FDA ANNOUNCES RECALL OF HERNIA PATCHOn December 22, 2005, the Food and Drug Administration, or FDA, announced the recall of the Bard Composix Kugel Mesh Patch. The Bard Composix Kugel Mesh Patch which is manufactured by Davol Inc, a subsidiary of C R Bard Inc, was created with the purpose of repairing ventral hernias.
Ventral, or incisional, hernias are most like to be attributed by the thinning or stretching of scar tissue which develops after surgery. The Bard Composix Kugel Mesh Patch is put in place behind the defected hernia through a tiny incision. Then, the patch is held open with the "memory recoil ring" which enables the patch to fold during insertion so that once it is in place it will spring open and lay flat.
The FDA is recalling the Bard Composix Kugel Mesh Patch because the "memory recoil ring" that is used to open the patch can break when placed under stress in the larger sized products that are inserted within the belly area. Once the patch breaks, this can cause bowel rupture and recurring abnormal connection with the intestines to other organs.
The original FDA recall of the Bard Composix Kugel Mesh Patch includes the X-Large Patch Oval with ePTFE that have the following lot numbers and must contain either of the letters M, N, O or P as the fourth character to qualify in the recall:
- Product Code 0010206 - The Extra Large Oval 8.7" x 10.7" All Lot Numbers
- Product Code 0010207 - The Extra Large Oval 10.8" x 13.7" All Lot Numbers
- Product Code 0010208 - The Extra Large Oval 7.7" x 9.7" All Lot Numbers
- All Extra Large Oval Patches should include these Lot Numbers:
- 41*M****-M=2002, 41*N****-N=2003, 43*M****-M=2002, 43*N****-N=2003, 43*O****-O=2004, 43*P****-P=2005
With this recall, Davol Inc, began notifying the customers on December 27, 2005 in a letter delivered Federal Express that use of the product should be discontinued and the unused units should be returned to the company.
Then, on March 31, 2006, the FDA expanded the recall to include the following products:
- Product Code 0010209 - The Oval 6.3" x 12.3" All Lot Numbers
- Product Code 0010202 - The Large Oval 5.4" x 7.0" with Lot Numbers:
- 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
- Product Code 0010204 - The Large Circle 4.5" with Lot Numbers:
- 41*L****, 41*M****, 41*N****, 43*L****, 43*M****, 43*N****
After the recall was updated, Davol Inc further sent letters to health care professionals and hospitals alerting to the updated recall products list. The notification further informed surgeons and hospitals were advised to stop using the recall products, but instead return all unused units to the company. It was then that patients were also informed that if they were implanted with any of the recalled devices, then medical attention should be sought immediately if any symptoms are experienced that could be associated with the ring breaking. These symptoms may include such things as abdominal pain, fever, tenderness at the implant site, or anything else that may be unusual.
With the FDA making another updated recall on January 24, 2007 to include additional products, more and more patients are finding out that they may be implanted with the Bard Composix Kugel Mesh Patch that falls into one of the recalled medical devices.
The new updated list includes these products:
- Product Code 0010202 - The Large Oval 5.4" x 7.0" and have Lot Numbers that were manufactured before October 2005 and include:
- All Lot Numbers with the letter O in the fourth position
- All Lot Numbers with the letter P in the fourth position and the letters A through I in the third position
- Product Code 0010204 - The Large Circle 4.5" and have Lot Numbers that were manufactured before October 2005 and include:
- All Lot Numbers with the letter O in the fourth position
- All Lot Numbers with the letter P in the fourth position and the letters A through I in the third position
Now, with this recall, Davol Inc has further expanded the recall by issuing a market withdrawal. A market withdrawal occurs when the manufacture decides to remove or correct products that have been distributed that may involve minor violations or even no violation of the law at all, and therefore, will not be subject to any legal action from the FDA. This withdrawal is to include:
- Product Code 0010202 - The Large Oval 5.4" x 7.0" manufactured from October 2005 to October 2006
- All Lot Numbers with the letter P in the fourth position and the letter J through L in the third position
- All Lot Numbers with the letter Q in the fourth position and the letters A through I in the third position
- Product Code 0010204 - The Large Circle 4.5" manufactured from October 2005 to October 2006
- All Lot Numbers with the letter P in the fourth position and the letter J through L in the third position
- All Lot Numbers with the letter Q in the fourth position and the letters A through I in the third position
Finally, Davol Inc, once again sent out letters to distributors and health care professionals informing them of the latest expansion in product recalls, and advised surgeons and hospitals to stop using the recalled products, but rather, to return all unused units back to the manufacturing company.
Fortunately, an upgraded product design has been created for both product codes and is available to replace the recalled medical devices. The replacement medical devices are labeled "Redesigned for improved ring integrity," and are not affected by the previous market withdrawal in any way.
So what does all this mean for patients that have been implanted with the Bard Composix Kugel Mesh Patch? With all the recalls, and with some of the medical devices not be recalled until a later date, damage to the patients may have been done. If a patient or loved one would like to know just how all this may affect them, please click here to request a free no obligation consultation.
