Bard Kugel Hernia Mesh
INJURED BY A DEFECTIVE KUGEL MESH HERNIA PATCH?
The Bard Composix Kugel Mesh hernia repair patch, manufactured by Davol Inc. (a subsidiary of C.R. Bard, Inc.) is a medical device approved for use in ventral hernia repair surgeries. The device, which consists of a plastic “memory recoil ring” surrounding two mesh layers, is folded and inserted through a small incision in the abdomen/groin. The memory recoil ring causes the mesh patch to spring open and lay flat once the device is in place.
The device gained FDA approval in 1996, but when the company began introducing larger versions of the patch in 2002, reports of problems with the mesh material and memory recoil ring began to pour in. These problems have led to a number of FDA warnings, alerts, and recall notices as well as hundreds of lawsuits over patient injuries and fatalities.
Thousands of actions were filed under a multidistrict litigation (MDL) against Bard and Davol for the defective medical device. In 2011, the manufacturers came to a settlement agreement with many plaintiffs for $184 million. Only six cases remain pending as of March 2017.
HISTORY OF KUGEL MESH FDA RECALLS
- 2005– The FDA issues a Class 1 recall of the Bard Composix Kugel Mesh hernia patch (X-Large Patch Oval with ePTFE).
- 2006– The FDA recall is expanded to include Oval, Large Oval, and Large Circle Kugel mesh hernia patches.
- 2007– The hernia patch recall is further updated to include additional product codes and lot numbers recalled by Davol/Bard since the first recall was issued.
WHAT ARE THE COMPLICATIONS ASSOCIATED WITH KUGEL MESH?
In 2002, Davol began receiving reports of Composix Kugel Mesh Patch complications and failures associated with both the mesh material and the memory recoil spring. Complications and injuries include:
- Buckled mesh
- Patch shriveling
- Bowel perforation
- Bowel obstruction
- Chronic intestinal fistulae
- Severe abdominal pain
- Tenderness at implant site
CONTACT AN EXPERIENCED DEFECTIVE MEDICAL DEVICE LAWYER
If you have been harmed after being implanted with a Kugel hernia mesh patch, contact Thomas J. Henry. Our attorneys are available 24/7, nights and weekends to evaluate your claim. Call us today for a free legal consultation.