The Composix Kugel Mesh Patch was removed from the U.S. market on December 22, 2005. The patch is used for ventral or incisional hernias and is manufactured by Davol, Inc., a division of C.R. Bard. The device was recalled because the "memory recoil ring," which opens the patch after it has been inserted into the intra-abdominal space, can break.
The "memory recoil ring" that is so critical to the the Bard Composix Kugel Mesh Patch is prone to breakage during the stress of placing it inside the body. If the device breaks, it can cause a number of serious and potentially life-threatening complications, such as bowel perforation, chronic intestinal fistulae, or abnormal connections of passageways between intestines and other gastrointestinal organs.
The following are the batches of the Bard Composix Kugel Mesh Patch affected by the recall:
- Bard® Composix® Kugel® Extra Large Oval, 8.7" x 10.7", all lot numbers
- Bard® Composix® Kugel® Extra Large Oval, 10.8" x 13.7", all lot numbers
- Bard® Composix® Kugel® Extra Large Oval, 7.7" x 9.7", all lot numbers
- Bard® Composix® Kugel® Oval, 6.3" x 12.3", all lot numbers
- Bard® Composix® Kugel® Large Oval, 5.4" x 7", lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
- Bard® Composix® Kugel® Large Circle, 4.5", lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
A Class 1 Recall is the highest health alert the FDA can enact. It means that there is a "reasonable probability that the use of or exposure to a product will cause serious injury or death." There have been at least 24 reports of broken rings since the recall, and patients with the device are advised to seek medical attention immediately if they suffer from unexplained and persistent abdominal pain, fever, tenderness at the implant site or unusual symptoms.
Bard Composix Kugel Mesh Patch News & Articles
Davol/Bard Composix Kugel Mesh Patch
- UPDATE 3/31/2006 - Davol/Bard and FDA notified healthcare professionals of an expanded recall of this product to include Oval, Large Oval and Large Circle Kugel mesh patches. ... View full statement.
- Posted 03/02/2006 - Bard/Davol and FDA notified healthcare professionals of a class 1 recall of Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. ... View full statement.
Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion
This recall notice was updated on January 24, 2007
- 2007 Safety Alert: Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal