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Bard issues hernia patch recall for Kugel mesh patch |
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Thursday, 22 December 2005 |
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C.R. Bard, Inc. and the FDA have announced a hernia patch recall for the Kugel mesh patch after reports indicated that the “memory-recoil ring” which surrounds the patch could break, leading to serious injury.
The recall covers three sizes of the extra large oval version of the Kugel mesh hernia patch. Davol, Inc., a subsidiary of Bard, began receiving reports of broken rings among Kugel hernia patch patients shortly after the extra large version of the patch was released in 2002. Some of these reports indicated a potential for serious injuries among patients with broken patches, including bowel perforation and chronic enteric fistulas—an abnormal connection between two sections of the intestines. Initially, Davol attributed these broken patches to mistakes made by doctors while they were implanting the patch. In August 2005, the company halted production of the extra large version of the Kugel mesh hernia patch and began holding training sessions for doctors to educate them on how to properly implant the device. But despite these safety measures, Davol continued to distribute the hernia patch to doctors.
In December 2005, tests run by Bard on one of the broken Kugel hernia patches indicated that the source of the ring breaks was a design flaw in the device and not doctor error. As a result, the company was forced to issue a hernia patch recall in order to take the defective Composix Kugel mesh patches off the market. |