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Kugel Mesh Hernia Patch

Ventral hernia sufferers are seeking medical attention from their doctors after news that the U.S. Food and Drug Administration (FDA) has issued an updated recall for Bard's Composix Kugel Mesh Patch. The patch, which is used in hernial repair surgeries, was first recalled in late 2005, but the FDA has posted another recall that affects more of the implantable mesh patches on the market.

Ventral hernias are very prevalent in the United States; in fact, the U.S. has the world's highest rate of deaths due to incisional hernias per year.

In its recent medical device recall alert, the FDA noted that the Composix hernia patch has the tendency to break inside the intra-abdominal space of the patient's stomach, causing chronic intestinal fistulae and bowel rupture or perforation. Fistulae affect the passages that connect organs and the intestines. These ruptures can cause side effects including tenderness, abdominal pain, and fever. These side effects can present an additional strain to hernia sufferers who already have undergone surgical intervention with the hernial patches and directly create the need for additional surgeries to repair the damage.

Composix Kugel Mesh Patches are manufactured by a subsidiary of Davol named Bard. The company not only makes hernia repair devises, but also designs and markets devices for laparoscopy, wound management, hysteroscopy, and orthopedics. The Extra Large Oval, Oval, Large Oval, and Circle sizes are subject to the hernia patch recall, which now encompasses product codes 0010202 and 0010204. In an attempt to maintain the problem, Davol has withdrawn some Kugel Mesh Patches from the market in the past due to health concerns. In addition, it has also issued a redesigned product marked with labels that indicate the product was "redesigned for improved integrity".

The FDA's hernia mesh recall only applies to the larger sizes of the Composix Kugel Mesh Patches. The defect occurs because the Composix patches, which are inserted behind incisional hernias in order to reinforce the very thin and weak or stretched post-operative scar tissue that forms there, and then they fail to engage properly. Their "memory recoil ring," which is a structural component that is designed to open the mesh patch after it has been folded and inserted, can fail to spring open or even break under the strain of placement, causing above-mentioned side effects.

If you had a ventral (incisional) hernia surgery involving a Composix Kugel Mesh Patch, you may be affected. Contact your doctor immediately to see if the hernia patch recall affects you and if you need the device removed or replaced. If you have suffered from side effects or symptoms due to your implantable mesh patch, contact a personal injury lawyer at Jim S. Adler & Associates for help with your potential case. We can explain your legal rights in the matter. You may be eligible for monetary compensation for your medical bills, lost wages and other expenses associated with the defective hernia patches. Call Jim S. Adler & Associates today! Call us today at 1-800-505-1414.

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1 FDA sends Kugel Mesh maker warning letter
2 Many not aware that Kugel Mesh was source of problem
3 Bard Composix Kugel Mesh Patch redesigned
4 FDA updates Kugel Mesh Hernia Patch recall
5 Thousands of patients affected by hernia patch recall