One of the recent developments in medical technology has been the hernia patch, a device designed to assist in post-operative healing of surgically repaired hernias. A hernia patch is a device composed of a fine mesh surface mounted on a flexible plastic ring. The ring can be bent during surgery and inserted in place behind the hernia. Once it is placed, the hernia patch springs back into its original shape and provides structural support for the damaged tissue while it is healing.
Davol Inc. is the manufacturer and distributor of these products, which are sold under a number of brands. The Kugel Hernia Patch, the Kugel Mesh Patch and the Composix Kugel Mesh Patch are all products that are manufactured and sold by this one company. They are produced in various sizes and shapes.
Most of the product lines have exhibited a flaw in the plastic ring that provides structure for the patch. It can break after being put in place, and the broken ends of the ring can perforate intestinal tissue or cause abdominal pain as the result of pressure on other areas. In all cases, the flexible plastic ring seems to break at the point where the plastic has been closed into a circle with a weld.
In late 2005 the FDA and Davol issued the first of several recalls on the hernia patches. This first public health advisory recalled just one model of the hernia rings and then only products that were manufactured during certain production runs. In March of 2006, a second recall was issued that was more comprehensive. In this medical warning, the entire production of one particular hernia patch model was recalled, along with an expanded list of production runs for other models.
It was with this recall that a letter was published by Davol and distributed to surgeons across the country. It warned of the possibility of intestinal perforation from the Kugel and Composix hernia patches and suggested that use of the products be discontinued. Nevertheless, in January of 2007 yet another recall was issued that once again expanded the list of recalled products by adding production runs and differing sizes of the products.
The FDA has recognized that damage from broken hernia patches can be fatal. Several lawsuits have been filed against Davol alleging internal damage caused by their hernia patches that resulted in deaths. Many more legal actions concerning product liability for hernia patches have been filed or are in preparation.
If you or a relative have suffered abdominal or intestinal problems after having a hernia patch implanted, you may be eligible for compensation. Contact our office and one of our attorneys will give you an in-depth analysis of your case at no charge. We are involved in the developing legal battles over hernia patch liability; our attorneys are familiar with recent legal activities concerning these products across the country.
