FDA and Manufacturer Warnings for IVC Filters

Featuring small central pieces surrounded by a dozen or more wiry metal “legs,” IVC filters look a bit like tiny robotic spiders straight out of a sci-fi movie. While they may look like something to avoid, these strange-looking medical devices are a popular way to prevent thrombosis-related problems in patients who can't take blood-thinners or for whom blood-thinning medications don't work as well as needed.

Doctors laparoscopically insert the IVC filter in the groin or neck and guide it into place in the inferior vena cava, the longest vein in the body. Once implanted, the device's spider-like legs catch blood clots that could otherwise travel to:

  • the brain, causing a stroke
  • the legs, causing deep vein thrombosis
  • the lungs, causing a pulmonary embolism

While IVC filters have no relationship to evil robots or spiders, they're connected to a number of serious side effects and complications that are truly the stuff of nightmares. Before undergoing an IVC filter implantation surgery, learn about the warnings associated with these devices.

Contraindications

blood cellsIVC filters are most often used to prevent blood clots in trauma patients or in extremely obese patients awaiting other, more extensive surgeries. While these devices can be potentially life-saving for some patients, they're not for everyone.

For example, IVC filters aren't recommended for patients with congestive heart failure, or for patients who have an inferior vena cava diameter that exceeds 28 mm. A caval diameter exceeding 28 mm may make proper implantation and fixation of an IVC filter difficult. A larger vena cava might also make it easier for the device to dislodge and migrate to other parts of the body.

Additionally, doctors should check patients for blood clots at the insertion site, in the iliac vein, or in the inferior vena cava to ensure that clots aren't dislodged, causing embolism, during catheter manipulation and device placement.

Potential Adverse Events

Like any surgery, an IVC filter implantation surgery isn't without risk. There are a number of things that could potentially go wrong before, during, or after the surgery, including:

  • Incorrect or improper filter placement
  • Bruising or bleeding at the insertion site
  • Infections
  • Blood clots at the insertion site
  • Air embolisms during insertion
  • Perforation of the veins, blood vessels, or organs
  • Filter breakage
  • Filter migration
  • Blood clots that form on the filter, blocking the flow of blood
  • Pulmonary embolism caused by blood clot dislodgement during placement or removal
  • Death caused by clots that reach the lungs or heart

FDA IVC Filter Warnings

Approximately 250,000 IVC filters are implanted in the United States each year. After receiving numerous reports of adverse events associated with these devices, the U.S. Food and Drug Administration (FDA) has issued two warnings for IVC filters.

In an August 2010 advisory letter, the FDA recommended that doctors remove retrievable IVC filters, also known as temporary IVC filters, as soon as the threat of pulmonary embolism had passed.

Four years later, in May 2014, the FDA issued another advisory letter, this time recommending that IVC filters be removed between 29 and 54 days after insertion. According to this letter, the risks associated with IVC filters begin to outweigh benefits after just 30 days, and become hazardous when left in place longer than 54 days.

Despite these strong and specific FDA warnings concerning how long retrievable IVC filters should remain in the body, many doctors continue to leave them in much longer than recommended. Sometimes, doctors may not retrieve the retrievable IVC filters at all, potentially setting their patients up for serious and possibly deadly side effects and complications.

Are You Considering an IVC Filter Lawsuit?

If you suffered serious side effects or complications caused by a retrievable IVC filter, you may be facing a long recovery period and medical bills that are well beyond what you initially expected. Fortunately, you may be able to file a personal injury lawsuit to hold the manufacturer of your IVC filter accountable for your injuries. To determine if you have an actionable IVC filter lawsuit, as well as what types of damages you could potentially seek, call McGartland Law today to schedule an appointment for a free initial consultation.