Kugel Patch

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Composix Kugel Mesh Patch – for hernia repair

The Composix Kugel Mesh Patch has caused serious medical complications in some patients and has most recently been linked to bowel perforation and chronic intestinal fistulae.

What is the Composix Kugel Mesh Patch?

The Composix Kugel Mesh Patch is used to repair ventral (incisional) hernias. The patch is inserted through a small incision and is placed behind the hernia. A small coil ring called a “memory recoil ring” allows the patch to remain closed during placement and then opens the patch after it is inside the body. Bard, Inc., a leading developer and manufacturer of medical products, located in Cranston, RI, manufacture the Composix Kugel Mesh Patch.

What you should be aware of:

The U.S. Food and Drug Administration (FDA) issued a Class I recall on selected lot numbers of the Bard Composix Kugel Mesh Patch on December 22, 2005. A Class I recall is the strongest recall available to the FDA. It is reserved for defective products that could cause serious injury or death. The recall was updated with additional patches and lot numbers in January and March 2006.

The patches were removed from the market because the “memory recoil ring” that opens the Bard Composix Kugel Mesh Patch can break under the stress of placement in the body, or the patch can “migrate” or change positions after placement. This can lead to bowel perforation and chronic intestinal fistulae, recurring abnormal connections or passageways between the intestines and organs. Please see the entire list of recalled patches below.

If you or a loved one has been implanted with one of the recalled devices and/or if you experience any of the following symptoms associated with a defective “memory recoil ring”, you should seek medical attention immediately:

• Unexplained or persistent abdominal pain
• Fever
• Tenderness in the area the device was inserted
• any other unusual symptoms.
  

Contact us:
If you or a loved one has been injured due to the use of the Composix Kugel Mesh Patch, you need an attorney familiar with new developments in the investigation of this product to help you make important personal and legal decisions. If needed your attorney can represent you in a Composix Kugel Mesh Patch lawsuit. Contact us now to get the help you deserve. Give us a call at 800-992-6878 or CLICK HERE for a free case evaluation.

Recalled Patches

0010206 Bard ® Composix ® Kugel Extra Large Oval, 8.7” x 10.7” All Lot Numbers December 2005 and January 2006
0010207 Bard ® Composix ® Kugel Extra Large Oval, 10.8” x 13.7” All Lot Numbers December 2005 and January 2006
0010208 Bard ® Composix ® Kugel Extra Large Oval, 7.7” x 9.7” All Lot Numbers December 2005 and January 2006
0010209 Bard ® Composix ® Kugel Oval, 6.3” x 12.3” All Lot Numbers March 24, 2006
0010202 Bard ® Composix ® Kugel Large Oval, 5.4” x 7” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006
0010204 Bard ® Composix ® Kugel Large Circle, 4.5” 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N**** March 24, 2006

Related Articles:

Class 1 Recall: Bard Composix Kugel Mesh Patch Expansion
http://www.fda.gov/cdrh/recalls/recall-122205.html

Expanded Recall/Market Withdrawal of Hernia Repair Patch
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=502