GYNECARE TVT SECUR™

The ETHICON Women’s Health and Urology GYNECARE TVT SECUR™ is 4 times shorter than the length of traditional slings and is inserted into the patient using an “attach and release” mechanism. This novel approach allows for a stable and controlled placement of the mesh but with the huge added benefit of no skin exits. Great for patient and surgeon alike.

The device is designed to encourage tissue ingrowth but until this is achieved, absorbable fixation tips made from Vicryl* (polyglactin 910) knitted mesh and PDS* (polydioxanone) suture yarn are used to hold the mesh in place thus providing mechanical fixation. This is the same material that has been used in implants for over 50 years. In most cases, the device can be implanted within a 10-15 minute procedure with the patient generally under local anaesthetic.

ETHICON Women’s Health and Urology GYNECARE TVT-SECUR™ 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 the standardised benefits found to be associated with the PROLENE™ Polypropylene mesh; there are additional benefits for ETHICON™ Women’s Health and Urology GYNECARE TVT-SECUR™ system. These are:

• Laser Cut Mesh– Technologically advanced laser-cut process
• Maximum Safety – Requires no exit points
• Less Invasive – Less material left in the body, avoids proximity to the bowel and major vessels and nerves.
• Less Dissection – Only requires two small paraurethral dissections (~ 1 cm)
• Less Pain – Less postoperative pain equalling increased patient comfort and reduces the risk of leg pain whilst also avoiding major nerve bundles.
• Minimal Passage through Tissue – Only 8cm long, fixated with an “attach and release” mechanism.
• Absorbable Fixation Tips – These tips sandwich the mesh inside the patient and do not encapsulate, allowing full mesh incorporation.
• Versatility – The device can be inserted in either a ‘U’ or ‘Hammock’ position, which is beneficial for different patient types. The ‘hammock’ approach is a supportive sling where as the ‘U’ is a compressive one.
• Precision Tensioning – Can tighten or loosen mesh to desired tension.
• Less Complicated – Designed to reduce the number of procedural steps whilst allowing for stable and controlled placement.
• 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.

The values that guide our decision-making are spelled out in Our Credo. It is more than just a morale compass; it is what we do business by. Our aim has always been to put the patient first and GYNECARE TVT SECUR™ does just that. It guides us to create more innovative products, which means that the patient not only gets a better quality product but one that also brings them less discomfort. We believe in our credo and we believe in GYNECARE TVT-SECUR™.

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

GYNECARE TVT-SECUR™ was designed to overcome two of the peri-operative complications reported with use of GYNECARE TVT™-O: thigh pain and bladder outlet obstruction ^1,2. GYNECARE TVT-SECUR™ was introduced into the European market in 2006 and as a result there are only short-term results for the use of this product. Long-term studies will need to be carried out in order to assess the long-term efficacy of the product.

GYNECARE TVT-SECUR™ is easier and quicker to administer and is relatively trouble free for both the patient and surgeon involved³. In a recent study, it was found that it might not be mandatory for intra-operative diagnostic cystoscopy and bladder catherization for an experienced surgeon using GYNECARE TVT-SECUR™ in the Hammock approach³. The same study also found that there were no clinical signs for operative bleeding, bladder or intestinal penetration, post-operative infection and/or bladder over activity through the use of GYNECARE TVT-SECUR™³. This was further reinforced by another study that found similar results, stating that the operative complications associated with GYNECARE TVT™ and GYNECARE TVT™-O were reduced with the use of GYNECARE TVT-SECUR™⁵. Another study found that patients who received GYNECARE TVT-SECUR™ for SUI were able to return to sexual function without complaint of dyspareunia⁴ and the overall procedural satisfaction rate was found to be 8.2/10 with all patients recommending local anaesthesia⁴. This particular study found the product to allow for a simple, fast, and reproducible procedure that required minimal vaginal dissection in almost all cases⁴, while postoperative pain was minimal, specifically at the level of the thigh⁴.

Another recent study by Marsh and Assassa found that the mean operative time for GYNECARE TVT-SECUR™ was 17 minutes with 90% of patients going home on the same day⁶. They also found significant reduction in incontinence episode frequency and improvements in 24hour pad loss, usage and nocturia⁶. Overall the study found that 74% of patients felt that they were cured with a further 12% feeling an improvement⁶ thus highlighting not only the short-term safety but also efficacy of GYNECARE TVT-SECUR™ producing results that are comparative to other forms of midurtheral tapes.

This was further reinforced by the significant improvement in quality of life found in the majority of patients during a recent study by Karram et al⁷ and was further backed up by the fact that complications are rare when compared with to retropubic or transobturator slings with similar success rates to other sling based techniques at the same time point⁸. GYNECARE TVT-SECUR™’s ability to be performed in both the ‘U’ and ‘Hammock’ position allows for a versatile tool in the treatment of SUI as it lends itself to both SUI patient groups, those who have greater mobility of the urethra and those with less mobility⁹.

Although the initial results for GYNECARE TVT-SECUR™ are very promising, follow up is still in the early stages and more long-term studies will need to be completed to assess the long term efficacy and safety of the product. It does however; offer the platform for a less invasive procedure with potentially the same clinical success as attributed to GYNECARE TVT™.

<sub>1. Neuman M. GYNECARE TVT and GYNECARE TVT-Obturator: Comparison of two operative procedures. Eur J Obstet Gynecol Reprod Biol, 2007; 131:89-92.
2. Neuman M. GYNECARE TVT-Obturator: Short-term data on an operative procedure for the cure of female stress incontinence performed on 300 patients. Eur Urol 2007; 51: 1083-1087.
3. Neuman M. GYNECARE TVT-SECUR: 100 teaching operations with a novel anti-incontinence procedure. Pelviperineology 2007; 26: 121-123.
4. Debodinance P, et al. GYNECARE TVT-SECUR: More and more minimal invasive-preliminary prospective study on 40 cases. Int Urogynecol J (2007) 18 (Suppl 1):S107-S244. 5. Neuman M. Training GYNECARE TVT-SECUR: The first 150 teaching operations. Int Urogynecol J (2007) 18 (Suppl 1):S25-S105.
6. Marsh FA, and Assassa P. An audit of the introduction of GYNECARE TVT-SECUR in clinical practice. Int Urogynecol J (2007) 18 (Suppl 1):S25-S105.
7. Karram M, et al. An Evaluation of the GYNECARE TVT-SECUR system (tension-free support for incontinence) for the treatment of stress urinary incontinence. Int Urogynecol J (2007) 18 (Suppl 1):S1-S24.
8. Oliveira R, Pinto R, Silva C, Silva A, and Cruz F. Short-term assessment of GYNECARE TVT-SECUR for treatment of female stress urinary incontinence. A Single-institution experience. Eur Urol Suppl 2008;7(3):122, 206.
9. Martan A, Masata J and Svabik K. GYNECARE TVT-SECUR System – Tension-free support of the urthera in women suffering from stress urinary incontinence – Technique and initial experience. Ces. Gynek. 72, 2007, c.1, s.42-49.</sub>

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

Links to:
http://www.womenshealthsolutions.co.uk/
http://www.womenshealthsolutions.ie
http://www.womenhealth.ch
http://www.gynecare.de
http://www.gynecare.at
http://www.saudedamulher.com.pt

The ETHICON™ Women’s Health and Urology GYNECARE TVT SECUR™ System is intended for use in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. This Device may be placed in either a “U” or “Hammock” position under the mid-urethra. Placement orientation is per the surgeon’s preference.

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