PM-36715
Titan & Titan Touch Inflatable Penile Prosthesis Brief Statement
Indications
The Titan Inflatable Penile Prosthesis is indicated for male patients with erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.
Contraindications
The Titan 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 a documented hypersensitivity or allergic reaction to silicone or polyurethane. 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
The Titan device should only be implanted by physicians experienced in the surgical procedures involving implantation of a penile prosthesis. Physicians should advise prospective patients, prior to surgery, of the warnings, precautions and potential complications associated with the use of this product, which may include the following: Potential for resurgery (Note: device is not a lifetime implant). Implantation makes latent natural erections, as well as other interventional treatment options, impossible. Implantation may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. Diabetic, as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs.
Vigorous exercise and manual massage could lead to device damage. Certain stresses and pressures (straddle seating, obesity, etc.) could lead to involuntary inflation or deflation.
Precautions
Patients with spinal cord injury may have an increased risk of infection. This device may be used to treat ED in the presence of Peyronie’s disease. A thorough preoperative consultation should include a discussion between the patient and physician of available treatment options and their risks and benefits. Patient selection should consider the following factors which could lead to increased risk of failure and can be critical to the eventual success of the procedure: Ability and willingness of the patient to follow instructions. Associated psychological status (e.g. psychogenic erectile dysfunction, inappropriate attitude or motivation). Health conditions which hamper sexual activity, such as severe angina, may prevent successful use of this device. Manual dexterity problems.
Potential Complications
Adverse events are known to occur with penile protheses procedures and implants; some may require revision surgery or removal of the implant. Adverse events following penile protheses implantation may be de novo, persistent, worsening, transient, or permanent.
Adverse events may include but are not limited to: Acquired phimosis, Adhesion(s), Bladder storage symptoms, Capsular contracture, Deformity, Delayed/Impaired/Abnormal wound healing, Discomfort, Erosion/Extrusion, Fistula, Foreign body reaction, Hematoma/Seroma, Hemorrhage/ Bleeding, Hernia, Hypersensitivity/Allergic reaction, Induration, Infection (local or systemic), Inflammation (including, but not limited to edema, erythema, redness, swelling), Male Dyspareunia, Necrosis, Obstruction/Occlusion, Pain, Perforation or injury of soft tissue (e.g., muscles, nerves, vessels), structures, or organs (e.g., bowel, bone, bladder, urethra, ureters), Scar tissue, Sexual dysfunction, Tactile disorders, e.g., hypoesthesia, numbness, Urinary incontinence symptoms, Urinary tract infection, Voiding symptoms.
The occurrence of these events may require one or more subsequent surgeries which may or may not always fully correct the complication.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
PM-02124 / Feb 2024
