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About Kugel Mesh Hernia Patch
Maker: Davol, Inc., Sub. C.R. Bard, Inc
The recall issued by Davol for the extra large size Kugel Mesh Hernia Patch in Dec. 2005 may be too little too late for many patients. Other sizes were left in use with no additional warnings and evidence exists that proves problems had been discovered with the patch as early as the summer of 2005. Ultimately, two FDA-ordered recalls were necessary to force the maker to inform physicians of the product's potential dangers.
The BardŽ Composix® KugelŽ Mesh Patch was designed to provide repair for ventral hernias, also known as incisional hernias. Scar tissue that has weakened and stretched over time can become herniated. With a small incision, the patch can be placed behind the hernia and a "memory recoil ring" within the patch will "reopen" the folded patch to its original size, laying flat to cover the herniated area. The memory recoil ring has been discovered to be faulty in several of the models and has been known to break, leading to physical injuries.
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