Stress urinary incontinence
patient reviews & stories

Virtue Male Sling is a polypropylene mesh device or “sling” intended to prevent involuntary urine leakage (incontinence) at times of increased pressure on the bladder (e.g., coughing, sneezing, laughing, lifting heavy objects, exercise). It is permanently implanted to support, elevate and gently compress the urethra, the tube that connects to the bladder to carry urine outside of the body.

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

The Virtue Male Sling is contraindicated in patients with one or more of the following conditions: 1) documented hypersensitivity or allergic reaction to polypropylene, 2) active infection, including untreated urinary tract and/or infection in the operative field, 3) patients with untreated or serious blood clotting (coagulation) disorders, 4) patients with blockage of urine flow (obstructive uropathy), 5) patients under the age of 18.

Your physician will conduct a complete evaluation with testing to confirm you are a candidate for a male sling. Patients will then be advised prior to surgery, of the warnings associated with the use of this product, the associated surgical and postoperative risks and potential complications. Sling associated complications may result in resurgery which may lead to partial or complete removal of the sling. Complete removal of the sling may not always be possible, and removal may not fully correct these complications. New onset (de novo) complications may occur. As with all surgical procedures, patients with certain underlying conditions may be more susceptible to postoperative bleeding, impaired blood supply, compromised/delayed healing, sling exposure or other complications and adverse events. The risk versus benefit of the male sling should be considered in patients with one or more of the following conditions: auto-immune disease, blood clotting (coagulation) disorder, connective tissue disease, impaired immune system (debilitated or immunocompromised state), diabetes, pelvic radiation therapy, physical characteristics (e.g., body mass index), kidney problems (renal insufficiency), smoking related conditions (e.g., COPD, chronic cough).

Adverse events are known to occur with sling procedures and implants. Adverse events following sling implantation may be immediate or delayed, localized or systemic, new onset (de novo) or worsening, acute or chronic, transient or permanent.

Adverse events may include but are not limited to: allergic reaction, hypersensitivity; abnormal immune response (autoinflammatory/autoimmunity syndrome); bladder symptoms (e.g., increased daytime frequency, urgency, nocturia (urinating more than once per night), overactive bladder, urinary incontinence); bleeding/hemorrhage; delayed/impaired/abnormal wound healing; exposure, extrusion or erosion of sling into other structures or organs; fistula formation (abnormal connection or passageway between two structures in the body); foreign body granuloma (abnormal tissue formation)/scar tissue formation; genital burning / tingling / numbness (paresthesia); infection; tissue swelling/redness/discomfort (inflammation/irritation); avoidance/difficult/painful intercourse (dyspareunia / sexual dysfunction); tissue death (necrosis); weakness or loss of sensation (neuromuscular disorder); palpable mesh; pain; perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel); collection of clear fluid or blood outside of tissue or vessels (seroma/hematoma); sling migration; urinary tract infection; inability to completely empty bladder (urinary tract obstruction); voiding symptoms (e.g., dysuria (painful urination), urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream).

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 male sling is right for you.

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

PM-15544 / Apr 2024