Have you or someone you know been injured by the Kugel Mesh Patch?

We are currently investigating injuries related to the recall of Bard Composix Kugel Mesh Patches that are used in the repair of hernias. The recalled patches were manufactured from 2001 through March, 2006 and include only the large and extra large patches.

The patches are held open by a "memory recoil ring" that allow the patch to be folded for insertion through a small incision and later sprung open to lay flat once it is in place. Unfortunately, the stress of placing the large-sized patches (4.5 inches in diameter and larger) in the intra-abdominal space can cause the ring to break, leading to serious and life-threatening injuries.

Injuries can include: persistent surgical site drainage, bowel paralysis, persistent abdominal pain, abdominal tenderness, distended abdomen, fever, fluid in the abdomen, abdominal abscess, intestinal or bowel perforation, intestinal fistulas, external fistulas, pelvic inflammatory disease, sepsis, peritonitis, or corrective surgery.

Products subject to recall: Large-sized patches used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is held open by a "memory recoil ring" that allows the patch to be folded for insertion through a small incision and later sprung open to lay flat once it is in place.

Kugel Mesh Patch

Davol Bard

surgeons

The recall is limited to specific lots and model numbers with manufacture dates beginning in 2001, through 2006. None of the recalled patches are smaller that 4.5" in diameter.

Nature of the defect: After insertion, the "memory recoil ring" can lead to bowel perforations and chronic intestinal fistulae. Patients with the following symptoms could be suffering from problems related to the broken ring: persistent surgical site drainage, bowel paralysis, persistent abdominal pain, abdominal tenderness, distended abdomen, fever or "other unusual symptoms." Other possible problems include: fluid in the abdomen, abdominal abscess, intestinal or bowel perforation, internal fistulas, external fistulas, pelvic inflammatory disease, sepsis, peritonitis, and corrective surgery.

Recalls: The first recall was initiated 12/22/2005. Shortly thereafter (12/27/2005), the company claims it sent notification to all U.S. customers via Federal Express. The recall was updated on 3/31/06 to include additional product codes and lot numbers. The company sent letters to hospitals and health care professionals regarding the additional recalled products on 3/24/06. The recall was further updated on 1/24/07 to include even more product codes and lot numbers. Letters regarding this expansion of the recall were sent to health care professionals and distributors on 1/10/07. Physicians were urged to contact their patients regarding these potential defects. There are no questions as to the adequacy of the notifications and it is likely many healthcare professionals were not timely made aware of the defects with these products.

Bard Composix Kugel Mesh Hernia Repair Products

Products subject to recall: Large-sized patches used to repair ventral (incisional) hernia caused by thinning or stretching of scar tissue that forms after surgery. The patch is held open by a "memory recoil ring" that allows the patch to be folded for insertion through a small incision and later sprung open to lay flat once it is in place.

The recall is limited to specific lots and model numbers with manufacture dates beginning in 2001, through 2006. None of the recalled patches are smaller that 4.5" in diameter.

Nature of the defect: After insertion, the "memory recoil ring" that opens the patch can break. The break is attributed to the stress of placement of the large sized patches in the intra-abdonimal space.

Typical damages/injuries: The broken "memory recoil ring" can lead to bowel perforations and chronic intestinal fistulae. Patients with the following symptoms could be suffering from problems related to the broken ring: persistent surgical site drainage, bowel paralysis, persistent abdominal pain, abdominal tenderness, distended abdomen, fever or "other unusual symptoms." Other possible problems include: fluid in the abdomen, abdominal abscess, intestinal or bowel perforation, internal fistulas, external fistulas, pelvic inflammatory disease, sepsis, peritonitis, and corrective surgery.

Recalls: The first recall was initiated 12/22/2005. Shortly thereafter (12/27/05), the company claims it sent notification to all U.S. customers via Federal Express. The recall was updated on 3/31/06 to include additional product codes and lot numbers. The company sent letters to hospitals and health care professionals regarding the additional recalled products on 3/24/06. The recall was further updated on 1/24/07 to include even more product codes and lot numbers. Letters regarding this expansion of the recall were sent to health care professionals and distributors on 1/10/07. Physicians were urged to contact their patients regarding these potential defects. There are questions as to the adequacy of the notifications and it is likely many healthcare professionals were not timely made aware of the defects with these products.