The Kugel Patch is a device designed to assist in the surgical repair of hernias. The full term for the device is the Bard Composix Kugel Hernia Patch: it is marketed and sold by Davol, which is a subsidiary of C.R.Bard, Inc. The patch itself is two layers of fine mesh which serve to help patch or cover a hernia that has just undergone surgical repair, until the wound can heal on its own. The patch is rimmed with a flexible plastic ring that folds for the insertion of the patch behind the herniated area. When in place, the ring springs back to its full width and spreads the patch where it has been placed.
The Kugel Patch was approved by the FDA for use in the U.S. in 1996. Five years later the company introduced large and extra large versions of the product, which led to repeated medical problems with their use. The plastic ring on the larger patches was breaking on occasion, when pressured by large organs in the abdominal area.
The ends of the broken ring were shown to be capable of perforating the bowel; of causing the development of fistulae; and on occasion rupturing organs. The chronic development of fistulae means repetitive growth of unnatural tissue connections between organs or vessels that aren’t designed to connect. They can result in severe pain and serious internal problems.
In 2002, shortly after the introduction of these large patches, problems with their use began to surface. Davol initially blamed the physicians who had used them by suggesting that they had not followed recommended procedures. Study of the patch failures showed, however, that the ring break almost always occurred where its ends were welded together.
Davol issued a recall on the extra large versions of its patch in November of 2005. The recall was amended and expanded on two subsequent occasions, in March of 2006 and January of 2007. The FDA strongly suggested and Davol complied with recalls of additional sizes of the patch and also defined their product recall in part by the dates on which the patches had been manufactured.
In 2006, the FDA inspected Davol’s manufacturing plant and found serious dysfunction in the company’s method of recording patient complaints about the patch and in tracking follow up procedures. The FDA formally concluded that Davol had been minimizing the number and severity of patch failures, one of which had possibly resulted in a fatality.
Also in 2006 the first lawsuit was filed against Davol and Bard for injuries suffered by a patient. The Rhode Island suit alleged that the patient had suffered severe pain and that the ring failure of the patch had resulted in bowel dissection surgery. Many suits have followed since.
The FDA has classified the Kugel Patch series of recalls as a Class I Recall, which places the Patch in the group of the most dangerous recalled products. In the Agency’s words, “A Class I recall is the most serious type of recall. In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death.” FDA Recall Info.
The FDA has also issued a warning letter to Davol and Bard, citing their findings of inadequate controls at the company’s facility for everything from manufacture to product storage to tracking of complaints. The history of corporate malfeasance combined with the hundreds of lawsuits filed against the company over Kugel Patch failures suggests that there is strong evidence of liability. There are so many federal lawsuits on this issue that the Federal Judiciary recently transferred all of them to the Federal District Court in Rhode Island for pretrial activities.
The Kugel Patch has a long history of use and presumably, of possible failure. If you or a family member has had a hernia operation in the last ten years and has had recurring abdominal difficulties, consult with a physician and with your surgeon on the possibility of a problem with your hernia repair.
If you wish to pursue legal action, you should know that our research has provided us with a thorough knowledge of the history of this product and its defects. Also, potential litigants in many states have told us that it is not only their ongoing health problems but also the company’s dishonest response to the issue that has driven them to consider legal recourse.