FDA upgrades Composix hernia patch recall

Class I status means patch could cause death or serious personal injury

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.

Davol Expands Recall of Hernia Patch

Composix patches linked to six complaints of ring breakage

On January 10, 2007 the U.S. Food and Drug Administration (FDA) announced that Davol has expanded previous recalls of mesh patches used in hernia surgeries due to rising complaints of breakage.

In December 2005 and January 2006, Davol issued a recall of six sizes of the Bard Composix Kugel Mesh Patch, used to repair ventral hernias. In March 2006, Davol expanded the recall to include additional sizes of the patch.

Composix Kugel Mesh Patches are placed behind hernia defects via a small abdominal incision. The patch is held open by a ring, known as a “memory recoil ring” that is designed to allow the patch to be folded for insertion through the small incision. Once in place, the “memory recoil ring” is supposed to spring open and lay flat.

The FDA has reported that among over 25,000 units manufactured between January 1, 2004 and September 30, 2005, six incidents of breakage have been reported, including two incidents of bowel perforation. The FDA warns that the Bard Composix Kugel Mesh Patch “memory recoil ring” welds may break under the stress placed on the product during surgical placement.

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

Davol has withdrawn from the market all remaining Bard Composix Kugel mesh patches, including the Bard Composix Kugel Large Oval and Large Circle patches that have the same component design. Davol has improved the product design, including changing the recoil ring stock to a less rigid stock, increasing the strength of the recoil ring weld and increasing the ring weld overlap at the weld’s joint.

Sources: FDA Safety Alert, January 10, 2007; FDA Class I Recall, Bard Composix Kugel Mesh Patch - Updated, December 22, 2005, accessed January 24, 2007.