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Hernia Patch Recall Lawsuit

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The Bard Composix® Kugel® Mesh Hernia Patch, manufactured by Bard/Davol, has been voluntarily recalled due to potential life-threatening side effects.

What is the problem with the Kugel Mesh Hernia Patch?

The Kugel Mesh Hernia Patch is used to repair Inguinal, Ventral and Laparoscopic hernias. The patch is placed behind the hernia through a small incision. The patch then opens and places itself against the abdominal wall by a memory recoil ring. Unfortunately, the memory recoil ring can break under stress of placement of the larger products. The following are the specific dates of the recall:

  • December 22, 2005
  • March 31, 2006
  • January 24, 2007

The following products were included in the recall:

Extra Large Oval, 8.7” x 10.7”
All Lot Numbers manufactured before January 2006
Product Codes: 0010206

Extra Large Oval, 10.8” x 13.7”
All Lot Numbers manufactured before January 2006
Product Codes: 0010207

Extra Large Oval, 7.7” x 9.7”
All Lot Numbers manufactured before January 2006
Product Codes: 0010208

Oval, 6.3” x 12.3”
All Lot Numbers manufactured before March 2006
Product Codes: 0010209

Large Oval, 5.4” x 7.0”
All Lot Numbers manufactured before October 2005 & also Including the following:
41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
Product Codes: 0010202

Large Circle, 4.5”
All Lot Numbers manufactured before October 2005 & also Including the following:
41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
Product Codes: 0010204

On January 8, 2008, a Federal Court judge expanded the scope of current hernia patch lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without “memory recoil rings.” Problems other than the memory recoil ring breaking include reports of “buckled mesh,” “patch shriveling” and “edges curled up,” as well as descriptions of the mesh as being “crumpled,” “wrinkled,” “rolled up,” “delaminated” and “folded.”

Side Effects of the Kugel® Mesh Hernia Patch

There are a variety of side effects associated with the Kugel Mesh Hernia Patch. Our firm is pursing the following types of serious, life-threatening side effects:

  • bowel perforation
  • bowel obstruction
  • chronic intestinal fistula
  • serious infection
  • unexplained or persistent abdominal pain
  • fever
  • tenderness at the implant site
  • other unusual symptoms
  • death

 

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