Patient Information; Surgical Procedure - Promedon ANCORIS POP Repair System Instructions D'utilisation

PATIENT INFORMATION

The surgeon is responsible for informing the patient and/or her
representatives before surgery about the possible complications related to
the implantation of the ANCORIS POP Repair System.
The patient should be warned that future pregnancies could invalidate the
surgical effects of implanting ANCORIS POP Repair System. The patient
should avoid heavy lifting, strenuous exercise (cycling, running, etc.)
and sexual intercourse for at least for 4 weeks after surgery. The doctor
determines when it is appropriate to resume her normal activities.
The patient should be advised that ANCORIS POP Repair System 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 discharges
• Hemorrhages or other difficulties
• Urinary obstruction
• Bowel problems

SURGICAL PROCEDURE

ANCORIS POP Repair System can be implanted by two different approaches,
the anterior (paravesical) and the posterior (pararectal) approach.
The decision of which approach is to be preferred depends on the
preconditioning of the patient and type of pelvic floor defect:
- In case of a uterine preservation the anterior (paravesical) approach is
recommended.
- In case of absence of uterus the approach depends on the type of
concurrent defect.
• In case that an anterior repair needs to be performed in the
same surgery it is recommended to implant ANCORIS POP Repair
System also via the anterior (paravesical) approach.
• In case that a posterior repair needs to be performed in the
same surgery it is recommended to implant ANCORIS POP Repair
System also via the posterior (pararectal) approach.
Anterior Approach:
The description of the technique is summarized in the following steps:
a. Patient should be in dorsal lithotomy position with legs raised and bent,
under spinal, local or general anesthesia. The administration of prophylactic
therapy with antibiotics should be considered, according to hospital
procedures.
b. Insert a size 12 or 14 Foley catheter in the urethra.
c. Make a lengthwise incision along the anterior vaginal wall, stopping 2 cm
before the cervix or vaginal vault.
d. Perform a lateral blunt dissection toward the ischial spine, then identify
the coccygeal muscle and the sacrospinous ligament on the right side. The
same procedure is performed on the left side.
e. Identify the right ischial spine as a point of reference and determine the
position, size and thickness of the sacrospinous ligament.
f. To prime the ANCORIS POP Repair System, the tip of the RIG needs to
be moved out by pressing the trigger on the handle down and shoving it
forward.
g. Once the tip of the RIG is fully moved out, attach the anchor to the tip
by firmly sliding it on to the tip. The TAS is fully connected when the metal
tip of the RIG is clearly visible on the top of the TAS. Please note during
the whole maneuver that the spikes of the TAS are sharp and may damage
gloves.
h. Optionally shove the protective tube over the RIG and make sure that the
sutures of the TAS are running inside the protective tube.
i. Carefully guide the TAS with the RIG downwards to the sacrospinous
ligament by guidance of the index finger.
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