Promedon Nazca TC User manual

M-90-15-0814 (05) / 06-Oct-17
Instructions for use
ENGLISH
Instructions D’Utilisation
FRANÇAIS
Gebrauchsanweisung
DEUTSCH
Instrucción de uso
ESPAÑOL
Instrução de uso
PORTUGUES
Istruzioni Per l’uso
ITALIANO
Kullanma Talimatlari
TÜRKÇE
Инструкция по эксплуатации

Brugsanvisning
DANSK
Navodila Za Uporabo

Instrucţiuni de utilizare
ROMAN
Indicácie na Použitie
SlOvAK
Indikace k Použití
CZECH
Wskazania do Stosowania

Інструкція по застосуванню




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 oor 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 difculty 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.

Manipulation and Storage Precautions: Nazca TC is provided sterile and
pyrogen-free. The packaging consists of a cardboard box that contains
two pouches: one with a Nazca TC mesh and the other with the surgical
instrument.
IF A POUCH IS DAMAGED, DO NOT IMPLANT THE MESH.
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
Nazca TC should be stored under the following conditions:
• TEMPERATURE: ROOM TEMPERATURE
DO NOT USE AFTER THE EXPIRATION DATE SHOWN IN THE PACKAGING.
MAGNETIC RESONANCE (MR) ENVIRONMENT
The implant does not affect and is not affected by magnetic resonance (MR)
environments.
COMPLICATIONS
The possible complications associated with the use of mesh must be
discussed with the patient before surgery.
The use of this mesh may result in some complications associated with the
medication and the methods used in the surgical procedure as well as the
reaction of the patient or the degree of intolerance to any foreign body
implanted in the body. Some complications may require the mesh removal.
Infections that do not respond to an antibiotic therapy require the prosthesis
removal.
Some patients may experience vaginal or suprapubic pain during the initial
post-surgery period. A therapy with ANALGESIC and ANTI-INFLAMMATORY
drugs could be enough to relieve the pain.
Other complications reported with this or other mesh include the following:
• Wound infection including a secondary necrosis. A serious infection cannot
be treated with the prosthesis implanted.
• Urethral or vaginal erosion.
• Vaginal pain.
• Serous or blood purulent ow.
• Vaginal inammation.
• Injuries of vessels and nerves.
• Presence of vaginal stula.
• Vesical instability.
• Vaginal Dehiscence.
• Urinary obstruction.
• Dyspareunia.
Post-surgery formation of a capsule of brous tissue around the mesh is a
normal physiologic answer to the implantation of a foreign body.
In case of vaginal exteriorization of the mesh, often due to infection, it is
necessary to remove the implant.
All surgeons must notify Promedon about any complication developed by
the use of Nazca TC.
SURGICAL PROCEDURE
Prepare the patient for surgery as usual, and introduce a Foley catheter in
the urethra.
Nazca TC is implanted combining the prepubic and transobturator
approach by following the currently accepted surgical technique, with local
or regional anesthesia. The administration of prophylactic therapy with
antibiotics should be considered, according to the procedure approved by
the hospital.
The technique is summarized in the following steps:
1. Anterior Colpotomy
Perform a longitudinal medium incision from about 1 cm of the external part
of the urinary meatus to the uterus neck or the hysterectomy scar.
2. Urethrovesical Dissection
From the incision, laterally release the vaginal wall with sharp and blunt
dissection up to the ascending portion of the ilium.
3. Mesh Placement
Make two 1-cm suprapubic incisions above the superior edge of the pubis 5
cm apart from one another. Introduce the prepubic needle transvaginally.
The surgeon guides the needle by introducing the finger lateral to the
urethral meatus and the needle prepubically up to the suprapubic incision.
The surgeon then changes the position of the grip, threads the arms of
the mesh in the needle and then pulls the grip until the mesh reaches the
desired place. The same maneuver is repeated on the other side.
The upper part of the mesh body is placed at the level of the mid third of
the urethra, tension-free.

The legs of the mesh are introduced through a transobturator.
Then, a punctiform cutaneous incision is made taking as reference the edge
of the ischiopubic branch at clitoris level, 2 cm lateral and 3cm downward.
At that point, introduce the Deschamps-type needle on the side of the
patient’s right obturator foramen. For that purpose, align the needle at
45º from a middle imaginary line of the patient. Then, go through the
transobturator internal membrane and the muscle. Rotate the needle behind
the ascending ischiopubic branch, guiding it with the index finger until the
needle end comes out through the vagina. Thread the mesh perforated end
in the needle end, and transfer the column through the tunnel previously
created with the needle.
Repeat the technique on the other side (left foramen).
In case the perforation of the silicone eyelet tears while going through the
patient’s tissues, make a suture at the end of the arm and thread it in the
needle eye. This maneuver will allow completing the mesh transfer with no
inconveniences.
Note: Before passing the needle, please check that the incision points are
anatomically appropriate by vaginal vulvar palpation using the index nger.
4. Fixing Without Tension
Place a pair of Metzenbaum scissors between the mesh and the urethra to
make tension regulation easier. Pull the prepubic arms up until the mesh
makes contact with the urethra/bladder neck.
Cut the mesh excess in the lower part and x its body with two non-
absorbable stitches in the cardinal ligaments or the apical vaginal wall.
Then, pull the TOT arms until the mesh makes contact with the bladder.
Finally, cut the arms excess.
The closing of the vaginal wall is made without cutting the excess by
Montgomery technique (Overlap). Once the rst ap above the mesh
is sutured, a supercial fulguration of the vaginal wall is made to avoid
epithelial cysts and also to facilitate healing.
The second ap is sutured above the rst one with absorbable stitches.
Postoperative care and therapy are at the Surgeon’s discretion.
In case a removal of implant is required, please note:
Polypropylene mesh integrate with patient’s tissue, so complete removal may
be difficult.
In case a mesh removal is necessary due to pain, we recommend trying to
cut all the tension areas identified by the surgeon.
In most cases, the risk of organ injury caused by mesh removal may be
higher than the benets resulting from this removal, so each case should be
assessed and decided at the surgeon’s discretion.