The Coloplast® Titan® inflatable penile prosthesis is a self-contained, fluid-filled system made from Bioflex and silicone. Bioflex is a supple, yet durable, biopolymer material. It is designed to emulate the look and performance of a natural erection. Titan is offered in both standard and narrow-base cylinder styles, peno-scrotal or infrapubic approach, and lengths ranging from 10-28cm depending on style.
The Titan penile implant consists of:
- A reservoir (placed in the abdomen)
- Two penile cylinders
- A pump
Each part is connected by silicone tubing. The Titan is MRI Conditional and latex free.
Titan Features:
- Bioflex® material for unmatched cylinder strength (cf. 1)
- Lock-out™ valve designed to prevent auto-inflation (cf. 1)
- Hydrophilic coating to aid in surgical placement (cf. 1)
- Zero degree angle proximal base input tubing for ease of surgical placement (cf. 2)
- Soft molded tip designed for suitable anatomic positioning (cf. 3)
Important Safety Information
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, faver, mitration, patient dissatisfaction, infection, hematoma wound leakage, bleeding, delayed wound healing, phimosis, sensory loss cylinder aneurysm, fibrous capsule formation, over/under inflation, erosion, scrotal ertthema, 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.
1/31/2013
References:
- Data on file.
- Köhler TS, Carrion R, et al. Initial evaluations for enhanced Coloplast Titan inflatable penile prosthesis: Results of a multicenter questionnaire. Presented at ISSM/SMS 2012 Annual Meeting, Chicago, IL, USA. August 2012.
- Hakky TS, Bradley P, et al. 3D reconstructoin of the corpus cavernosum with comparative 3D analysis of the inflatable penile prosthesis. Presented at ISSM/SMS 2012 Annual Meeting, Chicago, IL, USA. August 2012.