Since late 2005, several different recalls have been issued for the Composix Kugel Mesh Patch over product defects. The FDA sent Advisory letters were sent to the Chief of Surgery, Hospitals, and distributors warning of the . The patches, which are used in the treatment of ventral hernias, have flexible recoil rings that allow the device to be folded for insertion through a small incision and then spring back into shape once in place. The Food and Drug Administration, as well as our firm, has received numerous reports of these rings breaking and exposing rough, jagged edges—a problem that could lead to serious internal injuries in those implanted with defective devices. The problems and risks may not be limited to the recalled batches and have affected Ohio and Cincinnati residents.
Saturday, July 26, 2008
Kugel Mesh Injuries
Since late 2005, several different recalls have been issued for the Composix Kugel Mesh Patch over product defects. The FDA sent Advisory letters were sent to the Chief of Surgery, Hospitals, and distributors warning of the . The patches, which are used in the treatment of ventral hernias, have flexible recoil rings that allow the device to be folded for insertion through a small incision and then spring back into shape once in place. The Food and Drug Administration, as well as our firm, has received numerous reports of these rings breaking and exposing rough, jagged edges—a problem that could lead to serious internal injuries in those implanted with defective devices. The problems and risks may not be limited to the recalled batches and have affected Ohio and Cincinnati residents.
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