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The Contour Profile Tissue Expanders can be utilized 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.

The CPX™4 Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. In order to provide these tissue expanders with elasticity and integrity, the shells are made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the devices have integral, silicone elastomer, magnetically detected, injection ports and incorporate a BUFFERZONE® area with self-sealing technology that is attached to the inside of the anterior surface of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface. Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution. Suture fixation tabs are incorporated into some models of the MENTOR® CPX™4 Tissue Expanders to give surgeons the option to attach the device to surrounding tissue for enhanced device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

The Mentor NovaSilk Mesh is indicated for tissuc reinforcement and long-lasting rne Memor of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, cither as mechanical support or bridging matcrial for the fascial defect.

NovaSilk is a permanent, synthetic knitted polypropylenc mesh that is square in shape. It is a sterile, single use device which will be available in quantitics of three.

The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter. The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport. The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.

The Mentor ObTape Trans-obturator Surgical Kit consists of an implantable, suburethral support tape and introducers. It is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or sphincter deficiency.

The Mentor ObTape Trans-obturator Surgical Kit consists of two components: the Mentor ObTape Trans-obturator Tape and a set of Introducer Needles. The Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The tape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, allows tissue colonization and facilitates positioning during surgery. A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Kit.

The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

The Genesis Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence). The Prosthesis (used in pairs) is inserted into the corpora cavernosa. Each Prosthesis consists of a r roothed in panel in panel is a silver wire coil and silver wire coil and silver wire core in the flexible center section and a trimmable proximal section. The distal end is shaped to provide an anatomical fit under the glans penis. The silver wire coil and core in the flexible center section anatelinear in antost the gost into an erect position for intercourse, and then moved into a lowered position for concealment under clothing. Placed within the corpus cavernosum and crus of the penis, the Prosthesis will fit firmly at the ischial tuberosity. The ends fit the proximal culde-sacs of the cavernosa and provide support to the Prosthesis. All components of the Genesis Penile Prosthesis incorporate a hydrophilic coating on all external surfaces.

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. ObTape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, tissue colonization and facilitates positioning during surgery. Disposable and re-usable Introducer Needles necessary for the implantation are also available with the device.

The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.