Coloplast Patient Educators are men and their partners who have taken control of erectile dysfunction (ED) with a penile implant, or incontinence (leakage) with a male sling, and they’re ready to share their experiences with you. They understand how erectile dysfunction and incontinence can affect your self-confidence, relationships, and everyday life. If you have questions about what life is like with the Titan® penile implant and/or Virtue® male sling, these individuals are available to answer your questions.

These conversations reflect Patient Educators' experiences with the Titan® Inflatable Penile Implant and Virtue® Male Sling. Coloplast invited these Patient Educators to share their stories and they receive compensation. Each person’s situation is unique; your experience may not be the same. Talk with your doctor about whether these products are right for you.

 

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Titan® and Titan® Touch Inflatable Penile Prosthesis - Important Safety Information

 

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.

 

Indications

The Titan and Titan Touch 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 Touch Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following: (1) Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. (2) Patients with a documented sensitivity to silicone. (3) Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. (4) 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. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring.

 

Precautions

Removal of an implanted prosthesis without timely reimplantation of a new prosthesis may complicate subsequent reimplantation or may make it impossible. MRI quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Titan, and Titan Touch IPP. Be sure to consult with your physician. Patients should discuss all available treatment options and their risks and benefits with their physician. Health conditions which hamper sexual activity, such as severe chest pain (angina), may prevent successful use of this device. The prosthesis should not be implanted in patients who lack the manual dexterity or strength necessary to operate the device. Trauma to the pelvic or abdominal areas, such as impact injuries associated with sports (e.g., bicycle riding), can result in damage of the implanted device and/or surrounding tissues. This damage may result in the malfunction of the device and may necessitate surgical correction, including replacement of the device. The device may be used in the presence of Peyronie's Disease.

 

Potential Complications

Penile implants are surgical solutions requiring a healing period that have risks associated with surgery such as scrotal swelling, auto-inflation, discomfort, angulation/curvature, swelling (edema), device malfunction, chronic pain, difficulty with ejaculation, transient urinary retention, fever, migration, patient dissatisfaction, infection at surgical site or wound, deflation, swelling of clotted blood or clear fluid (hematoma/seroma), wound leakage, bleeding, delayed wound healing, narrowing of the opening of the foreskin (phimosis), sensory loss, cylinder malfunction, formation of thick tissue (fibrous capsule formation), over/under inflation, erosion, scrotal reddening (erythema), genital change, and inguinal hernia.

 

This treatment is prescribed by your physician. 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.

 

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.




Virtue® Male Sling System Important Safety Information

 

A male sling implant is concealed entirely within the body to address stress urinary incontinence (urine leakage) in men. The Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

 

It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. The product is contraindicated for the following patients:

 

• Patients with urinary tract infections or urinary tract obstruction.
• Patients with blood coagulation disorders or prescribed anticoagulation therapy.
• Patients with blockage of urine flow (obstructive uropathy).
• Patients under the age of 18.

 

It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product.

 

Check with your Physician on the warnings, precautions and risks associated with the use of this mesh sling.

 

Patients should be evaluated for the following before a sling is implanted: persistence of new onset (de novo) incontinence, good bladder function, presence of bladder neck or urethral narrowing or blockage (strictures), active urinary tract infection, and bladder muscle (detrusor) overactivity.

 

Patients with the following conditions should carefully consider the risks and benefits of using Virtue: blood clotting (coagulation) disorders, kidney problems (renal insufficiency) due to urinary tract obstruction and compromised immune systems or any other conditions that affect healing.

 

You should follow your physician's instructions. Patients should avoid physical strain, sexual intercourse and heavy lifting for 8 weeks, and see their surgeon immediately to report any bleeding, pain, painful urination (dysuria), or signs of infection. Although rare, some infections may require the mesh to be repositioned, loosened or tightened (revised), or removed.

 

No undesirable effects that could be directly attributed to the polypropylene fibers/materials have been reported in the literature. As with all foreign bodies, the Virtue sling system is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. The resulting response could lead to rupture of the surgical incision (wound dehiscence), extrusion, erosion, inflammation or abnormal connection between two hollow spaces (fistula formation). The following complications are known to occur with synthetic slings: urethral erosion, infection, bladder, urethra, vessel and nerve perforation. Patients should be monitored regularly after the device has been implanted. Known risks of incontinence surgical procedures include extrusion, erosion, infection, sling migration, pain, transient or permanent retention, bladder outlet obstruction, and, continued stress urinary incontinence and persistent or new overactive bladder symptoms. The occurrence of these responses may require operative intervention with removal of part of or the complete sling.

 

This treatment is prescribed by your physician. This list of risks is not necessarily comprehensive. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a male sling is right for you.

 

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.