Kugel Mesh Patch Recalled After Product Defect was discovered

Bard Kugel Mesh Patch defect - product recall


In January 2007 Kugel Mesh Patch, manufactured by Bard, was been recalled after reports of a defect where the patch's "memory recoil ring" breaks under stress, leading to ruptured bowels and/or abnormal passages from the intestine to either an internal organ or the body surface.

These hernia mesh patches are used in the repair of incisional (ventral) hernias. They are inserted behind the hernia through a small incision point and are intended to reinforce scarred or thinned areas that can present additional hernia dangers. This product was originally recalled back in December 2005.

Bard's patented "memory recoil ring" failed to open in some models of the Composix Mesh Patch, leading to product failure and putting patients at risk of further hernias, complications, surgeries, and even death. Side effects of unopened Composix hernia mesh patches include punctured organs, bowel rupture, and intestinal fistulae.

Symptoms may include "unexplained or persistent abdominal pain, fever, tenderness at the surgery site or other unusual symptoms. Product Codes which are affected are 0010202 and 0010204.

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