Patient Information; Surgical Procedure - Promedon Calistar A Instructions For Use Manual

Post operative formation of fibrous tissue around the implant is a normal
physiological response to the implantation of a foreign body.
In the event of vaginal exposure of the implant, generally due to infection,
it may be necessary to partially remove it. This is achieved by cutting off the
exposed part of the polypropylene mesh.
PROMEDON requires surgeons to report any complication associated with the
use of Calistar to the Company or to the Distributor.

PATIENT INFORMATION

The surgeon is responsible for informing the patient or her representatives
before surgery about the possible complications related to the implantation
of Calistar.
The patient should be warned that future pregnancies could invalidate the
surgical effects of implanting Calistar. The patient should avoid heavy lifting
and strenuous exercise involving exertion (riding a bicycle, running, etc.) and
not have sexual relations until the doctor determines that it is appropriate to
resume normal activities.
The patient should be advised that Calistar is a permanent implant, and any
complication associated with the implant may or may not require additional
surgery to correct the complication.
The patient should contact the surgeon immediately in the event of:
• Dysuria (pain or difficulty with urination).
• Vaginal pain.
• Fever.
• Serous, bloody or purulent secretions.
• 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 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:
Calistar A
1. Urethrovesical Dissection:
Perform a dissection of the anterior vaginal wall. The incision of the anterior
vaginal wall is made from the middle urethra to the cervix or the apex.
The pubocervical fascia is carefully dissected. A blunt bilateral dissection is
performed toward the ischial spine and coccygeal muscle, identifying the
ischial spines, and then, the sacrospinous ligaments.
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 RIG to its correct implant
location. The TAS should be bilaterally placed, one in each sacrospinous
ligament.
126º
Figure 1
3. Implant placement
For the insertion of the implant in the suburethral zone, firstly, the RIG is
connected to the front attachment arm and is introduced in the direction
of the obturator internus muscle, guided by the the surgeon's index finger.
When the central mark of the implant is below the urethra, the retractable
mechanism is activated to release the arm in its attachment place. This
maneuver is repeated on the other side. A pair of Metzenbaum scissors
can be introduced between the urethra and the implant in order to verify
adequate suburethral tension and to avoid hypermobility overcorrection. Two
attachment points are made with absorbable sutures on both sides of the mid
urethra to prevent subsequent displacement of the mesh.
A cystoscopy is not required.
Then the polypropylene sutures of the TAS go through the reararms of the
implant 1.5 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.