FDA Recall Of Defective Medical Device After Bowel Perforations Reported
According to the Food and Drug Administration, the Composix Kugel Mesh Patch can cause major injuries to those who receive the device during a hernia repair. For this reason, the agency has issued three recalls of various models of the patches, and has investigated manufacturer Davol, Inc.
Problems first emerged in 2002, shortly after Davol introduced the oval mesh patches in large and extra-large sizes. Physicians and patients reported that the memory recoil rings in the packages were breaking and leading to serious injuries like bowel obstructions, bowel perforations, and chronic enteric fistulas (abnormal connections between two parts of the intestines). These conditions can advance to blood infections and other health problems which are deadly.
The design of the Kugel mesh patch includes two layers of synthetic mesh surrounded by the previously mentioned memory recoil ring. During surgery, the patch is folded for insertion in the hernia cite, and with the help of the ring, springs back to the flat position to cover the problematic opening. However, surgeons said the stress of folding and re-opening the patch was breaking the rings, and that the broken parts were causing serious injury in the abdominal cavity.
Davol first blamed the Kugel Mesh problems on surgeon error, but the company’s own testing later showed that the breaks occurred almost exclusively at the point where the rings were welded together. The discovery of this defect led the company to announce an initial recall of the large and extra-large rings in December 2005. Further inquiry by the FDA, including an inspection of manufacturing processes and the handling of problem reports by the company, necessitated two expansions of the recall in March 2006 and January 2007.
As information has emerged about the problems with the Kugel Mesh Patch, and the numbers of serious injuries continues to climb, attorneys who specialize in defective products litigation have filed suit on behalf of the injured parties. They argue that the medical device has caused major health problems for these patients, and that the manufacturer should be held liable for their medical expenses, pain and suffering, and necessary future care. The number of lawsuits filed against Davol grows each month, as patients learn about their legal rights and the alternatives available to them.
Hernia patch lawyers spend significant time learning about products like the Kugel mesh device, and are uniquely qualified to represent those who have been injured by them. Additionally, the scope of litigation related to these patches has been broadened by the U.S. District Court to include the following products, which contain similar technology:
• Ventralex Hernia Patch
• CK Parastomal Hernia Patch
• CruraSoft Patch
• Composix Mesh
• Composix L/P Mesh
• Composix E/X Hernia Mesh
• Other Kugel products that have not been recalled
If either you or a loved one has received one of these devices as part of a hernia repair, report any troubling symptoms to your physician promptly. Warning signs of a serious problem may include abdominal pain, fever, gastrointestinal symptoms, or other unusual symptoms.
If you want legal advice regarding injuries received and the process of filing a lawsuit against the maker of the hernia patch, one of Legal Tube’s Kugel Mesh attorneys can help you. You may be able to recover compensation for medical costs and other damages. Contact an experienced professional today and protect your rights.
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