Faulty Spring Can Lead To Serious Side Effects For The Hernia Patch
The Bard Composix Kugel Mesh hernia patch is a medical device which first won FDA approval in 1996. The patch, consisting of two layers of mesh, is surrounded by a flexible plastic “memory coil ring.” The ring allows the patch to be folded for insertion at the hernia site, and subsequently causes the device to flatten and position itself correctly for healing of the hernia.
Problems for the Kugel Mesh device began to surface in 2002, shortly after manufacturer Davol, Inc., introduced the large and extra-large versions of the patch. Patients and their doctors reported that the rings in some of those patches were breaking, causing injury to internal organs and tissue, including bowel perforations, bowel obstructions, and chronic enteric fistulas.
The manufacturer of the Kugel Mesh hernia patch initially blamed the broken rings and associated injuries on mistakes made by doctors using the device in hernia repair surgery. However, testing conducted by Davol revealed that the failures almost always occurred at the point where the memory coil ring was welded together.
Given this finding, Davol issued a Kugel Mesh hernia patch recall for the extra-large model of the device in December 2005. The FDA later prompted the expansion of the recall in March 2006 and again in January 2007 after reports linked the patch to several fatalities and more than 80 injuries or health complications.
In early 2006, the FDA carried out an inspection of the Davol manufacturing plant where the Kugel Mesh hernia patch was produced. The federal agency discovered that the plant had major flaws in its system for tracking patient complaints and problems with the device. The FDA also determined that Davol had been minimizing the severity of injuries associated with malfunctioning patches, including evidence that one such patient may have died.
The side effects linked to the Kugel Mesh hernia patch are very serious, and can cause major injury or death. For those patients whose patch malfunctions, bowel obstructions are a potential hazard. This partial or complete blockage in the intestines, if undetected, can lead to infection, gangrene or bowel perforation. The warning signs of a bowel obstruction include abdominal pain, bloating, constipation, vomiting or diarrhea.
A bowel perforation is diagnosed when an opening forms in the intestinal wall, allowing its contents to flow into the abdominal cavity. A growing number of hernia mesh recipients have suffered this injury which can lead to sepsis, a potentially fatal blood infection. Symptoms of a bowel perforation include high fever, abdominal pain, nausea and vomiting.
Additionally, several Kugel Mesh hernia patch patients report development of chronic enteric fistulas. These are abnormal connections which form between two parts of the intestine. While some consumers report few major symptoms, others experience major abdominal pain. Sometimes one end of the fistula will close, created a pocket in which bowel contents collect, leading to an abscess or infection which may spread to the bloodstream. At least one patient died after suffering this complication.
Many patients who have experienced the consequences of receiving a Bard Composix Kugel Mesh hernia patch which failed to work properly are seeking compensation through lawsuits. A number of cases have been filed by consumers seeking damages from Davol, the device’s manufacturer.
If you or a loved one has suffered injuries related to the use of this device, a Kugel Mesh attorney may be able to help you. Legal Tube can help you identify a lawyer with expertise in this area.