1.Nilsson CG, Palva K, Aarnio R, Morcos E, Falconer C (2013) Seventeen years’ follow-up of the tension-free vaginal tape procedure for female stress urinary incontinence. Int Urogynecol J 24(8):1265– 1269.

2. Aigmueller T, Trutnovsky G, Tamussino K, et al. (2011) Ten-year follow-up after the tension-free vaginal tape procedure. Am J Obstet Gynecol 205(5):496.e1–5.

3.Olsson I, Abrahamsson AK, Kroon UB (2010) Long-term efficacy of the tension-free vaginal tape procedure for the treatment of urinary incontinence: a retrospective follow-up 11.5 years post-operatively. Int Urogynecol J 21:679–683.

4. Nilsson CG, Palva K, Rezapour M, Falconer C (2008) Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J 19:1043–1047.

5. Bjelic-Radisic V, Dorfer M, Greimel E, Frudinger A, Tamussino K, Winter R (2006) Quality of life and continence 1 year after the tension-free vaginal tape operation. Am J Obstet Gynecol 195:1784-1788.

6.Magee G, Roy S, Hinoul P, Moretz C, Kozarev R, Waters H, Whitmore K. A real-world comparative assessment of complications following various mid-urethral sling procedures for the treatment of stress urinary incontinence. J Long Term Eff Med Implants. 2012. 22(4): 329–340.

7. Published Sling Data Analysis. March 2013. Ethicon, Inc.

GYNECARE TVT™ FAMILY OF PRODUCTS
ESSENTIAL PRODUCT INFORMATION
INDICATIONS/INTENDED USE

GYNECARE TVT™ Tension-free Vaginal Tape
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer and Rigid Catheter Guide are available separately and are intended to facilitate the placement of the GYNECARE TVT DEVICE.

The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.

GYNECARE TVT™ with abdominal guides Tension-free Support for Incontinence
The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The GYNECARE TVT Introducer, and Rigid Catheter Guide are available separately and GYNECARE TVT Abdominal Guides and Couplers are included in each kit.

The GYNECARE TVT Introducer is a reusable device intended to aid in the placement of the GYNECARE TVT Device retropubically.

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT Device.

The GYNECARE TVT Abdominal Guides and Couplers are single use devices used to facilitate placement of the GYNECARE TVT Device when placed in a top-down retropubic fashion (also known as an abdominal approach).

GYNECARE TVT ABBREVO™ Continence System
The GYNECARE TVT ABBREVO Continence System is intended for use in women as a sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT ABBREVO Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO Device.

GYNECARE TVT™ Obturator System Tension-free Support for Incontinence
The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT Obturator Device.

The GYNECARE TVT EXACT Continence System
The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The GYNECARE TVT EXACT Continence System Trocar is a single use device intended to aid in the placement of the GYNECARE TVT EXACT Continence System retropubically. 

The GYNECARE TVT Rigid Catheter Guide is a reusable device intended to facilitate the identification of the urethra and bladder neck during the placement of the GYNECARE TVT EXACT Continence System.

CONTRAINDICATIONS
-    As with any suspension surgery, these procedures should not be performed in pregnant patients.
-    Additionally, because the PROLENE Polypropylene Mesh will not stretch significantly, these procedures should not be performed in patients with future growth potential, including women with plans for future pregnancy.

WARNINGS & PRECAUTIONS
-    Do not use the GYNECARE TVT Family of Products in patients who are on anti-coagulation therapy.
-    Do not use the GYNECARE TVT Family of Products in patients who have a urinary tract infection.
-    Bleeding may occur post-operatively. Observe for any symptoms or signs before releasing the patient from hospital.
-    Transient leg pain lasting 24-48 hours may occur and can usually be managed with mild analgesics after a GYNECARE TVT Obturator System or GYNECARE TVT ABBREVO System procedure.
-    Since limited clinical information is available about pregnancy following pubo-urethral sling procedure with the GYNECARE TVT Family of Products, the patient should be counseled that future pregnancies may negate the effects of the surgical procedure and the patient may again become incontinent.
-    Since limited clinical information is available with delivery following a pubo-urethral procedure with the GYNECARE TVT Family of Products, in case of pregnancy, mode of delivery should be determined by the obstetrician in consultation with the surgeon.
-    Post-operatively, the patient is recommended to refrain from heavy lifting and/or exercise (e.g. cycling, jogging) for at least four to six weeks and to refrain from intercourse for at least one month.  The patients can usually return to other normal activity after one or two weeks.
-    Prophylactic antibiotics can be administered according to the surgeon’s usual practice.

PATIENT FACTORS
The GYNECARE TVT Device, GYNECARE TVT Exact, GYNECARE TVT Obturator and GYNECARE TVT Obturator are intended for use for non-pregnant adult female patients not planning future pregnancies, who are affected by stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Surgeons should use their surgical experience and judgment to determine if PROLENE Mesh is appropriate for certain patients.  Patient-specific factors may impair wound healing, which may increase the likelihood of adverse reactions.

ADVERSE REACTIONS / UNDESIRABLE SIDE EFFECTS
-    Punctures or lacerations or injury of vessels, nerves, structures, or organs, including the bladder, urethra, or bowel, may occur and may require surgical repair.
-    Local irritation at the wound site may occur.  
-    As with any implant, a foreign body response will occur, the extent of which may differ. This response could result in extrusion, erosion, exposure, fistula formation and/or chronic inflammation, the severity of which is unpredictable, or other adverse reactions, which may be ongoing.
-    Fistula formation, acute and chronic inflammation and ongoing risk of mesh extrusion, exposure, or erosion into the vagina or other structures or organs (such as bladder, urethra or rectum) which may be difficult to treat and result in consequent pain. Mesh extrusion, exposure, or erosion into the vagina may also cause offensive vaginal discharge.
-    Infection following transvaginal implantation. As with all surgical procedures and the implantation of foreign bodies, there is a risk of infection and PROLENE Mesh may potentiate an existing infection.
-    Pain- which may be severe and chronic.
-    Temporary or chronic voiding dysfunction (or difficulty voiding) or urinary retention/obstruction independent from that caused by overcorrection or urethral hypermobility, i.e., too much tension applied to the tape, or from misplacement of the sling or placing the sling too tightly.
-    Pain with intercourse (dyspareunia) and loss of sexual function (apareunia) which may be ongoing and may not resolve in some patients.
-    Excessive contraction or shrinkage of the tissue surrounding the mesh, and vaginal scarring from causes which include, but are not limited to, chronic inflammation and mesh exposure.
-    Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area, and leg weakness, may occur.
-    Recurrence of incontinence.
-    Bleeding, including hemorrhage or hematoma. 
-    One or more revision surgeries may be necessary to treat these adverse reactions. Revision surgeries may not resolve complications and are associated with a risk of adverse reactions.
-    PROLENE Mesh is a permanent implant that integrates into the tissue. In cases in which the PROLENE Mesh needs to be removed in part or whole, significant dissection may be required. Removal of the implant in whole or in part will not necessarily alleviate the patient’s symptoms. Removal of part of the implant can be difficult. Surgery to remove the whole or part of an implant can result in further scarring and tissue damage which, in turn, may have adverse outcomes including severe chronic pain which may not be able to be satisfactorily treated. Surgery to remove the whole or part of the implant may also result in recurrence of SUI. Removal of the eroded mesh will not necessarily prevent further erosions or other adverse events.

OTHER ADVERSE REACTIONS/ UNDESIRABLE SIDE EFFECTS
-    Seroma
-    Urge incontinence, including de novo urge incontinence
-    Urinary frequency
-    Urinary retention
-    Adhesion formation
-    Atypical vaginal discharge
-    Exposed mesh may cause pain or discomfort to the patient’s partner during intercourse
-    Death

The surgeon should convey adverse reactions, undesirable side effects and risks associated with the product and the procedure to the patient prior to undertaking SUI and advise the patient to contact a surgeon in case of any deviation from the normal post-operative course. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the country-competent authority.

Consult your doctor to discuss the potential benefits and risks of your treatment options and whether PROLENE mesh is appropriate for you.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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