A surgical mesh company claims the FDA improperly called one of its products’ safety into question.
The agency said last week that two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates.”
It named FlexHD by MTF Biologics and AlloMax by BD as having had higher rates of explantation, reoperations and infections two years after surgery when compared with patients who received one of two other brands of surgical mesh or no mesh. The mesh type in question is an acellular dermal matrix (ADM) made of human or animal skin from which the cells are removed and the support structure is left in place.
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