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Defective Kugel Mesh Hernia Patch Can Still Cause Serious Injury

Oct 17, 2007 | Parker Waichman Alonso LLP

With the Kugel Mesh Hernia patch recall now nearing its second anniversary, it is important to note that not all hernia patients implanted with the patch have had it removed.  Understandably, those who have not experienced patch failure would not want to undergo the invasive surgical procedure required to replace a Kugel Mesh Hernia Patch.   But these patients must realize that their Kugel Patch could still fail, and it is important that they recognized the symptoms associated with such failure.

Hernias are an extremely painful condition where one part of the body bulges between the muscles surrounding it (for instance, the stomach could bulge through a fissure in the abdominal muscles).  Hernias cause extreme pain and discomfort and can greatly reduce a patient’s quality of life.  Surgery is the only way to permanently repair a hernia.   A patch, like the Kugel Mesh Patch is supposed to close the fissure and prevent the bulge.

Unfortunately, in 2005, the Food & Drug Administration (FDA) began receiving reports of failures with the Bard Composix Kugel Mesh X-Large Patch.  Once the device was implanted, the wire recoil ring that opened the patch was prone to breaking.  When this happened, patients often experienced serious problems like bowel perforations.  In December 2005, the FDA issued a Class I recall of the Bard Composix Kugel Mesh X-Large Patch.  A Class I recall means that the recalled product poses a serious danger to patients still using it.  In April 2006, the Class I recall was expanded to the “mid-line” size of the patch.  The recall was expanded for a third time in February of 2007 to include the large size patch.

Many patients had to have their Kugel patch replaced as a result of coil ring breakage, and at least one patient is known to have died from complications of a defective patch. Even now, the FDA continues to receive reports of serious injuries caused by the failure of a Kugel Mesh Hernia Patch. Since the first recall of the Kugel Mesh Hernia Patch in December 2005, hundreds of people have undergone emergency surgery to remove this defective medical device.

Unfortunately, some patients may not even be aware that their hernia surgery involved the use of a Kugel Patch.  Patients in this situation should contact their doctors to find out if they have one of the recalled patches.  All Kugel Patch patients should know that the ring can break at any time, and should seek medical help if they experience unexplained fever, persistent abdominal pain or tenderness at the incision site.  These could be a sign that the recoil ring has broken, and only immediate attention can prevent more serious health consequences.