Titan® Penile Implants

Coloplast offers the Titan Inflatable Penile Prostheses (IPPs) for those men who need surgical intervention for the management of erectile dysfunction. The Titan family of products are hydraulic systems designed to be surgically implanted in the penis. These cylinder sets are available in a variety of sizes ranging from 11cm to 28 cm, with two different pump options. All standard and narrow-base cylinders are provided pre-connected to the pump and the XL cylinders are available as separate components.

The implant consists of two Bioflex® cylinders that are implanted in the corpora cavernosa of the penis. The cylinders are attached to a pump which is placed in the scrotum. The pump is connected to a reservoir which is filled with sterile saline solution, and is implanted in the Space of Retzius or underneath the abdominal muscles.

The Titan and Titan Touch Zero Degree products feature zero degree angle input tubing at the proximal base of the cylinder and a silicone molded distal tip on the cylinder. These features are designed to facilitate suitable anatomic positioning and proximal placement of the product.

The Titan Touch IPP is available with our exclusive One Touch Release pump. Fluid pressure in the cylinders is released when the patient momentarily depresses the deflate button to activate the deflate mechanism. This process enables fluid to return to the reservoir, thus returning the penis to the flaccid state.

For ordering information, please call 800.258.3476.

 

Indications

The Titan and Titan Touch Inflatable Penile Prosthesis are 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 Touch Inflatable Penile Prosthesis are 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 a documented sensitivity to silicone. 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 (e.g., SLE and DLE), scleroderma (e.g., progressive systemic sclerosis), or myasthenia gravis should be carefully considered. Reuse of this single use product may create a potential harm to the user. Reprocessing, washing, disinfection and /or sterilization may compromise product characteristics, causing additional risk of physical harm to, or infection of the user. Products containing iodine should be carefully rinsed to remove residual solutions from the prostheses and the implant site.

Precautions

A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.

Potential Complications

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

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 at 1-800-258-3476.

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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