Kugel Mesh Patch News

History of Hernia Patch Raises Questions on Implant Recalls

By BARRY MEIER

Published: March 16, 2007

How do makers of implanted medical devices react when one of their products starts breaking?

One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient's internal organs and tissue.

At the time, Bard executives said they knew about some serious injuries potentially caused by the device, which is known as the Kugel patch. Since then, the Food and Drug Administration has received reports of more than 80 injuries and other problems possibly related to it, including several fatalities.

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Recalls:

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion
Date Recall December 22, 2005
Initiated:
Product: *This recall notice was updated on January 24, 2007, to include additional product codes and lot numbers recalled by the manufacturer since the first list was issued. The expanded list below includes all recalled product codes and lot numbers.*

Class 1 Recall: Bard® Composix® Kugel® Mesh Patch
*This recall notice was superseded with an updated notice on January 24, 2007, to include additional product codes and lot numbers recalled by the manufacturer.*
Date Recall December 22, 2005
Initiated:
Product: *This recall notice was updated on March 31, 2006, to include additional product codes and lot numbers recalled by the manufacturer since the first list was issued. The expanded list below includes all recalled product codes and lot numbers.*

Class 1 Recall: Bard® Composix® Kugel® Mesh X-Large Patch
Date Recall December 22, 2005
Initiated:
Product: Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:

• 41XMXXXX – M = 2002
• 41XNXXXX – N = 2003
• 43XMXXXX – M = 2002
• 43XNXXXX – N = 2003
• 43XOXXXX – O = 2004
• 43XPXXXX – P = 2005