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Q: Why was the Composix
Kugel Mesh Patch Recalled?A: The Composix Kugel Mesh Patch was recalled by the FDA because the memory recoil ring which opens the patch can
break causing serious and potentially fatal complications. The Composix Kugel Mesh Patch was removed from the U.S. market on December 22, 2005. If you had a
hernia surgically repaired before this date contact your doctor to learn if you had this mesh placed. http://www.fda.gov/cdrh/recalls/recall-122205.html
What is a hernia? A hernia is a weakness or defect in the lining of the abdominal cavity. The abdominal cavity among its many functions acts as a
"housing" for our bodies internal organs. Any part of this housing that is weak or defective represents a hernia. Complications if a Hernia is not
Treated There exist many types of hernia. The problem is not the hernia by itself but what can happen with an hernia. Imagine a hole in the middle of a
playground with children playing in it. Unless the hole is repaired someone is going to fall in and get hurt, maybe even seriously hurt. In the case of a hernia an organ
like a portion of intestine can potrude into the hernia and cause problems. If the piece of bowel is trapped (encarcerated) its blood supply can be compromised
(ischemia) an ischemic bowel is in danger of perforating (a very serious problem). Goal of Hernia Repair In order to prevent this problem doctors try
to repair hernias as soon as they are identified. A common practice is to bring the edges of the hernias together. Bringing the edges together places a lot of tension on
the hernia repair. And, since the hernia is by definition a weakened part of the abdominal cavity it usually has poor tensile strength and cannot hold sutures and the
hernia re-occurs. Another approach involves placing a piece of mesh in the repair. Essentially creating a "patch" for the hernia. A hernia patch is usually
performed in a way were very little tension is created. These types of repairs have a lower recurrence rate.The Kugel Mesh Patch The Kugel Patch has
a ring around the edges of the patch. Reasonably the ring was designed to create a better covering on inguinal hernias (a specific type of hernia). The ring in the patch
was prone to break thus creating a sharp edge that had the potential of perforating the bowel (exactly what doctors wanted to avoid from happening in the first place).
Therefore this particular hernia patch has been recalled by the FDA.
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