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New Study Offers More Than a Decade of Evidence for Minimally-Invasive Surgery to Treat Female Incontinence
Date:9/8/2008

Results add to body of clinical evidence demonstrating the efficacy and

safety of synthetic mesh slings for treatment of stress urinary

incontinence in women.

SOMERVILLE, N.J., Sept. 8 /PRNewswire/ -- A new study published in the August issue of International Urogynecology Journal analyzes data of an 11-year follow up study on the safety and effectiveness of tension-free vaginal tape (TVT) as a treatment for stress urinary incontinence (SUI) in women. Researchers followed women treated with GYNECARE TVT(TM) Retropubic System Tension-free Support for Incontinence and found that after 11 years, 90% were objectively cured and 97% considered themselves subjectively cured or improved. This study represents the most extensive follow up for modern mid-urethral sling operations to date.

The three-center prospective observational cohort study led by Professor Carl G. Nilsson, Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Finland, reports on 90 women suffering from urinary stress incontinence who were treated with GYNECARE TVT. Pre-operative assessment included a 24-hour pad test, a stress test, physical examination and a visual analog scale for assessing how bothersome the condition was to each patient. Of the original cohort, 69 women were available for post-operative follow-up 11.5 years after surgery. These women were evaluated using a stress test, a pad test, the patient's overall impression of the cure and a questionnaire administered to assess the patient's quality of life. More than 11 years after surgery, 97% of women assessed subjectively considered themselves cured or improved and researchers determined that 90% of patients were objectively cured based on 24-hour pad tests and stress tests.

"Our results substantiate the evidence showing that the TVT procedure is a safe, effective solution that offers excellent long-term cure rates for women suffering with SUI," said Professor Nilsson. "We are encouraged by the fact that we saw no reports of adverse effects such as tape erosion or tissue reactions found during follow up and continue to believe that the TVT procedure represents a significant advance in the treatment of female SUI."

SUI, a condition that affects more than 13 million women in the United States, is the involuntary leakage of urine during routine activities that put pressure on the bladder or urethra, such as laughing, sneezing or coughing. It can be an embarrassing problem that women are hesitant to bring up with their doctor and as a result, only one in 12 women seeks treatment.

To date, more than one million women worldwide have been treated with the GYNECARE TVT family of products, helping to restore their quality of life.

About GYNECARE TVT

The minimally-invasive GYNECARE TVT* Tension-free Support for Incontinence device uses a mesh sling to provide support to the middle of the urethra, the section that is strained during physical activities. This positioning of the device provides support only when needed and creates a "tension-free" treatment solution that reduces the risk of over-correcting.

As with any suspension surgery, this procedure should not be performed in pregnant patients. Additionally, because the PROLENE polypropylene mesh will not stretch significantly, it should not be performed in patients with future growth potential including women with plans for future pregnancy. Although rare, complications associated with the device include injury to blood vessels or nerves, difficulty urinating and bladder and bowel injury.

The family of GYNECARE TVT products is marketed by ETHICON Women's Health & Urology, a division of ETHICON, INC., a Johnson & Johnson company.

About ETHICON Women's Health and Urology

ETHICON Women's Health & Urology offers treatment solutions for a range of common, female pelvic health disorders. The technologies are marketed under the GYNECARE family of brands and include treatments for menorrhagia (heavy periods), fibroids, stress urinary incontinence and pelvic organ prolapse. ETHICON Women's Health & Urology is a division of ETHICON, Inc, a Johnson & Johnson company. For more information visit http://www.gynecare.com.


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SOURCE ETHICON Women's Health & Urology
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