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EPPERLY
& FOLLIS, P.C.
7 East Franklin Street
Richmond, VA 23219
1-888-703-0109
(804)
648-6480
depperly@lawyersva.com |
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KUGEL MESH
Since 2005, mesh surgical patches by Davol Inc. – a
division of C.R. Bard -- have been recalled or otherwise
pulled from the market because they caused serious health
complications in patients. In December 2005 and January
2006, the company’s Extra Large Patches were recalled, and
in March 2006 the Large Patches were recalled. At the urging
of the U.S. Food and Drug Administration (FDA), in January
2007 Davol Inc. expanded its voluntary recall of specific
lots of Bard Composix Kugel Large Oval and Large Circle
Patches.
The patches have been used in a number of hernia repair
surgeries. The January 2007 recall required the immediate
discontinuation of use of the Large Oval and Large Circle,
because they have the same component design as the
previously recalled patches. The FDA notice lists the
following product codes that were to be immediately
withdrawn from the market:
Product Code: 0010202, Bard® Composix® Kugel® Large Oval,
5.4” x 7.0”
Product Code: 0010204, Bard® Composix® Kugel® Large
Circle, 4.5”
The mesh patches were designed to repair ventral (incisional)
hernias that occur when post-surgery scar tissue is
stretched. After the hernia operation, the patch is held
open by a “memory recoil ring” that allows the patch to be
folded so it can be inserted through a small incision behind
the affected area. Once in place, that memory ring allows
the patch to spring open and lay flat.
Anyone who has had hernia surgery since 2005 may be at risk
of serious physical injury or death.
If you or someone you care about had a hernia surgery where
a Bard Composix Mesh Patch was used and suffered from
abdominal pain, fever, tenderness at the incision site, or
painful lumps or bulges where surgery occurred, contact your
doctor immediately. You may be entitled to compensation,
even if you have an implanted device on the recall list but
have not experienced any symptoms.
However, the patches were recalled because certain lot
numbers with the recoil ring would break under the stress of
placement, which could lead to tears in the bowel or cause
problems with the intestines and other organs. Problems
reported by Davol include:
Broken ring migrated into or through abdominal wall with
associated infection
Ring migration into vagina
Bowel perforation
Bowel obstruction
Death from septic shock
Consumptive coagulopathy and acute myocardial infarction
An FDA investigation revealed that the manufacturer allowed
the Kugel patches to remain on the market long after they
learned of serious injuries caused by their products.
The law firm of Epperly & Follis is representing patients
and families who have been harmed by Bard Composix Kugel
Mesh patches. Anyone who has had hernia surgery since 2005
may be at risk of serious physical injury or death. The FDA
has advised patients who have received this device to seek
medical attention immediately if abdominal pain, fever,
tenderness at the implant site or other unusual symptoms
occur. The FDA also has instructed surgeons and hospitals to
immediately stop using the recalled products and return the
unused patches to the company.
If you or a loved one has suffered an injury because of this
company’s negligent actions regarding its hernia patch, it
is important to consult with an attorney who understands
this type of injury and is experienced in handling these
sensitive cases.
Let us put our legal expertise to work for you, to get the
recovery you deserve. Contact Epperly & Follis for a free
consultation today at 1-888-703-0109 or (804) 648-6480, or
contact us via our online Contact
Form. |
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