September 4, 2015: Bard and Cook IVC Filter May Malfunction, Cause Artery Perforation

IVC filters, a device made of small prongs that act like a cage for blood clots, are primarily used on patients at risk for blood clots in the lungs, also known as a pulmonary embolism. While these devices are ultimately very beneficial to most patients, in some cases the “cage-like” prongs may puncture the wall of the vein in which it was placed, or migrate to puncture blood vessels and organs.

Any of these occurrences could lead to internal bleeding, cardiac tamponade, deep vein thrombosis, pulmonary embolism, or death, according the U.S. Food and Drug Administration (FDA).

The FDA’s concerns are focused on two main medical device manufacturers. C.R. Bard and Cook Medical are the producers of the five allegedly problematic products:

• The Bard Recovery filter,
• The Bard G2 filter,
• The Bard G2 Express filter;
• The Cook Gunther Tulip filter,
• The Cook Celect filter.

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The Weinberg Law Firm is currently assisting individuals injured by medical devices, including vaginal mesh, power morcellators, IVC filters, and endoscopes/duodenoscopes as well as other devices. Mr. Weinberg also serves as local counsel for mesh lawsuits filed against manufacturers C.R. Bard and Johnson & Johnson consolidated in New Jersey Superior Court in Bergen County.

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Details of Bard IVC Filter and Cook IVC Filter Flaw

According to a 2015 study published in the Journal of Vascular Interventional Radiology, versus the Option filter, the Cook Celect filter had a 43 percent rate of perforation (puncturing the wall of the vein) versus a competitor’s filter, which had a zero percent perforation rate.

The Bard Recovery Filter likewise stands out as particularly susceptible to complications. In the words of Bard’s own internal study, “Recovery demonstrates a consistent, statistically significant and potentially clinically important higher rate of reporting of adverse events in many analyzed categories.”

The Recovery filter has been connected to at least 27 deaths, and many more non-lethal complications, since receiving FDA approval. Furthermore, a NBC News investigation of C.R. Bard found the device manufacturer may have known about the filter’s major flaws as early as 2002.

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In the last decade, there have been 921 device adverse events associated with IVC filters reported to the FDA. In response to these dangerous malfunctions, the FDA warned that the risk of adverse effects could be significantly lowered if retrievable IVC filters are removed as soon as the patient’s risk for blood clots subsided. However, in reality, according to the National Center for Biotechnology Information, a majority of retrievable IVC filters are never retrieved, which increases the chances of complications.

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