From December 2005 through January 2006, Davol, Inc., makers of Kugel Mesh Hernia Patches issued expanded recalls. Here is a timeline of the Kugel Mesh Patch recalls:
December 22, 2005 – voluntary hernia mesh recall
U.S. customers notified of a voluntary Class I recall of the Bard Composix Kugel Mesh X-Large Patch in a letter delivered via Federal Express. The recall is issued after reports that a component of the patch, the memory recoil ring, may not withstand certain stresses associated with specific surgical placement techniques. Breakage of the memory recoil ring can cause bowel perforation problems and chronic intestinal fistulae.
The hernia damage recall patches included Bard® Composix® Kugel® Mesh X-Large Patch Oval with ePTFE with the following lot numbers:
- 41XMXXXX – M = 2002
- 41XNXXXX – N = 2003
- 43XMXXXX – M = 2002
- 43XNXXXX – N = 2003
- 43XOXXXX – O = 2004
- 43XPXXXX – P = 2005
(If the lot number did not contain M, N, O or P as the 4th character then the lot was not affected by this recall.)
March 24, 2006 – expanded hernia mesh patches to hospitals and surgeons
An urgent letter is sent to hospital administrators advising them that the Class I recall has been expanded to include certain lots of the Large Oval and Large Circle products, as well as all lots of the Oval product.
Bard Composix Kugel Mesh Patch expanded recall includes all lots of the oval midline size (product code 0010209), and lots manufactured before 2004 of the large oval (0010202) and large circle (0010204) products. The recall previously affected only the extra-large oval patch.
A letter sent to distributors of the Kugel Mesh Patch states that the recall includes lots manufactured up to and including December 2003. The letter also stated the risk that the welds could break under the stress placed on the large-sized products during placement, leading to potential patient complications such as abdominal pain, bowel perforation problems, or chronic enteric fistulas.
Finally, a letter is also sent to surgeons on that very same day requesting that they immediately stop using the specific products listed in the recall and give copies of the Important Patient Management Information to professionals who are managing patients already implanted with the recalled products.
The expanded hernia patch recall is issued because the maker of the Kugel Mesh Patch has learned of further memory recoil ring breaks, including cases of bowel perforation problems, memory recoil ring migration through the abdominal wall, bowel obstruction, and in one instance where a patient died after developing septic shock, blood clotting, and acute heart attack from surgery to repair bowel fistulas caused by perforation from the broken memory recoil ring.
December 18, 2006 – hernia mesh patch lawsuit filed
A hernia damage lawsuit is filed against the maker of the Kugel Mesh Patch. The plaintiff claims problems of the surgical Mesh Patch resulted in severe pain and required bowel dissection surgery to remove the Patch, which had become stuck to the plaintiff's bowel. The bowel dissection surgery resulted in chronically inflamed bowels.
Mesh Patch lawyers for the plaintiff argue that Davol, Inc. (maker of the Mesh Patch), knew that there was a possibility of failure in the Kugel Mesh Patch but did not properly warn the public.
January 10, 2007 – Kugel Mesh Patch recall extended/hernia damage complications multiply
The maker of Kugel Mesh Patch extends the recall to include large-sized Composix Kugel Patches (oval and circle) due to additional reports of memory recoil ring breakage. Another product with the same component design is also recalled because of the potential for breakage. The new recall, which is in addition to earlier recalls in December, 2005, and January and March, 2006, affects Kugel Mesh Patches manufactured between January 1, 2004 and September 30, 2005.
The affected mesh patches are:
- Product Code: 0010202, Bard Composix Kugel Large Oval, 5.4" X 7.0"
- Product Code: 0010204, Bard Composix Kugel Large Circle, 4.5"
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