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Kugel-mesh

The FDA issued a Class I recall for the Composix Kugel Mesh Patch - the strongest recall available to the FDA, reserved for dangerous or defective products that predictably could cause serious health problems or death. The Class I recall was issued on December 22, 2005, and then updated on March 31, 2006, to include additional lots of defective patches.

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.

The FDA says surgeons and hospitals should immediately stop using the recalled products and return the unused patches to the company.

Patients who have been implanted with one of the recalled devices should seek immediate medical attention if they experience:

Persistent or unexplained abdominal pain

• Fever
• Tenderness at implant site
• Any other unusual symptoms

If you or someone you know has suffered injuries as a result of a defective Composix Kugel Mesh Patch, please contact us immediately.

Call us at 800-777-4878

To tell us about your case, click on the GOLD button on to the left of this page.