Hernia Patch Attorneys
The US Food and Drug Administration (FDA) and Davol, Inc (a subsidiary
of C.R. Bard, Inc), have notified healthcare professionals regarding the
expansion of a class 1 recall for a ventral hernia repair device (Bard
Composix Kugel Mesh Patch) to include all lots of the oval "midline"
size (product code 0010209), and lots manufactured before 2004 of the
large oval (0010202) and large circle (0010204) products. The recall previously
affected only the extra-large oval patch.
The recall is due to the potential for breakage of the "memory recoil
ring" under the stress of placement into the intra-abdominal space,
leading to bowel perforation and/or chronic enteric fistulae, according
to an alert sent yesterday from MedWatch, the FDA's safety information
and adverse event reporting program.
Surgeons and hospitals are advised to cease using the products with codes
and lots affected by the recall and to return unused units to the company.
Patients who have received one of the recalled devices should seek immediate
medical attention if they experience symptoms such as unexplained or persistent
abdominal pain, fever, tenderness at the implant site, or other unusual
symptoms potentially related to ring breakage.
The device is indicated for the repair of ventral (incisional) hernias
caused by thinning or stretching of scar tissue that forms after surgery.
The "memory recoil ring" allows it to spring open and lie flat
behind the defect after having been folded for insertion through a small
incision..
An Attorney For You is a free consumer service.
We are not a law firm. We help consumers find the best representation
for their legal needs. Our service allows the consumer to review responses
by many law firms. This process introduces competition amongst the law
firms and allows the consumer to find superior legal representation.
Fill out one simple form and get responses from Kugel Mesh Patch Attorneys
competing for your case. Email up to 10 law firms in one click; you review
the responses in order to choose the right attorney for you. | 
