Answers to Common Kugel® Mesh Patch Questions

What is the Kugel® Mesh Patch?

The Bard Composix Kugel hernia patch is a self-expanding patch used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is made of a double layer of monofilament polypropylene on one side, and expanded polytetra-fluoroethylene (ePTFE) on the other. The patch also contains a "memory recoil ring", which was designed to cause the patch to spring open and maintain its shape during placement.

How does the Kugel® Mesh Patch work?

The patch is placed behind the hernia defect through a small incision. The patch is then held open by the "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 Monofilament polypropylene was designed to stimulate tissue ingrowth and help reduce the risk of recurrence. The ePTFE barrier was designed to minimize tissue attachment to the prosthesis, while helping to protect against erosion of the mesh into vital organs.

Why was the Kugel® Mesh Patch® recalled?

The FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Repair Patches on December 22, 2005 and updated the list on March 31, 2006 and again on January 24, 2007. The Kugel Mesh Patch was recalled because the "memory recoil ring" that opens the Bard® Composix® Kugel® Mesh Patch can break in the intra-abdominal (inside the belly area) space, which can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

The FDA has advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur.

The FDA has instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company.

If you or a loved one has had hernia surgery and received a Bard Composix Kugel Mesh Patch, call us at 866-445-9599 for more information. You or your loved one may be entitled to medical monitoring and compensation from the manufacturer.

If you have been given a Kugel Mesh Patch and have additional questions about the patch, visit our page on serious risks or contact your doctor.

How do I know if the Kugel Mesh Patch® I received was recalled?

The product codes for all 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	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"

How many people have experienced life-threatening complications as a result of using the Kugel Mesh Patch®?

There is no way to know exactly how many people have been injured by the patch until all victims come forward. The initial recall of the Bard Composix Kugel Mesh X-Large Patch was made after receiving 24 reports that the device's plastic coil ring was not withstanding the increased stress associated with certain surgical placement techniques. Through March 10, 2006, the manufacturer said a total of 31 ring breaks were reported and 20 involved patient injury, including 11 cases where the broken ring migrated into or through the patient's abdominal wall, with infection in 2 cases; 1 case where the ring migrated into the vagina; 7 cases of bowel perforation; 1 case of bowel obstruction; and 1 death where the patient developed septic shock, consumptive coagulopathy and acute myocardial infarction (heart attack) after surgery to repair small and large bowel fistulas caused by perforation from the broken ring.

What should I do if I have been given or been injured using the Kugel Mesh Patch®?

If you have been given or have been injured or a loved one has been injured or died from using the Kugel Mesh patch, please contact Douglas & London, P.C., immediately. We can evaluate your Kugel Mesh Patch claim, answer your questions, and assist you in taking legal action against the manufacturers of the Kugel mesh hernia patch.

Contact Douglas & London if you have additional Kugel Mesh Patch® questions about how the patch works, side effects, or whether you or a loved one may have a potential claim against the makers of the Kugel Mesh patch.