Surgical Procedure - Promedon Calistar P Instructions D'utilisation

• Hemorrhages or other problems.
• Urinary obstruction.
• Bowel problems.

SURGICAL PROCEDURE

Prepare the patient for surgery in the usual manner and insert a Foley catheter
into the urethra.
Calistar P is implanted under local or regional anesthesia. Prophylactic
antibiotic therapy should be administered according to procedures approved
by the hospital.
The description of the technique is summarized in the following steps:
1. Pararectal Dissection
Perform a dissection of the posterior vaginal wall.
The incision in the posterior vaginal wall is made towards the cervix or the
apex.
Make a blunt bilateral dissection toward the ischial spine, then identify the
coccygeal muscle and sacrospinous ligament on the right side. The same
procedure is performed on the left side.
Sacrouterine ligaments are identified bilaterally and are held with Allis forceps.
A 2-0 polypropylene suture point is applied to each sacrouterine ligament to
reconstruct the posterior face of the pericervical ring.
2. Insertion of the TAS (Tissue Anchoring System):
The TAS is inserted into the RIG (Retractable Insertion Guide).
Insert the TAS in the anterior wall of the sacrospinous ligament 2.0 - 2.5
cm medial to the ischial spine (Figure 1 shows the correct direction to apply
pressure when inserting the TAS). The surgeon should use his index finger to
touch and identify the ligament and to guide the retractable insertion guide to
its correct implant location. The TAS should be bilaterally placed, one in each
sacrospinous ligament.
Figure 1
3. Implant placement
Then the polypropylene sutures of the TAS go through the rear arms of the
implant 2 cm from the end, taking care to keep a distance of at least 5 mm
between both threads in order to make a double sliding knot.
Two additional attachment points must be made on the posterior body of the
implant with non-absorbable sutures, which are attached to the sacrouterine
ligaments and to the posterior surface of the pericervical ring.
Reduction of the apical/posterior defect is achieved by moving the implant
toward the sacrospinous ligaments, using the slipknots previously made on
the arms of the implant, until the correction of the apical/posterior is achieved.
The implant must remain below the bladder, free of tension, and the rear end
excess may be trimmed.
The front end excess is trimmed and then sutured bilaterally to the fascia of
the levator ani muscle.
The remnants of the rectovaginal fascia are used to cover the front part of the
implant, which allows for greater protection from the exposure of the implant.
The vaginal incision is closed as usual.
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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