Ventral hernia sufferers are rushing to their doctors after
hearing that the federal Food and Drug Administration (FDA)
has issued an updated recall for Bard's Composix Kugel Mesh
Patch. The patch, which is used in hernial repair
surgeries, was first recalled in late 2005, but the FDA has
posted another recall, which affects more of the
implantable mesh patches on the market. Ventral hernias
are prevalent in the United States; in fact, the nation has
the world's highest rate of deaths due to incisional
hernias per year. In its recent medical device recall
alert, the FDA noted that the Composix hernia patch can
break inside the intra-abdominal space of the patient's
belly, causing chronic intestinal fistulae and bowel
rupture or perforation. Fistulae affect the passages that
connect organs and the intestines, and such ruptures can
cause side effects including tenderness, abdominal pain, or
fever. These can present an additional strain to hernia
sufferers who already have undergone surgical intervention
with the hernial patches and cause additional surgeries to
repair the damage.
Composix Kugel Mesh Patches are manufactured by Bard, a
subsidiary of Davol. In addition to its hernia repair
devices, the company makes and markets devices for
laparoscopy, wound management, hysteroscopy, and
orthopedics. The Extra Large Oval, Oval, Large Oval, and
Circle sizes are subject to the hernia patch recall, which
now encompasses product codes 0010202 and 0010204. Davol
has withdrawn some Kugel Mesh Patches from the market in
the past due to health concerns; it has also issued a
redesigned product marked with labels that indicate the
product was "redesigned for improved integrity".
The FDA's hernia mesh recall applies to the larger sizes of
the Composix Kugel Mesh Patches. The defect occurs because
the Composix patches, which are inserted behind incisional
hernias in order to reinforce the thinned or stretched
post-operative scar tissue that forms there, fail to engage
properly. Their "memory recoil ring," a structural
component designed to open the mesh patch after its has
been folded and inserted, can fail to spring open or even
break under the strain of placement, causing the side
effects listed above. If you had a ventral (incisional)
hernia surgery involving a Composix Kugel Mesh Patch, you
may be affected.
Contact your doctor immediately to see if the hernia patch
recall affects you and if you need the device removed or
replaced. If you have suffered from side effects or
symptoms due to your implantable mesh patch, contact an
experienced medical device attorney to find out about your
legal rights in this matter. You may be eligible for
monetary compensation for your medical bills, lost wages
and other expenses associated with the defective hernia
patches.
----------------------------------------------------
LegalView.com, your source for everything legal on the Web,
provides users with information on everything from finding
a mesothelioma lawyer to determining the right construction
accident law firm. Those suffering from a traumatic brain
injury (TBI) can find out medical information and how to
locate a http://brain-injury.legalview.com . For more legal
information visit http://www.legalview.com/ .
No comments:
Post a Comment