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From December 2005 through January 2006, Davol, Inc., makers of Kugel Mesh Hernia Patches issued expanded recalls due to memory recoil ring breaks that have been the cause of bowel perforation problems, memory recoil ring breaks that have migrated through the abdominal wall, bowel obstruction, and death caused by septic shock, blood clotting, and acute heart attack due to surgery to repair bowel fistulas caused by perforation from the broken memory recoil ring.
Here is a timeline of the Kugel Mesh Patch recalls:
December 22, 2005 – Voluntary hernia mesh recall
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.
March 24, 2006 – Letters sent to hospitals and surgeons about mesh patches
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. 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.
March 24, 2006 – STOP using Kugel mesh patches!
A second letter is 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.
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.
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.
Davol, Inc. is a subsidiary of C.R. Bard, Inc., a Murray Hill, New Jersey company engaging in the design, manufacture, packaging, distribution, and sale of medical, surgical, diagnostic, and patient care devices worldwide. At the time of the first recall in December 2005, the company sold approximately 32,000 units worldwide since 2002 and the products generated approximately $11 million in 2005 alone.