Two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates,” according to an FDA analysis.
Patients implanted with FlexHD by MTF Biologics and AlloMax by BD 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 agency said late yesterday.
FDA Warns on Use of Certain Surgical Mesh in Breast Reconstruction
