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Kugel Mesh Hernia Patch Recall
Class I Recall
The Composix Kugel Mesh Hernia Patch has been voluntarily recalled by the manufacturer three separate times. The first Kugel Mesh Hernia Patch 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 the recalled product will cause serious health problems or death. In March 2006, and again in January 2007, the recall notice was updated to include additional Kugel Mesh Hernia Patch product codes and lot numbers. Bard has since redesigned all recalled versions of the Kugel Mesh Hernia Patch and has released the products back on to the market.
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Kugel Mesh Hernia Patch Recall, Main Defect and Side Effects
The main defect in the Composix Kugel Mesh Hernia Patch 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 that springs open once in place, allowing the patch to lay flat. When the memory recoil ring inside the Kugel Mesh Hernia Patch breaks, it can cause serious adverse side effects such as:
- bowel perforations
- bowel obstructions
- chronic intestinal fistulae
- serious infections
- death
While Bard’s first Kugel Mesh Hernia Patch recall was in December 2005, complaints made to Bard about the Kugel Mesh Hernia 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 Kugel Mesh 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 Kugel Mesh Hernia Patch recall.
After the first Composix Kugel Mesh Hernia Patch recall, FDA officials went to Davol (Bard’s subsidiary) headquarters to perform an inspection. According to the FDA’s inspection report, a range of problems in Davol’s complaint tracking system existed, possibly causing Bard to miscalculate the number and severity of Kugel Mesh Hernia Patch complaints. These flaws might explain why Bard failed to recall its Composix Kugel Hernia Patch earlier than 2005.
If you or someone you love have been injured by a recalled Composix Kugel Mesh Hernia Patch, contact us to learn more about your legal rights.
