Bard Composix Kugel Mesh Hernia Patch Recall

Davol, Inc. is expanding its earlier recall of the Composix Kugel Patch, which is used to repair ventral hernias that can appear at the site of a prior surgical incision.

The recalled patches have a "memory recoil ring" that allows the patch to be folded for insertion and then once in place, to spring open and lay flat. The problem is that this ring can break, and if that happens, it can cause a bowel perforation or chronic intestinal fistula.

Davol is now notifying health care professionals about an expanded recall and market withdrawal of additional patches that have a similar design. These actions affect Large Oval and Large Circle patches that have this design. Health care providers who have patches from the recalled lots should stop using them immediately.

The recalled products are as follows:

Product Code	Description	Lot Numbers Recalled	Date Recalled
0010206	Bard® Composix® Kugel® Extra Large Oval, 8.7” x 10.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010207	Bard® Composix® Kugel® Extra Large Oval, 10.8” x 13.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010208	Bard® Composix® Kugel® Extra Large Oval, 7.7” x 9.7”	All Lot Numbers manufactured before January 2006	December 2005 and January 2006
0010209	Bard® Composix® Kugel® Oval, 6.3” x 12.3”	All Lot Numbers manufactured before March 2006	March, 24, 2006
0010202	Bard® Composix® Kugel® Large Oval, 5.4” x 7.0”	Lot Numbers manufactured before October 2005 (see below)	January 10, 2007
0010204	Bard® Composix® Kugel® Large Circle, 4.5”	Lot Numbers manufactured before October 2005 (see below)	January 10, 2007

Here's what the company recommends for managing patients who have already received one of the recalled devices:

• First, identify these patients. Advise them about the recall and tell them to seek 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.

• Examine symptomatic patients for conditions that could be associated with ring breakage. These include bowel obstruction, perforation or fistula, abdominal wall pain or infection, palpable abdominal wall mass, or migration or movement of the ring.

• Evaluate the patient's condition based on clinical signs and symptoms and clinical judgment.

• And finally, report any problems to the company.

Note that Davol has redesigned this product to correct the problem. These newer patches are not being recalled. They are identifiable by a label that says "redesigned for improved ring integrity."

If you or someone has received on of these recalled hernia patches then you should contact your doctor immediately.   You should also contact an attorney as you may be eligible to make a claim for compensation.  For a free case review fill out the form below.  An attorney will review your form and may contact you to discuss your claim.