Ethicon GYNECARE TVT EXACT Mode D'emploi page 6

bladder will go from a spherical to a spheroid confi guration. This moves the bladder away from the back of the
pubic symphysis (See Figure 7A and 7B). Additionally, it moves the bladder neck and the urethra to the left as
the Trocar Sheath is passed on the patient's right side, thereby minimizing the risk of bladder perforation
(See Figure 8A and 8B).
11. Hold the Trocar Handle using your dominant hand. Pass the tip of the white Trocar Sheath that has been
mounted on the Trocar Shaft (see Step 8 above), paraurethrally through the urogenital diaphragm at the level
of the midurethra. Initial insertion of the device is controlled by using the tip of the index fi nger of the non-
dominant hand, which is placed in the vagina under the anterior vaginal wall, just lateral to the suburethral
incision. The curved part of the Trocar Shaft should rest in the palm of the non-dominant hand. (See Figure 9).
Pass the Trocar Sheath through the urogenital diaphragm into the retropubic space. During the initial placement
into the paraurethral dissected space, the Trocar Sheath tip should be oriented horizontally, i.e. in the frontal
plane. During passage through the urogenital diaphragm, lower the Trocar Handle to ensure that the Trocar
Sheath Tip passes vertically while staying in close contact to the back of the pubic symphysis. After passage
through the urogenital diaphragm resistance to the passage of the Trocar Sheath is signifi cantly reduced once it
enters the retropubic space.
12. At this point, the non-dominant hand is moved from the vagina to the suprapubic exit site. The Trocar Sheath
tip is guided through the retropubic space staying as close to the back of the pubic symphysis as possible.
This is achieved by lowering the Trocar Handle, thereby pressing the Trocar Sheath tip against the back of the
pubic bone.
13. During passage through the retropubic space aim the Trocar Sheath tip towards the pre-marked abdominal
exit site.
14. Move the Trocar Sheath tip upwards toward the abdominal skin exit sites keeping in close contact with the pubic
bone until exiting the skin (See Figure 10). Once the Trocar Sheath tip exits the skin, grasp the exposed Trocar
Sheath tip with a clamp. Release the Trocar Sheath from the Trocar Sheath Lock on the Trocar Handle by pushing
the Trocar Sheath appendage laterally and off the Trocar Sheath Lock, and carefully withdraw the Trocar Shaft
from within the Trocar Sheath. DO NOT PULL the Trocar Sheath up any further.
15. The procedure is now repeated on the patient's other side while repeating steps 9 – 14. NOTE: IN ORDER TO
MINIMIZE THE RISK OF BLADDER INJURY, IT IS IMPORTANT THAT THE BLADDER NOW BE DISPLACED TO THE
CONTRALATERAL SIDE USING THE MANEUVERS OUTLINED IN STEP 10.
16. Once both white Trocar Sheaths have been passed and before the Implant is pulled into place, remove the 18
French Foley catheter and perform a cystoscopy (70 degree lens recommended).
17. Once bladder integrity is confi rmed, gently pull the Trocar Sheaths upward to bring the Implant loosely (i.e.
without tension) under the midurethra. Cut the Implant bilaterally close to the connection to the Trocar Sheaths.
Adjust the Implant so that leakage is reduced, allowing only a few drops of urinary leakage to occur under stress.
For this, use patient feedback, i.e. coughing with a full bladder (approximately 300 mL).
18. Grasp the Implant Sheaths that surround the Implant with clamps, taking care not to grasp the Implant. Then
individually remove the Implant Sheaths by gently pulling up on the clamps, away from the abdomen, one at a
time. To avoid putting tension on the Implant, a blunt instrument (scissors or forceps) should be placed between
the urethra and the Implant during removal of the Implant Sheaths.
19. NOTE: Premature removal of the sheaths may make subsequent adjustments diffi cult.
20. After proper adjustment of the Implant, close the vaginal incision. The abdominal ends of the Implant are then
cut and left in the subcutis; do not suture the Implant.
21. Close the skin incisions with suture or surgical skin adhesive.
22. Empty the bladder. Following this procedure, postoperative catheterization is not typically required. The patient
should be encouraged to try to empty their bladder 2-3 hours after the operation.
CONTRAINDICATIONS
As with any suspension surgery, this procedure should not be performed in pregnant patients. Additionally, because
the PROLENE Mesh will not stretch signifi cantly, 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 EXACT™ Continence System on patients who are on anti-coagulation therapy.
• Do not perform the GYNECARE TVT EXACT™ Continence System procedure on patients who have a urinary
tract infection.
• Users should be familiar with surgical technique for SUI Sling placement and should be adequately trained in
implanting the GYNECARE TVT EXACT™ Continence System before employing it. It is important that the Implant
be located without tension under mid-urethra.
• Acceptable surgical practice should be followed for the GYNECARE TVT EXACT™ Continence System procedure
as well as for the management of contaminated or infected wounds.
• The GYNECARE TVT EXACT™ Continence System procedure should be performed with care to avoid large
vessels, nerves, bladder and bowel. Attention to local anatomy and proper passage of the Trocar Sheaths will
minimize risks.
• Retropubic bleeding may occur post-operatively. Observe for any symptoms or signs before releasing the
patient from the hospital.
• Cystoscopy should be performed to confi rm 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 Foley catheter remains
properly in place.
• Do not remove the Implant Sheath until the Implant has been properly positioned.
• Ensure that the Implant is placed with minimal tension under the 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 eff ects of the surgical procedure and
the patient may again become incontinent.
• Since no clinical experience is available with vaginal delivery following the GYNECARE TVT EXACT™ Continence
System procedure, in case of pregnancy delivery via cesarean section is recommended.
• 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 should be 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.
• As with other incontinence procedures, de novo detrusor instability may occur following the
GYNECARE TVT EXACT™ Continence System procedure. To minimize this risk, make sure to place the
Implant tension-free in the mid-urethral position.
• Do not contact the PROLENE Mesh with any staples, clips or clamps, as mechanical damage to the mesh
may occur.
• Do not resterilize the GYNECARE TVT EXACT™ Continence System. Discard opened, unused devices.
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