Defective Composix Kugel Mesh Patch. Parker Waichman LLP (www.yourlawyer.com) announced that it has been retained by hundreds of clients who have been injured by defective Composix Kugel Mesh Patch manufactured by Davol, a division of C.R. Bard (NYSE: BCR). The company first recalled the Composix Kugel Mesh Patch in December 2005 because the “memory recoil ring”, that is used to open the device once it has been inserted, could break.
In March 2006, the company recalled additional sizes and batches of Kugel Mesh. In January 2007, the FDA expanded the recall to a Class 1 recall after deciding that the defective device can cause serious life threatening injuries, including bowel perforations and/or chronic intestinal injuries. Parker Waichman LLP is currently assessing hundreds of additional inquiries.
If you or a loved one were injured by a defective hernia mesh patch, you can request a free case evaluation by visiting http://www.herniapatchinjuries.com or //composix-kugel-patch-side-effects-may-result-severe-infection-lawsuits/ . Case evaluations are also available by calling Parker Waichman LLP at 1-800-YOURLAWYER (1-800-968-7529).
The following batches of Composix Kugel Patches have been recalled:
January 2007 Expanded Recall and Market Withdrawal:
- Bard® Composix® Kugel® Large Sized Patch Class I Recall and Market Withdrawal
- Bard® Composix® Kugel® Large Oval, 5.4″ x 7.0″, Product Code: 0010202
- Bard® Composix® Kugel® Large Circle, 4.5″, Product Code: 0010204
March 24, 2006 recall:
- Bard® Composix® Kugel® Oval, 6.3″ x 12.3″, all lot numbers
- Bard® Composix® Kugel® Large Oval, 5.4″ x 7″, lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
- Bard® Composix® Kugel® Large Circle, 4.5″, lot numbers 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
December 2005 recall:
- Bard® Composix® Kugel® Extra Large Oval, 8.7″ x 10.7″, all lot numbers
- Bard® Composix® Kugel® Extra Large Oval, 10.8″ x 13.7″, all lot numbers
- Bard® Composix® Kugel® Extra Large Oval, 7.7″ x 9.7″, all lot numbers
An article appearing in the March 16, 2007 edition of the New York Times questions the conduct of C.R. Bard after the company became aware that the Kugel mesh patch was defective. The article criticizes the company’s executives for not recalling the product sooner even though they knew about the injuries it was causing patients. The critique from the New York Times was based on information the reporter received under the Freedom of Information Act.
inspectors reported “discrepancies” and “inconsistencies” in how Davol
This information showed that in early 2006 inspectors reported “discrepancies” and “inconsistencies” in how Davol tracked and analyzed device-related complaints. The FDA said Davol did not accurately report the possible severity of complaints to the agency. FDA inspectors reported that company officials had also understated, in several reports to the agency, the potential severity of device-related injuries, including three reports involving injuries and one report involving a possible device-related death.
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Parker Waichman LLP is a leading products liability and personal injury law firm that represents plaintiffs nationwide. The firm has offices in New York and New Jersey. Parker Waichman LLP has assisted thousands of clients in receiving fair compensation for injuries resulting from defective medical devices and medications. The firm is currently representing individuals injured by Guidant and Medtronic Defibrillators, Drug Coated Coronary Stents, Ortho Evra, Ketek, ReNu with MoistureLoc, and many other defective drugs and medical devices.