Genesis® Malleable Penile Prosthesis

The Genesis malleable penile prosthesis not only offers a solution for surgeons, but is also a solution for patients with finger or hand dexterity issues, hand muscle fatigue or limited reach and range of mobility.

Other features include:

  • No springs, cables, or moving internal parts to compromise reliability
  • Trimmable – custom sizing to fit to each individual’s corporal length
  • Easy assembly – no special tools required, simply connect

The Genesis Penile Prostheses comes in the following sizes:

  • Size 9.5 mm diameter
  • Size 11 mm diameter
  • Size 13 mm diameter

For ordering information, please call 800.258.3476

Indications

The Genesis Prosthesis is designed for the management of impotence stemming from a variety of causes, including: epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; cystectomy; 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.

Contraindications

Implantation procedures are not advisable if infection is present anywhere in the body, especially urinary tract or genital infection.  The Prosthesis should not be used in patients who have unresolved problems such as elevated residual urine from bladder outlet obstruction, or neurogenic bladder.  The Prosthesis should be used with caution in diabetic patients who are more susceptible to infection and the complications of infection than nondiabetic patients.  Other contraindications include unresolved urinary problems, any condition which may hamper sexual activity (such as severe angina), a history of sensitivity to foreign materials, compromised wound healing, compromised immune system, any anatomic or physiologic abnormality that could lead to significant postoperative complications, an unwillingness to undergo any further surgery for revision and psychological instability of the patient.

Warnings

Implantation of the device may make latent natural erections, as well as other interventional treatment options, impossible. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of infection associated with a prosthesis. Failure to evaluate and promptly treat erosion may result in a substantial worsening of the condition, leading to infection and loss of tissue. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. This device contains solid silicone elastomer. The risks and benefits of implanting this device in patients with lupus, scleroderma, myasthenia gravis, or documented sensitivity to silicone should be carefully considered. The issue of the possible relationship between silicone (and other implantable materials) and various diseases has been the subject of debate.

Precautions

A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.  Surgeons implanting penile prostheses should be familiar with the currently available techniques for measuring the patient, determining implant size, and performing the surgery.

Potential Complications

Scrotal swelling, discomfort, angulation/curvature, edema, device malfunction, pain, difficulty with ejaculation, transient urinary retention, fever, migration, infection, hematoma  wound leakage, bleeding, delayed wound healing.

See the device instructions for use for detailed information regarding the implant procedure, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Coloplast Corp and/or consult the company website at www.coloplast.com.

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or properly licensed practitioner.

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