MESH HERNIA PATCH RECALL

The Bard Composix Kugel Mesh Hernia Patch Recall is a patch used in the repair of hernias. The patch has caused dangerous complications in some patients.

mesh-3

1- Mesh for Hernia Repair

mesh-installed

2- Hernia Repair with Kugel Mesh Patch

broken-mesh

3- Broken Memory Ring of Mesh

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 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.

NON – RECALLED HERNIA MESH PATCHES NOW UNDER INVESTIGATION

We have expanded our investigation to include non-recalled hernia mesh, hernia patches, and hernia mesh patches manufactured by Davol, Inc. and Bard. We are now evaluating claims for patients with

  • All nine (9) models of Bard® ComposiX® Kugel® Hernia Patches (Product Codes 0010201 through 0010209)
  • All other Davol hernia patches with PET rings, including the Bard® Kugel® Hernia Patch; Bard® VentraleX® Hernia Patch; Bard CK Parastomal Patch; and Bard® Modified Kugel™ Patch; and
  • Other Davol hernia meshes composed of layers of polypropylene and ePTFE, including the Bard® Composix® E/X Mesh.
Product Code Description Size Date Recalled
10206 Bard ® Composix ® Kugel Extra Large Oval, 8.7” x 10.7” December 2005 and January 2006
10207 Bard ® Composix ® Kugel Extra Large Oval, 10.8” x 13.7” December 2005 and January 2006
10208 Bard ® Composix ® Kugel Extra Large Oval, 7.7” x 9.7” December 2005 and January 2006
10209 Bard ® Composix ® Kugel Oval, 6.3” x 12.3” 24-Mar-06
10202 Bard ® Composix ® Kugel Large Oval, 5.4” x 7” March 24, 2006 and updated Jan. 11, 2007
10204 Bard ® Composix ® Kugel Large Circle, 4.5” March 24, 2006 and updated Jan. 11, 2007
10203 Bard ® Composix ® Kugel Small Circle, 7.6 cm Not-recalled to date however defects have been reported and claims are being evaluated.
10201 Bard ® Composix ® Kugel Small Oval, 8 cm x 12 cm Not-recalled to date however defects have been reported and claims are being evaluated.
10205 Bard ® Composix ® Kugel Medium Oval, 11 cm x 14 cm Not-recalled to date however defects have been reported and claims are being evaluated.
Bard® Kugel® Hernia Patch All sizes Not-recalled to date however defects have been reported and claims are being evaluated.
Bard® VentraleX® Hernia Patch All sizes Not-recalled to date however defects have been reported and claims are being evaluated.
Bard CK Parastomal Patch All sizes Not-recalled to date however defects have been reported and claims are being evaluated.
Bard® Modified Kugel™ Patch All sizes Not-recalled to date however defects have been reported and claims are being evaluated.
Bard® Composix® E/X Mesh All sizes Not-recalled to date however defects have been reported and claims are being evaluated.

HAD A HERNIA SURGERY?

We have represented clients in every state and helped thousands of injured clients nationwide make recoveries for their injuries. We are ready to help you! Our clients are never at risk of paying any fees, expenses, or costs out of pocket. All fees costs and expenses are paid only out of any recovery we make for you.

Do not delay. Contact us now to find out if we can help. The claim evaluation is free. All claims have strict time limitations which will bar any recovery you or your loved may be entitled if the claim is not brought on time.

UNITED STATES FOOD AND DRUG ADMINISTRATION

CLASS 1 RECALL: BARD COMPOSIX KUGEL MESH PATCH – UPDATED 2/1/2007

2/1/2007 – FDA – Recall classified as 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. Customers should stop using the recalled product and return unused units to the company.

Use:

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.

Recalling Firm:

Davol, Inc., Sub. C.R. Bard, Inc.
100 Sockanossett Crossroad
Cranston, RI 02920

Reason for Recall:

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).

FDA Comments:

  • 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

FOLLOW UP WITH THE FDA