Surgical Procedure - Promedon STEEMA Instructions For Use Manual

Postoperative formation of a fibrous tissue capsule around the sling is a
normal physiological response to the implantation of a foreign body.
PROMEDON S.A. requires that all surgeons inform the Company or the
Distributor of any complication observed with the use of STEEMA Retropubic.

SURGICAL PROCEDURE

The sling is implanted by a vaginal approach, following the currently accepted
and used surgical techniques and under regional, local or general anesthesia.
The administration of prophylactic therapy with antibiotics should be
considered following the procedure approved by the hospital.
1. Make a punctiform incision in the suprapubic area 2 to 3cm from the
midline bilaterally.
2. MIDLINE COLPOTOMY: Make a 1.5 cm long sagittal incision, starting
approximately 1 cm from the lower edge of the urethral meatus.
3. PARAURETHRAL DISSECTION: Perform paraurethral dissection into the
retropubic space by means of sharp and blunt dissections.
4. Use your index finger to move the urethra and protect it from possible
injury during the needle insertion through the vagina toward the suprapubic
area.
5. Insert the needle into the connector arm
6. Introduce the assembly (needle plus connector arm) through the vaginal
incision into the retropubic space. Take into account the following steps:
a) The needle must be positioned horizontally with the tip of the needle
pointing to the patient´s shoulder and the handle reference number 1
should be pointing at the surgeon eyes. See Figure 1
b) The needle rotates to a vertical position, maintaining the tip in the
same position. The handle reference number 2 should be pointing at the
surgeon eyes. See Figure 2
c) Keeping the needle tip in constant contact with the posterior surface
of the pubis and toward the patient's ipsilateral shoulder, the needle is
inserted until its free end appears in the suprapubic puncture. The handle
reference number 3 should be pointing at the surgeon eyes. See Figure 3
d) Then clamp the connector arm with forceps and release the needle.
1
3
2
Figure 1
Figure 2
Figure 3
5