Kugel Patch Recall

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What is hernia mesh patch and what is all the fuss about?

I had hernia surgery and now I found out I have to have inguinal hernia surgery. I read online there is a big lawsuit going on concerning the patches they use in the hernia repair procedure, what is hernia mesh patch and how do I know if it was used in my surgery?

Written by admin on September 28th, 2008 with 2 comments.
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Hernia Patch – Bard Composix Kugel Mesh Patch Injuries And Danger

The Composix Kugel Mesh Patch, manufactured by Davol, Inc., a subsidiary of C.R. Bard, is a medical device used to repair ventral hernias caused by the thinning or stretching of scar tissue that commonly occurs after hernia surgery. These tissues are already delicate and sensitive, and after serious medical procedures they are even more so. The folded patch is inserted into the body behind the hernia area, where the spring-loaded plastic memory recoil holds it in place.

Unfortunately, there is a significant problem with the memory recoil ring. In some cases the memory ring can break entirely which can lead to a bowel perforation or chronic enteric fistulae, or abnormal connections between two tissues that are not normally connected. Further complicating the potential problems of the Composix Kugel Mesh Patch is that even mild pressure exerted during other surgical techniques can cause it to break and result in potentially serious consequences.

The Food and Drug Administration and Bard joined together to recall a number of defective lots of Composix Kugel Mesh Patches due to their propensity to break. There were three different recalls that occurred in December 2005, January 2006, and March 2006 that included:

• PC#0010206 Bard Composix Kugel Extra Large Oval 8.7″ x 10.7″

• PC#0010207 Bard Composix Kugel Extra Large Oval 10.8″ x 13.7″

• PC#0010208 Bard Composix Kugel Extra Large Oval 7.7″ x 9.7″

• PC#0010209 Bard Composix Kugel Oval 6.3″ x 12.3″

• PC#0010202 Bard Composix Kugel Large Oval 5.4″ x 7″

• PC#0010204 Bard Composix Kugel Large Circle 4.5″

Written by admin on November 19th, 2007 with no comments.
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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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