Composix Kugel Mesh Patch Recall

Press Release

Davol is expanding the voluntary recall of specific lots of Bard® Composix® Kugel® Large Oval and Large Circle Patches. Immediately discontinue use of the specific product codes and lot numbers listed in the attachment. Additionally, please immediately distribute copies of the Important Patient Management Information to clinicians who may have implanted, or who may be managing, patients already implanted with one of these products under voluntary recall. This information supplements information contained in the recall letters issued by Davol in December 2005 and January 2006 for the Extra Large Patches and March 2006 for the Large Patches.

Summary of the Product Recall Communications:

Extension of the previous recall to specific lots of Bard® Composix® Kugel® Patches is being conducted because we have received additional complaint reports for PET recoil ring breakage on lots of product codes 0010202 manufactured from January 1, 2004 through September 30, 2005. That rate of occurrence is defined below. There is a risk that the ring welds could break under stress placed on these products during placement, which could potentially lead to patient complications such as abdominal pain, bowel perforation or chronic enteric fistulas. The products and lot numbers being recalled are listed on the attached Acknowledgement/Stock Status Form, which has been sent to all hospital administrators, risk managers, materials managers, OR managers, and distributors.

Observed Rate of Occurrence and Clinical Implications:

Product Code 0010202, Bard® Composix® Kugel® Large Oval Patch: A total of 6 ring breaks have been reported, and four of these complaints have been confirmed, from the approximately 25,835 units manufactured between January 1, 2004 and September 30, 2005, for a reported occurrence rate of 0.023%.

Incidents:

• One (1) Incident occurred during the mesh placement surgery and the product was not implanted.
• One (1) incident of a broken ring was noted at the time of surgery and the ring was removed but the mesh was left implanted. No patient symptoms have been reported following this procedure.
• One (1) incident was reported where a broken ring had migrated into the abdominal wall and was removed, leaving the mesh implanted.
• One (1) incident was reported where the mesh was explanted as a response to reported abdominal pain and a broken ring was noted.
• Two (2) inconclusive incidents were reported where bowel perforation and broken rings were noted at the time of explant.

Product Code 0010204, Bard® Composix® Kugel Large Circle: No ring breaks have been reported in this product. However, because of the similarity of the ring joint welding process and PET ring diameter, this product is being recalled as a precaution.