Promedon ANCORIS POP Instructions D'utilisation page 4

• Bladder instability
• Bowel problems
• Recurrence of prolapse
Post-operative formation of fibrous tissue around the implant is a normal
physiological response to the implantation of a foreign material.
In the event of vaginal exposure of the implant, generally due to infection, it
may be necessary to partially remove it.
PROMEDON requires surgeons to report all complications associated with
the use of ANCORIS POP Repair System to the company or to the distributor.
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.
4