Because Expericence Matters

Bard/Davol?s Composix Kugel Hernia Patch - Accepting cases on patches implanted from 2000 to 2006

Internal/Abdominal damage caused by broken hernia-patch ring

Breaking News January 24, 2007: FDA Expands Recall of Bard Composix Kugel Patches. More Product/Lot numbers now included in recall.

The Bard® Composix® Kugel® Mesh Patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The patch is placed behind the hernia defect through a small incision. The patch is then held open by a “memory recoil ring” that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

The "memory recoil ring" that opens the Bard® Composix® Kugel® Mesh Patch can break under the stress of placement of the large-sized patches inside the abdomen. This can lead to bowel perforations (rupture) and/or intestinal fistula (abnormal opening between the intestines and other organs).

SIGNS OF PATCH-RING BREAKAGE:

  • Fever
  • Tenderness at the Incision Site
  • Painful Lumps or Bulges Where Surgery Occurred
  • Large Bulge at Site of Previous Injury
  • Bowel Perforation
  • Intestinal Fistula (hole)
  • Stabbing Abdominal Pain
Recalled product codes and lot numbers as of January 24, 2007:
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

Davol is also withdrawing from the market the following specific lots from the product code groups 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###."

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###."
Please note, that this list is constantly updated, as further lot numbers are added by the Food and Drug Administration (FDA). For detailed information, please click here.

The manufacturer Bard/Davol company may admit that its medical device is flawed and may agree to reimburse patients for medical expenses related to replacing the hernia patch. However, they may attempt to limit such reimbursement to cases where medical expenses are not covered by the patient's medical insurance or by Medicare.

In most states, product liability extends further, and Miller & Associates will evaluate the merits of your case to recover additional compensation. Patients who received the Davol/Bard Kugel hernia patches may be entitled to:

  • compensation for any of their pain and suffering,
  • future medical care,
  • physical therapy,
  • lost wages and earnings,
  • or non-medical expenses incurred as a result of receiving the defective or recalled hernia patch.

If you suspect you may have an injury caused by a defective hernia patch or simply have a recalled device implanted, contact The Miller Firm LLC for a free consultation.

The Miller Firm, LLC
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