Bard Composix® Kugel Mesh Hernia Patch
The Bard Composix® Kugel Mesh Hernia Patch is used to repair ventral hernias. The Patch is manufactured by C.R. Bard, Inc., and their subsidiary, Davol, Inc. who owns the patent on the device. The Patch is made of two pieces of mesh that surround a flexible plastic ring. The surgeon places the mesh patch in a small incision. The surgeon would fold the patch and place it at the site of the hernia. The released ring would then spring back into its original shape, flattening the patch. The mesh-like material would serve as a substrate, allowing the hernia patient's own tissue to grow and assist in healing the hernia.
The Bard Composix® Kugel Mesh Hernia Repair Patch Recall has been upgraded by The United States Food and Drug Administration to "Class I" because the defect associated with the use or exposure to the Bard Composix® Kugel Mesh Large Patch has a reasonable probability to cause serious adverse health consequences, including death.
The FDA issued an immediate recall of Bard Composix® Kugel Mesh Hernia Repair Patches on December 22, 2005 and updated the list again on January 10, 2007. (See the Recall Notices and Affected Device List Below).
The "memory recoil ring" that opens the Bard Composix® Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
The FDA has advised patients who have received this device to seek medical attention immediately if abdominal pain, fever, tenderness at the implant site or other unusual symptoms occur. The FDA has instructed surgeons and hospitals to immediately stop using the recalled products and return the unused patches to the company.
We are now evaluating claims for patients with non-Recalled Bard Composix® Kugel Hernia Mesh Patches as well as recalled ones. If you or a loved one has had hernia surgery and received a Bard Composix® Kugel Patch please contact one of our lawyers today, to assess any potential claim and possible lawsuit.
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Product Code
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Description
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Lot Numbers Recalled
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Date Recalled
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0010206
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Bard ® Composix ® Kugel Extra Large Oval, 8.7" x 10.7"
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All Lot Numbers
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December 2005 and January 2006
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0010207
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Bard ® Composix ® Kugel Extra Large Oval, 10.8" x 13.7"
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All Lot Numbers
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December 2005 and January 2006
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0010208
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Bard ® Composix ® Kugel Extra Large Oval, 7.7" x 9.7"
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All Lot Numbers
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December 2005 and January 2006
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0010209
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Bard ® Composix ® Kugel Oval, 6.3" x 12.3"
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All Lot Numbers
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March, 24, 2006
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0010202
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Bard ® Composix ® Kugel Large Oval, 5.4" x 7"
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All Lot Numbers
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March 24, 2006 and updated Jan. 11, 2007
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0010204
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Bard ® Composix ® Kugel Large Circle, 4.5"
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All Lot Numbers
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March 24, 2006 and updated Jan. 11, 2007
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0010203
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Bard ® Composix ® Kugel Small Circle, 7.6 cm cm
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not-recalled to date however defects have been reported and claims are being evaluated
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0010201
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Bard ® Composix ® Kugel Small Oval, 8 cm x 12 cm
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not-recalled to date however defects have been reported and claims are being evaluated
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0010205
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Bard ® Composix ® Kugel Medium Oval, 11 cm x 14 cm
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not-recalled to date however defects have been reported and claims are being evaluated
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Use:
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The Composix® Kugel Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.
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Recalling Firm:
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Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920
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Reason for Recall:
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The "memory recoil ring" that opens the Composix® Kugel Mesh Patch can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).
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FDA Comments:
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- Surgeons and hospitals should stop using the recalled product and return unused units to the company.
- Patients who have who have been implanted with one of the recalled devices should seek medical attention immediately if they experience symptoms that could be associated with ring breakage such as unexplained or persistent abdominal pain, fever, tenderness at the implant site or other unusual symptoms.
- Davol, Inc. (a subsidiary of C.R. Bard) notified U.S. customers of the recall by letter on 12/27/05 via Federal Express.
- On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use clarifying the proper insertion technique and Supplemental Patient Management Information
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