Kugel Mesh Info for YOU!
Posted by
Allison SnoddyJune 27, 2007 12:44 PMTags:
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Kugel Mesh was developed to treat ventral hernias, which are caused by a stretching or thinning of scar tissue that forms after abdominal surgery. Due to numerous complaints of uncomfortable side effects such as persistent abdominal pain, tenderness near the implant site, fever, nausea and vomiting, the bard composite Kugel mesh patch products have been pulled from the market since 2006.
Recently, the FDA inspected Davol Inc., a manufacturer of the mesh. According to the FDA, "in several instances, Davol did not accurately report the possible severity of complaints to the [FDA]" and that Davol company officials "had understated the potential severity of device-related injuries." Thus, it is becoming clear that this company did not adequately inform the public of the serious side effects and risks posed by the Kugel hernia mesh product. On December 22, 2006, Davol announced a massive recall of the Kugel Mesh Patch. However, according to oshmanlaw.com, FDA records show that the manufacturer began receiving reports of serious injuries caused by the Kugel Mesh as early as 2002. Most of these problems were related to the extra-large sized Kugel Mesh patches. The recall prompted the FDA investigation, which found several inconsistencies and discrepancies in the way Davol tracked and managed Kugel Mesh injury reports.
For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.