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FDA releases warning letter sent to Kugel patch maker |
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Wednesday, 15 October 2008 |
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The Food and Drug Administration has released a warning letter that was sent to the manufacturer of the Composix Kugel hernia patch over “adulterated” products that were manufactured at its Puerto Rico plant, which include the Kugel patch.
C.R. Bard has issued three separate hernia patch recalls since 2005 over problems with the Kugel patch. Because the memory recoil rings that surrounds larger sizes of the patch and hold them in place are prone to fracture, patients who receive these devices are at an increased risk of complications, including bowel perforation, bowel obstruction and chronic enteric fistulas.
According to the new FDA warning letter, inspections of the plant revealed violations of “Good Manufacturing Practices,” including failure to make sure that products met design requirements and failure to identify quality control problems that could lead to safety issues with products manufactured there. The letter also notes that Bard has received several complaints regarding mislabeled products, including one involving the Kugel mesh patch.
More than 2,000 patients who had received the Kugel patch have filed lawsuits against Bard since the three recall notices were announced. These lawsuits have alleged that the hernia patch caused them to suffer serious and potentially fatal side effects due to problems with the way the patch was designed or manufactured. |