FDA ALTERNATIVE BREAST PROSTHESES DRAFT GUIDANCE ON TESTING

Executive Summary

FDA ALTERNATIVE BREAST PROSTHESES DRAFT GUIDANCE ON TESTING outlines four potential options for postmarket epidemiologic studies of nonsilicone gel-filled implants, in decreasing order of cost per study subject: a "prospective center-based cohort study of implant recipients"; a "medical record-based retrospective cohort study of implant recipients"; a "questionnaire screening of implant recipients"; and a "mortality screen." The draft guidance will be a topic of discussion at an Oct. 21 FDA workshop in Washington, D.C. ("The Gray Sheet" Sept. 5, In Brief).