McGhan expands breast implant trial:
This article was originally published in Clinica
Executive Summary
McGhan Medical has received permission from the US FDA to upgrade to a full-scale pivotal study the feasibility trial of its Style 410 silicone-filled breast implant. The expanded study will involve 940 patients at 100 institutions undergoing augmentation, reconstruction or revision of existing implants. McGhan, a subsidiary of Santa Barbara, California-based Inamed, says that data from the trial will form the basis of a PMA application to the FDA.