Promedon Splentis Gebrauchsanweisung Seite 3

Surgical procedure and aftercare
• DO NOT deviate from the implantation procedure as described in the
section SURGICAL PROCEDURE of this IfU and consider patients' individual
anatomical variations since aberrations can cause perforation or injury of
surrounding tissue and organs, e.g. blood vessels, nerves, ureters, urethra,
bladder or bowel to avoid complications, such as revision surgery.
• DO perform full thickness vaginal wall dissection since split thickness
vaginal wall dissection increases the risk for mesh exposure and extrusion.
• Attachment of Splentis to the posterior cervix may be associated with a
risk of lower performance since the mesh may rip out and physiologic axis of
the vagina may not be maintained.
• DO NOT attach Splentis to the vaginal vault (i.e. colpopexy) due to the
increased risk of mesh exposure or extrusion.
• Tension free implantation technique is mandatory to avoid urinary
obstruction, lower urinary tract symptoms, pain, mesh exposure or
extrusion.
• DO limit trimming of the vaginal epithelium in order to minimize the risk of
vaginal stricture formation (i.e. contraction) since this may cause dyspareunia
and pain.
• The surgical procedure must be carried out carefully, avoiding damage
to surrounding organs and tissues, e.g. blood vessels, nerves, bladder, or
bowel.
• Check carefully before releasing the patient from hospital.
• The patient should avoid heavy lifting, excessive physical exercise and
sexual intercourse or other vaginal insertions for at least six weeks after
surgery.
Handling of the device
• DO NOT handle the implant with pointed, serrated, or sharp objects
since any damage, perforation, or tearing can cause device damage and or
deficiency.
• Avoid excessive tension of the implant.
• Maximum precautionary measures must be taken when connecting the
TAS with the insertion guide in order to ensure the integrity of the anchors.
• Avoid excessive pressure in the wrong direction during TAS placement.
General aspects
• DO NOT use the product if the package is open or damaged, as Splentis
components are supplied sterile.
• Polypropylene may cause inflammatory reaction.
• Splentis components are designed for SINGLE use only.
• Ensure that the product is discarded according to the local rules and
be aware of the risks of contamination of the environment, patients and
personal.
• DO NOT reuse or resterilize since this could decrease the performance
of the device and increase the risk of improper sterilization and cross-
contamination.
• Maximum precaution must be taken to avoid contamination. Operating
room conditions must meet hospital, administrative and/or local
governmental requirements.
SUPPLY AND STORAGE
• Splentis is provided sterile and pyrogen-free in pouch or blister packaging.
• Any damage to the sterile barriers results in contamination of the device,
hence the device is non-sterile.
• Splentis should be stored at room temperature.
• DO NOT use Splentis after the expiration date indicated on the packaging.
MAGNETIC RESONANCE ENVIRONMENT
The implant does not affect and is not affected by magnetic resonance
environments.
POTENTIAL ADVERSE EVENTS AND SAFETY RELEVANT TOPICS
Reported adverse events and safety relevant topics with this or similar
implants include (please also consider the above mentioned warnings and
precautions):
Adhesion
Anchor breaks during surgery
Atrophic vagina
Bacterial or mycotic vaginosis
(vaginal discharge)
Bleeding (unspecified)
Mesh exposure (i.e. a condition
of displaying, revealing,
exhibiting, or making accessible)
Mesh extrusion (i.e. passage
gradually out of a body structure
or tissue)
Mesh rips (rupture) during
surgery
Necrotizing fasciitis
Neuroma
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