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Following an expanded recall of the Kugel hernia patch, The U.S. Food and Drug Administration (FDA) has inspected the headquarters of its manufacturer, Davol, Inc., and issued the company a warning, citing serious quality control problems related to the manufacture...

... (r) Composix(r) Kugel(r) Mesh Patch, a device used to repair incisional (or ventral) hernias. The patch is manufactured by Davol, Inc., a subsidiary of C.R. Bard. The patch contains a "memory coil ring" that allows the patch to be ... . More than 80 injuries and several fatalities have been reported to the FDA as a result of the use of the patch. Because the manufacturer, Davol, does not have access to patient records, it only notified its customers, who are hospital and doctors. Although Davol has ...

Kugel Mesh patches, used to repair ventral and incisional hernias, were approved by the FDA in 1996. By 2002, Davol Inc. began receiving complaints, but blamed injuries on the doctors who were installing the patches. However, they issued a ... process as well as the methods it used to handle product complaints. The FDA believes that these problems hindered Davol's ability to timely and effectively deal with the problems. A company that negligently (or intentionally) fails to monitor complaints, all ...

... 13 actions against C.R. Bard and its wholly-owned subsidiary Davol, Inc. alleging that implantable hernia patch can break and cause personal ... District of Georgia Nature of Suits: Consists of twenty actions against ConAgra Foods, Inc. asserting claims relating to consumption or purchase of allegedly contaminated peanut butter manufactured ... New Jersey Nature of Suits: Consists of thirteen actions against Menu Foods, Inc. and other defendants stemming from recall of pet food products allegedly tainted ...

... by means of an incision. The patch is then held open by a memory recoil ring. The Composix® Kugel Mesh Patch was recently recalled by its manufacturer, Davol, Inc., a subsidiary of C.R. Bard, Inc., after it was discovered that the memory recoil ring can break under stress and perforate internal organs. Patients who have had a hernia repair using the patch have been urged by the FDA to contact their hernia ...

The Bard® PerFix® Plug, introduced by Davol, Inc. and C.R. Bard, Inc., in 1993, is a medical device used to repair "primary and recurrent inguinal hernias."

The victims of product liability and wrongful death have begun to sue Davol Inc., the manufacturer of the hernia repair device called Composix Kugel Mesh Patch. Some of the patches have failed some time after hernia surgeries causing serious injuries and death. The use of the defective product has caused perforated bowels, has abnormally attached itself to other organs or passageways and has stuck to other internal ...

... (autologous tissue graft), but that method was very invasive, and surgeons turned to using synthetic materials. DePuy, Inc., submitted a 510(k) for its surgical mesh and listed equivalent devices, including Peri-Guard. In reviewing the DePuy ... . Boston Scientific Corporation acquired Vesica and the Vesica System. Boston Scientific Corporation also acquired Meadox Medicals, Inc., which manufactured a bovine collagen covered polyester fabric called Hemashield, and that fabric was a tubular graft ...