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Inamed amends PMA (premarket approval) application Style 410 silicone breast implant:

This article was originally published in Clinica

Executive Summary

Supporting efforts to secure US marketing clearance for its next-generation cohesive gel-filled breast implants, BioDimensional Style 410, Inamed has filed an amendment with the US FDA concerning the product's premarket approval (PMA) application. Information submitted with the amendment included three-year follow-up data from the Style 410 core study cohort and new 5-9 year rupture prevalence data from a European study, the Santa Barbara, California firm said. Style 410 silicone implants have been available internationally for almost ten years. Silicone breast implants were withdrawn from the US market in 1992 due to concerns over their long-term efficacy. Inamed submitted the Style 410 PMA to the FDA in December 2004.

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