Product Insert Data Sheet Mentor（产品插入数据表导师）.pdfVIP

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Product Insert Data Sheet Mentor（产品插入数据表导师）.pdf

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Product Insert Data Sheet Mentor（产品插入数据表导师）

ENGLISH 1 Product Insert Data Sheet TISSUE EXPANDER 102921-001 Rev B Effective May 2014 LAB100053182v2 DESCRIPTION The Tissue Expander is used in a variety of procedures to develop skin flaps for defect correction. The device consists of a silicone elastomer inflatable expander with a remote silicone elastomer injection dome. The round, rectangular, elliptical and crescent-shaped expanders are available with a smooth elastomer shell. The expander and remote injection dome are for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months. The devices have a remote injection dome that is attached to the expander with a length of silicone elastomer tubing. A stainless steel connector is supplied with each of these devices for use in connecting the tubing should shortening of the tubing be desired. All tissue expanders have polyester mesh reinforced silicone elastomer bases. All injection sites have integral stainless steel needle guards to help prevent inadvertent needle puncture. INDICATIONS The Tissue Expander can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. CONTRAINDICATIONS The use of this expander is contraindicated in patients who have one or more of the following conditions: • Active infection anywhere in the body. • Recent history of breast abscess. • Diffuse painful cystic mastitis or breast tumor. • Clinically persistent or re