Ethicon GYNECARE TVT EXACT Mode D'emploi page 5

Please read all directions, precautions, and warnings prior to use. Failure to properly follow instructions may result in
improper functioning of the devices and/or may lead to injury. These instructions for use provide direction for using
the GYNECARE TVT EXACT™ Continence System. This is not a technique manual nor a substitute for appropriate
training and experience in surgical technique for correcting Stress Urinary Incontinence. The device should be used
only by physicians trained in the surgical treatment of Stress Urinary Incontinence and specifi cally in the use of the
GYNECARE TVT EXACT™ Continence System. These instructions are recommended for general use of the GYNECARE
TVT EXACT™ Continence System. Variations in use may occur in specifi c procedures due to individual technique and
patient anatomy.
DESCRIPTION
The GYNECARE TVT EXACT™ Continence System consists of the following sterile, single-use components:
A. GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly (See Figure 1):
1. Implant
2. Implant Sheath
3. Trocar Sheath
4. Trocar Sheath Cut-out
The GYNECARE TVT EXACT™ Continence System Trocar Sheath / Implant Assembly consists of one piece of blue
(Phthalocyanine blue, color index number 74160) PROLENE™ Polypropylene Mesh (Implant) approximately
1/2 x 18 inches (1.1 x 45 cm), covered by a clear plastic Implant Sheath and held between two white Trocar Sheaths,
which are bonded to the Implant and Implant Sheath. PROLENE Mesh is constructed of knitted fi laments of extruded
polypropylene strands identical in composition to that used in PROLENE™ Polypropylene Nonabsorbable Surgical
Sutures. The Implant is approximately 0.027 inches (0.7 mm) thick. This material, when used as a suture, has been
reported to be non-reactive and to retain its strength indefi nitely in clinical use. PROLENE Mesh is knitted by a
process which interlinks each fi ber junction.
B. GYNECARE TVT EXACT™ Continence System Trocar (See Figure 2):
5. Trocar Handle
6. Trocar Sheath Lock
7. Trocar Shaft
The GYNECARE TVT EXACT™ Continence System Trocar consists of the stainless steel Trocar Shaft and the plastic
Trocar Handle. The Trocar Shaft is designed to fi t inside the white Trocar Sheaths on the GYNECARE TVT EXACT™
Continence System Implant / Trocar Sheath Assembly, and is used to position the GYNECARE TVT EXACT™ Continence
System Implant in the patient from a vaginal incision up through the abdominal wall.
GYNECARE TVT Reusable Rigid Catheter Guide
(available separately – not included in GYNECARE TVT EXACT™ Continence System)
The GYNECARE TVT Rigid Catheter Guide is a non-sterile reusable instrument intended to facilitate the identifi cation
of the urethra and the bladder neck during the surgical procedure. It is inserted into a Foley catheter (recommended
size 18 French) positioned in the bladder via the urethra. To facilitate insertion, it can be lubricated with gel.
INDICATIONS
The GYNECARE TVT EXACT™ Continence System is intended to be used as a pubourethral sling for treatment of
female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter defi ciency.
The GYNECARE TVT Rigid Catheter Guide is available separately and is intended to facilitate the placement of the
GYNECARE TVT EXACT™ Continence System.
INSTRUCTIONS FOR USE
1. The procedure can be carried out under local anesthesia, but it can also be performed using regional or
general anesthesia.
2. Before the patient is prepped and draped, she should be placed in the lithotomy position, taking care to avoid
hip fl exion greater than 60°.
3. Insert an 18 French Foley catheter and leave it to open drainage.
4. At the level of the mid urethra, inject a small amount of local anesthesia submucosally to create a space between
the vaginal wall and the periurethral fascia. The extent of dissection required for placement is minimal. Only a
small paraurethral incision is required over the mid urethra to position the tip of the Trocar Sheath. Using forceps,
grasp the vaginal wall at each side of the urethra. Using a small scalpel, make a sagittal incision no more than 1.5
cm long starting approximately 1.0 cm cephalad from the urethral meatus. This incision will be positioned over
the mid-urethral zone and will allow for subsequent passage of the Implant.
5. With a small pair of blunt scissors, make two small paraurethral lateral dissections (approximately 0.5 to 1.0 cm)
to accommodate the tips of the Trocar Sheaths.
6. Identify the two Trocar Sheath exit sites, which should be 2–2.5 cm on each side of the midline, immediately
above the pubic symphysis (See Figure 3). Either mark these sites or, if desired, place two small 3–4 mm
transverse stab incisions at the intended exit site. In order to avoid the inferior epigastric vessels it is important
that the intended exit sites be not more than 2.5 cm from the midline. It is important that the exit sites for the
Trocar Sheath passages be near the midline and close to the superior aspect of the pubic bone, in order to avoid
anatomic structures in the abdomen, inguinal area and lateral pelvic sidewall.
7. If retropubic infi ltration of local anesthesia is not performed then consider infi ltrating the retropubic space with
two injections of normal saline on either side of midline. Starting at the needle exit sites pass an 18 gauge needle
along the back of the pubic bone until the tip of the needle touches the endopelvic fascia. As the needle is
withdrawn inject 30 to 50 cc. By so doing it opens up the retropubic space to further minimize the risk of bladder
puncture during retropubic Trocar passage.
8. Confi rm that all urine has been drained from the bladder. Once the bladder is empty, insert the GYNECARE TVT
Reusable Rigid Catheter Guide (available separately) into the channel of the 18 French Foley catheter. The handle
of the GYNECARE TVT Reusable Rigid Catheter Guide should be fi xed around the catheter at its proximal end. The
purpose of placing the GYNECARE TVT Reusable Rigid Catheter Guide into the catheter is to allow contralateral
displacement of the bladder, bladder neck and urethra away from the tip of the Trocar Sheath as it is passes
through the retropubic space.
9. Place the Trocar Shaft inside one of the two white Trocar Sheaths (See Figure 4). Secure the Trocar Sheath to the
Trocar Handle by hooking the Trocar Sheath Cut-out onto the Trocar Sheath Lock on the Trocar Handle (See Figure
5). NOTE: Ensure that the Trocar Sheath Cut-out goes completely over the Trocar Sheath Lock and is holding the
Trocar Sheath on the Trocar Shaft securely. Be careful not to manipulate the Trocar Sheath appendage hanging
past the Trocar Sheath Lock during the procedure, as that may result in the unintended disengagement of the
Trocar Sheath Lock.
10. Gently push the tip of the 18 French Foley catheter toward the posterior lateral wall of the bladder opposite to
the intended Trocar Sheath passage (See Figure 6). For example, by pushing toward the patient's left side the
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