Investigations

In addition to bowel obstruction, bowel perforation, and chronic intestinal fistulae, defects in the Bard Composix Kugel Mesh Hernia Patch can cause serious infections or even death. Due to the serious side effects and potential for death, Bard has voluntarily recalled certain Kugel Mesh Hernia Patches three times since 2005. These side effects are primarily the result of a defect in the Kugel Mesh Hernia Patch’s memory recoil ring that causes the ring to break inside hernia patients’ stomachs, causing serious injuries or death. Hundreds of personal injury lawsuits and one wrongful death lawsuit have already been filed against Bard, the Composix Kugel Mesh Hernia Patch’s manufacturer, by injured patients and their families. 

To date, the Kugel Mesh Hernia Patch has allegedly caused at least one person’s death. According to a wrongful death lawsuit filed against Bard, a serious infection at the site of 63 year old woman’s incision caused her death two months after being fitted with a Kugel Mesh Hernia Patch. The woman was treated with antibiotics but the infection only got worse. Finally, after several trips to the hospital, the infection led to her death.

The Kugel Mesh Hernia Patch has been recalled by the FDA for safety reasons three separate times. The first recall was on December 22, 2005, when the FDA issued a Class 1 medical device recall for the extra-large version of the Kugel Mesh Hernia Patch. A Class 1 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. The recall notice was updated two more times, once in 2006 and once in 2007, when it was discovered that the large Kugel Mesh Hernia Patches could also cause serious injuries or death.

Due to the potential for serious side effects and death, more than 75,000 Composix Kugel Mesh Hernia Patches have been recalled to date. Among the 75,000 that were recalled, the FDA has received 34 memory recoil ring breakage reports so far. Unfortunately, 21 of those memory recoil ring breaks caused serious patient injuries, including death. In addition to the recalled Kugel Mesh Hernia Patches, there have also been reported injuries and deaths caused by the non-recalled hernia patches. 

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If you or a loved one has received a Bard Composix Kugel Mesh Hernia Patch and suffered serious side effects or death, you may be eligible to file a personal injury or wrongful death lawsuit.