Promedon EXIA Mode D'emploi page 4

• Pain (acute or chronic), discomfort, irritation, sensitization
• Dyspareunia, partner pain and/or discomfort during intercourse
• Purulent, serous, or bloody discharge
• Inflammation (acute or chronic)
• Wound dehiscence
• Injury or perforation of soft tissue (e.g. blood vessels, nerves, ligaments,
muscles), structures, or organs (e.g. bladder, bowel, urethra, rectum, ureters,
vagina) during the implantation procedure
• Hematoma, seroma, abscess or vaginal fistula formation
• Urinary retention, bladder outlet obstruction and other voiding and
defecatory dysfunctions (e.g. dysuria, incomplete emptying, constipation, etc.)
• Urinary incontinence
• Contraction, device migration
• Recurrence of prolapse
Promedon requires surgeons to report any complication associated with the
use of EXIA 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
EXIA (see POSSIBLE COMPLICATIONS).
Promedon and their distributors delegate to the surgeon the responsibility
to inform the patient of the advantages and possible risks related to the
implantation and the use of EXIA.
The patient should be warned that future pregnancies could invalidate the
surgical effects of EXIA implant.
It is recommended for the patient to avoid heavy lifting and strenuous exercise
involving exertion (riding a bicycle, running, etc.) and not have sexual relations
at least four weeks after surgery. The doctor should determine when it is
appropriate for the patient to resume her normal activities.
The patient must be warned that EXIA is a permanent implant, and any
complication associated with the implant may or may not require one or more
additional surgeries to correct the complication. In some cases, complete
removal of the mesh may not always be possible. Additional surgery does not
ensure the total repair of complications.
The patient must contact the surgeon immediately in the event of:
• Dysuria (pain or difficulty with urination)
• Vaginal pain
• Fever
• Presence of serous, bloody, or purulent secretions
• Hemorrhage or other discomfort
• Vaginal exteriorization of the mesh.
SURGICAL PROCEDURE
EXIA is implanted by abdominal approach, following the currently accepted
and used surgical techniques under general or regional anesthesia. The
administration of prophylactic therapy with antibiotics should be considered
following the procedure approved by the hospital.
Use of Y- shaped mesh:
Note:
Standard operative technique should be followed when using the EXIA
Y-Implant:
1. Using your preferred procedural methodology (laparotomy, laparoscopic or
aided by a robot), prepare the patient anatomy for attachment of the EXIA Y
mesh to the anterior and posterior vaginal walls, and the anterior longitudinal
ligament overlying the sacral promontory.
2. Determine the length of anterior wall that is to be covered by a vaginal flap
of the EXIA Y mesh. Trim one vaginal flap to this length and designate this as
the 'anterior' flap.
3. Determine the length of the posterior wall that is to be covered by the other
vaginal flap of the EXIA Y mesh. Trim the remaining vaginal flap to this length
and designate this as the 'posterior' flap.
4. Introduce the mesh into the pelvic cavity, ensuring that the 'anterior' and
'posterior' flaps are oriented to the corresponding anatomy. Position the
mesh such as that the apex of the vaginal flaps is aligned with the apex of
the vagina. The midline marker may be used as a visual aid in lengthwise
orientation of the mesh to the vagina.
Note: The order of attachment ie. anterior before posterior/posterior before
anterior, is at the discretion of the implanting physician.
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