Promedon EXIA Mode D'emploi page 3

nerves or organs, repair surgery may be necessary.
As with all foreign bodies, the polypropylene mesh could exacerbate a pre-
existing infection.
The patient must be warned that future pregnancies could invalidate the
surgical effects of the implant.
EXIA is supplied sterile. DO NOT USE the product if the package is open or
damaged.
EXIA kit components are designed for SINGLE use. Therefore, DO NOT REUSE,
REPROCESSED or RESTERILIZE, since this could affect the device performance
and increase the risk of inadequate sterility and cross-contamination, which
may result in patient injury, illness or death.
PRECAUTIONS
The implant must not be handled with pointed, serrated, or sharp objects. Any
damage, perforation, or scratch may lead to complications.
Maximum precaution must be taken to avoid contamination. Fluff,
fingerprints, powder, bacteria or other items contaminating the implant
surface may cause infections or reactions to foreign bodies.
Avoid excessive tension on the implant during insertion.
Like with all surgical procedures, there are certain known risk factors that may
affect the results on the patient's pelvic floor and which may include, but are
not limited to, altered vascularization (e.g. diabetes, smoking status, estrogen
status, previous radiation of the pelvic floor, etc.), or impaired wound healing
(e.g. diabetes, steroid usage, etc.). The pathophysiologic conditions previously
described must be considered at the time of determining whether the patient
is a suitable candidate for mesh implantation.
Postoperative bleeding may occur in some patients. The patient must be
carefully monitored before leaving the hospital.
Operating room conditions must comply with the local hospital, administrative
or government procedures and regulations.
After use, discard the product and packaging according to the local hospital,
administrative or government procedures and regulations.
SUPPLY AND STORAGE
EXIA is provided sterile and pyrogen-free in double pouch. Any damage to the
sterile barriers makes the device non-sterile. EXIA should be stored under the
following conditions:
• TEMPERATURE: Room temperature.
DO NOT USE AFTER THE EXPIRATION DATE INDICATED ON THE PACKAGING.
MAGNETIC RESONANCE (MR) ENVIRONMENT
The implant does not affect and is not affected by magnetic resonance (MR)
environments.
POSSIBLE COMPLICATIONS
Possible complications associated with the use of implant should be discussed
with the patient before surgery. Adverse events following mesh implantation
may be de novo, persistent, worsening, transient, or permanent.
The use of this implant may result in complications related to the surgical
procedure. There may also exist complications associated with the patient´s
reaction or degree of intolerance to any foreign material implanted in her
body.
The use of polypropylene mesh in urogynecologic procedures such as the
treatment of pelvic organ prolapse, has been associated with cases of erosion.
Erosion has been reported in bladder, vagina, urethra, ureter and bowel.
Treatment of the erosion may require surgical removal of the mesh.
Postoperative formation of a fibrous capsule around the implant is a normal
physiological response to the implantation of a foreign body.
Some complications may require removal of the mesh. Such procedure may
involve multiple surgeries. In some cases, total removal of the implant may not
be possible. Performance of multiple surgeries does not ensure the total repair
of complications.
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.
Infections not responding to antibiotic treatment require the partial or total
removal of the implant.
Some patients may experience vaginal pain in the post-operative period.
Treatment with analgesics and anti-inflammatories may relieve pain. There may
be unresolved pain with or without mesh explantation.
Complications reported with this or other similar implants include:
• Infection
• Extrusion through vaginal epithelium or erosion into surrounding viscera and/
or mucosa
• Adhesion formation, granulation tissue formation
• Vaginal scarring, tightening, rigidity, shortening and/or contracture
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