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Spangenberg Shibley & Liber LLP | Oct 9, 2015

Delayed Complications of Bard IVC Filters

Categories: Product Liability

The Bard inferior vena cava filter has been the subject or recent lawsuits related to injury and harm suffered as a result of the device. The IVC filter is a small cage-like device made up of tiny metal wires which are meant to trap blood clots before they reach the lungs. While blood thinning drugs are still the first line of defense for a patient with a blood clot, there are some patients who are unable to take the drugs or who are victims of trauma. In these cases the IVC filter is placed in the largest vein in the belly which returns blood from the legs to the heart. When IVC filters were first used, they were permanent; later, retrievable filters gained popularity. Unfortunately, many of these retrievable filters—which are meant to be left in place from 3-8 weeks—are being left in patients permanently, resulting in a number of serious, even fatal complications.

FDA MAUDE DATABASE INCLUDES IVC ADVERSE EVENT REPORTS

Adverse reports in the Maude database between 2002 and 2005 for IVC filters found sixteen cases of IVC filters which had migrated to a patient’s heart. In two patients, the IVC filter migrated to another location in the body, three patients suffered IVC perforation, five patients experienced excessive bleeding as a result of the IVC filter and eight patients experienced filter fractures. The Maude database contains medical device reports submitted to the FDA by mandatory reporters such as manufacturers, as well as voluntary reporters including patients, consumers and health care professionals.

The FDA uses these medical device reports to detect potential safety issues related to medical devices. Between 2002 and 2015, more than 1,000 adverse event reports were sent to the FDA regarding IVC filter complications. Most of these adverse event reports were for Bard G2 Express Filters, Bard G2 Filters and Bard Recovery Filters, Bard Eclipse Filters and Bard Meridian Filters and the Cook Gunther Tulilp and Cook Celect IVC filters although the following IVC filters are also in use:

  • B Braun Tempofilter IVC filter
  • Cordis OptEase IVC filter
  • ALN IVC filter
  • Rex Medical Option IVC filter

MIGRATION OF IVC FILTERS

IVC filters can migrate from where they are implanted to another area of the inferior vena cava, to the pulmonary outflow tract, or to the heart. When migration of an IVC filter occurs, removal is attempted via a loop snare or other retrieval devices. Should the IVC filter migrate to the heart valve, right ventricle or pulmonary outflow, retrieval can become impossible, requiring surgery.

DEEP VEIN THROMBOSIS CAUSED BY IVC FILTERS

While Bard IVC filters are known to decrease the incidence of pulmonary embolism, the device may actually increase the risk of deep vein thrombosis. One study found a 40 percent incidence of deep vein thrombosis after an inferior vena cava retrievable filter was implanted among patients with no evidence of DVT prior to the filter implantation. In another study of trauma patients, 44 percent developed deep vein thrombosis following the implantation of an IVF filter.

COMPLICATIONS OF BARD RETRIEVABLE IVC FILTERS

The Bard retrievable IVC filters, as well as other manufacturer’s retrievable IVC filters, are not designed to be long-term solutions. As soon as a patient’s risk for pulmonary embolism has decreased, the temporary filter should be removed. According to the FDA, the primary cause of complications related to the retrievable IVC filters, are due to the filters remaining in patients’ bodies long after the blood clotting problems are over. Some serious IVC retrievable filter side effects include:

  • Heart or chest pain;
  • Pulmonary embolus;
  • Death;
  • Migration of the filter;
  • Perforation of the heart, lungs, blood vessels or kidneys;
  • Erosion into the inferior vena cava;
  • Bleeding or fluid buildup around the heart, and
  • Broken filter fragment embolization.

If you or a loved one suffered injuries after having a Bard IVC retrievable filter implanted, you may be able to seek compensation. If you would like to speak with one of our attorneys about your rights and legal options, contact our office right away by calling us at (877)-696-3303 or by filling out this form. It is in your best interests to act quickly. There is a time limit in each State for filing injury claims known as the Statute of Limitations. If a claim is not filed against the manufacturer, marketers, retailers and healthcare providers before the statute of limitations expires, an injured party will not be able to bring a claim against those liable for their injuries.