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Product description

Simple. Adaptable. Dependable.


Simplicity for Physician

  • Trimmable: ’Trimmable – custom sizing to fit to each individual’s corporal length
  • Easy assembly: No special tools required. Simply connect.
  • Adjustable: Threes sizes of tail caps available for adjusting the prosthesis length.


Simplicity for Patients

The Genesis malleable penile prosthesis offers simplicity and ease of use when needing to simulate an erection.


Adaptability

Coloplast’s Genesis is the only malleable penile prosthesis with a hydrophillic coating. This hydrophyllic coating:

  • Is proven to absorb water.
  • Allows physicians flexibility to change or maintain their current device preparation.
  • Is covalently bonded and designed for long-term attachment to the device


Dependable

  • No springs, cables, or moving internal parts to compromise reliability
  • Distal shaft column strength helps prevent buckling
  • Positionability virtually eliminates springback and aids in concealment


Important Safety Information


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 manual 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.
1/31/2013

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Product name Item number Diameter Length (numeric) Units in package
One pair with three pairs tail caps 519250 9.5 mm 23 cm 1
One pair with three pairs tail caps 519260 11 mm 25 cm 1
One pair with three pairs tail caps 519270 13 mm 27 cm 1
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