Designed to make hernia operations easier and to decrease post-surgical pain, the Kugel mesh patch gained U.S. Food and Drug Administration approval in 1996. Six years later, the Composix Kugel mesh patch made by Davol hit the market. The patch consists of two layers of synthetic mesh enclosed by a flexible plastic “memory-recoil ring.” Surgeons fold the patch for insertion then, the ring springs into place, allowing the hernia to heal and grow around the flattened patch.
Initial reports of ring breakage caused alarm, and Davol eventually found that ring failures were occurring at the point of the ring weld. Patch recalls were issued in December 22, 2005, March 14, 2006, and January 11, 2007, after the FDA linked several deaths, injuries and other medical problems to the Kugel mesh patch.
Kugel Hernia Mesh Patch Warning Signs
If you have already received one of these recalled medical devices in a hernia repair operation, you should contact your doctor. Additionally, you should seek immediate medical attention for symptoms that could be associated with breakage, such as:
- Persistent or unexplained abdominal pain
- Tenderness at the implant location
Conditions that Could be Associated with Breakage
Serious personal injury could occur with breakage of the Bard Composix Kugel mesh patch. Even though your hernia surgery may have occurred several years ago, the ring can still break and cause conditions like:
- Bowel perforation
- Bowel obstruction
- Chronic intestinal fistulae
- Abdominal pain
- Migration or movement of the ring
If you have been negatively affected by the Bard Composix Kugel mesh patch, you may be entitled to receive compensation through a defective product claim. The attorneys at Jacoby & Meyers can evaluate your case to determine the best way to proceed.
- PC#0010206, Bard Composix Kugel, Extra Large Oval 8.7 x 10.7
- PC#0010207. Bard Composix Kugel, Extra Large Oval 10.8 X 13.7<
- PC#0010208, Bard Composix Kugel, Extra Large Oval 7.7 X 9.7
- PC#0010209, Bard Composix Kugel, Oval 6.3 X 12.3
- PC#0010202, Bard Composix Kugel, Large Oval 5.4 X 7
- PC#0010204, Bard Composix Kugel, Large Circle 4.5