Recalled Kugel Hernia Patch Implanted at Sentara Hospitals
June 6th, 2008 amy
Recalled Kugel Hernia Patches have been implanted at Sentara Hospitals in seven patients at two hospitals, MyFox Hampton Roads reports. 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.”
Thames also blames the way the recall happened — in stages — as part of the problem. Indeed, there was a lot of confusion. The first Kugel patch recall happened in 2005, because 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 2006 because it posed a risk of breaking. They issued a third recall in January of’ 2007. 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 may have been implanted with the recalled patch. Apparently not! But one woman is complaining of constant pain from the Kugel Mesh Patch she was implanted with during this confusing time.
The Kugel Mesh Hernia Patch was implanted in thousands of patients before it was finally removed from the market. Thousands of people still live with the Kugel Mesh Hernia Patch, and the device could fail at any time. Symptoms of problems with the defective patch include unexplained fever, persistent abdominal pain, or tenderness to the incision site.
