Hernia Patch Recall
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Hernia Patch Recall
A major product liability issue has developed around a product developed by Davol Inc. and marketed as the Kugel Mesh Patch, the Kugel Hernia Patch and the Composix Kugel Mesh Patch. This hernia patch recall – or rather, series of recalls – is the result of a seemingly flawed product design. The patch is comprised of a fine mesh attached to a circular or oval flexible plastic ring. The ring is meant to fold while being inserted behind the hernia during surgery, and then to spring back to its original shape once it is in place. This ring has broken at its weld point after installation in many cases.
The first hernia patch recall was issued by the FDA and Davol in December of 2005. The initial recall included a certain size of the hernia patch and only certain production runs of that size. In March of 2006, another hernia patch recall was issued by Davol in conjunction with the FDA, this time for additional production runs of some products and all runs of one particular design. Urgent warning letters were put out to surgeons and medical professionals asking them to cease using the recalled hernia patches immediately and to monitor their patients for potential intestinal perforations or other abdominal problems that can result from exposed sharp plastic pointed objects such as the broken ends of the hernia patches.
In January of 2007, yet another hernia patch recall was issued by Davol that expanded to more products with similar designs as well as additional production runs of previously recalled patches. The FDA recognizes this hernia patch recall as a serious issue; some suits have been filed claiming fatalities as the result of failed hernia patches.
