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Composix Kugel Mesh Patch Removed from Market
The Composix Kugel Mesh Patch was removed from the U.S. market on December 22, 2005. The Composix Kugel Mesh Patch is used for ventral or incisional hernias and is manufactured by Davol, Inc., a division of C.R. Bard. The device was recalled because the "memory recoil ring," which opens the patch after it has been inserted into the intra-abdominal space, can break.
The plastic coil ring is designed to aid in its deployment but can break when increased stress is placed on it from certain surgical placement techniques. As of the recall date, the company received 24 reports of broken rings with the product. A malfunction of this device can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
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If you or a loved one had hernia surgery where a Kugel Mesh was used, the FDA recommends seeking medical attention immediately if symptoms that could be associated with ring breakage exist. These symptoms include persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms. If you or a loved one has been injured by a Composix Kugel Mesh Patch device, please contact the Law Office of G. Patrick Jacobs for a free case evaluation.