The Bard Composix Kugel Mesh hernia patch is used to repair ventral hernias. These hernias are caused by post-surgical thinning or stretching of scar tissue. The patch is generally inserted behind the hernia through a small incision; its "memory recoil ring" allows the device to be implanted while in a folded state, then spring open once it has been properly placed. The Food and Drug Administration (FDA) recalled issued a recall in December 2005 due to malfunctions of the patch's "memory recoil ring", which have been found to cause intestinal fistulae, punctured organs, and/or bowel rupture in some patients. The recall was updated in early 2007 when other product codes were found to have the same defect.
FDA Approves New Hernia Mesh Patch
The federal Food and Drug Administration (FDA) has approved the C-QURLite Mesh Patch, a hernia repair device produced by Atrium Medical.
Atrium Medical receives FDA approval for its...
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Hernia Patch Recall Affects Thousands of Patients
Ventral hernia sufferers are rushing to their doctors after hearing that the federal Food and Drug Administration (FDA) has issued an updated recall for Bard's Composix Kugel Mesh Patch. The patch, which is used in hernial repair surgeries, was first recalled in late 2005, but the FDA has posted another recall which affects more of the implantable mesh patches on the market. In its recent medical device recall alert, the FDA noted that the Composix hernia patch can break inside the intra-abdominal space of the patient's belly, causing chronic intestinal fistulae and bowel rupture or perforation.
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Composix Mesh Hernia Patches Can Cause Intestinal Fistulae
Defective "memory recall rings" that lead to punctured organs, bowel rupture, or dangerous intestinal fistulae. They are folded and placed through a small incision, at which point the "memory recall ring" engages, causing the patch to snap open to its full size and begin reinforcing the weakened hernia area. This failure can cause complications in the interabdominal cavity, some of which include bowel issues or even intestinal fistulae.
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Composix Kugel Hernia Mesh Patch Glossary
Hiatus Hernia
Ventral Hernia
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Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion
Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion
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Hernia mesh patch
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Incisional hernia
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