Product News and Recalls

Filters linked to dangerous blood clots

According to a report on MedPage Today, the use of inferior vena cava (IVC) filters caused a significantly higher risk of potentially fatal blood clots during bariatric – or weight-loss – surgery.

The report says venous thromboembolism, or the blockage of an artery by a blood clot, occurred in 1.8 percent of 1,045 patients who received filters, versus 0.4 percent of another group with similar risk factors. Of the two groups, 0.07 percent of the filter recipients died within 30 days, compared with 0.02 percent who did not receive the filters.

The report notes that concern about potential risks associated with IVC filters prompted the U.S. Food and Drug Administration to issue a safety alert in 2010, stating that the agency received almost 1,000 adverse event reports related to IVC filters since 2005.

According to the FDA, most of the reports involve filters that migrate elsewhere in the body, block arteries, perforate arteries, or fracture. A study conducted by the New England Society for Vascular Surgery found that 31 percent of the IVC filters fracture.

The IVC filter is a small, cage-like device implanted in a major vein that runs from the legs to the heart, designed to catch blood clots before they travel to the lungs.

The FDA recommended that physicians and surgeons consider removing retrievable IVC filters, and encouraged close follow-up testing of all patients who had a filter.

According to MedPage Today, investigators from the Michigan Bariatric Surgery Collaborative made note of IVC-related complications a year or two before the FDA alert.

Jonathan D. Finks, MD, reported the findings about bariatric surgery in San Diego at a recent meeting of the American Society for Metabolic and Bariatric Surgery.

The report quotes Finks as saying: “In bariatric surgery, the risks of IVC filter insertion exceed the benefits and their use should be discouraged.”

If you’ve received an IVC filter, you should consult with a doctor if you have any ongoing symptoms or health concerns. If you have significant injuries, you should also consult with an IVC filter lawyer to discuss your legal rights.

See the story here:

http://www.medpagetoday.com/MeetingCoverage/ASMBS/33406