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GYNECARE TVT Tension-free Support for Incontinence is a device used in a minimally invasive procedure available to most women with stress urinary incontinence. The procedure can be performed under local anesthesia and takes only about half an hour to complete. Patients who undergo treatment have a very short recovery period and experience few complications and minimal scarring after surgery

GYNECARE TVT is a minimally invasive, highly effective surgical alternative for the treatment of stress urinary incontinence. GYNECARE TVT is positioned close to the high pressure zone of the urethra, and when needed, TVT provides tension-free support of the urethra in the correct position. The procedure takes approximately 20 to 30 minutes, with minimal tissue dissection. Clinical studies have shown an 90% success rate with a low rate of complication.

INDICATIONS

The GYNECARE TVT device is intended to be used as a pubourethral 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 intended to facilitate the placement of the GYNECARE TVT device.

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.

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 mid-urethra.
• Acceptable surgical practice should be followed for the GYNECARE TVT device as well as for the management of contaminated or infected wounds.
• Incontinence repair using the GYNECARE TVT device should be performed with care to avoid large vessels, nerves, bladder and bowel. Attention to local anatomy and proper passage of needles will minimize risks.
• Retropubic bleeding may occur postoperatively. Observe for any symptoms or signs before releasing the patient from hospital.
• Cystoscopy should be performed to confirm bladder integrity or recognize a bladder perforation.
• The rigid catheter guide should be gently pushed into the Foley catheter so that the catheter guide does not extend into the holes of the Foley Catheter.
• When removing the rigid catheter guide, open the handle completely so that the catheter remains properly in place.
• Do not remove the plastic sheath until the tape has been properly positioned.
• Ensure that the tape is placed with minimal tension under mid-urethra.
• PROLENE mesh in contaminated areas should be used with the understanding that subsequent infection may require removal of the material.
• The patient should be counseled that future pregnancies may negate the effects of the surgical procedure and the patient may again become incontinent.
• Post-operatively the patient is recommended to refrain from heavy lifting and/or exercise (i.e. cycling, jogging) for at least three to four weeks and intercourse for one month. The patient can return to other normal activity after one or two weeks.
• Should dysuria, bleeding or other problems occur, the patient is instructed to contact the surgeon immediately.
• All surgical instruments are subject to wear and damage under normal use. Before use, the instrument should be visually inspected. Defective instruments or instruments that appear to be corroded should not be used and should be discarded.
• Do not contact the PROLENE mesh with any staples, clips or clamps as mechanical damage to the mesh may occur.
• Do not resterilize GYNECARE TVT device. Discard opened, unused devices.

• 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, erosion, 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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