The problems with the Composix Kugel mesh patch began to surface in 2002, shortly after Davol Inc. introduced the large and extra-large models of the hernia patch.

Reports came in 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.

The Kugel mesh patch, designed to make hernia operations easier and to reduce patients’ post-surgical pain, won FDA approval in 1996.

The patch, consisting of two layers of synthetic mesh surrounded by a flexible plastic “memory-recoil ring," is implanted at the site of a hernia. The ring then springs into place, allowing the hernia to heal and regrow around the flattened patch.

Davol blames the doctors

Davol initially attributed the broken rings to mistakes made by doctors while performing hernia-repair surgery. However, company tests soon revealed that the failures nearly always occurred at the spot where the ring was welded together.

In response to the design and manufacturing 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) at the prompting of the FDA after reports had linked the hernia patch to several fatalities and more than 80 injuries or other problems.

FDA inspection, lawsuits against Davol

In early 2006, the FDA carried out an inspection of Davol’s manufacturing plant. The agency found major flaws in the system for tracking and reporting patients’ complaints about the Kugel mesh hernia patch side effects .

FDA inspectors determined that Davol had been downplaying the severity of injuries related to the Kugel hernia patch, including the fact that one person may have died.

The first Kugel mesh hernia patch lawsuit was filed in Rhode Island in December 2006. Kugel patch attorneys alleged that their client suffered severe pain and had to undergo bowel dissection surgery. Many other patients have filed hernia patch lawsuits since then.