Virtue® Male Sling System

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

Contraindications
The Virtue Male Sling is contraindicated in patients with one or more of the following conditions: Documented hypersensitivity or allergic reaction to polypropylene. Active infection, including untreated urinary tract and/or infection in the operative field. Patients with untreated or serious blood coagulation disorders. Patients with obstructive uropathy. Patients under the age of 18.

Warnings
It is the responsibility of the physician to advise prospective patients prior to surgery, of the warnings associated with the use of this product and the associated surgical risks. The Virtue Male Sling should only be implanted by physicians experienced in the surgical procedures and techniques involving placement of stress urinary incontinence slings.
A thorough assessment of each patient should be conducted, based on current medical practice guidelines, to determine the suitability of a sling procedure. Patients should be counseled that the Virtue Male Sling is permanent.
It is recommended that sling candidates are evaluated for overactive bladder syndrome and post-void residual. Residual sphincteric function should be considered prior to sling surgery.
It is recommended that sling candidates are evaluated for the presence of bladder neck contracture or urethral strictures prior to sling surgery.
The patient should be counseled to consider conservative incontinence treatments as well as other treatments.
Sling associated complications may result in one or more revision surgeries 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. De novo complications may occur.
The additional risks versus benefits of Virtue Male Sling should be considered in patients with one or more of the following conditions:
auto-immune disease, coagulation disorder, connective tissue disease, debilitated or immunocompromised state, diabetes, pelvic radiation therapy, physical characteristics (e.g., body mass index), renal insufficiency, smoking related underlying conditions.

Potential Complications
Adverse events are known to occur with sling procedures and implants. Adverse events following sling implantation may be immediate or delayed, localized or systemic, de novo or worsening, acute or chronic, transient or permanent.
Adverse events may include but are not limited to: allergic reaction, hypersensitivity; autoinflammatory /autoimmunity syndrome; bladder storage symptoms (e.g., increased daytime frequency, urgency, nocturia, overactive bladder, urinary incontinence); bleeding/hemorrhage or hematoma, delayed/impaired/abnormal wound healing; exposure, extrusion or erosion of sling into other structures or organs; fistula formation; foreign body granuloma/scar tissue formation; genital paresthesia; infection; inflammation/irritation; male dyspareunia; necrosis; neuromuscular disorder; palpable mesh; pain; perforation or injury to adjacent muscles, nerves, vessels, structures, or organs (e.g., bone, bladder, urethra, ureters, bowel); seroma; sexual dysfunction; sling migration; urinary tract infection, urinary tract obstruction; voiding symptoms (e.g., dysuria, urinary retention, incomplete emptying, bladder outlet obstruction, straining, position-dependent voiding, slow stream).