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Composix Kugel Mesh PatchesThe US Food and Drug Administration along with Davol, Inc., a subsidiary of C.R. Bard, Inc., have instituted a recall of certain models of the Bard Composix Kugel Mesh Patch. The patches are used for the repair of hernias caused by thinning or stretching of scar tissue that forms after hernia surgery.
Composix Kugel Mesh Hernia Patch
How the patch is usedThe folded patch is placed inside the abdominal cavity through an incision and positioned behind the hernia.The patch is then unfolded and held open by a plastic "memory recoil ring" once it is in place. There have been reports that this ring has broken and created a number of health problems for the patients. The hernia repair device was recalled because of these reports. If the ring should break, the broken ends could poke through th mesh and create bowel perforations and/or a condition called "chronic enteric fistulae." The ring is designed to aid in deployment of the patch, but it can break when increased stress is placed on it during certain surgical placement techniques. According to the FDA Recall Notice "Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage. These symptoms include:unexplained or persistent abdominal pain, fever, tenderness at the surgery site or other unusual symptoms." In a March-24-06 recall notice, Bard recommends that health care professionals "Immediately discontinue use of the specific product codes and lot numbers listed below. Additionally, please immediately distribute copies of this Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall." The product codes for the Dec-05, Jan-06 and Mar-06 recalls are:
Send your Kugel Mesh ComplaintIf you or a loved one has suffered bowel perforation or chronic enteric fistulae due to the Kugel Mesh patch, please send your complaint to an attorney by clicking the link below. Your claim will be reviewed by a lawyer at no cost.Posted on Oct-23-06 Updated on Nov-20-08 |
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Lenoir, NC: Tish H. has had serious health problems since a Kugel Mesh hernia patch was used to repair her hernia. She says that she has had every complication associated with the patch and now faces a lifetime of medications and potentially life-threatening problems. She has also undergone numerous surgeries that have caused even more health problems. [ 
San Antonio, TX: When patients have hernia repair surgery, they do not expect that down the road they will be in worse shape than before surgery. Unfortunately, that is exactly what happened to some patients who received Kugel Mesh Hernia Patches. Yvonne G. had a hernia repair and is still suffering because of complications from the hernia patch. [ 
Rockville, MD: Based on all the problems patients have experienced with the Kugel Mesh hernia patch it should come as no surprise that the maker of the patch, C.R. Bard, recently received a warning letter concerning its plant in Puerto Rico. Of course, that is the plant at which the Kugel Mesh patches are manufactured. [ © 2001-2008 Online Legal Marketing. All rights reserved.