Defective Medical Device: Kugel Hernia Repair Patch
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Kugel Mesh Patch Recalled. The Food and Drug Administration (FDA) in December of 2005 recalled the Kugel Patch because it can pose serious risks to patients and/or cause death.
The FDA has issued a Class 1 recall for the Composix Kugel Mesh Patch. This is the strongest recall available to the FDA and is reserved for dangerous or defective products that could cause serious health problems, including death.
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 medical patch is placed behind the hernia defect through a small incision made by a physician. The medical 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 by the surgeon.
The reported problem with the Composix Kugel Mesh Patch is that the plastic "memory recoil ring" can break. If the ring breaks it can cause bowel perforations and chronic intestinal fistulae (abnormal connections or passageways between intestines and other organs).
According to the medical patch's manufacturer, C.R. Bard, Inc., as of earlier this year, the company had received 24 reports of broken rings.
IF YOU OR A LOVED ON HAS UNDERGONE SURGERY AND A KUGEL MESH PATCH WAS USE IN THE PROCEDURE - CALL OUR LAW FIRM DAY OR NIGHT AT 1-800-862-1260. THE CALL IS FREE AND THE CONSULTATION IS FREE. CALL US WE CAN HELP.
Patients who have received the product and where the product has been implanted with a recalled devices should seek medical attention immediately if they experience any of the following symptoms that could be associated with ring breakage:
- unexplained or persistent abdominal pain
- fever
- tenderness at the implant site, or other unusual symptoms
IF YOU OR A LOVED ON HAS UNDERGONE SURGERY AND A KUGEL MESH PATCH WAS USE IN THE PROCEDURE - CALL OUR LAW FIRM DAY OR NIGHT AT 1-800-862-1260. THE CALL IS FREE AND THE CONSULTATION IS FREE. CALL US WE CAN HELP.
TRADEMARK NOTICE: Kugel is a trademark of Davol, Inc.
The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Davol, Inc. The use of this mark is solely for informational and product identification purposes.


