Guidance for Industry and Food and Drug Administration Staff; Saline, Silicone Gel, and Alternative Breast Implants; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Saline, Silicone Gel, and Alternative Breast Implants." This version of the guidance document updates preclinical, clinical, and labeling recommendations described in "Guidance for Saline, Silicone Gel, and Alternative Breast Implants," dated January 13, 2004. The update is based on the latest scientific and medical information on breast implants, and clarifies the type and amount of scientific data that should be submitted to allow FDA to evaluate whether these devices are safe and effective.