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Bard® Composix® Kugel® Mesh Patch
Recalled - Hernia Patch Failures Noted
The FDA has listed a Class 1 Recall of the Bard® Composix®
Kugel® Mesh Patch. You may also know it as a Hernia Patch.
The FDA states "The Composix® Kugel® Mesh Patch is
used to repair ventral (incisional) hernias caused by thinning or
stretching of scar tissue that forms after surgery. The patch is
placed behind the hernia defect through a small incision. The patch
is then held open by a “memory recoil ring” that allows
the patch to be folded for insertion and later spring open and lay
flat once it is in place."
The FDA notes that "The "memory recoil ring" that
opens the Composix® Kugel® Mesh Patch can break under the
stress of placement of the large sized products in the intra-abdominal
space. This can lead to bowel perforations and/or chronic intestinal
fistulae (abnormal connections or passageways between the intestines
and other organs)."
The FDA says:
- Surgeons and hospitals should stop using the recalled product
and return unused units to the company.
- Patients who have who have been implanted with one of the recalled
devices should seek medical attention immediately if they experience
symptoms that could be associated with ring breakage such as unexplained
or persistent abdominal pain, fever, tenderness at the implant
site or other unusual symptoms.
If you have been implanted with one of these recalled devices,
learn more about your options and get an instant
answer to your questions. Call today and speak with an Attorney:
1.800.838.0800.
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$1.5 Million: Over the counter Pharmacy
cases. Two cases involving an over the counter drug. 2004
$5+ Million: Multiple pharmacy cases.
Involving damage caused by a prescription drug. 2004
"I was amazed at how the team at Burke and Eisner was able
to cut through it all, and successfully obtain the highest possible
compensation for my losses."
(NH Client)
FDA: 2007 Safety Alert: Davol/Bard
Composix Kugel Large Sized Patch, Recall and Market Withdrawal
FDA:
Class 1 Recall: Bard® Composix® Kugel® Mesh Patch
NY Times: History
of Hernia Patch Raises Questions on Implant Recalls
FDA: Medical
Safety Alert
FDA: Dear
Chief of Surgery Letter (PDF)
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