In the case of hernia surgery, leaving something inside is what's SUPPOSED to happen. A medical patch is inserted inside the abdomen during surgery to repair the hernia, and that patch stays with you.
However, if you happen to have a Bard Composix Kugel Mesh patch inside of you - you may want it outta there. The FDA announced in February that it is recalling certain versions of the patch over problems with an expander device.
The Kugel Mesh is a folded patch that expands once inside the abdomen by way of a plastic expander ring, which holds the patch in place behind the hernia.
In certain versions of the patch, these rings have the potential to fail. Specifically, they can break, and sharp edges risk poking through the bowel and other internal organs.
David Pauley of Denver, Colorado was diagnosed with a hernia after heart surgery and was fitted with a Kugel Mesh over Thanksgiving in 2004. Within 30 days he began experiencing discomfort and swelling of his abdomen, and a hole actually opened up, oozing fluid from his abdomen. It wasn't until two years later, complicated by job loss and continuing health problems, that David had the infected mesh removed, in December 2006. By then his health had gone downhill: his bowels have been affected, and his digestive system is failing.
The Kugel Patch has been in the news since 2005, when C.R. Bard Inc. announced a recall of certain versions of the device. Manufactured by Bard subsidiary Davol, the patch began generating complaints about broken plastic rings as early as 2002, when the largest patch went into production. Davol stopped producing the large patch in 2005, and took steps to ensure the device was being managed properly during surgery. But the reports kept coming.
Davol expanded its recall of the patch in January of this year. Less than a month later, the FDA cited the Kugel Mesh with a class 1 recall and instructed doctors to stop using the recalled patch immediately.
The affected patches were made between January 1st 2004, and September 30th 2005. The concern remains the plastic expander ring, which stays inside the abdomen after surgery. Officials are worried about the ring welds, which could fail and break, leaving sharp pieces exposed to soft internal organs, and especially the bowel.
Richard Keough of North Lauderdale, Florida has had several experiences with Kugel Mesh. One after another, Kugel Mesh patches were inserted, and then removed in the face of raging infections. It has left the Keough family devastated financially. Richard is no longer working, and his wife was fired from her job for taking too much time off to care for her husband. They have used up their life savings, and are looking to recover their substantial expenses.
Since the recall was announced, there have been 80 reports of health problems, and some deaths. A woman in Salt Lake City, Utah died within eighteen months of having a hernia repaired, at the age of 62. She had received one of the recalled patches.
David Pauley, from Denver, did too. He's getting his medical records together, and has contacted a lawyer.
The affected patch is the Bard Composix Kugel Mesh patch, identified in three manufacturer's recalls - December 2005, January 2006 and March 2006. All outstanding devices have been ordered returned to the manufacturer.
In the meantime, if you have recently had hernia surgery and experience sharp pains or tenderness of the abdomen, nausea, fever, redness and a foul discharge from the incision, or any unusual symptom, seek medical help immediately.
It would also be a good idea to check your medical records to see if you may have a recalled Kugel Mesh, sitting inside of you.