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Gynecare TVT Blue Our commitment to your and your patients begins with innovative technology but it doesn't end there. As a full-service medical device partner, we offer comprehensive support for the advancement of women's health, including unmatched clinical and consumer education and ongoing research and development to improve existing technologies and solve unmet needs. References
- Data on file.
- Leach G, Dmochowski R, Appell R. Female stress urinary incontinence clinical guidelines panel summary report on surgical management of female stress urinary incontinence. j Urol. 2001; 158 (3): 875-880.
Summary of Package Insert Indications The Gynecare TVT device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontience resulting from urethral hypermobility and-or intrinsic sphincter deficiency. The Gynecare TVT introducer and ridit catheter guide are available separately and intended to facilitate the placement of the Gynecare TVT device. Contraindications 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. Warnings and Precautions Do not use Gynecare TVT device for patients who are on anticoagulation therapy. Do not use Gynecare TVT device for patients who have a urinary tract infection.
- Users should be familiar with surgical technique for bladder neck suspensions before employing the Gynecare TVT device. It is however important to recognize that Gynecare TVT is different from a traditional sling procedure in that the tape should be located without tension under midurethra.
- Acceptable sugrical practice should be followed for the Gynecare TVt device as wel as for the management of contaminated or infected wounds.
Adverse Reactions
- Punctures or lacerations of vessels, nerves, bladder or bowel may occur during needle passage and may require surgical repair.
- Transitory local irritation at the wound site and a transitory foreign body response may occur. This response could result in extrusion, erosio, fistula formation and inflammation.
- As with all foreign bodies, Prolene mesh may potentiate an existing infection. The plastic sheath initially covering the prolene mesh is designed to minimize the risk of contamination.
- Over correction i.e. too much tension applied to the tape, may cause temporary or permanent lower urinary tract obstruction.
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