Kugel Mesh Patch Subject Of Medical Device Recall
Davol, Inc., a subsidiary of C.R. Bard, Inc., has been faced with three product recalls in recent years for its mesh hernia repair patches. The patch recalls were issued following numerous reports of breakages in the defective device, and associated abdominal injuries. In some cases, these injuries have been fatal.
Davol’s Composix Kugel Mesh Patch is a flexible, synthetic mesh device used in the repair of abdominal hernias. The patch contains a patented “memory recoil ring” which allows the surgeon to fold it for insertion into a small incision. Once positioned behind the hernia opening, the ring’s recoil action flattens the patch, covering the hernia. This allows the physician to close the gap and return any protruding tissue to the proper position without stretching the membrane, which can damage the fragile surrounding tissue and cause yet another hernia.
Unfortunately, the memory recoil rings in the Kugel patches have a tendency to break, causing serious problems like bowel obstructions and perforations, and chronic enteric fistulas. These conditions can have life-threatening consequences.
Davol recalled two versions of the patch (large and extra-large oval) when their own testing proved that the rings had a weakness at the point where they are welded together. Soon thereafter, the drug administration FDA became involved and conducted its own investigation into the matter.
The FDA, which is responsible for issuing safety alerts and medical device recalls for dangerous products, visited the production facilities for the Kugel mesh patches. There, they determined that Davol did not properly ensure the safety and integrity of the product in the production and distribution process, and that it failed to adequately monitor complaints about the patches. They broadened the scope of the recall, adding other sizes and varieties of the patch to the list.
Currently, the recalled mesh patches include:
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 For the patients injured by the defective patches, the damages have been painful, expensive and life-altering. Many of these consumers are seeking the help of mesh patch attorneys to recover financial compensation for their losses, such as medical costs, lost wages, and pain and suffering.
Attorneys for the patch recipients feel strongly about Davol’s liability in the matter, based upon their negligence with regard to product safety, and their delay in issuing the recalls. The lawyers argue that the company put scores of hernia patients at serious risk, and that they have a responsibility to those individuals.
If you have received a Composix Kugel Mesh Patch in the course of a hernia repair procedure, report troubling symptoms to your physician at once. Warning signs such as abdominal pain, fever, tenderness at the sight of the hernia, or other unusual symptoms could signal a very serious injury. Delayed treatment may increase the likelihood of complications or death.
To learn more about the legal alternatives available to you, schedule a consultation with a Kugel mesh attorney. A legal professional with experience in this area can evaluate your case and help you gain the reimbursements and compensation you deserve. Legal Tube can help you find the right attorney for the job.
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