Hernia Patch Recalled

Shannon Weidemann

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The Composix® Kugel Hernia Mesh Patch recall was upgraded to a Class 1 by the FDA because the device could cause serious health problems or death.

People who have had hernia repair surgery should contact their doctor or hospital to find out if they are included in the recall. They should pay attention for the following symptoms: fever, tenderness at the site of the surgery, and/or persistent abdominal pain. They may be eligible for monitoring and compensation from Davol, the manufacturer of the patch.

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 patch is placed behind the hernia defect through a small incision. The 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.

The "memory recoil ring" can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to numerous complications including infections, bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).