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Editor: Bob Binstock, Attorney at Law
Profession: Defective Medical Device Attorney

Category: Hernia Patch Recalls

The U.S. Food and Drug Administration (FDA) recalled several hernia patches in January 2006. The hernia patch recall was classified as a "Class 1" recall by the FDA because they believe the defect associated with the use or exposure to the Kugel Mesh Large Patch has reasonable probability to cause serious and sometimes fatal adverse health effects.

The FDA advises patients who may have been implanted with one of the recalled devices to immediately seek medical attention if they begin to experience symptoms such as unexplained or persistent abdominal pain, fever, tenderness at the implant site.

A recent inspection by the FDA of Davol Inc, manufacturer of the Kugel Mesh Hernia Patch, discovered the company had not accurately reported the possible severity of complaints to the FDA and that the company had understated several reports regarding the potential severity of injury by those implanted with the device.