Earlier this month a law firm out of Mt. Pleasant, South Carolina, announced that they are filing suit on behalf of their client against Davol, Inc., the manufacturer of Composix Kugel Mesh Patch, which as been used in a number of hernia repair surgeries. The defective medical device has been known to cause serious complications in patients who have undergone hernia surgery in which is was employed.
The patch was recalled in 2005, but many patients did not receive the information about the recall. A news release from the law firm of Motley Rice details the case:
The suit was filed in Superior Court in the State of Rhode Island on behalf of plaintiff Jimmy Warren of St. Charles County, Missouri, whose inserted Kugel Mesh Patch failed following a product recall, causing severe abdominal pain and resulting in necessary bowel dissection surgery to remove the failed patch. Additional defendants in the case include New Jersey-based C.R. Bard, Inc., the parent company of Davol, Inc.
On January 6, 2004, Mr. Warren underwent hernia repair surgery, during which he received a Kugel Mesh Patch developed by Davol, Inc. The following year, Davol recalled many of the Kugel Mesh Patches under an FDA Class I recall – a recall issued for medical devices that are potentially life-threatening or could cause a serious risk to a patient’s health. In 2006, this recall was expanded to include the patch inserted in Mr. Warren. Following his surgery, Mr. Warren developed abdominal tenderness, and according to the complaint, another hernia had developed in Mr. Warren in April 2006.
During surgery to repair the second hernia, a piece of the failed Kugel Mesh patch was discovered adhered to Mr. Warren’s bowel. Mr. Warren was subjected to a prolonged bowel dissection to release the mesh from his bowel, leaving him with chronically inflamed bowels, as well as ongoing physical pain and mental anguish. It is alleged that the manufacturers of the Kugel Mesh Patch were aware of the high degree of complication and failure rate of the product.