Kugel Hernia Patch
The Kugel Hernia Patch – also known as the Kugel Mesh Patch – was brought to market by Davol Inc. for use as a surgically implanted device that provides support to a newly repaired hernia. The design element of the Kugel Hernia Patch that made it attractive to surgeons is the flexible plastic outer rim, or frame of the device could be folded and inserted behind the herniated area during surgery. When in place, the Kugel Patch would then spring back to its original shape and provide covering support for the newly sutured area.
As the result of a rising number of patient complaints, Davol issued a partial recall on the Kugel Hernia Patch in December of 2005. That recall was confined to certain production runs of only one of the several sizes and shapes that were on the market. The problem with the Kugel Hernia Patch was the inherent weakness in the flexible plastic ring that made it work: the point at which the plastic was welded to form the closed patch frame was subject to failure. The result was that the Kugel Hernia Patch frame opened to expose two narrow and sharp plastic ends that were capable of damaging internal tissue and organs.
There were multiple reports of punctured intestines caused by failed Kugel Hernia Patches, and the first lawsuit seeking damages from Davol was introduced in early 2006. An additional major recall was issued in January of 2007, covering additional sizes and production runs of the Kugel Hernia Patch and warning medical professionals of the potential dangers of the product.
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