Corrosion of stainless steel sternal wire after long-term implantation

Abstract

A variety of metallic components have been used in medical devices where lifelong durability and physical strength are demanded. To investigate the in vivo changes of implanted metallic medical devices in humans, stainless steel sternal wires removed from patients were evaluated. Stainless steel (316L) sternal wires removed from four patients after 10, 13, 22, and 30 years of implantation were evaluated using scanning electron microscopy (SEM) and energy dispersive X-ray spectroscopy (EDS). Macroscopically, the removed specimens maintained their metallic luster and color. Under SEM, small holes were observed sporadically at 10 years and they tended to connect in the drawing direction. The longer the implanted duration, the more numerous and deeper were the crevices observed. By EDS, sulfur, phosphorus, and calcium were identified in all areas at 10 years, in addition to the component elements of stainless steel, comprising iron, chromium, nickel, and manganese. Corrosion products observed at 30 years were identified as calcium phosphate. In conclusion, stainless steel sternal wires develop corroded pores that grow larger and deeper with time after implantation; however, the pores remain shallow even after decades of implantation and they may not be a cause of mechanical failure. An amount of metal ions equivalent to the corroded volume must have been released into the human body, but the effect of these metal ions on the body is not apparent.