Location:

2224 1st Avenue North
Birmingham, Alabama 35203

Main:  (205) 326-3336
Fax:  (205)-326-3332
Toll Free:  1-800-241-9779

Mailing Address:
Post Office Box 11310
Birmingham, Alabama 35202

Bard Composix® Kugel Mesh Hernia Repair Patches

Heninger Garrison Davis is investigating injuries caused by the Kugel Mesh Hernia Patch that is used in hernia repair surgery. 750,000 such surgeries are performed each year in the United States.  The patch is named for its developer, Dr. Kugel, and is designed to reduce recovery time after surgery and decrease the recurrence rate of hernias.  The rights to the patch belong to medical device maker Davol / C.R. Bard.

FDA issues immediate recall

The hernia patch has caused serious complications that have led to the need for additional surgeries to repair bowel perforations and to remove the patch.  On December 22, 2005, the FDA issued an immediate recall of the Bard Composix® Kugel Mesh Hernia Repair Patch, and it updated that recall list on March 31, 2006, and again on January 24, 2007.The FDA recalled the device because the "memory recoil ring" that opens the Mesh Patch can break into the abdominal (belly) space, which can lead to bowel perforations (rupture) and/or recurring intestinal fistulae (abnormal connections or passageways between the intestines and other organs).  Those adverse events can lead to serious infection and require additional surgery to repair a perforation.  Deaths have been reported from the adverse events.

What to do if received the patch

According to the FDA, patients who have received the patch should seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur.  The FDA has instructed surgeons and hospitals to immediately stop using the recalled device and return the unused patches to the maker.