There are about 20 million hernia repairs conducted annually worldwide. In the U.S., there are about 700,000 of these hernia repair operations each year.
Kugel Mesh is the brand name for a line of hernia repair devices sold by Davol, Inc. and subsidiary company C.R. Bard, Inc. The Food and Drug Administration recalled a great number of the Kugel Mesh devices on December 22, 2005. Then on March 24, 2006, the manufacturer sent an urgent warning letter to hospital administrators, advising them that even more of the Kugel Mesh devices had been recalled as potentially defective. Most recently, on January 24, 2007, the FDA again expanded the Kugel Mesh recalled product list.
For an illustration of how these products work, it helps to compare the abdominal wall structure to an automobile tire with an inner tube. If the thick outer tire developed a split, the thin skinned inner tube could bulge out through that split. Similarly, if the thick outer musculature of the abdomen develops a tear or split, portions of the thin skinned inner organs, such as the intestines, can pop through, creating a hernia.
In the old days, hernia repair involved tucking the bulging tissue back where it belonged and tightly stitching up the outer musculature. This is called a "tension repair". The problem with the tension repairs was that the muscle tissue would often tear open again.
Along came the Kugel Mesh patch. It allowed surgeons to make a "tension-free" repair by placing the mesh on the inside of the muscle layer. The surgeon could make a small incision and insert the folded patch. Once inside the abdominal cavity, the patch's "memory recoil ring" caused the patch to spring open and stay flat. The mesh would hold the muscle tissue together while it healed.
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But imagine what happens if, once inside the belly wall, the Kugel Mesh memory recoil ring breaks. Here's what does happen: the ring snaps apart and breaks out through the surgery site. The sharp ends of the ring can then migrate and create havoc. They can perforate the bowel, stick to internal organs, create fistulas (abnormal connections or passageways between the intestines and other organs), or cause abdominal pain and even death.
In Part 2 of this article, I will tell you why this may become a widespread problem, and how to know if you, or someone you love, may be at risk. What you learn may send you to a lawyer for help.