GYNECARE TVT* Tension-free Support for Incontinence
What is GYNECARE TVT Tension-free Support for Incontinence?
The GYNECARE TVT system is an innovative, minimally-invasive and simple surgical device alternative for the
effective treatment of
female stress urinary incontinence with proven long-term results. To date, more than 75,000patients worldwide have been treated with the GYNECARE TVT system. Clinical studies have demonstrated an 86
percent success rate, and most patients notice immediate improvement.
How Does the GYNECARE TVT Device Alleviate Stress Urinary Incontinence?
Female stress urinary incontinence is caused 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 loss of urine. When a woman suffers from stress urinary
incontinence, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its
correct position. As a result, during normal movement as pressure is exerted on the bladder from the diaphragm,
the urethra cannot retain its seal, permitting urine to escape.
The GYNECARE TVT system combines the use of a safe material, PROLENE* polypropylene mesh tape, with a
traditional surgical procedure known as the sling, to correct stress urinary incontinence. The PROLENE mesh tape
is woven through pelvic tissue and positioned underneath the urethra, creating a supportive sling. When pressure is
exerted, the tape applies an adequate amount of support to the urethra, allowing it to keep its seal. The tape,
therefore, uniquely provides support only when needed, without any unnecessary tension on the urethra (it is
tension-free
).
Key Patient Benefits of the GYNECARE TVT Device:
¨
Simple Procedure. A procedure using the GYNECARE TVT system can be completed within 30 minutesunder regional anesthesia by a trained surgeon. As a result, the
GYNECARE TVT system offers a short recovery time and minimal pain.Ø
In contrast, of the many surgical treatments currently in use for treating SUI, most involve generalanesthesia, extensive surgery, and a lengthy recuperation.
¨ No traditional surgical anchors required. As the tape passes through several pelvic tissue layers, friction iscreated which secures the tape in place. Over time, the natural in-growth of tissue into the mesh reinforces and
restores connective tissue between the vaginal wall, urethra and pelvic floor muscles.
This friction allows the tape to be tension-free and helps to minimize the risk of complications that tension
brings to other surgical procedures.
¨ Provides support only when needed. The mesh tape loosely supports the middle of the urethra rather than thebladder neck and, therefore, uniquely provides tension-free support only when needed. This reduces the need
for catheterization.
¨
Safe. There have been no cases of PROLENE polypropylene tape rejection to date.
Is GYNECARE TVT 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 should not be used in women who plan
future pregnancy.
Risks Associated with GYNECARE TVT:
All surgical procedures carry risks. Although rare, complications associated with GYNECARE TVT include injury
to blood vessels of the pelvic sidewall and abdominal wall, hematomas, and bladder and bowel injury.
GYNECARE TVT Tension-Free Support for Incontinence is marketed by GYNECARE, the women’s
health division of ETHICON, INC.
*Capitalized names are trademarks of ETHICON, INC.