IVC Filters Not Meant for Permanent Implantation

IVC Filters Not Meant to Be Used for Permanent Implantation
IVC Filters Not Meant to Be Used for Permanent Implantation

What is an IVC Filter?

An inferior vena cava (IVC) filter is often prescribed for patients who are unable to take anticoagulants or for whom the drugs are not effective. The devices are also prescribed for other issues including when a patient is diagnosed with a blood clot or recurrent pulmonary embolism (PE), or a clot that may travel to the heart, lungs, or brains in patients diagnosed with deep vein thrombosis (DVT) or if a patient suffered a significant accident or injury such as a fall, gunshot wound, stab wound, car accident, or damage to the spinal cord. The tiny devices are meant to help ensure blood clots that may form do not travel to major organs; however, IVC filters have been associated with serious side effects.

Blood clots from the lower body may also occur following knee or hip replacement surgeries and may travel to the heart or lungs, which may lead to a PE. Should a blood clot travel to the lungs it may cause serious complications that include difficulty breathing, chest pain, or heart attack.

The U.S. Food and Drug Administration (FDA) approved IVC filters in 1979. Then, only 2,000 devices were implanted. By 2007, the number of IVC filter implantations rose to 167,000.

IVC filters are small medical devices that are inserted in the inferior vena cava, which is one of the body’s main veins. The human body has large veins known as the inferior vena cavas, which carry deoxygenated blood from the legs to the heart. The devices are “spider shaped” and look similar to a small cage. The filters are implanted in the IVC, are about one-and-a-half-inches in size, are constructed of metal, and are inserted into the IVC where they trap blood clots that may travel to the heart, lungs, and brain.

Typically, IVC filters are meant to remain in the body on a temporary basis and to be removed when the threat of blood clots is over. In the past, some IVC filters have been left in the patient’s body permanently or for extended time periods, which may lead to life-threatening complications.

IVC Filters Associated with FDA Warnings, Injuries

In 2010, the FDA warned that the long term use of IVC filters should be discontinued due to the risk of IVC filter damage and noted that it had received almost 1,000 adverse event reports in the prior five years. Of those injury reports, over 300 involved migration of the IVC filter, nearly 150 involved detachment of the filter’s components, 70 involved perforation of the IVC, and 56 involved fracture of the device.

The FDA noted that IVC filters are meant to be a temporary measure and warned physicians to consider the risks of these devices when discussing removal of the IVC filter. Four years later, in 2014, the agency updated the warning and recommended that retrievable IVC filters be removed between 29 and 54 days following implantation. Research has found that IVC filters’ risks outweigh their benefits should the filter remain in the body for more than two months.

The FDA noted that the most common IVC filter damage complications include:

  • Access site thrombosis
  • Caval penetration
  • Deep vein thrombosis (DVT)
  • Filter migration
  • IVC filter fracture
  • IVC thrombosis

Many of the IVC filters on the market were approved through the 510(k) clearance route. This method has been tied with controversy and is considered by many as a careless method in which to release a device to market. The regulatory route enables device manufacturers to receive approval for their devices without having to undergo clinical testing as long as the manufacturers are able to provide proof that their products are substantially equivalent to a previously approved product.

In one of the FDAs two warnings over IVC filter safety and efficacy, the agency indicated that IVC implants may break in a patient’s body and may potentially travel through the bloodstream and into vital areas of the body. This may potentially puncture veins and organs and pieces may become lodged in high-risk areas, including the intestines and in other areas of the body in which surgical removal is impossible, according to NBC News.

A number of patients have filed lawsuits against IVC manufacturers such as Boston Scientific, Cook Medical, Cordis Corporation, and C.R. Bard. Allegations include that IVC filters were defectively designed, according to The State Journal. Allegations also include severe pain, bleeding, and the formation of additional blood clots. These issues appear to be associated with the length of time the IVC filter remained in the patient’s body.

In 2016, a new Meridian IVC lawsuit was filed by a Virginia woman who joined over 1,000 plaintiffs in an IVC filter litigation brought against C.R. Bard. She alleges she suffered from complications after being implanted with the Meridian device in October 2012.

The first lawsuit brought against Cook Medical is scheduled for trial in early 2017.

IVC Filters Not Meant to Be Used for Permanent Implantation
IVC Filters Not Meant to Be Used for Permanent Implantation

Bard’s first IVC filter, known as the Recovery filter, was recalled in 2005 over increasing complication reports that included numerous deaths. Since then, Bard produced other IVC filter models and patients alleged similar issues. Thousands of other patients across the country allege suffering serious side effects associated with IVC filters such as device migration, device fracture, vena cava wall perforation, device embolization into vital organs (including a piece of the device). Judge David G. Campbell is overseeing the Bard IVC multidistrict litigation. In 2016 case selection was put forth to identify 50 cases suited to go to trial first from approximately 400 pending cases in federal court, according to The Legal Examiner. Bellwether trials are the preliminary cases brought to trial in a large litigation that enables both sides in the cases to determine how juries may react to presented evidence and legal arguments that would be seen should similar cases reach trial. When a trend is seen in bellwethers cases, a settlement may be quickly negotiated or the remaining cases may be brought to trial.

Filing an IVC Filter Lawsuit

If you or someone you know suffered injuries related to the use of an IVC filter implant, you may have valuable legal rights. Our IVC filter lawyers offer free, no-obligation case evaluations. For more information, call 1-800-YOURLAWYER (1-800-968-7529).