Kugel® Mesh Hernia Patch Recall

The popular Bard® Composix® Kugel® Mesh Hernia Patch has been linked to serious, life-threatening side effects and has been voluntarily recalled by its manufacturer and in association with the U.S. Food & Drug Administration (FDA).

Kugel Hernia Patch Lawsuit Update: On January 8, 2008, a Federal Court judge expanded the scope of current hernia patch lawsuits to include all Davol/Bard Marlex/Teflon patches, with or without “memory recoil rings.”

As early as August 2001, Davol began receiving reports of complications and failures of its hernia mesh patch. These reports advise of bowel obstructions, adhesions, constipation, and fistula resulting from implantation of Composix® Kugel® Mesh Patches. The reports also contain descriptions of problems other then memory recoil ring breakage including, “buckled mesh,” “patch shriveling” and “edges curled up,” as well as descriptions of the mesh as being “crumpled,” “wrinkled,” “rolled up,” “delaminated” and “folded.”

Our firm is pursuing litigation involving the following defective hernia patches: Composix® E/X Mesh Patch, the Composix ®Kugel ®Patch, and the Composix® L/P patch.

What You Can Do & How We Can Help – We are committed to helping victims of recalled Kugel hernia patches. Our law firm is one of the most active firms in the in country actively handling these types of cases.

Free Case Evaluation: If you or a loved one has received a recalled/defective Kugel patch or suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection or an unfortunate loss linked to the Kugel patch, you should contact us immediately. You may be entitled to compensation and we can help.

FDA Video: Bard® Composix® Kugel® Mesh Hernia Patch Recall

Below is an excellent video produced by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of the nationwide recall of Composix Kugel mesh hernia patches and provides information about the defective memory recoil ring and possible side effects from ring breakage.

Read the Full Transcript: Bard® Composix® Kugel® Mesh Hernia Patch Recall

What is the Kugel Patch?

The Kugel patch is used to repair Inguinal, Ventral and Laparoscopic hernias. In the more common Ventral or Incisional hernia, 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.

Timeline – Why was the Kugel Patch Recalled?

In three (3) separate product recalls, Davol Inc. and its subsidiary C.R. Bard Inc. in association with the FDA initiated a voluntary recall of the Kugel patch. The dates for the specific recalls are as follows:

• December 22, 2005
• March 31, 2006
• January 24, 2007

The recall of the hernia patch was initiated because the “memory recoil ring” that opens the Kugel patch can break under the stress of placement of the large sized products in the intra-abdominal space.

What are the Side Effects & Injuries Associated with Defective Kugel Patches?

The memory recoil ring defect in the hernia patch can lead to serious, life-threatening side effects. The side effects of a defective patch are as follows:

• bowel perforation;
• bowel obstruction;
• chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs);
• serious infection; and/or
• death.

Signs of a Problem

The FDA has advised patients who have been implanted with one of the recalled devices to seek medical attention immediately if they experience symptoms that could be associated with ring breakage. Symptoms of ring breakage are as follows:

• unexplained or persistent abdominal pain;
• fever;
• tenderness at the implant site; and/or
• other unusual symptoms.

Kugel Patch Recall List

Included below is the list of recalled devices, along with the product codes affected and relevant manufacturing dates.

Note: It is important to remember that if you or a loved one have received a recalled/defective patch or suffered from any of the aforementioned side effects, we would like to speak with you – regardless of which model Kugel patch you received.

• Extra Large Oval, 8.7” x 10.7”
  All Lot Numbers manufactured before January 2006
  Product Codes: 0010206
   
• Extra Large Oval, 10.8” x 13.7”
  All Lot Numbers manufactured before January 2006
  Product Codes: 0010207
   
• Extra Large Oval, 7.7” x 9.7”
  All Lot Numbers manufactured before January 2006
  Product Codes: 0010208
   
• Oval, 6.3” x 12.3”
  All Lot Numbers manufactured before March 2006
  Product Codes: 0010209
   
• Large Oval, 5.4” x 7.0”
  All Lot Numbers manufactured before October 2005 & also Including the following:
  41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
  Product Codes: 0010202
   
• Large Circle, 4.5”
  All Lot Numbers manufactured before October 2005 & also Including the following:
  41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
  Product Codes: 0010204

Do I have a Kugel Patch Lawsuit?

The Medical Device and Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Kugel patch lawsuits. We are handling individual litigation nationwide and currently accepting new Kugel patch recall cases in all 50 states.

If you or a loved one has received a recalled/defective Kugel patch or suffered from bowel perforation, bowel obstruction, chronic intestinal fistulae, infection or an unfortunate loss linked to the Kugel patch, you should contact us immediately. You may be entitled to compensation and we can help.