Surgical Procedure - Promedon Nazca TC Instructions D'utilisation

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 flow.
• Vaginal inflammation.
• Injuries of vessels and nerves.
• Presence of vaginal fistula.
• Vesical instability.
• Vaginal Dehiscence.
• Urinary obstruction.
• Dyspareunia.
Post-surgery formation of a capsule of fibrous 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.