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Kugel Mesh Hernia Patch Lawsuit

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The Composix® Kugel® mesh hernia patch has been linked to serious, life-threatening side effects and has been voluntarily recalled by its manufacturer (Davol, Inc.) and in association with the U.S. Food & Drug Administration (FDA).

 

Kugel Mesh Injuries

  • abdominal abscess formation
  • abdominal tenderness
  • bowel paralysis
  • corrective surgery
  • distended abdomen
  • external fistulas
  • fluid in abdomen
  • internal fistulas
  • intestinal or bowel perforation
  • pelvic inflammatory disease
  • peritonitis
  • persistent surgical site drainage
  • sepsis
  • severe persistent abdominal pain

Hernia Patch Recall

What is the Kugel mesh patch?

The Kugel mesh 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 it 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 mesh patch can break under the stress of placement of the large sized products in the intra-abdominal space.

Side Effects & Injuries

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 Mesh 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 mesh 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

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