FDA Recalls Dangerous Kugel Mesh Hernia Patches 3 Times
Defects in the Kugel Mesh Hernia Patch, a prosthetic used to treat hernias, have caused a number of patients to develop serious side effects, ranging from bowel obstruction to blood infections. In fact, at least one man has died as a result of Kugel Mesh Hernia Patch complications, and hundreds more have been seriously injured.
To warn and protect the public, the FDA has issued three recalls for six different models of the Kugel Mesh Hernia Patch. The first recall was on December 22, 2005, when the FDA issued a Class I medical device recall for the extra-large version of the Kugel Mesh Hernia Patch. A Class I medical device recall is the most serious FDA recall classification and means that there is a reasonable chance that a particular product will cause serious health problems or death. In March 2006, and again in January 2007, the recall notice was updated to include additional product codes and lot numbers. Bard, the Kugel Mesh Hernia Patch’s manufacturer, has since redesigned all recalled versions of the Kugel Mesh Hernia Patch and has released the products back on to the market.
The main Kugel Mesh Hernia Patch defect, which is behind its multiple recalls, is that the stress of placing the patch inside the body can cause the memory recoil ring to break inside the belly. The memory recoil ring is the device inside the Kugel Mesh Hernia Patch that allows the patch to be folded for insertion into the body and springs open once in place, allowing the patch to lay flat. When the memory recoil ring breaks, it can cause serious adverse side effects such as bowel perforations, bowel obstructions, chronic intestinal fistulae, serious infections, and death.
Although Bard’s first Kugel Mesh Hernia Patch recall was in December 2005, complaints made to Bard about the patch indicate that Bard was aware of the patch defect in 2002. In fact, Bard was even aware that serious injuries might be occurring. According to Bard, the company did not recall the hernia patch in 2002 because, at that time, complaints about the patch were too few and random to indicate a problematic pattern. Starting in June 2005, ten complaints about memory recoil ring breaks in a three-month period finally motivated the company to initiate the first recall.
Bard is currently facing more than 300 lawsuits filed by patients claiming injuries from the defective Kugel Mesh Hernia Patches. If you or a loved one has used a patch and suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection, or any other serious injury associated with the Bard Composix Kugel Mesh Hernia Patch, you may be eligible for compensation. Please contact one of our Kugel Mesh Hernia Patch attorneys for a free and confidential case review.