The patches, manufactured by Davol, were designed to reduce patients’ post-surgical pain and also to help with hernia repair surgery, obtained FDA approval in 1996. The patch consists of two layers of synthetic mesh surrounded by a flexible plastic “memory-recoil ring.” After implantation at the site of a hernia, the ring then springs into place, allowing the hernia to heal and grow around the flattened patch.
As early as 2002, reports surfaced that the rings in some of those devices were breaking, causing injury to patients’ internal organs and tissue from hernia patch side effects, including bowel perforations, bowel obstructions and chronic enteric fistulas. In early 2006, the FDA carried out an inspection of the plant of Davol, the manufacturer. The FDA found major flaws in the tracking and reporting patients’ complaints about the patch side effects.
In response to the flaws uncovered in its tests, Davol issued a hernia patch recall for the extra-large model of the Kugel mesh hernia patch in December 2005. Davol then issued two more Kugel mesh hernia patch recalls (March 2006 and January 2007) after reports had linked the hernia patch to several fatalities and more than 80 injuries or other problems.
As St. Louis injury attorneys, we handle Kugel Mesh cases in both Missouri and Illinois. If you live outside of these states, we can find an attorney to help you. Contact St. Louis Personal Injury Attorney Lindsay Rakers or call at 800-517-0602.