GYNECARE TVT™ Retropubic System Tension-Free Support for Incontinence

GYNECARE TVT Retropubic System is a retropubic mid-urethral sling used for the treatment of female stress urinary incontinence. The needle curvature and tip radius is designed to maintain contact with the posterior aspect of the pubic bone during passage. The system had a 91% objective cure rate and a 87% subjective cure rate reported from a 17 year study.1-5 Also, the system had significantly lower rates of urinary obstruction/retention6 and has been evaluated in over 100 RCTs.7

TVT Retropúbico

Product Specifications

Product Code

Product Code

Description

 
810041A 810041A GYNECARE TVT™ with abdominal guides 

Product Code

Product Code

Description

 
810041B 810041B GYNECARE TVT™ (mechanical cut mesh) 

Product Code

Product Code

Description

 
810041BL 810041BL GYNECARE TVT™ (laser cut mesh) 

Product Code

Product Code

Description

 
830041 830041 GYNECARE TVT™ Undyed 

Product Code

Product Code

Description

 
830041B 830041B GYNECARE TVT™ (mechanical cut mesh) 

Product Code

Product Code

Description

 
830041BL 830041BL GYNECARE TVT™ (laser cut mesh) 

Supporting Documentation

Clinical Evidence

GYNECARE TVT™ Family of Products Magee Clinical Article

Product Support

GYNECARE TVT Family of Products Brochure

GYNECARE TVT Family of Products Patient Brochure

References

1. 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
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2. Serati M, Bauer R, Cornu JN et al. TVT-O for the treatment of pure urodynamic stress incontinence: efficacy, adverse effects, and prognostic factors at 5-year follow-up. Eur Urol. 2013 May;63(5):872-8.

3. Cheng D, Liu C. Tension-free vaginal tape-obturator in the treatment of stress urinary incontinence: a prospective study with five-year follow-up. Eur J Obstet Gynecol Reprod Biol. 2012 Apr;161(2):228-31.

GYNECARE TVT™ FAMILY OF PRODUCTS
ESSENTIAL PRODUCT INFORMATION
INDICATIONS
The GYNECARE TVT™ Tension-free Support for Incontinence, GYNECARE TVT EXACT® Continence System and GYNECARE TVT™ with Abdominal Guides Tension-free Support for Incontinence, are intended to be used in women as pubourethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
GYNECARE TVT™ Obturator System Tension-free Support for Incontinence and GYNECARE TVT ABBREVO® Continence System are intended to be used in women as sub-urethral slings for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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, it 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 or infection may occur post-operatively.
-    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 no clinical information is available about pregnancy following sub-urethral sling procedure with the GYNECARE TVT Family of Products, the patient should be counseled that future pregnancy may negate the effects of the surgical procedure and the patient may again become incontinent.
-    Since no clinical information is available about vaginal delivery following sub-urethral sling procedure with the GYNECARE TVT Family of Products, in case of pregnancy, delivery via cesarean section should be considered.
-    Post-operatively, refrain from heavy lifting and/or exercise (e.g. cycling, jogging) for at least three to four weeks and to refrain from intercourse for one month.  The patients can usually return to other normal activity after one or two weeks.
-    Contact your surgeon immediately if there is burning sensation during urination, unusual bleeding, problems voiding or other problems.

PATIENT FACTORS
Physicians 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
-    Punctures or lacerations or injury of vessels, nerves, structures or organs, including the bladder, urethra, or bowel, may occur and may require surgical repair.
-    Improper placement of the GYNECARE TVT Family of Products devices may result in incomplete or no relief from urinary incontinence or may cause temporary or permanent urinary tract obstruction.
-    Transitory local irritation at the wound site may occur.  
-    As with any implant, a foreign body response may occur. This response could result in extrusion, erosion, exposure, fistula formation and/or inflammation. 
-    Mesh extrusion, exposure, or erosion into the vagina or other structures or organs.
-    As with all surgical procedures, there is a risk of infection.  As with all foreign bodies, PROLENE Mesh may potentiate an existing infection.
-    Acute and/or chronic pain.
-    Voiding dysfunction.
-    Pain with intercourse which, in some patients may not resolve. 
-    Neuromuscular problems, including acute and/or chronic pain in the groin, thigh, leg, pelvic and/or abdominal area may occur.
-    Recurrence of incontinence.
-    Bleeding including hemorrhage or hematoma. 
-    One or more revision surgeries may be necessary to treat these 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.
OTHER ADVERSE REACTIONS
-    Seroma
-    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

Consult your doctor to discuss the potential benefits and risks of your treatment options and whether PROLENE mesh is appropriate for you.
026356-180221

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