Recoil Ring Is Faulty In Davol Hernia Patch, It May Perforate The Bowel
A hernia is a protrusion of a tissue, structure, or part of an organ through the muscle tissue or the membrane by which it is normally contained. Typically this condition is treatable by surgically closing the opening through which the protrusion has occurred. Older surgical methods involved stretching the already-weakened tissue and sewing it back together. But many surgeons now use a hernia mesh patch to reinforce the fragile muscle and hold the protruding tissue or organ in place.
One such hernia mesh product is the Bard Composix Kugel Mesh patch. This device was approved for use by the FDA in 1996. However, problems began to appear around 2002 when the large and extra-large models of the patch were introduced by manufacturer Davol, Inc. Doctors and patients began to report that some of these devices were breaking, causing internal injuries and serious complications.
The hernia mesh patch designed and sold by Davol was intended to be used to repair ventral (incisional), and inguinal (in the groin area) hernias. The patch, consisting of two layers of synthetic mesh surrounded by a flexible plastic memory recoil ring, is folded and implanted inside the abdominal wall at the site of the hernia. The memory recoil ring then causes it to spring back to the flat position, allowing it to cover the opening and reinforce the repair while the surrounding tissue heals.
Davol initially blamed the failure of its Kugel hernia mesh patch on the error of doctors who implanted it. However, the company’s own testing eventually showed that the device almost always failed at the point where the ring was welded together. In December 2005, Davol recalled the two largest versions of the hernia mesh patch. The recall of the device was expanded in March 2006 and again in January 2007 to include other sizes and models.
The injuries suffered by patients who received the defective surgical product have been serious and in some cases, deadly. The broken Kugel mesh patches have been linked to bowel obstructions, bowel perforation, and chronic enteric fistulas. Some of these complications have advanced to sepsis, a potentially fatal blood infection.
A growing number of these injured individuals have filed Kugel Patch lawsuits against the maker of the product. These parties are seeking compensation for the health problems they developed as the result of receiving the defective patches during their hernia repair surgeries. These lawsuits allege that Davol, Inc., knew about the problems with the Kugel Mesh patch, but delayed the first recall by suppressing that information.
If you or a loved one experiences the symptoms of a serious illness after undergoing a hernia repair surgery in which the Kugel Mesh patch was used, immediate medical attention should be sought. Those warning signs include:
• Abdominal pain
• Vomiting or Diarrhea
• High fever
If you need additional information about the possible side effects of this surgical device, and what you can do to protect your health and your rights, a Kugel Mesh patch lawyer may be of help to you. Some attorneys specialize in litigation involving defective drugs or products, and are uniquely qualified to answer your questions, and handle your case. Legal Tube helps you identify those lawyers who are right for your legal needs.