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Composix Kugel Hernia Mesh Patch
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.
Fast Facts
| Device name: | Composix Kugel Mesh Patch |
Groin - The area where the upper thigh meets the torso. More specifically the groin in the fold or depression in the juncture between the lower abdomen and the inner part of the thigh. See our Hernia Glossary |
| Manufacturer: | C.R. Bard | |
| Approved uses: | Repair of ventral (incisional) hernias caused by post-surgical thinning or stretching of scar tissue. | |
| Malfunctions: | The patch's "memory recoil ring" may break under the stress of intra-abdominal placement, leading to ruptured bowels and/or recurring intestinal fistulae. | |
| Related topics: | DES - Drug-Eluting Stents, Guidant defibrillator | |
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...
Read More at the Composix Kugel Hernia Mesh Patch BlogHernia 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,... read more
Composix Mesh Hernia Patches Can Cause Intestinal Fistulae
Patients who have had surgery within the last two to three years might be at risk for serious complications and even death due to recently-recalled Bard Composix Kugel Mesh Patches. The patches,... read more
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Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion
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