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Composix Kugel Hernia Mesh Patch Left on the Market Even After Maker Davol Inc. had Knowledge That Defective Spring Could Cause Death

Jun 18, 2007 | Parker Waichman LLP

    Considering how dangerous a hernia can turn out, the public needs to be aware of the treatment options available.  One way to treat it is to operate on and repair the afflicted area followed by applying a Composix Kugel Mesh Patch that will act as a mechanism to aid in the stretching and movement of muscle.  The process is painful and difficult to go through.   

        Unfortunately, those suffering from this debilitating condition are being done an injustice by the company Davol, Inc. based out of Rhode Island.  Davol makes the Bard Composix Kugel Hernia Mesh Patch which is used to treat hernias that usually occur where a previous incision has been made on the body.  The patch has a recoil spring that helps it to be folded and inserted, after which it is supposed to spring open and flatten.  Davol, Inc. began recalling the patches in January of 2007 after the springs in the patches began to break.  The breaking of the spring caused serious and fatal injuries including bowel perforation and death.

    Despite the fact that people began reporting injuries from the company's defect in December 2005 when an initial recall was sounded, the recall did not greatly expand until January of this year.  This kind of chronological oversight meant many lives were in jeopardy and the FDA even classified it as a "Class 1 because the defect associated with the use or exposure to (the patch) has a reasonable probability to cause serious adverse health consequences, including death." The FDA has accused Davol, Inc. of knowingly keeping their defective patches on the market for too long, insisting that Davol officials understated the severe and dangerous complications associated with the patches. 

    In the summer of 2005, the company received reports of up to 10 complications from the patches, resulting in one possible fatality and yet the company did not report a massive recall until December of that same year.  However, the shady company had had reports of people becoming injured long before the summer of '05.  As early as 2002, shortly after its product was introduced, Davol had received its first reports of the patch defects.  There is no reason good enough to get Davol, Inc. off the hook for essentially ignoring a small public outcry.  Perhaps if they'd acted more quickly, fewer people would have been spared the painful experience of recovering from a hernia.  And if recovering from a hernia wasn't enough, imagine doing it with a defective product with the potential to kill.

    Hernias are a painful condition in which an organ abnormally bulges out through the tissues that surround it.  Usually occurring in the abdomen, a hernia can cause major problems for the afflicted individual.  Hernias cause extreme pain and discomfort which ultimately decreases mobility, severely inhibiting a person's ability to walk, stand, or bend.  

    If left untreated, a hernia can cause something called strangulation where the portion of the organ which is protruding out of the body, experiences a blockage of blood-flow.  Should this blockage occur, a necrosis or decaying of the organ and tissue will happen and must be immediately operated on.


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