Supply And Storage; Possible Complications; Patient Information - Promedon Calistar P Instructions D'utilisation

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 "2" of the surgical procedure)
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.

SUPPLY AND STORAGE

Calistar P is provided sterile and pyrogen-free in pouch or blister packaging.
Any damage to the sterile barriers makes the device non-sterile.
Calistar P 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

The surgeon is responsible for informing the patient or her representatives
before surgery about the possible complications related to the implantation
of the mesh.
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 reported complications with this or other similar implants include:
• Infection.
• Urethral or vaginal erosion.
• 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.
• Urinary problems.
• Bowel problems.
• Recurrence of prolapse.
• Dyspareunia
• Neuro-muscular problems
• Vaginal scarring
• Shrinkage
Bleeding can occur. Check carefully before releasing patient from the hospital.
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. This is achieved by cutting off the
exposed part of the polypropylene mesh.
The occurrence of events listed above may require new surgical intervention.
In some instances, the response to these events may persist as a permanent
condition after the intervention.
PROMEDON requires surgeons to report any complication associated with the
use of Calistar P 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 Calistar P.
The patient should be warned that future pregnancies could invalidate the
surgical effects of implanting Calistar P. 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 Calistar P 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 secretions.
3