Kugel Mesh Hernia Patch Recall
Attorney
(866) 735-1102 Ext 590
The FDA has issued a recall notice regarding the Bard Composix Kugel Mesh Patch. These devices were used to repair ventral hernias caused by thinning or stretching of scar tissue that occurs around incisions after surgery. The working component of the patch is a "memory recoil ring" that causes the patch to spring open after surgeons fold it flat in order to insert it into the body.
Sadly, this "memory recoil ring" that is so critical to the the Bard Composix Kugel Mesh Patch is prone to breakage during the stress of placing it inside the body. Should this device break, it can cause a number of serious and potentially life-threatening complications, such as bowel perforation and/or chronic intestinal fistulae, or abnormal connections of passageways between intestines and other gastrointestinal organs.
The following are the batches of the Bard Composix Kugel Mesh Patch
Bard® Composix® Kugel® Extra Large Oval, 8.7" x 10.7", all lot numbers
Bard® Composix® Kugel® Extra Large Oval, 10.8" x 13.7", all lot numbers
Bard® Composix® Kugel® Extra Large Oval, 7.7" x 9.7", all lot numbers
Bard® Composix® Kugel® Oval, 6.3" x 12.3", all lot numbers
Bard® Composix® Kugel® Large Oval, 5.4" x 7", lot numbers 41L, 41M,41N, 43L, 43M, 43N
Bard® Composix® Kugel® Large Circle, 4.5", lot numbers 41L, 41M, 41N, 43L, 43M, 43N