The Kugel Mesh Patch 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
- & Vomiting
the bard composite Kugel Mesh Patch products have been pulled from the market since 2006.
Recently the FDA has inspected Davol Inc., the 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.”
It is now 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 records by the FDA, it shows that Davol 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 patches. The recall prompted the FDA investigation, which found several inconsistencies and discrepancies in the way Davol tracked and managed Kugel mesh injury reports.
If you have experienced side effects such as:
- Bowel perforation
- Bowel obstruction
- Chronic intestinal fistulae and/or
- Serious infection
Then contact the office of Reich and Binstock for an evaluation.