Promedon Ophira Instructions D'utilisation page 4

A description of the single-incision technique can be summarized in the
following steps:
1. MIDLINE COLPOTOMY
Make a sagittal incision 1.5 cm long, starting 1 cm from the urinary meatus.
2. PARAURETHRAL DISSECTION
Starting at the incision, dissect the vaginal wall up to the superior ramus
of the pubic bone, in the direction of the homolateral shoulder, without
perforating the endopelvic fascia. Perform a minimal vaginal dissection in
order to form a tunnel that will permit passage of the retractable insertion
guide.
3. PLACEMENT OF THE MINI SLING
Push the button on the retractable insertion guide forward and insert the tip
into the opening at the end of the Mini Sling.
The retractable insertion guide is inserted with the Mini Sling through the
vaginal incision, guided by the surgeon's finger, which was previously placed
on the vaginal fornix to prevent perforation of the vaginal wall. Once the
retractable insertion guide touches the superior ramus of the pubic bone, it
is inserted behind the bone, perforating the endopelvic fascia until it reaches
a point 1 cm above the vaginal fornix (arcus tendineus).
The anatomical reference points for insertion of the Ophira are as follows:
1- Define a horizontal line at a point located halfway between the urinary
meatus and the clitoris.
2- Identify the genitofemoral fold.
3- The intersection of the above two references will serve as the reference
point for guiding the insertion on both sides of the patient.
Warning: Avoid inserting the retractable insertion guide along a higher
trajectory since it will encounter resistance from the pubic bone, thus
preventing it from reaching the recommended anchorage depth.
The arm of the Mini Sling will be attached to the obturator internus muscle
at the level of the arcus tendineus. The proper insertion depth for the first
anchor arm is defined when one can see the central mark on the suburethral
mesh, already inserted below the ipsilateral side of the vaginal incision.
When half of the Mini Sling (central mark) has been inserted into the
incision, retract the button on the retractable insertion guide to release it.
The same maneuvers are repeated on the opposite side. The insertion depth
of the second anchor arm is defined using a stress test or tension-free
test, by inserting an instrument that verifies the absence of tension on the
urethra. Stress test: Holding the retractable insertion guide in place, fill the
bladder with 200 mL of saline solution and perform the stress test. If the
patient continues to lose urine, the retractable insertion guide is adjusted
by inserting the Mini Sling farther. If you wish to reverse the adjustment
or release the tension on the Mini Sling, slowly pull on the thread that is
attached to one of the arms on the Mini Sling.
Immediately after the adjustment, remove the retractable insertion guide
by retracting the button to release it. Next, remove the adjustment reversal
thread. Lastly, suture the vaginal incision in the normal fashion in order to
completely cover the polypropylene mesh with enough epithelial thickness
to minimize risks of the mesh being exposed.
Postoperative care and therapy are at the surgeon's discretion.
In case a removal of implant is required, please note:
Polypropylene mesh integrate with patient's tissue, so complete removal may
be difficult.
In case a mesh removal is necessary due to pain, we recommend trying to
cut all the tension areas identified by the surgeon.
In most cases, the risk of organ injury caused by mesh removal may be
higher than the benefits resulting from this removal, so each case should be
assessed and decided at the surgeon's discretion.
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