Hospital Patients Implanted With Recalled Kugel Mesh Patch
Tuesday, June 10, 2008
On May 6, 2008 information was released announcing that a total of seven patients at two Virginia hospitals were implanted with the defective, and recalled Davol Bard Kugel Mesh Hernia Patches. Four patients were at Sentara Virginia Beach General, and the other three were at Sentara Leigh in Norfolk.FDA records show that as far back as 2002, Davol Bard began to receive complaints about broken rings in the extra large versions of the patch. Davol initially blamed the broken devices on doctors improperly folding the patches for placement during hernia repair.
It was not until December 2005 that Davol ran tests and realized that the broken rings were not due to doctor error, but rather failure at the ring weld. In 2006, the FDA found that Davol was tracking complaints about the hernia patch improperly and that adverse reports were understated, which resulted in a major recall. Then again in 2007, a third recall occurred.
Sentara's Vice President Of Medical Affairs Dr. Tom Thames says, "It happened as a result of human error. It's one no one intended to make and it's one we're conducting an in-depth, thorough analysis of."
Dr. Thames says as soon as the hospital realized the recalled product was on its shelves, staff removed it sometime in mid 2007.
MyFox Hampton Roads asked if at that time it didn't occur to anyone that patients might have been implanted with the recalled patch. Thames said, "that appears to be the case."
Sentara has offered to help the patients, but Dr. Thames says it's not likely this mesh is causing pain, because he says there have been no reports of breakage in these particular patches.
Patients with questions or concerns about a procedure done at a Sentara hospital can call 1-800-SENTARA.
Posted in Medical Devices • Davol Bard Composix Kugel Hernia Mesh Patch