06/07/2008- VIRGINIA BEACH, VA. (MyFox Hampton Roads) -- There is new information on a medical mishap at Sentara hospital. One woman says she's been left her in constant pain.
Today Sentara told MyFox Hampton Roads that they implanted a recalled mesh hernia patch in seven patients at two hospitals.
Four patients were at Virginia Beach General, three at Sentara Leigh in Norfolk.
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 the FDA recall was confusing. It happened in stages.
The first happened in 2005. The FDA said a plastic ring inside the Kugel Hernia Patch could break and puncture a person's bowel.
The FDA later recalled the large size patch in '06 because it posed a risk of breaking.
They issued a third recall in January of' '07.
Dr. Thames says as soon as the hospital realized the recalled product was on its shelves, staff removed it - sometime in mid '07.
MyFox Hampton Roads asked if at that time it didn't occur to anyone that patients may 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.