Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
Product Code: 0010202, Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”
Product Code: 0010204, Bard® Composix® Kugel® Large Circle, 4.5”

In January 2007, Davol expanded the voluntary recall of specific lots of Bard^® Composix^® Kugel^® Large Oval and Large Circle Patches. I mmediately discontinue use of the specific product codes and lot numbers listed in the attachment. SUMMARY OF THE PRODUCT RECALL COMMUNICATIONS:

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.

MARKET WITHDRAWAL

Davol has decided to voluntarily withdraw from the market all remaining Bard^® Composix^® Kugel^® Large Oval and Large Circle Patches that have the same component design as the manufacturing lots included in the expanded recall. This includes product manufactured from October 2005 to October 2006. Davol has improved the product component design as described below and has reviewed this strategy with the FDA and received concurrence with this action.

The new product component design is characterized by several important changes in these patches which include –

• Change from a 0.042” diameter recoil ring stock to a less rigid 0.030” diameter recoil ring stock (already used on other sizes of Bard^® Composix^® Kugel^® patch).
• Increase of the recoil ring weld strength by a factor of four times
• Increase of the recoil ring weld overlap at the weld joint from 0.180” to 0.480”
• Inclusion of the most current product IFU to provide guidance to preclude inappropriate manipulation during surgical insertion of the product.

If you have been injured as a result of the patch you should seek immediate medical attention.  You should also speak to an attorney.  For a free case evaluation, please fill out the form below.