On January 10, 2007 the U.S. Food and Drug Administration (FDA) announced that Davol has expanded previous recalls of mesh patches used in hernia surgeries due to rising complaints of breakage.

In December 2005 and January 2006, Davol issued a recall of six sizes of the Bard Composix Kugel Mesh Patch, used to repair ventral hernias. In March 2006, Davol expanded the recall to include additional sizes of the patch.

Composix Kugel Mesh Patches are placed behind hernia defects via a small abdominal incision. The patch is held open by a ring, known as a “memory recoil ring” that is designed to allow the patch to be folded for insertion through the small incision. Once in place, the “memory recoil ring” is supposed to spring open and lay flat.

The FDA has reported that among over 25,000 units manufactured between January 1, 2004 and September 30, 2005, six incidents of breakage have been reported, including two incidents of bowel perforation. The FDA warns that the Bard Composix Kugel Mesh Patch “memory recoil ring” welds may break under the stress placed on the product during surgical placement.

Improper placement of the Kugel hernia mesh patch could result in serious personal injury to a patient implanted with the device, including:

• Chronic enteric fistulas
• Bowel perforation
• Bowel obstruction
• Abdominal pain
• Abdominal infection

Davol has withdrawn from the market all remaining Bard Composix Kugel mesh patches, including the Bard Composix Kugel Large Oval and Large Circle patches that have the same component design. Davol has improved the product design, including changing the recoil ring stock to a less rigid stock, increasing the strength of the recoil ring weld and increasing the ring weld overlap at the weld’s joint.

Sources: FDA Safety Alert, January 10, 2007; FDA Class I Recall, Bard Composix Kugel Mesh Patch - Updated, December 22, 2005, accessed January 24, 2007.