Composix Kugel Mesh Patches are used to repair ventral or incisional hernias that result from thinning and stretching of scar tissue after surgery. These products are manufactured by Davol, Inc., a subsidiary of C.R. Bard, Inc. Between December 2005 and March 2006, specific lot numbers of Composix Kugel Mesh Patches were recalled by the manufacturer after it was discovered that the part known as the “memory recoil ring,” which opens the patch, can break under stress when placed in the intra-abdominal cavity. This can lead to serious injuries and conditions, including bowel perforations and chronic intestinal fistulae, which are abnormal connections between the intestines and other organs.

After the last lot numbers of Composix Kugel Mesh Patches were recalled in March of 2006, the FDA sent a recall letter to physicians and patients, advising patients who had been implanted with one of the recalled lot numbers to seek medical attention if they experienced persistent abdominal pain, tenderness at the implant site, fever, or related symptoms. The recall was both product-code and lot-specific, and applied to the larger sized patches. The specific product codes and descriptions recalled are:

PC#0010206 - Bard Composix Kugel - extra large oval - 8.7" x 10.7"

PC#0010207 - Bard Composix Kugel - extra large oval - 10.8" x 13.7"

PC#0010208 - Bard Composix Kugel - extra large oval - 7.7" x 9.7"

PC#0010209 - Bard Composix Kugel - oval - 6.3" x 12.3"

PC#0010202 - Bard Composix Kugel - oval - 5.4" x 7"

PC#0010204 - Bard Composix Kugel - large circle - 4.5"

Suthers & Thompson is currently investigating cases involving injuries related to Composix Kugel Mesh Patches. For more information, contact us online or call us on our toll free number, 1-800-320-2384, to set up a FREE consultation.