Bard hernia product recall labelled with most serious classification:
This article was originally published in Clinica
The US FDA has designated CR Bard's worldwide recall of its ventral hernia repair product, the Composix Kugel mesh X-large patch, as a class I recall. The company has initiated the action in December 2005 following reports that the device's "memory" coil ring, which holds the patch in place after insertion, broke after insertion into the abdomen. This could lead to bowel perforation and/or the creation of abnormal connections between the intestines and other organs. The company's fourth-quarter revenues took a $7.8m hit as a result of the recall (see Clinica No 1192, p 19).