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Cook Celect IVC Filters Linked with High Rate of Strut Perforation and Other Dangerous Side Effects

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In June 2015, researchers published a new study on Cook IVC filters. They compared the Cook Celect with the Option filters, and reported the results. Those results raised concerns in the medical community that certain IVC filters, which are used to help prevent pulmonary embolism (“PE,” or blood clot in the lung), may present greater risks than benefits in certain situations.

Study Shows Cook Celect More Likely to Result in Perforation

For examples in one study, researchers followed 99 patients who were implanted with a temporary Cook Celect IVC filter, and 86 patients who were implanted with a temporary Option filter. The study went for 33 months and was conducted at a single medical institution.

Results showed the following:

• After an average of about two months, 59 percent of patients with Celect filters and 74.7 percent of patients with an Option filter came back to have the filters removed.
• Doctors were unable to retrieve the filters in 3.4 percent of patients with the Celect, and 7.7 percent of the patients with the Option.
• The filters were found to have significantly “tilted” in 5.4 percent of Celect patients, and 18.3 percent of Option patients.
• At least one “strut,” or small component of the Celect filters, broke off and perforated the vein in a total of 43 percent of Celect filters, and none of the Option filters.

Researchers concluded that most outcomes with the two filters were similar, though the Option required more time and techniques to remove. The one thing that was glaringly different was the rate of strut perforation. “The Celect filter had a significantly higher rate of strut perforation,” the authors wrote. Strut perforation can result in the leg or legs of the filter to pierce through bodily organs or structures. Strut perforation can cause significant pain, nausea and vomiting and other serious complications. It can also lead to a need for further surgeries. Even worse, in other cases, surgery can be difficult or impossible.

In another recent 2015 study found that in patients at risk for PE who could take anticoagulant drugs, IVC filters offered no additional benefits.

The Cook Celect IVC (inferior vena cava) filter is a small cage-like device that is implanted into the vena cava, the main vein that takes blood from the lower legs back to the heart. Patients at risk for PE, such as those with deep vein thrombosis, who can’t take blood-thinning drugs, may be treated with such a device to lower risk of a potentially fatal blood clot.

These and other studies however, have raised concerns about these devices. In 2010, the FDA released a safety communication warning physicians and patients that IVC filters had been linked to the following potential side effects:

• Part of the device perforates the vein
• The device moves or “migrates” to another part of the body
• Certain parts of the device detach and create a blockage
• The device fractures

Between 2005 and 2010, the FDA received over 900 reports of IVC causing these types of problems.  In 2014, they released an updated communication stating that after further analysis, they had found it best for these filters to be removed between 29 and 54 days after implantation—potentially much sooner than often happens in clinical settings.

Patients May Recover Damages in a Cook IVC Filter Lawsuit

Patients who were implanted with a Cook IVC filter and then suffered serious injuries may be able to recover damages through a Cook IVC filter lawsuit. In October 2014, all federally filed Cook IVC filter lawsuits were consolidated into the Southern District of Alabama. Over 100 cases are currently pending there.