Find out if you have a Kugel® Mesh Patch® legal claim
What is the Bard® Composix® Kugel® Mesh Patch?
Manufactured by Davol, a rubber drug and surgical supply maker owned by C.R. Bard, the Kugel® Mesh Patch is used to repair certain types of hernias caused by scar tissue thinning or stretching after surgery. The patch is placed behind the damaged tissue through a small incision. A “memory recoil ring” then springs the folded patch into its unfolded shape, thus making it lay flat over the affected area of the hernia.
Why is the Bard® Composix® Kugel® Mesh Patch dangerous?
The memory recoil ring has been noted to break under the stress of placement in the intra-abdominal area (inside the belly). This breakage can lead to bowel perforations and recu
rring intestinal fistulae (abnormal connections between the intestines and other organs). The ring had also been known to break away from the patch and migrate to other areas of the abdomen, causing infections and a need for further surgery.
The Food and Drug Administration has received over 80 reports of injuries, infections and even fatalities related to the patch. The FDA has also found serious problems at the Davol headquarters, including the system Davol uses to track complaints regarding the patch. The FDA has warned Davol that these problems must be investigated and fixed or regulatory actions will be taken.
Davol has since recalled the Kugel® Mesh Patch, but not before there were up to 31 reports of broken memory recoil rings. Of these reports, the majority indicated pain and injury related to the broken ring. Eleven reports were cases of the broken ring migrating into or through the abdominal wall, causing infection. Some of the reported incidents even occurred during the placement surgery. The broken rings were removed, but the patch was left in place. This successfully repaired the hernia in some cases, but requires explant of the patch in others.
Reports of fatalities related to the Kugel® Mesh Patch are under investigation. One patient died in March 2007 after developing a fistula and infection following her hernia surgery, and another died after an emergency bowel surgery compromised the patch.
Do you believe you or a loved one has been injured by the Bard® Composix® Kugel® Mesh Patch? Goldberg & Osborne can help.
The law firm of Goldberg & Osborne is dedicated to helping injured people nationwide and is currently accepting cases for victims of the Bard® Composix® Kugel® Mesh Patch. For a FREE case evaluation, please call us toll-free at 1-800-THE-EAGLE (1-800-843-3245) or submit a short and simple online case form here.