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NONSILICONE BREAST IMPLANT CLINICAL STUDY CONTROLS REQUIREMENTS

This article was originally published in The Gray Sheet

Executive Summary

NONSILICONE BREAST IMPLANT CLINICAL STUDY CONTROLS REQUIREMENTS remained unresolved among members of an FDA-convened panel of 17 scientific experts at an Oct. 21 workshop on alternatives to silicone gel-filled breast implants. The panel could not come to a consensus in response to FDA's question on establishing "appropriate control/comparison group for safety, effectiveness, and quality of life measures" for clinicals of breast implants filled with materials other than silicone gel.
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