South Carolina Kugel Mesh Lawyers

The problems with the Composix Kugel mesh patch started to come about in 2002, right after Davol Inc. produced the large hernia patch units.

Reports surfaced that the rings in certain devices were breaking, leading to injuries to patients’ internal organs and tissue from hernia patch side effects, including bowel perforations, bowel obstructions and chronic enteric fistulas.

The Kugel mesh patch was  intended to make hernia operations go more smoothly.  The patch also aimed to lower patients’ post-surgical pain.  It won approval from the Food and Drug Administration in 1996.

The patch consists of two layers of synthetic mesh enclosed by a flexible plastic “memory-recoil ring,” which is implanted at the site of a hernia. The ring then springs into place, allowing the hernia to heal and re-grow around the compressed patch.

Read More about Kugel Mesh Products.

Davol stated the Physicians were Liable

Davol first attributed the broken rings to mistakes made by doctors while performing hernia-repair surgery. Later, however, company studies revealed that the failures almost always took place at the spot where the ring was fused together.

In December 2005, as a result of 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.

Shortly after, Davol issued two more Kugel mesh hernia patch recalls (March 2006 and January 2007) as a result of FDA reports which connected the hernia patch to quite a few fatalities and more than 80 injuries and other problems.

Lawsuits

In early 2006, the FDA performed an inspection at Davol’s manufacturing plant. The administration found major defects in the system for tracking and reporting patients’ complaints about the Kugel mesh hernia patch’s unwanted side effects.

FDA officials found that Davol had been downplaying the significance of injuries related to the Kugel hernia patch, including the fact that one person may have passed away.

For more information on faulty mesh products, click here.