Kugel Mesh Patch Recall Timeline

Since December 2005, the makers of the Kugel Mesh Hernia Patches have issued a recall for its Kugel Mesh Hernia Patch and expanded the recall twice. Below is a timeline of the recalls:

December 27, 2005:

C.R. Bard notifies US customers of a voluntary Class I recall of the Bard Composix Kugel Mesh X-Large Patch by letter delivered via Federal Express. The recall is issued after reports that a component of the patch, known as the memory recoil ring, may not withstand certain stresses associated with specific surgical placement techniques. Breakage of the memory recoil ring can cause bowel perforations and chronic intestinal fistulae. At the time, approximately 32,000 units had been sold worldwide.

March 24, 2006:

An urgent letter is sent by Bard to hospital administrators advising them that the Class I recall has been expanded to include certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product.

A letter sent to distributors of the Kugel Mesh Patch states that the recall includes lots manufactured up to and including December, 2003, and notes that "there is a risk that the welds could break under the stress placed on the large sized products during placement, which could lead to potential patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas."

Finally, a letter is sent to surgeons the same day requesting that they immediately stop using the specific products listed in the recall and give copies of the Important Patient Management Information to professionals who are managing patients already implanted with the recalled products.

The expanded recall is issued because Davol, Inc., has learned of further ring breaks, including cases of bowel perforation, ring migration through the abdominal wall, bowel obstruction, and one instance in which a patient died after developing septic shock, consumptive coagulopathy and acute myocardial infarction from surgery to repair bowel fistulas caused by perforation from the broken ring.

December 18, 2006:

A lawsuit is filed against Davol, Inc. related to the Kugel Mesh Patch. The plaintiff in the case, filed in Rhode Island, claims failure of the Kugel Mesh Patch resulted in severe pain and required bowel dissection surgery to remove the Patch, which had become stuck to the plaintiff's bowel. The bowel dissection surgery resulted in chronically inflamed bowels. Lawyers for the plaintiff argue that Davol, Inc., knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.

January 10, 2007:

Davol extends the recall to include Large Sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage.

The letter sent to medical professionals notes that a new product design will include several alterations designed to address problems of breakage. These alterations include increasing the recoil ring weld strength and increasing the recoil ring weld overlap.

Davol, Inc. is a subsidiary of C.R. Bard, Inc. The voluntary recall of the Kugel Mesh Patches was serious enough to warrant a Class I recall which is used in cases where the recalled device could potentially cause serious injuries, pain and possibly death.

FDA Comments about the Class I Recall of Bard® Composix® Kugel® Mesh Patches

On January 10, 2007, Davol, Inc. (a subsidiary of C.R. Bard) sent letters to health care professionals and distributors notifying them of the most recent expansion of this recall of specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Mesh Patches for product codes 0010202 and 0010204. Surgeons and hospitals should stop using the recalled product and return unused units to the company.

Patients 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.

It should be noted that product codes 0010202 and 0010204 were involved in both recall expansions. The lots manufactured prior to January 2004 were recalled during the March 2006 expansion. Since the March expansion, Davol received 4 confirmed complaints of recoil ring breakage from product code 0010202 manufactured between January 2004 and September 2005. There were no complaints for product code 0010204 . Davol is recalling the following lots for product codes 0010202 and 0010204:

• All lots with the letter "O" in the fourth position
• All lots with the letter "P" in the fourth position and the letters "A" through "I" in the third position.
• For instance, an example of a recalled lot number is "43IPD###."

Davol also decided to withdraw from the market specific lots of 0010202 and 0010204 manufactured from October 2005 to October 2006. A market withdrawal is a firm's removal or correction of a distributed product that involves a minor violation or no violation of the law and would not be subject to legal action by the FDA. Davol is withdrawing the following lots:

• All lots with the letter "P" in the fourth position and the letters "J" through "L" in the third position
• All lots with the letter "Q" in the fourth position and the letters "A" through "I" in the third position
• For instance, an example of a withdrawn lot number is "43IQD###."

An upgraded product design for both product codes is available for replacement. Product codes and lot numbers that contain the re-designed product can easily be identified on the case or unit package with the label stating "Redesigned for improved ring integrity." If this label is affixed to your case stock and/or individual packages, this product is not affected by this market withdrawal and need not be returned to Davol.

Davol notified U.S. customers of the initial recall by letter on 12/27/05 via Federal Express. On March 24, 2006, Bard issued letters to hospitals and health care professionals alerting them to the additional recalled products. The letters included updated Instructions for Use ("IFU") clarifying the proper insertion technique and Supplemental Patient Management Information. Copies of current product IFUs to be used for both Open Placement and Laparoscopic Placement for the Large Bard® Composix® Kugel® Mesh Patches are available from Davol Customer Service by calling 1-800-531-4124.

For more information, customers can contact Davol Customer Service at 1-800-531-4124. Physicians may contact Bard's Medical Services and Support Department at 1-800-562-0027 or to speak with the Bard Medical Director, call 1-908-277-8306. A copy of the company's press release regarding this recall expansion can be found on the Davol website.