Bard Composix Kugel Mesh Patch Injuries
Orlando, Florida
The Bard Composix Kugel Mesh Patch is a medical device used to repair ventral hernias. Recalls of the device began in 2005. On January 10, 2007 Davol, Inc. and the Food and Drug Administration (FDA) announced an expansion of this recall.
Ventral hernias
A ventral hernia is a gap or tear in the abdominal wall, caused by thinning or stretching of scar tissue after surgery. Hernias can be very painful but sometimes present no symptoms. An internal organ can protrude through this gap and if the organ becomes tightly trapped, the blood supply can be cut off, requiring emergency surgery.
The Kugel Mesh Patch and hernia repair
The mesh patch is used in hernia repair to reinforce weakened tissue. It is folded before it is inserted through an incision. After it is placed behind the hernia, it is unfolded. A plastic ring called the “memory recall ring” holds the patch open.
The defect
The memory recall ring can break when placed under stress during certain surgical placement techniques. If this ring breaks, the broken ends can tear through the mesh causing serious internal injuries including bowel perforations and/or chronic enteric fistulae, a condition involving abnormal connections or passageways between the intestines and other organs. Both can lead to serious or deadly infections.
Symptoms and side effects
According to the FDA, symptoms which may indicate the presence of a broken memory recall ring include:
- Persistent abdominal pain
- Fever
- Tenderness at the implant site
- Other unusual symptoms
If you experience any of these symptoms following hernia surgery, you should seek immediate medical attention.
Recall history
Davol began receiving complaints about the defect in 2002 but did not recall the product until 2005, after 24 reports of broken rings. The initial recall only applied to the extra large patches:
- Extra Large Oval, 8.7” x 10.7”
- Extra Large Oval, 10.8” x 13.7”
- Extra Large Oval, 7.7” x 9.7”
In March, 2006 the recall was expanded to include Oval, 6.3” x 12.3”. The most recent recall expansion, issued January 10, 2007, includes:
- Large Oval, 5.4” x 7.0”
- Large Circle, 4.5”
If you have had hernia surgery using one of the recalled patches, your doctor may or may not feel that it is in your best interest to remove the device. For some patients who show no symptoms of breakage, replacement surgery poses a greater risk than leaving the defective Kugel Mesh Patch in place. If the ring has broken, it may be possible to remove the broken ring and leave the patch in place, or it may be necessary to replace the patch entirely.
If you or a loved one has suffered any of the above side effects after hernia surgery, it may be because your doctor implanted a defective Kugel Mesh Patch. If you believe you may have been injured by a defective Kugel Mesh Patch, please contact one of our Orlando Florida defective medical device attorneys today. We will evaluate your defective medical device claim at no charge to you, and we work on a contingency basis (we don’t get paid unless we recover monetary damages for you).
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