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FDA warns Kugel patch maker of manufacturing problems |
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Tuesday, 14 October 2008 |
The Food and Drug Administration has issued a letter to the manufacturers of the Composix Kugel mesh hernia patch warning them about problems uncovered at the company’s Puerto Rico plant. Products manufactured by C.R. Bard Inc. at the plant include the Vacora Biopsy Probe and the Composix Kugel mesh hernia patch. The company has issued three separate Kugel mesh recalls since December 2005 because of problems with the device.
According to the FDA warning letter, inspectors who visited Bard’s Puerto Rico plant between November 2007 and February 2008 discovered manufacturing practices that were in violation of federal manufacturing standards. Among the problems cited in the letter were sorting errors that caused different sizes of the hernia patch to become mixed up. Despite this fact, the FDA says that Bard did not take additional action to correct the problem.
Bard issued hernia patch recalls for the Kugel patch in December 2005, March 2006 and January 2007 because of problems with the durability of the patch. According to notices issued by the company, the “memory recoil ring” that surrounds the patch and holds it in place after surgery could break, leaving some patients at risk of serious and potentially deadly side effects, including bowel perforation and chronic enteric fistulae. |