Kugel Hernia Mesh Patch: The Facts About Recalls, Injuries & Lawsuits
The Kugel Hernia Mesh Patch has been on the market for over eight years, but it’s been the subject of a great deal of controversy since that time – including recalls, injuries and lawsuits. Here are the facts about the product in a nutshell:
What is it?
The Bard Composix Kugel Mesh Patch, more often simply referred to as the Kugel Mesh or Kugel Hernia patch, is manufactured by Davol, Inc., which is a subsidiary of C.R. Bard. It is used to strengthen the abdominal wall and repair incisional hernias caused by the stretching or thinning of scar tissue that form after surgery. It was approved by the U.S. Food & Drug Administration (FDA) for market use in 2001, but complaints starting rolling in as far back as 2002.
Why is it dangerous?
The patch is surrounded by a “collapsible” plastic coil ring that is sandwiched between two pieces of mesh fabric so that it can be inserted into a small incision and then “un-coil” once inside the body – the design is similar to a collapsible sun shade used at the beach. It’s that coil ring which is causing all of the problems. In some circumstances, that ring has broken creating a sharp surface that has caused havoc with patients’ internal organs and intestines.
The FDA announced a Class 1 recall of the patch in December 2005 (the most serious form of recall) because the product’s memory coil ring could break, causing the user’s bowels to perforate or create abnormal connections or passageways between the intestines and other organs. The FDA announced a second recall of the product in March 2006 and a third recall in January 2007 due to reports of bowel perforations and other injuries.
The FDA says that patients implanted with one of the recalled devices* should, “seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.”
To view which devices were recalled, see the FDA’s website at http://www.fda.gov/cdrh/recalls/recall-122205.html.
Injuries & lawsuits
Injuries associated with a defective patch can be extremely painful – and often deadly. In some cases, patients’ bowels have been perforated which have caused serious, life threatening injuries. While Davol initially blamed doctors for inserting the patch incorrectly, it was later discovered – by Davol’s own studies –that the plastic ring was not welded correctly and that problems were not due to surgical error. In some cases, the patch must be replaced by additional, and often painful, surgery.
Numerous product liability lawsuits have been filed against the company alleging that it knew about the problems associated with the patch well before the FDA recalls, but did not alert the public or the FDA.
What can you do?
There are several tests that can be done to determine whether your Kugel Mesh Patch is defective including 1) a lower plate X-Ray, 2) barium fluid swallowed or as an enema, and 3) a reverse imaging CT scan. Your doctor can explain how these work.
If you believe that you many have been injured by the Kugel Mesh Patch, contact an experienced products liability attorney to discuss your situation and evaluate your options. Consultations are free, without obligation and are strictly confidential.