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Tuesday, February 20, 2007

Kugel Recall

"On December 22, 2005 the FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Repair Patches and updated the list on March 31, 2006 and again on January 24, 2007. The Kugel Mesh Patch, used to repair ventral (incisional) hernias, was recalled because the 'memory recoil ring' that opens the Mesh Patch can break in the intra-abdominal (inside the belly area) space, which can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs). This can also lead to serious infection due to migration of a broken memory coil ring, which can require additional surgeries to repair a perforation caused by a broken ring, or even death."More...:

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