Expanded Recall/Market Withdrawal of Hernia Repair Patch

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Davol, Inc. is expanding its earlier recall of the Composix Kugel Patch, which is used to repair ventral hernias that can appear at the site of a prior surgical incision.

The recalled patches have a "memory recoil ring" that allows the patch to be folded for insertion and then once in place, to spring open and lay flat. The problem is that this ring can break, and if that happens, it can cause a bowel perforation or chronic intestinal fistula.

Davol is now notifying health care professionals about an expanded recall and market withdrawal of additional patches that have a similar design. These actions affect Large Oval and Large Circle patches that have this design. Health care providers who have patches from the recalled lots should stop using them immediately.

Here's what the company recommends for managing patients who have already received one of the recalled devices:

• First, identify these patients. Advise them about the recall and tell them to seek attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.

• Examine symptomatic patients for conditions that could be associated with ring breakage. These include bowel obstruction, perforation or fistula, abdominal wall pain or infection, palpable abdominal wall mass, or migration or movement of the ring.

• Evaluate the patient's condition based on clinical signs and symptoms and clinical judgment.

• And finally, report any problems to the company.

Note that Davol has redesigned this product to correct the problem. These newer patches are not being recalled. They are identifiable by a label that says "redesigned for improved ring integrity."

Additional Information:

FDA MedWatch Safety Alert. Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal. January 12, 2007:




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