Advantage® Transvaginal Mid-Urethral Sling System

Prescriptive Information

The Advantage Mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.

Contraindications

The The Advantage Mesh Implant is contraindicated in pregnant patients. Additionally, this procedure should not be performed in patients with potential for future growth or patients with plans for future pregnancy. Use of the surgical mesh is contraindicated for use in any patient in whom soft tissue implants are contraindicated.

Warnings

For single patient use only. Do not reuse, reprocess or resterilize.

Potential Adverse Effects

Potential complications that may occur in a suburethral sling procedure are allergic reaction, fistula, abscess, irritative voiding symptoms including urgency and urge incontinence, detrusor instability, infection, pelvic, vaginal pain, urinary retention, dysparenia, vaginal bleeding, vaginal discharge, erosion of the vaginal or urethral mucosa or bladder wall, dehiscence of vaginal incision, edema at the wound site, erythema at the wound site.

The following complications have been reported as consequences thatmay occur in a suburethral sling procedure:

Cautions

Federal (USA) law and governing law outside the USA restrict these devices to sale by or on the order of a physician.
Refer to Directions for Use provided with this product for complete instructions, warnings, and precautions prior to using this product.