December 2005 Bard Composix Kugel Mesh Patch Recall

Source | FDA 

Class 1 Recall: Bard® Composix® Kugel® Mesh X-Large Patch

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

(If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall.)

Use:

The Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

Reason for the Recall:

The “memory recoil ring” that opens the Composix® Kugel® Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Do I Have a Kugel Mesh Patch Lawsuit?

If you or a loved one has suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection or an unfortunate loss linked to the Kugel Mesh Patch, you should contact us immediately. You may be entitled to compensation and we can help.

Kugel Mesh Patch Lawsuit