent with first generation devices, and 12 percent with second-generation devices.

The FDA sent a warning letter to C.R. Bard, one of the most prolific manufacturers of IVC filters, because the company did not address or correct violations found at its facilities. The FDA had previously cited Bard for the issues. Questions arose as to the level of adherence to Quality System Regulations, notably this misclassification of serious IVC filter injuries and deaths as “device malfunctions.”

NBC News investigated Bard IVC filters, and questioned Bard’s internal process to clear its IVC filters for market. A company insider revealed that the FDA failed to approve one application for the device. After that misfire, Bard recruited a regulation specialist to help it gain the necessary clearance with the federal agency. The specialist ultimately was concerned about the safety of the IVC filters and refused to sign the application paperwork. An allegation of the forgery of her signature on the documents was later levied.

Raizner Slania, Handling Bard IVC Filter Injury and Death Claims Nationally

If you or somebody you know had an IVC filter implanted, you may have a legal claim and can potentially reach an IVC filter lawsuit settlement. Contact the experienced defective medical device lawyers of Raizner Slania for a free and confidential consultation about your concerns.

IVC Filter

IVC Filter Lawsuit Settlements

Lawsuits involving Bard and Cook IVC filters have been underway for a few years. Recently, a few of these cases were settled, one of which during trial.

In October 2014, several federal court IVC filter lawsuits were consolidated into multidistrict litigation. Since that time, now at least 56 lawsuits are on file in the Bard MDL (In Re: Bard IVC Filters Products Liability Litigation, MDL 2641) and at least 133 lawsuits have been filed against Cook Medical in MDL 2570 (In Re: Cook Medical, Inc., IVC Filters Marketing, Sales, Practices And Products Liability Litigation).

IVC Filter Claims That Have Been Settled

A Nevada IVC filter lawsuit where a patient implanted with a Bard Recovery Filter System had his organs perforated, requiring open heart surgery was recently resolved during trial.

IVC Filter
IVC Filter

While some courts have found in favor of the medical device manufacturers, several claims have been resolved positively for the injured plaintiffs. In Nevada, a Bard plaintiff filed suit after his implant migrated to his heart, requiring emergency open-heart surgery. Ten days into this year’s February trial, C.R. Bard settled with the plaintiff for a confidential amount.

Another confidential settlement was reached after 11 days of a Bard trial in January of this year. According to court documents in that case, the Recovery Filter fractured at a rate 28.3 times higher than all similar devices combined.

So far, no IVC filter lawsuits have gone to a verdict, but the first bellwether trials in the Cook Medical MDL have been requested for August 2016.

What’s So Bad About IVC Filters?

IVC filters are placed to prevent blood clots in certain patients. There is a growing body of clinical evidence regarding the association between inferior vena cava (IVC) filters and life-threatening health complications, even going so far as to question whether trauma patients really benefit from having these implants placed at all.

A June 2015 study in the Journal of Vascular Interventional Radiology found that Cook Celect IVC filters have a statistically significant risk of puncturing a major blood vessel and a 43% rate of perforation when compared to other types of filters.

The latest study on IVC filters was published in the October 2015 edition of the Annals of Surgery, where researchers analyzed 803 cases in which trauma patients were implanted with IVC filters. The research found that if these patients had their filters removed, they had an 83% increased risk of developing deep vein thrombosis (DVT), a type of blood clot. They also found that there was no increase in life expectancy with the implant versus without, indicating these devices may be largely prophylactic and without purpose.

Raizner Slania Handles Defective Medical Device Claims Nationally

Our experienced IVC filter lawyers are currently reviewing potential claims across the country. Plaintiffs may be entitled to compensation for medical expenses, lost income, lost future earning capacity, pain and suffering, and more.