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Bard Composix Kugel Mesh Hernia Repair Patch Dangers
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.
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.
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/injuries include:
- Adhesions
- Buckled mesh
- Patch shriveling
- Bowel perforation
- Bowel obstruction
- Chronic intestinal fistulae
- Severe abdominal pain
- Tenderness at implant site
- Infection
- Death
Contact An Experienced Bard-Kugel Hernia Mesh Repair Attorney
Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division has the knowledge and resources necessary to represent our clients efficiently and aggressively. We represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.
Your choice does matter. If you or a loved one has suffered serious injuries because of a Bard-Kugel Hernia Mesh repair surgery, call Thomas J. Henry Injury Attorneys immediately. We are available 24/7, nights and weekends.
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