Virtue® Urinary Incontinence Sling

Virtue Male Sling System

The Coloplast Virtue male sling is a treatment designed for stress urinary incontinence (SUI) in male patients. Virtue utilizes a unique four-arm approach designed to provide compression made of 100% monofilament polypropylene.

For ordering information, please call 800.258.3476.

Indications
The Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence.

Contraindications
The product is contraindicated for the following patients: with urinary tract infections or urinary tract obstruction; with blood coagulation disorders or prescribed anticoagulation therapy; with obstructive uropathy; under the age of 18.

Warnings
Carefully consider the risks and benefits of implantation in patients with the following: persistence of de novo incontinence; good bladder function and low volume detrusor overactivity; presence of bladder neck or urethral strictures; blood coagulation disorders, renal insufficiency due to urinary tract obstruction, or compromised immune systems. The patient should not have an active infection at the time of implantation.
Precautions
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.
This product should only be used by surgeons who are qualified to perform this type of surgery, and who are familiar with the use of non-absorbable mesh and the specific insertion technique for Virtue.
A 6-month period of non-invasive treatment is recommended before a sling implant is considered for males with stress urinary incontinence.

Adverse Reactions:
Local irritation, a foreign body response, wound dehiscence, extrusion, erosion, inflammation, fistula formation, urethral erosion, infection, bladder, urethra, vessel, nerve perforation.

Other known risks of incontinence surgical procedures include 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.

See the device instructions for use for detailed information regarding the implant procedure, a full listing of 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.

Coloplast Corp.

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