Kugel Mesh Hernia Patch Defects Put Patients at Risk, Yet Davol Waited Before Issuing Recall

The recalled Kugel Mesh Hernia Patch was supposed to eliminate dangerous complications from hernia surgeries. Before the Davol Composix Kugel Mesh Hernia Patch, repair was conducted by tension repair surgery,

which could cause problems if muscle tissue re-tore. Unfortunately, design flaws inherent in the defective Kugel Mesh Hernia Patch led to even more serious complications and injuries for many patients.

Over 700,000 hernia repair surgeries are performed in the U.S. annually. Hernias are areas where an organ breaks through weakened or torn tissue. The Kugel Mesh Hernia Patch—developed to reduce re-tears—is constructed of two mesh pieces surrounding a plastic ring. The surgeon makes a tension-free repair using a small incision and places the folded patch behind the hernia. The spring-like ring opens the Kugel Mesh Hernia Patch where it lays flat behind the incision allowing internal tissue to grow and repair the tear or weakness, resolving the hernia.

Written by admin on November 14th, 2007 with no comments.
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What Is A Hernia?

A hernia is a protrusion of a tissue, structure, or part of an organ through the muscular tissue or the membrane by which it is normally contained. The hernia has 3 parts: the orifice through which it herniates, the hernial sac, and its contents.

A hernia may be likened to a failure in the sidewall of a pneumatic tire. The tire’s inner tube behaves like the organ and the side wall like the body cavity wall providing the restraint. A weakness in the sidewall allows a bulge to develop, which can become a split, allowing the inner tube to protrude, and leading to the eventual failure of the tire.

Written by admin on November 14th, 2007 with no comments.
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