Breast implant reports top medical device report (MDR) list:
This article was originally published in Clinica
Executive Summary
Of the 45,184 medical device reports received by the CDRH's Office of Surveillance and Analysis last year, nearly 20% concerned silicone breast implants. Endosseous implants accounted for 16.7%; pacemaker electrodes, 14.4%; implantable pacemakers, 10.7%; surgical staplers, 9.2%; impotence devices, 8.9%; saline breast implants, 8.1%; intra-aortic balloons, 4.7%; infusion pumps, 4.3%; and clip appliers, 3.6%.