INSTRUCTIONS FOR USE
DESCRIPTION
Nazca TC is a kit for the surgical treatment of cystocele, whose pathologies
may or may not be related to urinary incontinence (UI), containing:
• 1 Nazca TC mesh (Ref: NAZCA-TC), manufactured with highly
biocompatible synthetic materials.
• 2 Deschamps-type needles (Ref: DPN-HA), disposable, designed to be used
with the mesh in its implantation.
•1 Prepubic-type needle (Ref: DPN-TC), disposable, designed to be used with
the mesh in its implantation
All components of Nazca TC are sold sterile and ready to use.
The Nazca TC mesh is a permanent implant consisting of a polypropylene
monofilament central mesh between four arms of the same material, and a
set of disposable surgical instruments to make implantation easier.
INDICATIONS
The Nazca TC, Anterior Prolapse, is indicated for tissue reinforcement and
log-lasting stabilization of fascial structures of the pelvic floor in vaginal wall
prolapse where surgical treatment is intended, either as mechanical support
or bridging material for the fascial defect.
CONTRAINDICATIONS
• Nazca TC cannot be prescribed if there is some kind of infection, specially
genital or related to the urinary tract.
• Nazca TC must not be used with patients under anticoagulation therapy,
during pregnancy or with an existing urinary tract infection.
• Nazca TC should be used with precaution in diabetic women.
WARNING
The prosthesis must not be manipulated with pointed, serrated or sharp
elements since any hollow, damage, hole or tear can be the cause of
subsequent complications.
Fluffs, fingerprints, talcum powder or any contaminated surface can be the
cause of reactions to foreign bodies. Maximum precautions should be taken
to avoid contamination.
Punctures or injuries of blood vessels, bowels or nerves could occur when
passing the needle and a surgical repair may be needed.
As with all foreign bodies, the polypropylene mesh could potentiate an
existing infection.
The components of Nazca TC have been designed to be used only ONCE.
Therefore DO NOT RE-USE OR RE-STERILIZE, as this can potentially result
in compromised device performance and increased risk of inappropriate
resterilization and cross contamination.
INFORMATION FOR THE PATIENT
The surgeon has the responsibility of informing the patient or her
representative about the possible complications related to the implantation
of Nazca TC before the surgery.
Promedon and its distributors delegate to the surgeon the responsibility of
informing the patient about the advantages and the possible risks related
to the implantation and use of the mesh. The patient should be advised
that the implantation of the mesh might loose effectiveness with future
pregnancies, and that she could become incontinent again. It is convenient
that the patient avoids weight lifting or intense exercises that involve effort
(cycling, aerobics, etc.) for the first three to four weeks after the surgery, and
sexual relationships for at least one month.
It is essential that the patient contacts the surgeon immediately in case of:
• Dysuria (pain or difficulty during urination).
• Vaginal pain.
• Fever.
• Presence of serous, bleeding or purulent secretion.
• Bleeding or other problems.
PRECAUTIONS
A careful patient selection as well as a complete diagnosis previous to
surgery is essential.
The mesh should be carefully manipulated avoiding the use of pointed,
serrated or sharp elements.
Fluffs, fingerprints, talcum powder, bacteria or other elements inclined to
contaminate the surface of the mesh may be the cause of infections or
reactions to foreign bodies. Maximum precautions should be taken to avoid
contamination. That is why it is suggested to keep the mesh in contact with
antibiotics during surgery.
The surgical procedure should be performed with care to avoid large vessels
and bowels. Attention to local anatomy and proper passage of needle will
minimize risks.
