Patient Information - Promedon Splentis Instructions For Use Manual

PRECAUTIONS
The implant must not be handled with pointed, serrated, or sharp
objects since any damage, perforation, or tearing can cause subsequent
complications.
Maximum precautions must be taken to avoid contamination.
Avoid excessive tension on the implant during insertion.
Maximum precautionary measures must be taken when joining the TAS to
the insertion guide and to avoid exerting pressure in the wrong direction
during TAS insertion. (See point "H" of the surgical procedure)
Handling and Storage Precautions: Splentis is provided sterile and pyrogen-
free. The packaging comprises a cardboard box containing a blister pack
and four pouches: one pouch contains the reinforcement implant, the other
three contain the TAS and a blister pack containing the Retractable Insertion
Guide. IF ANY OF THE POUCHES AND/OR THE BLISTER PACK IS DAMAGED,
DO NOT IMPLANT.
Operating room conditions must meet hospital, administrative or local
government procedure.
After use, discard the product and packaging according to hospital,
administrative or local government procedure.
STORAGE
Storage of Splentis should meet the following conditions:
TEMPERATURE: Room temperature
DO NOT USE AFTER THE EXPIRY DATE SPECIFIED IN 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.
The use of a prosthesis may cause complications related to each patient's
specific degree of intolerance to any foreign body implanted in the body.
Some complications may require removal of the implant.
Some patients may experience vaginal pain during the initial post-operative
period. Treatment with ANALGESICS and ANTI-INFLAMMATORY DRUGS may
be sufficient to relieve pain.
Other complications reported with this or other similar implants include:
• Infection.
• Mesh exposure.
• Adhesion formation.
• Vaginal pain, discomfort, irritation.
• Purulent, serous or bloody discharge.
• Inflammation.
• Injuries to blood vessels or nerves.
• Presence of vaginal fistula.
• 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 body.
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 any complication associated with
the use of Splentis 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 Splentis.
The patient should be warned that future pregnancies could invalidate the
surgical effects of implanting Splentis. The patient should avoid heavy lifting
and strenuous exercise involving exertion (riding a bicycle, running, etc.) and
not have sexual relations until the doctor determines that it is appropriate to
resume normal activities.
The patient should be advised that Splentis 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: