GYNECARE TVT™ Family of Products Tension free support for Incontinence

ETHICON™ Women’s Health and Urology GYNECARE TVT™ revolutionised the treatment pathway for SUI. Sub-urtheral sling procedures are now accepted as the Gold standard for the treatment of SUI and our GYNECARE TVT™ product holds 11 years worth of clinical data supporting its safety and efficacy.

ETHICON's™ Women’s Health and Urology GYNECARE TVT™ combines the use of PROLENE™ polypropylene mesh tape, with the traditional surgical procedure SUI. The PROLENE™ mesh is woven through the pelvic tissue and positioned so that it sits underneath the urethra thus acting as a supportive sling. When pressure is exerted, the mesh applies a sufficient amount of support to the urethra, thus allowing it to keep its seal and prevent leakage. This makes the ETHICON’s™ Women’s Health and Urology GYNECARE TVT™ a product that not only provides support when needed, but also does so without forming any unnecessary tension on the urethra – hence making it tension-free. This then reduces the risk of over correcting, because the mesh is made from a permanent material that is tolerated by the body, it will help to support a patient’s urethra for the rest of their life. 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.

Due to the fact that ETHICON™ Women’s Health and Urology use a PROLENE™ mesh, which is 100% polypropylene, thus giving it several key differences from other meshes such as pore size, monofilament, elasticity and strength.

For clinical information about GYNECARE TVT, view the information below.

New Study Offers More Than A Decade Of Evidence For Minimally-Invasive Surgery To Treat Female Incontinence

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., SEPTEMBER 8, 2008 - A new study published in the August issue of the 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™ 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 seek 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.

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

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

Continence occurs with ETHICON™ Women’s Health and Urology GYNECARE TVT™ because it reinforces the dysfunctional puburethral ligaments and brings fresh connective tissue to the paraurethral area, which results in a solid floor underneath the urethra. The table below explains some other capabilities that ETHICON™ Women’s Health and Urology GYNECARE TVT™ is capable of.

Capabilities Explanation

Inertness : Due to its chemical properties as a non-absorbable and permanent polypropylene material, ETHICON™ Women’s Health and Urology GYNECARE TVT™ causes a very limited foreign body reaction².

Resistance to Infection : The macroporous, monofilament GYNECARE TVT™ (Type 1) mesh allows macrophages entry into the pores and thus does not promote or harbour infection. ^3,4,5,6,7

Rapid Fibrinous Fixation : Due to its macroporous configuration, GYNECARE TVT™ minimises the risk of seroma formation and allows the formation of proper scaffolding. ^3,4

Host Tissue Incorporation : GYNECARE TVT’s™ uniform Interlock® structure with a pore size of 164 x 96 μ (Type 1 Mesh) offers an excellent incorporation of the surrounding tissue during the healing process.^3,4,5,8,9,10

Elasticity Of all tested materials, GYNECARE TVT™ has the lowest resistance to deformation. GYNECARE TVT™ and other wide-weave PROLENE™ tapes have biomechanical characteristics that may be at least partly responsible for the apparent clinical success of the implants and the very low erosion rates.

<sub>References
1.Data on file. ETHICON WOMEN’S HEALTH AND UROLOGY WORLDWIDE, a division of ETHICON, INC. Somerville, NJ. 20.Ward K, Hilton P, on behalf of the United Kingdom and Ireland Tension-free Vaginal Tape Trial Group. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002;325:1-7.21.Ward KL, Hilton P, on behalf of the United Kingdom and Ireland GYNECARE TVTTrial Group. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004;190:324-331. 24.Ulmsten U. Surgery of incontinence revisited. Menopause Review. 1998;3:33-39.
2. Beets G.L. et al. Foreign body reactions to monofilament and braided polypropylene mesh used as preperitoneal implants in pigs (Eur J Surg 1996, 162:823-5)
3. Amid P.K. Classification of biomaterials and their related complications in abdominal wall hernia surgery (Hernia 1997, 1:15-21)
4. Amid P.K. et al. Biomaterials for <> hernioplasties and principles of their applications (Minerva Chir 1995 Sep, 50(9):821-6)
5. Goldstein H.S. Selecting the right mesh (Hernia 1999, 3:23-26)
6.Shuhaiber H. et al. In Vitro adherence of bacteria to sutures in cardiac surgery (J Cardiovasc Surg 1989 Sep-Oct, 30(5):749-53).
7. Merritt K. et al. Tissue colonization from implantable biomaterials with low numbers of bacteria (J Biomed Maters Res 1999 Mar 5, 44(3):261-5)
8. Brenner J. et al. Mesh materials in hernia repair (Expert Meeting, Karger 1995, 172-9)
9. Bobyn J.D. et al. Effects of Pore size on the peel strength of attachment of fibrous tissue to porous-surfaced implants (J Biomed Mater Res 1982 Sep, 16 (5):571-84)
10. Dietz H.P et al. Mechanical properties of urogynecological implant materials (Int Urogynecol J 2003, 14:239-243)</sub>