Possible Complications - Promedon Calistar A Instructions For Use Manual

passing the retractable insertion guide, perforation or injury may occur to
blood vessels, organs or nerves, and repair surgery may then be necessary.
As with all foreign bodies, the polypropylene mesh and attachment arms
could exacerbate a pre-existing infection.
Calistar must be used with care in patients with:
• Diabetes.
• Coagulation problems.
• Obstruction of the upper urinary tract.
• Renal insufficiency.
• Autoimmune diseases affecting connective tissue.
Calistar components are supplied sterile. Do not use the product if the
package is open or damaged.
Calistar components are designed for a SINGLE use only. Therefore, DO NOT
REUSE or RESTERILIZE, since this could decrease the performance of the device
and increase the risk of improper sterilization and cross-contamination.
The patient must be warned that future pregnancies could invalidate the
surgical effects of the implant.
The patient should avoid heavy lifting and strenuous exercise that involves
exertion (riding a bicycle, running, etc.) for the first three to four weeks
after surgery, as well as sexual intercourse, for at least one month after the
operation.
The patient should contact the surgeon immediately in the event of:
• Dysuria
• Vaginal pain
• Fever
• Serous, bloody or purulent secretions
• Hemorrhages or other problems
PRECAUTIONS
The implant must not be handled with pointed, serrated, or sharp
objects since any damage, perforation, or tearing can cause subsequent
complications.
Maximum precaution 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 "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 is provided sterile and pyrogen-free in pouch or blister packaging. Any
damage to the sterile barriers makes the device non-sterile.
Calistar 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 the 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 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 obstruction.
• Bowel problems.
• Recurrence of prolapse.