Blog Home »

Defective Medical Device - Composix Kugel Mesh Patch

February 6th, 2007

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 made by a physician. 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 problem with the Composix Kugel Mesh Patch is that the plastic “memory recoil ring” can break causing bowel perforations and chronic intestinal fistulae (abnormal connections or passageways between intestines and other organs).

Here is a list of the product codes and lot numbers recalled by the manufacturer:

Product Code

Description

Lot Numbers Recalled

Date Recalled

0010206 Bard ® Composix ® Kugel Extra Large Oval, 8.7” x 10.7” All Lot Numbers December 2005 and January 2006
0010207 Bard ® Composix ® Kugel Extra Large Oval, 10.8” x 13.7” All Lot Numbers December 2005 and January 2006
0010208 Bard ® Composix ® Kugel Extra Large Oval, 7.7” x 9.7” All Lot Numbers December 2005 and January 2006
0010209 Bard ® Composix ® Kugel Oval, 6.3” x 12.3” All Lot Numbers March, 24, 2006
0010202 Bard ® Composix ® Kugel Large Oval, 5.4” x 7” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006
0010204 Bard ® Composix ® Kugel Large Circle, 4.5” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006

Patients who have been implanted with one of the recalled devices should seek medical attention immediately if they experience any of the following symptoms that could be associated with ring breakage:

  • unexplained or persistent abdominal pain
  • fever
  • tenderness at the implant site, or
  • other unusual symptoms

If you have been injured by the Patch, please contact us.

Comments are closed.