A penile implant, also called a penile prosthesis, is concealed entirely within the body to address erectile dysfunction (impotence). The implant requires some degree of manipulation before and after intercourse to make the penis erect or flaccid.

Penile implants are surgical solutions requiring a healing period that have risks associated with surgery such as pain, anesthesia reactions, repeat surgery due to infections, or mechanical problems with the device. The implant eliminates the possibility of a natural erection. Considerations in choosing a penile implant may include your medical condition, lifestyle, personal preference and cost.

This treatment is prescribed by your physician. Although many patients benefit from the use of this device, results may vary. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a penile implant is right for you.

For further question, call Coloplast Corp at 1-800-258-3476 and/or consult the company website at www.coloplast.us.



Titan Brief Statement:

Indications
The Titan or Titan OTR Inflatable Penile Prosthesis is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

Contraindications
The Titan and Titan OTR Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following conditions: Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. Patients unwilling to undergo any further surgery for device revision.

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, autoinflaction, discomfort, angulation/curvature, edema, device malfunction/deflation, pain, difficulty with ejaculation, transient urinary retention, fever, mitration, patient dissatisfaction, infection, hematoma wound leakage, bleeding, delayed wound healing, phimosis, sensory loss cylinder aneurysm, fibrous capsule formation, over/under inflation, erosion, scrotal erythema, genital change, inguinal hernia
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.