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.