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Hernia Mesh Patch Recall Timeline: Are
You at Risk?
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.
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.
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.
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