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Company says seven patients received Kugel patch after recall |
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Thursday, 05 June 2008 |
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The company which runs hospital that admitted to using a Composix Kugel mesh patch after the Food and Drug Administration issued a hernia patch recall now says that at least six additional patients at two facilities also received the device after the recall date. Sentara Healthcare says that four patients at Virginia Beach General Hospital and three at Sentara Leigh Hospital received a Kugel patch implant months after the hernia patch recall was issued.
The FDA issued three Kugel patch recalls between 2005 and 2007 after learning that the memory recoil ring that surrounds the device was prone to breaking. When this occurs, patients may experience severe pain or other Kugel side effects, including bowel perforation, bowel obstruction or chronic enteric fistulas.
The vice president of Sentara says that the hospitals’ use of the Kugel mesh patch was the result of human error that occurred because of confusion about which devices were involved in the hernia patch recall. He says that staff at the two hospitals removed the patch from their shelves in mid-2007—several months after the third Kugel mesh recall was issued.
Several patients who were injured after using the Kugel patch have filed hernia patch lawsuits against its manufacturers, Davol Inc. and C.R. Bard Inc. These lawsuits have alleged that the two companies knew about potential design problems with the hernia patch soon after its release, but waited for years to inform the FDA of the increased risk of hernia patch side effects. |