Home arrow Hernia Patch Recall for Bard Composix Kugel Mesh
Kugel Mesh Hernia Patch Recall

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.

Latest News - 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
0010206
Bard ® Composix ® Kugel
Extra Large Oval, 8.7” x 10.7”
December 2005 and January 2006
0010207
Bard ® Composix ® Kugel
Extra Large Oval, 10.8” x 13.7”
December 2005 and January 2006
0010208
Bard ® Composix ® Kugel
Extra Large Oval, 7.7” x 9.7”
December 2005 and January 2006
0010209
Bard ® Composix ® Kugel
Oval, 6.3” x 12.3”
March, 24, 2006
0010202
Bard ® Composix ® Kugel
Large Oval, 5.4” x 7”
March 24, 2006 and updated Jan. 11, 2007
0010204
Bard ® Composix ® Kugel
Large Circle, 4.5”
March 24, 2006 and updated Jan. 11, 2007
0010203
Bard ® Composix ® Kugel
Small Circle, 7.6 cm
Not-recalled to date however defects have been reported and claims are being evaluated.
0010201
Bard ® Composix ® Kugel
Small Oval, 8 cm x 12 cm
Not-recalled to date however defects have been reported and claims are being evaluated.
0010205
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.

If you or a loved one has had a hernia surgery and received a Bard Composix Kugel Mesh Patch then you should call us toll free now at 1-866-374-0338 because you may be entitled to medical monitoring and compensation from the manufacturer.

Get your free, no obligation claim review by a lawyer today.

  • Call us at toll free 1-866-374-0338, or
  • use the Free Claim Evaluation form to your right, or
  • click on Live Support on the right of this page.

 

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.

CALL NOW 1-866-374-0338

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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

 


If you or a loved one has had a hernia surgery and received a Bard Composix Kugel Mesh Patch then please call our office toll free now at 1-866-374-0338 to discuss your legal options or complete the online form. You may be entitled to medical monitoring and compensation from the manufacturer.



The Johnson Law Firm announced today that it has expanded its investigation of the Kugel Mesh Hernia Patch to include non-recalled devices.

The firm has received numerous inquiries from patients who have non-recalled Kugel mesh patches and have had complications related to the device, including broken memory recoil rings. The defective memory recoil ring led to an FDA recall of many of the lot numbers of the Kugel Mesh Patch. The Law Firm is now investigating
claims nationwide of all Kugel Hernia Mesh Patches, regardless of lot number, product code, or reference number.

Read more...
 

Hernia Mesh Patch Recall Information and Nationwide Claims Filing Department Opened by National Law Firm

1/26/2007 - Patients with a hernia repair that used a mesh patch should review the latest recall information to see if they are affected and qualify to file claims for compensation and medical monitoring.

Read more...
 

Hernia Mesh Patch Recall; Reasonable Probability of Serious Injury and Death : FDA

2/1/2007 - FDA - Certain C.R. Bard Inc. surgical patches, already under recall, could cause death or serious health problems, the U.S. Food and Drug Administration said on Thursday.

"Customers should stop using the recalled product and return unused units to the company," the FDA said of the company's Composix Kugel Mesh Large Patch.

Read more...
 
2/1/2007 - FDA - Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal - Recall Upgraded to Class I due to risk of death and serious injury
Read more...
 
FDA 2007 Safety Alert: Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal

 

01/12/2007 - FDA - Davol/Bard and FDA notified healthcare professionals of an expanded recall and withdrawal of Large Oval and Large Circle patches. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas.
Read more...
 

1/10/2007 -- Expanded Recall NoticeSafety Alert: Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal

Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”
Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5”

Read more...
 

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