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For temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.

The Motiva Flora® SmoothSilk® Tissue Expander (MFSTE) is intended for temporary subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage and is not intended for use beyond six (6) months. All MFSTEs require periodic, incremental inflation with sterile saline for injection until the desired tissue expansion is developed. Once the desired tissue expansion is achieved, the tissue expander is surgically removed and a breast implant is inserted within the breast pocket. The MFSTE is constructed of successive cross- linked layers of silicone elastomer with an Integrated Injection Port system for incremental expander filling. The Tissue Expanders are available in a range of sizes to meet diverse patient needs and achieve individualized aesthetic results. The MFSTE has a controlled surface architecture produced by the mandrel imprinting technique with an average roughness of 4 microns. Each MFSTE is supplied sterile. The injection port is dome-shaped with a radiofrequency identification (RFID) coil embedded in the needle stop. This needle stop prevents inadvertent puncture through the base of the injection port during the filling process. The injection port is found with the Motiva Flora® Port Locator accessory through the air wound coil's RFID signal placed inside the needle stop. The RFID wireless system comprises two components: the tag and the reader. The Motiva Flora® Port Locator (the reader) has antennas that emit radio waves and receive the signal coming from the RFID coil tag in the needle stop to locate the center of the injection port. The user interface of the Motiva Flora® Port Locator includes LED lights to guide the user during the process. This is an innovative technology not available in other tissue expanders on the market. In addition, the RFID transponder functions as a traceability feature, which provides a unique electronic serial number (ESN) for each expander. The ESN allows access to a database with the device information (serial and lot number, size, projection, model, manufacturing date, etc.). Additional design features of the MFSTE include a non-ferromagnetic component design that allows the device to be used with Magnetic Resonance (MR) and Computerized Tomography (CT) under certain conditions. The MFSTE includes six (6) fixation tabs (TrueFixation®) to provide the surgeon options to suture the tissue expander in the breast pocket. Another design feature is its reinforced base.