Bard Composix Pain Patch
The Bard Composix Kugel Patch is a popular device used around the world for hernia repair. The patch has a “memory recoil ring” that enables the device to fold (for insertion) and then later spring open and flatten out (once in place inside the body). The FDA and the products manufacturer, Davol, Inc. (a subsidiary of Bard, Inc.), recently recalled the device because the memory recoil ring can break, causing bowel perforation, chronic enteric fistulae, severe abdominal pain, fever, tenderness and other unusual symptoms.
The following Bard Composix Kugel Patches have been recalled:
- PC#0010206, Extra Large Oval, 8.7” x 10.7”
- PC#0010207, Extra Large Oval, 10.8” x 13.7”
- PC#0010208, Extra Large Oval, 7.7” x 9.7”
- PC#0010209, Oval, 6.3” x 12.3”
- PC#0010202, Oval, 5.4” x 7”
- PC#0010204, Large Circle, 4.5”
According to a March 24th, 2006 product recall, Bard recommends that healthcare professionals immediately discontinue the use of the specific product codes and lot numbers listed above. It has also been recommended that any patient who received the Kugel Mesh Patch and experiences any side effects should seek medical attention immediately.
Defective Composix Kugel Mesh Patch Side Effects:
- Bowel Perforation (a whole in the wall of the stomach, small intestine or large bowel, resulting in intestinal contents flowing into the abdominal cavity)
- Chronic Enteric Fistulae (complication of improper wound closure)
- Sever abdominal pain
- Fever
- Tenderness near the site of the surgery
More about the procedure:
An estimated 750,000 hernia surgeries are performed in the United States every year. During these procedures, the Kugel Mesh Patch is implanted behind the hernia through a small incision. The patch is made of two layers that create a “positioning pocket” that guides the patch into the correct location where it is then held open by the memory recoil ring. Reports of defective memory recoil rings ultimately lead to the device’s recall.
If you or a loved one have experienced any side effects from the Bard Composix Kugel Patch, please call us at (800) 966-4999 or fill out our online contact form for a free case evaluation.
