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Incisional Hernias
In the United States, more people die each year because of incisional hernias than any other country in the world. A hernia occurs when a part of an organ pushes through an opening in the organ's wall, creating a painful bump in the abdomen or groin. Incisional hernias happen after a prior surgery leaves a hole in one of these areas, and the thinning or stretching of scar tissue allows the organs to protrude out of this hole.
Patched Up
Hernias are generally repaired by a simple procedure that stitches the abdominal muscles back together. More than 750,000 hernia repair surgeries are conducted each year in the U.S. But this common procedure isn't always possible because the stomach muscles can be too weak to withstand surgery. In these cases, doctors can make a tiny incision and insert a medical patch behind the hernia to reinforce the tissue. A "memory recoil ring" holds this medical patch open and allows it to be folded for insertion purposes, and then opened once it's in place. These patches work by laying flat against the inner body cavity and prohibiting the hernia from pushing through a thin or weak tissue wall.
The bad news is that these patches can break. This break can result in bowel rupture and abnormal connections between the intestines and other organs (called chronic intestinal fistulae). These are severe health conditions that create a dangerous health risk to affected patients.
Class 1 Recall
In December of 2005, the Food and Drug Administration (FDA) issued a Class 1 recall for the Composix Kugel Mesh Patch. This recall is the strongest the FDA can issue, and is reserved for dangerous and defective products that are associated with serious health risks, including death. The problem with the Composix Kugel Mesh Patch was that the plastic "memory recoil ring" was breaking. In fact, the patch's manufacturer, C.R. Bard, Inc., received 24 reports of broken rings.
Symptoms of broken rings can include nausea, vomiting, abdominal discomfort or a noticeable and/or painful bulge where the previous surgery occurred. If you've had incisional (ventral) hernia surgery involving a Composix Kugel Mesh Patch, you may be affected by this recall.
Contact your doctor immediately to see if the medical patch recall impacts you, and whether you should get your device replaced or removed completely. If you are affected, you may also be eligible for compensation for your medical bills, lost wages, pain and suffering, or other expenses associated with these faulty hernia patches.
If you live in Alabama, Florida, Tennessee or Georgia and you or a loved one has a Composix Kugel Mesh Patch, contact our product recall attorneys at Burke, Harvey & Frankowski. We can help you collect what you are entitled by law. Call or e-mail us today for a free consultation.

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