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The HUTCHISON Inflatable Silicone Tissue Expanders are designed for use in: - . Scar/defect revision - Reconstruction of the breast following subcutaneous mastectomy and other suitable . procedures or trauma - Breast underdevelopment and combined breast and chest wall abnormalities .

The HUTCHISON Inflatable Silicone Tissue Expander is currently manufactured and marketed in Europe. The HUTCHISON Inflatable Silicone Tissue Expanders will be sold in the US, sterile for single use only and in double-peel pouches to facilitate aseptic handling during implantation in the patient. Product packaging is designed to allow sterilization gases onto the product and permit proper degassing. The Silicone Tissue Expanders are constructed from silicone elastomer and consist of a silicone connection tube and an injection site. The injection site is a self-sealing dome valve to allow for sterile saline injections for expanding the implant. The HUTCHISON Inflatable Silicone Tissue Expanders will be manufactured and available to physicians with two surface finishes, smooth or textured. Hutchison Silicone Tissue Expanders are available in various designs and sizes to meet the patient and surgeon's needs. A more detailed description of size and volume is provided in Section 3. The available styles are: - . Round - Rectangle . - . Crescent - Cylindrical . - Croissant . - U design . The manufacturer, Biosil Ltd., uses a high-strength silicone dispersion to produce the shell. The silicone materials used in producing the shell and the valve assembly have all received full biocompatibility assessment by the raw materials supplier. Biosil has conducted extensive tests of the mechanical properties of the silicone shell and the fused joints, including the results from pre and post sterilization studies of elongation, tensile strength, tear resistance, and valve competence.