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The Kugel Mesh Hernia Patch has been recalled. Kugel Mesh Recall has been instituted by the FDA and the U.S. Food and Drug Administration reported that the Kugel Patch has a reasonable probability to cause serious adverse health consequences, including death. |
The Food and Drug Administration (FDA) ordered an immediate recall of Bard Composix® Kugel Mesh Hernia Patch on December 22, 2005 and updated the list of products on the hernia patch recall list once again on January 10, 2007.
One should note that the "memory recoil ring" that is the device that opens the Composix Kugel Mesh Patch insertion into the abdominal cavity area may allegedly break. The result of the coil breaking can cause bowel perforations and/or intestinal fistulae (abnormal connections or passageways between the intestines and other organs). This is why the Kugel Mesh Patch Hernia device has been recalled.
Patients should immediately seek advice from their physician or surgeon if they are experiencing symptoms related to the hernia surgery and the Kugel Mesh Hernia Patch. Such symptoms might include abdomen pain, fever, and sensitivity at the implant site or if other unusual symptoms are occurring.
The FDA is instructing doctors to cease use of the Kugel Patch and to comply due to the Kugel Mesh Recall instructions. Also, they are asked to return the unused or recalled Kugel Mesh Patch to the manufacturer.
Since the Kugel Mesh Hernia Patch has been recalled, we are now evaluating claims for all patients who have used this kugel patch in compliance with the Kugel Mesh hernia patch recall.