Problems with the patches were identified shortly after the extra large Kugel Mesh patches were introduced on the market in 2005. At that time, Davol Inc. received a disproportionate number of complaints about broken rings related to the extra large patches. However, even though Davol stopped production of the extra-large patches in 2005, it continued to distribute the patches and doctors continued to implant them.
After tests were run on the Kugel Mesh patch that showed the problem was caused by the patch itself and not by the doctors implanting the patch, Davol recalled the extra-large patch and then the large patch. Prior to the testing, Davol maintained that the problem was actually with how doctors implanted the patch, rather than being a problem with the design or manufacturing of the patches.
According to an article in the New York Times (March 16, 2007), the US Food and Drug Administration has received reports of over 80 injuries, including more than one death, linked to the Kugel Mesh patches since a letter announcing a recall of the patches was sent in late 2005. Subsequent recalls were announced in January and March of 2006. In February 2007 the recall was upgraded to Class 1.
The New York Times article reports that FDA officials inspected Davol Inc., a subsidiary of CR Bard, in 2006 and found that there were inconsistencies in how complaints were tracked and analyzed. They also found that that Davol failed to report the possible severity of complaints that it received.
FDA regulations state that makers of implantation devices such as the Kugel Mesh patch must have methods of collecting and analyzing complaints received about their devices, as well as informing the FDA about any device failure that may have caused or contributed to the injury of a patient. Unfortunately, companies also have the freedom to choose not to forward a complaint if an internal review determines that the product was not the cause of the harm.
Kugel Mesh patches were recalled because the memory recoil ring component of the large and extra large patches had problems with breaking. Breakage of the rings led to migration through the abdominal wall, bowel obstruction, and septic shock. The patches were implanted to help repair ventral hernias.
Lawsuits have been filed against the makers of the Kugel Mesh patch. One suit was filed in December, claiming that a defective patch required bowel dissection surgery to fix the problem. The surgery then resulted in chronically inflamed bowels.
If you have had a Kugel Mesh patch implanted and are experiencing unusual symptoms, speak to your doctor to discuss your options.