Product News and Recalls

FDA warns about blood clot filters

A report in the Boston Globe concerns a U.S. Food and Drug Administration warning that filters meant to stop blood clots from reaching the lungs can move or break, with potentially deadly consequences for patients.

The FDA issued an advisory to doctors and patients, informing them that the agency had received more than 900 reports about the devices since 2005. The filters, which are inserted in an abdominal vein, have spidery metal legs designed to catch migrating clots before they reach the lungs.

Although some are permanent, many are removable and designed for short-term use, the story says. When they’re left in too long, they can migrate and pieces can break off – drifting through the bloodstream and perforating vital organs, including the heart.

The report quotes an FDA official as saying that many of the filters likely stay in too long either because doctors fail to follow up, or because they don’t understand the risks of leaving them in. The FDA advises that once patients are no longer at risk of blood clots, doctors should consider removing the filters.

The Boston Globe reports that about 30,000 filters are implanted each year. Problems have been reported with all available brands.

A report in the Archives of Internal Medicine specifically mentions filters made by a division of New Jersey-based C.R. Bard Inc. Of 80 patients at a hospital in York, Pa., who received the Bard filters, 16 percent suffered a filter break. That increased to 25 percent among patients who received an older version, which the report describes as an “astounding rate.”

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.boston.com/business/healthcare/articles/2010/08/10/fda_warns_clot_filters_pose_risks/