General Questions
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THE USE OF INTRAOPERATIVE, SINGLE-USE, STERILE, SILICONE BREAST SIZERS MOTIVA IMPLANT MATRIX® AS LONG-TERM BREAST IMPLANTS IS ABSOLUTELY CONTRAINDICATED. The use of these devices as long-term implants may result in serious endangerment to the patient´s health and safety. Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are contraindicated in the same cases where Motiva Implant Matrix® Breast Implants are contraindicated. Please refer to the Motiva Implant Matrix® Silicone Breast Implants Product Insert for information on the implants contraindications.
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Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix®MUST NOT BE REUSED OR RESTERILIZED UNDER ANY CIRCUMSTANCE. They are intended for SINGLE USE ONLY and are designed for TEMPORARY USE AND MUST NOT BE LONG-TERM IMPLANTED. The Sizers’ boxes are specifically labeled “SINGLE-USE- DO NOT RESTERILIZE” and "NOT FOR LONG-TERM IMPLANTATION". The patch also identifies the devices as SIZER. NEVER, UNDER ANY CIRCUMSTANCE, ATTEMPT TO RESTERILIZE THIS DEVICE.
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The filling gel is tinted with pigments, in order for the Sizers to be clearly differentiated from the long-term implantable devices. This visual indicator is a very important feature because the sizers are single-use, temporary devices that must never, under any circumstance, be for long-term implanted and must be discarded after being used.
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Intraoperative, Single-use, Sterile, Silicone Breast Sizers Motiva Implant Matrix® are used during breast augmentation or reconstruction procedures to assist the surgeon in determining the appropriate size of the long-term breast implant to use. Prior to using the Intraoperative, Single-use, Sterile, Silicone Breast Sizers, the physician should be familiar with all the literature associated with the Motiva Implant Matrix® implants to be used
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