|Device name:||Composix Kugel Mesh Patch|
|Approved uses:||Repair of ventral (incisional) hernias caused by post-surgical thinning or stretching of scar tissue.|
|Related topics:||DES – Drug-Eluting Stents, Guidant defibrillator|
Bard Composix Kugel Hernia 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.