The In-Fast^TM Ultra is used to place a suburethral sling through a single transvaginal incision. A concomitant repair, such as cystocele, can be performed at the same time.

Following is a brief summary of the surgical procedure.

Caution: This information is for educational purposes only. See the Instructions For Use document and videos for more detailed instructions on this surgical procedure.


Step 1
Incise anterior vaginal wall to provide access to the periurethral anatomy. A midline incision is recommended.

Step 2
Dissect laterally away from the midline urethra toward the pubic ramus, forming a small tunnel up to the posterior surface of the pubic bone. Repeat the process on the contralateral side.

Step 3
The In-Fast Ultra inserter comes with the first screw preloaded. Follow this procedure to load each additional screw.

• With the In-Fast safety lock in the safe position, thread the suture through the tip of the inserter. Pull the suture until the screw tip sits properly at the tip of the In-Fast. Push the screw cap until the screw is seated.
• With tension on the suture, guide the suture into the suture trough and affix the suture onto the posterior end of the In-Fast.
• Confirm that the screw is properly seated and place the safety lock to the safe position.

Step 4

• After palpating the bladder neck, pass the inserter into the vagina and place it 2 cm lateral to the urethra at the level of the bladder neck.
• Position the inserter so that the head is perpendicular to the angle of the pubic bone. Pulling up firmly collapses the safety shield and seats the screw.
• Move the switch to "Ready" and depress the operate button to activate the motor unit. The self-tapping screw should easily penetrate the bone cortex. A distinct change in motor sound may occur after 5-10 seconds, confirming full screw deployment.
• After releasing the button, move the inserter away from the surface of the pubic bone and carefully withdraw from the vagina, leaving the screw and attached suture in place.
• The inserter is reloaded with a second screw and placed on the contralateral side of the urethra in the same manner and the same steps are repeated.
• Slight tugging on the sutures extending through the vaginal incision will confirm screws are securely seated.

Step 5
Perform cystoscopy to verify bladder and urethral integrity. If bone screw insertion results in bladder perforation, the sutures should be cut with scissors while using a cystoscope. A replacement screw can then be inserted.

Step 6
Prepare the graft material. AMS recommends use of InteXen^TM, a porcine dermal matrix.

If a sling only is being placed, a 2x7 cm graft is recommended. If a combined sling plus cystocele repair is being performed, a 6x8 cm graft can be used, depending on patient's anatomy and size of the cystocele.

Step 7
If a sling only is being placed:

• Cut the end of the suture attached to the bone screws to create two free strands.
• Thread the sutures through the graft, approximately 0.5 cm from the edge of the graft.
• Advance the sling toward the periurethral tissue at the bladder neck.
• Tie off the sutures on one side of the graft all the way to the pubic bone, using 3-6 knots.
• Tie a single temporary knot on the other side to assess the sling's tension; use silk suture under knot for quick release.
• Set the proper tension by placing a Mayo scissors or right angle clamp between the sling graft and the urethra. The instrument should pass easily between the graft and urethra.
• Tie off the second side to the maximum with the clamp in place. Remove the silk suture. Complete the tying by adding 3-6 knots.

Step 8

• Irrigate with antibiotic solution.
• Confirm the placement of the sling. The physician may choose to fixate the graft anterior and posterior to periurethral tissue to prevent curling.
• Close the vaginal wall incision with absorbable suture.
• The vagina may be packed if necessary.

Step 9
If a sling plus cystocele repair is performed:

• The vaginal incision is extended from the mid-urethra to apex of cystocele.
• The bladder is dissected off the anterior vaginal wall and dissection is carried laterally to the levator muscles and pubocervical fascia on either side and superiorly to the cervix or vaginal cuff.
• The endopelvic fascia is then perforated on either side at the level of the bladder neck.
• The In-Fast screws are placed in the same manner as the sling-only procedure.
• Additional sutures (not bone screws) are placed (two) in the medial aspect of the levator muscles on each side as well as one into the apex or vaginal cuff. These additional sutures will secure the graft extending from the sling and support the cystocele repair.
• For the combined sling plus cystocele repair, a 6x8 cm graft of InteXen can be used. The upper portion of the graft is cut into a 2 cm wide strip, keeping the middle 2-3 cm of the strip attached to the rest of the graft.
• The In-Fast sutures affixed to the screws are threaded through the two ends of the graft strip and the levator and apical sutures are threaded through the lateral edges and end of the graft.
• The sling portion of the graft is tensioned and fixed as in the sling-only procedure, the levator and apical sutures are then knotted and fixed so the graft lays flat, supporting the bladder.
• Cystoscopy may be performed.
• The incision is closed, vaginal packing used at physician's discretion.