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Important Safety Information

The ARTOURA^® Breast Tissue Expander and CONTOUR PROFILE^® Breast Tissue Expander are used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. ARTOURA^® Breast Tissue Expander and CONTOUR PROFILE^® Tissue Expanders include magnetic injection domes, which contain a rare earth permanent magnet, and are NOT MRI compatible. Do not use the ARTOURA^® Tissue Expander nor CONTOUR PROFILE^® Tissue Expander in patients where an MRI may be needed. The device could be moved by the MRI causing pain or displacement, potentially resulting in a revision surgery. DO NOT use the ARTOURA^® Breast Tissue Expander and CONTOUR PROFILE^® Tissue Expander in patients that have a previously implanted device such as pacemakers, drug infusion devices, artificial sensing devices, etc. that could be affected by a magnetic field. Mentor has not tested the in vivo effects of radiation therapy with ARTOURA^® Breast Tissue Expander and CONTOUR PROFILE^® Expander devices and cannot warrant the safety of such use. The incidence of extrusion of the expander has been shown to increase when the expander has been placed in injured areas: scarred, heavily irradiated or burned tissue, crushed bone areas, where severe surgical reduction of the area has previously been performed and where steroids are used in the surgical pocket.

For detailed indications, contraindications, warnings, and precautions associated with the use of all MENTOR^® Implantable Devices, which include MENTOR^® Saline-filled Implants, MemoryGel^® Implants, MemoryShape^® Implants, ARTOURA^® Expanders, and CONTOUR PROFILE^® Expanders, please refer to the Instructions for Use (IFU) provided with each product or visit www.mentorwwllc.com.

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