On Wednesday, January 31, 2007, the FDA issued a statement underlining the serious nature of the recently announced recall of the Bard Composix Kugel Mesh Large patch, a product used in hernia repair procedures. The statement upgraded the recall of the Bard Composix Kugel Mesh Patches to a Class I Recall.

Class I Recalls are the most serious class of product recalls issued by the FDA. A Class I recall is issued to alert the public that the product in question poses an imminent risk to the public and may cause death or serious personal injury to consumers.

In its recall notices, the FDA stated

• “Surgeons and hospitals should stop using the recalled product and return unused units to the company,” and
• “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.”

The specific problem with the Bard Composix Kugel Mesh patch is a “memory recoil ring” designed to allow the patch to be folded for insertion through a laparoscopic incision for placement behind a hernia defect. Once in place, the patch is supposed to spring open and lay flat against the hernia. However, the FDA has received six reports of the patches breaking free from the hernia defects and either obstructing or perforating the abdominal wall or bowels of affected individuals.

Improper placement of the Kugel hernia mesh patch could result in serious personal injury to a patient implanted with the device, including:

• Chronic enteric fistulas
• Bowel perforation
• Bowel obstruction
• Abdominal pain
• Abdominal infection

Sources: “C.R. Bard surgical patch recall is serious: FDA,” Reuters, February 1, 2007; U.S. Food and Drug Administration, Class 1 Recall: Bard® Composix® Kugel® Mesh Patch - Expansion, January 31, 2007.