Defective Kugel Hernia Mesh Patch Recalled By FDA

Craig Cherry

Contributor

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C.R. Bard Inc., its subsidiary Davol, Inc., along with the Food & Drug Administration (FDA) have intiated three separate voluntary recalls regarding the Bard Composix Kugel Hernia Mesh Patch.

The Kugel patch is used to repair ventral hernias caused by stretching of scar tissue that forms after surgery. The Kugel patch is also used to repair inguinal and laparoscopic hernias in addition to the ventral hernia. The mesh 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.

The companies initially sent out a recall recommending that doctors discontinue using certain versions of the Kugel patch because a plastic component imbedded in the patch can break and cause injuries to a person's internal organs.

The component at issue is a "memory coil ring", which opens the Kugel patch, but can break under the stress of placement of the large sized products in the intra-abdominal space. If the ring breaks, it can lead to bowel perforation and/or chronic intestinal fistulae.

Since 2005, the FDA has received complaints and reports of more than eighty (80) injuries associated with the Kugel patch, including several fatalities.