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Composix Kugel Mesh Patch
En Español [KUGEL MESH]
The US Food and Drug Administration first approved the Kugel Mesh Patch in 1996. The Composix Kugel Mesh patch is surgically implanted via a small incision, positioned behind the hernia, and its ‘memory coil ring’ opens the patch behind the herniated area. The mesh patch is then supposed to repair the hernia.
Kugel Mesh Patch
The memory ring is designed to aid in deployment of the patch, but it can break when increased stress is placed on it during certain surgical placement techniques. If the ring should break, the broken ends could poke through the mesh and create bowel perforations and/or a condition called "chronic enteric fistulae."
The first Kugel Mesh recall occurred in 2005. It was recalled again in 2006 and 2007, both times to recall several other sizes of the device. The FDA, along with Davol, Inc., a subsidiary of C.R. Bard, Inc., recalled certain models of the Bard Composix Kugel Mesh Patch (below) after reports that the memory ring had broken, causing a number of painful and serious injuries in hernia patients.
Kugel Mesh Recalls
Because the reports of side effects were so severe, the FDA designated specific lots of the Kugel Mesh X-Large Patch as a Class I recall. This level of recall is defined as a product that is dangerous or defective and could cause serious health problems or death.
According to the FDA Recall Notice, "Patients who have been implanted with a Composix Kugel Mesh Patch during hernia surgery should seek medical attention immediately if they experience symptoms that could be associated with ring breakage. These symptoms include the following:
The product codes for the Dec-05, Jan-06 and Mar-06 recalls are:
Kugel Mesh attorneys are also investigating the following hernia mesh patches manufactured by Davol and Bard that have not been recalled, but defects have been reported.
For further information on the three recalls, visit the FDA website.
In its second-quarter filings, C.R. Bard reported it settled some lawsuits related to use of the Composix Kugel Mesh Patch. According to The Providence Journal (07/06/11), Bard will pay $184 million to settle 2,600 of approximately 3,600 lawsuits filed against the company to date. The lawsuits claimed that the company's Composix Kugel Mesh hernia patch caused serious medical complications including bowel perforation, sepsis, intestinal fistulas and abdominal abscess formation.
Kugel Mesh Lawsuits
In 2010 a jury in the U.S. District Court for the District of Rhode Island found Davol and Bard liable for injuries suffered by plaintiffs Christopher Thorpe and Laure Thorpe. The drug device company was also found liable for the failure to warn of dangers associated with the patch. The Thorpe case resulted in a $1.5 million verdict for the plaintiffs. Christopher Thorpe’s attorneys claimed that he suffered severe internal injuries caused by a broken plastic ring on the hernia repair mesh, which included an abdominal wall abscess and fistula and resulted in him undergoing a number of surgeries to repair the damage. The jury award $1.3 million by the jury for personal injury damages and $200,000 for loss of consortium.
Thousands of cases are pending and underway against the Kugel Mesh manufacturer in Rhode Island federal court’s first consolidated multidistrict litigation (MDL). Almost 2,000 more cases are pending in Rhode Island Superior Court.
By the time of the first recall in December 2005, Davol had sold about 32,000 of its Kugel Mesh Patches worldwide since 2002. In 2005 alone, the device sales reached $11 million.
Kugel Mesh Legal HelpIf you or a loved one has suffered bowel perforation or chronic enteric fistulae due to the Kugel Mesh patch, please send your complaint to a Kugel Mesh attorney by clicking the link below. Your claim will be reviewed by a Kugel Mesh lawyer at no cost.
Last updated on Mar-13-12
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