Kugel Hernia Patch
On January 10, 2007, the FDA and Davol Inc. issued an updated product recall for the Kugel mesh hernia patch after reports had linked it to several fatalities and more than 80 injuries or other problems. The hernia patch recall expanded two previous product recalls which had been issued for the Kugel mesh patch.
First reports of problems
The hernia patch is comprised of two pieces of synthetic mesh surrounded by a flexible ring. The Kugel mesh patch is implanted at the site of a hernia. The plastic ring that surrounds the patch then springs into place, allowing damaged tissue to regrow around the flattened patch.
In 2002, Davol began receiving reports of broken plastic rings in the largest models of the Kugel mesh hernia patch.
In some cases, these broken rings could cause side effects such as internal tears, leading to bowel perforation, bowel obstruction or chronic enteric fistula, an abnormal connection between two organs or parts of the body that aren’t supposed to connect.
Blaming the doctors
Davol initially attributed the broken rings to mistakes made by doctors while performing hernia repair surgery. But when company tests revealed that the failures consistently occurred at the spot where the ring was welded together, Davol was forced to issue a hernia patch recall for the extra large model of the Kugel mesh hernia patch.
This recall was later expanded to include the oval, large oval and large circle models of the patch.
The FDA conducted an inspection of Davol’s manufacturing plant in early 2006 and found significant flaws in the company’s system for tracking and reporting complaints related to the Kugel mesh hernia patch.
Inspectors from the agency found that Davol had understated the severity of side effects related to the hernia patch, including three reports of injury and one possible death.
If you have suffered bowel perforation, bowel obstruction, chronic enteric fistulas or other injuries as a result of the Composix Kugel mesh patch and are considering a hernia repair lawsuit, contact the attorneys at Hissey Kientz. You can reach us by calling toll-free at (866) 275-4454 or by filling out a free case evaluation form to the right of this page.