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Editor: Bob Binstock, Attorney at Law
Profession: Defective Medical Device Attorney

Category: Kugel Hernia Patch

Almost two years ago the FDA issue a Class I recall of the Bard Composix Kugel Mesh Hernia Patch in certain sizes. The recalled patched have the potential to produce serious injury and even death due to a defect in the memory recoil ring that can lead to breakage of the ring. The broken ring can cause bowel perforation and other serious internal injuries to vital tissue and organs. The most disturbing part of this recall is that patients implanted with the defective patches are faced with a very difficult decision, remove the patch through another surgery or leave the patch in and hope for the best.

This perilous choice is a tough one but most people have decided to leave the patch implanted rather than go through another painful surgery to remove a patch that may not ever have any problems. However, if the recoil ring was to break, the decision could cost them their lives.

The original recall has been expanded twice to include more shapes and sizes of patches, increasing the number of persons implanted with recalled patches substantially. While it cannot be determined when or even if the patches currently implanted in patients will malfunction the danger of injury will always be present and possible.

Implanted patients are encouraged to be observant of warning signs of injury. These signs consist of redness and swelling of the site, pain, tenderness, nausea, fever and chills. Patients that experience these symptoms should immediately contact their physician, as this could be a sign of a possible life threatening injury.