Composix Kugel Mesh Patches Recall and class action suit

[ESPAÑOL]
The 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.


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:
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 Large
Oval
5.4" x 7"
PC#0010204
Bard Composix Kugel
Large Circle
4.5"
Kugel Mesh Stories and ArticlesFDA Warned Kugel Mesh Patch Maker of Serious ViolationDavol Inc., maker of the Bard Composix Kugel Mesh Patch, was issued a warning letter in 2006 from the FDA, citing serious problems with quality assurance systems used during the manufacturing process of the patch. The FDA also found that Davol did not report the possible severity of complaints that it received. Another Kugel Mesh Lawsuit FiledAnother lawsuit has been filed against Davol Inc., regarding the company's Kugel Mesh Patch. The lawsuit was filed in May and alleges a man died because of a defective hernia repair patch. Dan's Story: Routine Surgery Gone WrongKugel Mesh? Get Your Surgical ReportComposix Kugel Mesh: Imagine if it Breaks Inside of YouKugel Mesh Compromised My HealthMedical Devices - April 2007 Litigation Update Part IITo the Makers of Kugel Mesh: Cover My Medical ExpensesKugel Mesh Infection: One Woman’s AccountKugel Mesh Cause of DeathKugel Mesh Recall Too Late for SomeKugel Mesh Patch Messed UpKugel Mesh Recall Updated to Class 1Kugel Mesh One Big MessKugel Mesh Recalls – A TimelineKugel Mesh Patches: More Units RecalledKugel Mesh Patches Lead to LawsuitKugel Mesh One Big MessKugel Mesh Patches Considered a Serious RecallKugel Mesh Patch: Recalled due to Serious InjuriesInjuries and Death Reported in Patients Implanted with Bard Kugel Mesh PatchKugel Mesh Patches Recalled