Frequently Asked Questions
About Incontinence and the TVT procedure

What is GYNECARE TVT tension-free support?
GYNECARE TVT tension-free support is an innovative, minimally-invasive and simple surgical device alternative for the effective treatment of female stress urinary incontinence. Clinical studies have demonstrated that 84-91 percent of patients were dry after treatment and an additional 6-12 percent reported a significant reduction of symptoms.

The device was cleared for marketing in November 1998 by the U.S. Food and Drug Administration. To date, more than 200,000 patients worldwide (more than 50,000 U.S.) have been treated. In fact, in Europe it is estimated that GYNECARE TVT tension-free support is used in about half of all incontinence surgical procedures.

How does the treatment alleviate stress urinary incontinence?
Female stress urinary incontinence is caused predominantly by an improperly functioning urethra; it is not a problem of the bladder. Normally, the urethra - when properly supported by strong pelvic floor muscles and healthy connective tissue - maintains a tight seal to prevent involuntary urine loss. When a woman suffers from stress urinary incontinence, however, weakened muscle and pelvic tissue don't support the urethra adequately. As a result, the urethra doesn't maintain a tight seal during exercise or other movement and urine escapes.

GYNECARE TVT tension-free support combines the use of safe material, PROLENE polypropylene mesh, and a variation of a traditional operation known as a sling procedure to correct stress urinary incontinence. The PROLENE mesh is inserted through the vagina and positioned underneath the urethra, creating a supportive sling. During movement or exercise, the mesh supports the urethra, allowing it to maintain its seal to prevent urine loss. The tape, therefore, uniquely provides support only when needed, without any unnecessary tension on the urethra (tensions-free).

Key patient benefits of GYNECARE TVT tension-free support:
• Simple procedure. A procedure using GYNECARE TVT tension-free support can be completed within 30 minutes under local anesthesia by a trained surgeon, and patients may return home the same day. GYNECARE TVT tension-free support offers short recovery time with minimal pain. Most patients will not require catheterization after surgery. In contrast, many surgical treatments currently in use for treating SUI involve general anesthesia, extensive surgery and a lengthy recuperation.
• No traditional surgical anchors required. As the tape passes through several pelvic tissue layers, friction is created, which secures the tape in place. Over time, the natural in-growth of tissue into the mesh further secures the tape.
• Regional anesthesia permits evaluation during procedure. The procedure is usually performed under regional anesthesia. In addition to the avoidance of general anesthesia, this also allows the surgeon to make any necessary adjustments to the mesh tape intra-operatively utilizing a cough test, which improves placement of the sling and the success rate.
• Provides support only when needed. The mesh tape loosely supports the middle of the urethra and therefore, uniquely provides support only when needed without tension. This reduces the need for catheterization.

Are there risks associated with a procedure using GYNECARE TVT tension-free support?
All surgical procedures present risks. Although rare, complications associated with the system include injury to blood vessels of the pelvic sidewall and abdominal wall, difficulty urinating and bladder and bowel injury.

Is the GYNECARE TVT tension-free system appropriate for pregnant women or women who want to become pregnant?
As with any surgery of this kind, this procedure should not be performed in pregnant patients. Additionally, because the mesh-like tape will not stretch significantly, GYNECARE TVT tension-free support should not be used in women who plan future pregnancy.

Select published clinical studies:
Ulmsten, Flaconer, Johnson, et al. "A MultiCenter Study of Tension-free Vaginal Tape For Surgical Treatment of Stress Urinary Incontinence," International Urogynecology, 1998.

Ulmsten, "Three Year Follow-Up of Tension-free Vaginal Tape," British Journal of Obstetrics and Gynecology, 1999.

Ulmsten, "An Ambulatory Surgical Procedure for Stress Urinary Incontinence," International Urogynecology, 1996.

For more information: GYNECARE TVT tension-free support for incontinence is marketed by GYNECARE, the women's health division of ETHICON, INC., a Johnson & Johnson company. Consumers who want more information about GYNECARE TVT tension-free support for Incontinence or a list of physicians in their area who offer the treatment can call 1-888-GYNECARE toll free, or visit the web site at www.controlsuddenurineloss.com.