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The Food and Drug Administration (FDA) has issued a guidance document requiring that clinical studies be conducted to establish the safety and efficacy of silicone-filled breast implants (“Guidance on Preclinical and Clinical Data and Labeling for Breast Prosthesis”, January 13, 2004). The Inamed Style 410 Silicone-Filled Breast Implant is an experimental device that is available to patients who participate in this clinical study. This study is designed to provide access to a shaped, silicone-filled implant to reconstruction and revision patients and to provide additional information to the Style 410 IDE regarding the safety and effectiveness of Inamed Style 410 Silicone-Filled Breast Implants in women undergoing breast implant reconstruction or revision surgery.
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