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FDA ALTERNATIVE BREAST PROSTHESES DRAFT GUIDANCE ON TESTING

This article was originally published in The Gray Sheet

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FDA ALTERNATIVE BREAST PROSTHESES DRAFT GUIDANCE ON TESTING outlines four potential options for postmarket epidemiologic studies of nonsilicone gel-filled implants, in decreasing order of cost per study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 The draft guidance will be a topic of discussion at an Oct. 21 FDA workshop in Washington, D.C. ("The Gray Sheet" Sept. 5, In Brief).
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