The Kugel Mesh Hernia Patch has been recalled

Were you aware that the Kugel Mesh Recall was announced by the Food and Drug Administration on December 22, 2005? The Kugel Mesh Hernia Patch is used for hernia surgery and is produced by Davol, Inc., a division of C.R. Bard. There was a Kugel Mesh Recall because the "memory recoil ring," which assists in opening the product after it has been placed into the abdominal cavity has at times, malfunctioned. Unfortunately the malfunction of the coil may cause rupture or other problems.

The "memory recoil ring" that is so crucial to the Bard Composix Kugel Mesh Patch may break during the process of inserting it into the abdominal cavity. If the breakage of the coil happens, it can cause many adverse and sometimes severe health conditions. Some of these are bowel perforation, chronic intestinal fistulae, or abnormal connections of passageways between intestines and other gastrointestinal parts of that part of the body.

The following are the Kugel Mesh Hernia Patch batches 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****

Since the Kugel Mesh Hernia Patch Recall has started, potential clients should know that a Class 1 Recall is the most serious health alert the FDA can employ. It defines risk of a product and 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 Kugel Mesh recall began, and patients with the device are advised to seek medical assistance at once if they are experiencing any problems relating to this hernia surgery.

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
  Posted: 01-12-2007