Contraindications - Promedon Calistar P Instructions D'utilisation

ENGLISH
INSTRUCTIONS FOR USE
DESCRIPTION
Calistar P is a kit for the surgical treatment of the posterior and apical
prolapse, that contains:
• 1 Calistar P implant (Ref.: CALISTAR-P), manufactured with biocompatible
synthetic materials.
• 1 Retractable insertion guide (Ref.: DPN-MNL), disposable, designed to
be utilized along with the implant when the placement is performed and
provided with a tube in order to protect the tissues during the surgical
procedure.
• 3 TAS (Tissue Anchoring System) anchors.
Calistar P a consists of a permanent implant comprised of a Type 1
polypropylene single-filament central mesh and three TAS anchors with their
corresponding sutures.
All the components of Calistar P are supplied sterile and ready to use.
INDICATIONS
Calistar P is intended for the surgical treatment of the Posterior and Apical
Prolapse by means of tissue reinforcement and stabilization of the soft tissues
of the female pelvic floor.

CONTRAINDICATIONS

Calistar P must not be used in patients
• undergoing anticoagulant therapy,
• with infectious processes, especially of the genital system or in the urinary
tract,
• with vaginal, cervical, or uterine cancer,
• during pregnancy,
• with known sensitivity or allergy to polypropylene products,
• or with pre-existing conditions that pose an unacceptable surgical risk.
WARNINGS
Calistar P must only be used by surgeons familiar with the procedures and
techniques for implanting Calistar P.
Careful patient selection and complete diagnostic evaluation are essential prior
to surgery.
Maximum precautions must be taken to avoid contamination.
The surgical procedure must be carried out carefully, avoiding damage to large
blood vessels, nerves, and organs. Risks can be minimized by closely observing
the local anatomy and by inserting the retractable insertion guide correctly.
It has been established that the surgical technique is safe, but in the case of
very severe deviations from this and/or very marked anatomic variations, when
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 P 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 P components are supplied sterile. Do not use the product if the
package is open or damaged.
Calistar P 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.
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