Recoil Rings On Hernia Patch May Perforate Bowel
Medical device manufacturer Davol, a subsidiary of C.R. Bard, Inc., has announced the recall of several versions of its mesh hernia patches. Widespread evidence of a product defect began to surface in 2002, forcing the company to perform further independent testing of the device and to publicize a hernia mesh recall for certain models of the patch.
The product is sold under the name Bard Composix Kugel Mesh Patch, and is used to repair abdominal hernias. The patch consists of two layers of mesh surrounded by a flexible memory recoil ring. The ring is intended to allow the patch to be folded for insertion into the hernia site, and then to cause it to spring back to the flat position and cover the opening. Problems became apparent when the company introduced the patches in large and extra-large sizes. Physicians and patients began to report that the devices were breaking and causing serious internal injuries.
The problem stemmed from memory recoil rings which broke during the insertion process, and once left in the abdominal cavity caused bowel obstructions, bowel perforations, chronic enteric fistulas (abnormal connections between two portions of the intestine), and even death. Davol initial claimed that the fault lay with the surgeons who had implanted the devices. However, when they conducted their own testing it was discovered that the large rings and extra-large rings were almost always breaking at the point where they were welded together. Realizing that the products were, indeed, defective, the manufacturer announced the first hernia mesh recall.
The initial recall only applied to the large and extra-large oval patches. But the FDA became involved at that point, and inspected the facility where the medical device is made. The agency found that Davol did not have an adequate system for tracking adverse outcomes and problems associated with the Kugel Mesh Patch. They also criticized the company for minimizing the size and scope of the problem with the device. Subsequently, more sizes and varieties of the patch have been added to the hernia mesh recall, in March 2006 and January 2007.
This recall warns patients that the Kugel hernia repair mesh has a reasonable probability to cause serious adverse health consequences, including death, according to the FDA. The agency urges consumers who had a hernia repaired with these patches to seek immediate medical attention if they experience abdominal pain, fever, tenderness at the implant site, or other unusual symptoms. This is considered a Class One recall, the most serious issued by the FDA.
Some consumers who received their mesh patches before the hernia mesh recall and who have suffered illness or injury as a result have initiated lawsuits against the product’s maker. These individuals contend, like the FDA, that Davol was slow in recalling the product and warning patients and physicians about the risks. With the help of skilled product liability lawyers, the injured parties hope to recover compensation for medical expenses, additional surgeries, pain and suffering, and other damages specific to their individual circumstances.
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