Other people who had their patch fail are left wondering if their replacement patches are among those recalled.
Gary Sharp had a Composix Kugel Mesh Patch implanted in December, 2004, to repair a hernia. However, within three months the patch had failed. "The mesh tore right off the ring," Gary says. "It messed up my intestine. In fact, I lost almost a foot of intestine because of the mesh."
The failed patch caused Gary to suffer from abdominal pain; however his doctor mistakenly believed the pain in Gary's abdomen was due to scar tissue from cancer rather than from the hernia patch. Gary spent the next nine months dealing with abdominal pain. "Some days it was worse than others," Gary says. "If I had a hard day at work then the pain was worse. It was very uncomfortable."
Gary went back to his doctor in December, 2005, because a lump had developed in his abdomen. The doctor performed surgery where it was discovered that Gary's hernia patch had failed and he would lose up to a foot of his intestines as a result of the mesh embedding in part of his intestine. At the same time, a new patch was implanted.
"So far, I haven't had trouble with the new patch," Gary says. "I've still got pain, but now I just deal with the pain." Gary has tried to get some information regarding the original patch that was implanted, but the hospital has yet to provide that information. "I sent a request for the records to find out what was used," Gary says. "I requested information on the original patch, but they sent me the information for the replacement. I had to put in another request to get the information for the original patch. I still do not know what was used the first time."
Unfortunately, with all the recalls, it can be difficult to remember exactly which product codes have been recalled and which have not (see below for a list of recalled product codes). The first recall was announced December 27, 2005, but since then the recall has been expanded at least twice. The expanded recalls occurred March 24, 2006, and January 10, 2007.
The recalls were serious enough to receive a US Food and Drug Administration Class 1 classification. Class 1 recalls are used in situations in which there is a possibility that exposure to the recalled device could cause serious injuries and even death. According to the FDA, failure of the Kugel Mesh Patch can cause serious injuries including bowel perforations and abnormal connections between the intestines and other organs.
Davol Inc., is currently facing at least one lawsuit as a result of defective Kugel Mesh Patches, however more lawsuits will likely be announced as more injuries are reported.
If you have had a Kugel Mesh Patch implanted it is a good idea to find out if doctors used one of the now recalled products. If they did, speak to your doctor about your options. If you notice unexplained or persistent abdominal pain, tenderness at the implant site, fever, or other unusual symptoms contact your doctor right away.
Units affected by the Kugel Mesh Patch recall are:
| PC#0010206 | Bard Composix Kugel | Extra Large Oval | December 2005 and January 2006 |
| PC#0010207 | Bard Composix Kugel | Extra Large Oval | December 2005 and January 2006 |
| PC#0010208 | Bard Composix Kugel | Extra Large Oval | December 2005 and January 2006 |
| PC#0010209 | Bard Composix Kugel | Oval | March 24, 2006 |
| PC#0010202 | Bard Composix Kugel Large | Oval | January 10, 2007 |
| PC#0010204 | Bard Composix Kugel | Large Circle | January 10, 2007 |