GYNECARE TVT™ Obturator System

The product itself is a safe, simple and effective treatment option for women suffering from stress incontinence. GYNECARE TVT™ Obturator System is so simple and safe that it is often administered as a day procedure, and carries all the benefits that ETHICON™ Women’s Health and Urology GYNECARE TVT™ does with the additional benefit of not entering into the retropubic area thus minimising damage to the bladder or urethra. The recovery time is short meaning patients should have little interference with daily activities but it is advised that they avoid heavy lifting and intercourse for four to six weeks.

The system is a sterile, single-patient-use procedure kit consisting of three major components that are packaged in a user-friendly workstation with the device already positioned for use. The three components are blue PROLENE™ mesh, helical passers (specific for the left and right side) and winged guides. The helical passers are used to deliver the GYNECARE TVT™Obturator System device with the winged guides facilitating the accurate passage of the helical passers through the dissection tract. The winged guides have two lengths to aid treatment with patients who may be obese. The device consists of one piece of blue PROLENE™ polypropylene mesh tape covered by a plastic sheath overlapping in the middle. It is the same mesh used in the ETHICON™ Women’s Health and Urology GYNECARE TVT™.

ETHICON Women’s Health and Urology GYNECARE TVT™Obturator System uses PROLENE™ Polypropylene Mesh , which is the same material used in ETHICON™ PROLENE™ Sutures and in ETHICON Women’s Health and Urology GYNECARE TVT™.

On top of these standardised benefits found to be associated with the PROLENE™ Polypropylene mesh; there are additional benefits to ETHICON™ Women’s Health and Urology GYNECARE TVT™Obturator system. These are:

• Avoids the retropubic space – This is beneficial for select patient populations and thus optimises safety. It also minimises the risk of retropubic haematoma and avoids the bowel. There is a reduction in major vascular injury with this technique.
• Utilises the “inside-out” technique¹ – Device passes away from the urethra and bladder, reducing the potential the risk of injury to the bladder or urethra.
• Minimal vaginal dissection – With accurate instrumentation passage.
• Maintains key critical success factors of GYNECARE TVT™
• Anatomically designed instruments – Has two stainless steel, uniquely curved helical passers that have been ergonomically designed for the effective delivery of the GYNECARE TVT™ Obturator System.
• Precision Tip Tubing – Allows smooth, continuous passage of the device
• Safety Features – Not to be found in any other obturator devices.
• Quicker Recovery Time - This means that there are more beds available in the hospital and in turn this will free up hospital resources meaning less expenditure is required for patient care after surgery.

This reinforces our drive to constantly develop and evolve our product base so that the patient receives the best treatment options available to them. ETHICON™ Women’s Health and Urology GYNECARE TVT™ Obturator System has taken the success of the GYNECARE TVT™ system and developed it further so that added safety measures are in place and the patient receives a successful operation. Our Credo strives us to constantly innovate and develop new products and to deliver them to healthcare professionals with clinical data so that they are able to make informed decisions regarding a patient’s well being. This product does just that.

<sup>References
1. De Leval, J. et al. Novel surgical technique for the treatment of female stress urinary incontinence: Transobturator vaginal tape inside-out (GYNECARE TVT-O). Department of Urology, University Hospital of Leige, Belgium.</sup>

For clinical information about GYNECARE TVT™ OBTURATOR SYSTEM, view the information below.

This is a clinically proven system that has shown a cure rate of 90.9% for women suffering from SUI, who were treated with GYNECARE TVT™-O and visited one year after surgery. A further 5% noted a considerable improvement¹.

Three-year follow up data found that no erosion or persistent pain was noted by patients who underwent the GYNECARE TVT™-O procedure. Disappearance and improvement of SUI was noted in 88.4% and 9.3% of the patients taking part in the study, respectively. These cure rates do not differ drastically from the one’s found in the 1-year study discussed above. Frequency and urge symptoms were improved and maximum flow rates decreased².

<sup>References
1. De Leval, J. et al. Novel surgical technique for the treatment of female stress urinary incontinence: Transobturator vaginal tape inside-out (GYNECARE TVT-O). Department of Urology, University Hospital of Leige, Belgium.
2. Waltregny, D., et al. 2007. GYNECARE TVT-O for the treatment of female stress urinary incontinence: Results of a prospective study after a 3 year minimum follow-up. Department of Urology, University Hospital of Leige, Belgium</sup>

The following brochure provides information for patients about GYNECARE TVT™ OBTURATOR SYSTEM .

Information for patients is available at the links below:

• www.womenshealthsolutions.co.uk
• www.womenshealthsolutions.ie
• www.womenhealth.ch
• www.gynecare.de
• www.gynecare.at
• www.saudedamulher.com.pt

The following booklet provides information about Anatomical Considerations .