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Hernia Patch Recall Affects Thousands of Patients

Mar 20, 2008
Ventral hernia sufferers are rushing to their doctors after hearing that the federal 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, which affects more of the implantable mesh patches on the market. Ventral hernias are prevalent in the United States; in fact, the nation 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 can break inside the intra-abdominal space of the patient's belly, causing chronic intestinal fistulae and bowel rupture or perforation. Fistulae affect the passages that connect organs and the intestines, and such ruptures can cause side effects including tenderness, abdominal pain, or fever. These can present an additional strain to hernia sufferers who already have undergone surgical intervention with the hernial patches and cause additional surgeries to repair the damage.

Composix Kugel Mesh Patches are manufactured by Bard, a subsidiary of Davol. In addition to its hernia repair devices, the company makes 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. Davol has withdrawn some Kugel Mesh Patches from the market in the past due to health concerns; it has also issued a redesigned product marked with labels that indicate the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 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 thinned or stretched post-operative scar tissue that forms there, fail to engage properly.

Their "memory recoil ring," a structural component designed to open the mesh patch after its has been folded and inserted, can fail to spring open or even break under the strain of placement, causing the side effects listed above.

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 an experienced medical device attorney to find out about your legal rights in this matter. You may be eligible for monetary compensation for your medical bills, lost wages and other expenses associated with the defective hernia patches.
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