Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Bard Composix Kugel Mesh hernia patch (X-Large Patch Oval with ePTFE) is used to repair scar tissue, which occurs after hernia repair surgery.  After a small incision, the patch is placed behind the hernia defect. A “memory recoil ring” allows the patch to be folded for an insertion. When in place, the patch will later spring open and lay flat.

The Bard Composix Kugel Mesh hernia patch (X-Large Patch Oval with ePTFE) was recalled on December 22, 2005. According to the FDA, “The “memory recoil ring” that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal (inside the belly area) space. This can lead to bowel perforations (rupture) and/or chronic (recurring) intestinal fistulae (abnormal connections or passageways between the intestines and other organs).”

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We live in a time when ultramodern technology permeates every aspect of our lives at blistering speeds. Nearly every day we hear of yet another advancement that promises to better our lives in some way. Medicine and medical technologies, such as the Kugel Mesh Patch used to treat hernias, stand on the forefront of medicine’s quantum push forward. Manufactured by Devol, Inc., the Kugel Mesh Patch consists of a circle or oval of mesh that is surrounded by a plastic ring. The device is engineered and folded so that it may be surgically inserted into a small incision. Once in place, the patch unfolds and expands and the abdominal wall is reinforced.

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In 2003, when Janine Ryan’s (not her real name pending a lawsuit) mother, Sophia, had a Kugel Mesh hernia patch implanted, neither knew that there were any possible risks associated with the patch. But Sophia’s patch broke, causing her to experience severe pain and other serious problems. Like many other people, Ryan and Sophia are upset that they were never warned about the possibility of the Kugel Mesh patch breaking.

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How do makers of implanted medical devices react when one of their products starts breaking?

One answer can be found in the case of a hernia repair device made by a subsidiary of C. R. Bard Inc. In late 2005, the company sent out a recall, urging doctors to stop using some versions of the product because a plastic component could break and cut through a patient’s internal organs and tissue.

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Rockville, MD: Just because the Kugel Mesh Patch was recalled over a year ago does not mean that adverse event reports regarding the hernia patch are no longer being submitted to the U.S. Food and Drug Administration (FDA). In fact, the FDA received numerous reports in August of serious problems with the Kugel Mesh Patch, some of them life-threatening incidents.

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