Promedon STEEMA User manual

M-30-15-2973(03) / 27-Nov-2017
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

Navodila Za Uporabo

Instrucţiuni de utilizare

Indicácie na Použitie
SLOVAK
Indikace k Použití
CzECH
Wskazania do Stosowania
POLISH



INSTRUCTIONS FOR USE
DESCRIPTION
Steema is a kit indicated for the treatment of stress urinary incontinence,
containing:
- 1 Steema Sling (Ref.: SL-100S), manufactured with biocompatible synthetic
materials.
- 2 Deschamps-type needles (Ref.: DPN-ST), disposable, designed to be used
together with the sling at the time of implantation.
- 1 Urethral Protector (Winged guide) (Ref.: GA) disposable, designed to be
used optionally during the sling implantation.
All Steema components are provided sterile and ready-to-use.
The Steema Sling is a permanent implant consisting of a central polypropylene
mesh covered by two protecting sheaths, with a positioning tab and two
dilator arms with suture loops at their ends.
Once the surgical procedure has nished, the protecting sheaths, positioning
tab, dilator arms and suture loops are removed. All of these are NOT implanted
permanently.
INDICATION FOR USE
Steema has been designed for the treatment of female stress urinary
incontinence due to urethral hypermobility and/or intrinsic sphincter deciency.
CONTRAINDICATIONS
Steema should not be prescribed if there is any type of infection, especially
genital or related to the urinary tract.
Steema should not be used in patients who:
• are pregnant,
• are sensitive or allergic to polypropylene products,
• have pre-existing pathologies or conditions posing an unacceptable surgical risk,
• have soft tissues pathologies in the site intended for implant placement, or
• have pathologies or other conditions that compromise wound healing.
WARNINGS
This product must be used only by properly trained surgeons with experience
in the treatment of female stress urinary incontinence.
Careful patient screening, as well as a complete diagnostic study, is essential
before surgery.
The surgical technique is safe, but in the event of severe deviations and/or
major anatomical variations, there may occur perforations or injuries to blood
vessels, organs or nerves, and surgical repair may be required.
When the needle passes, perforation or injury of blood vessels, organs or
nerves may occur. Further repair surgery may be necessary.
Steema must be implanted without tension, that is, the central portion of the
mesh must seat under the medium urethra without any tension. Implantation
with tension brings about urinary retention and urethral erosion.
As with all foreign bodies, the polypropylene mesh could exacerbate an
existing infection.
Steema components have been designed to be used only ONCE. Therefore,
its components should NOT BE REUSED, REPROCESSED OR RESTERILIZED, as
that may seriously harm the device performance and increase the risk of poor
resterilization and cross contamination, which may result in patient injury,
illness or death.
PATIENT INFORMATION
Surgeons are responsible for providing information to the patient or her
representatives on possible complications associated to the sling implantation,
prior to the surgery (see POSSIBLE COMPLICATIONS).
Promedon S.A. and their distributors delegate to the surgeon the responsibility
to inform the patient of the advantages and possible risks related to the
implantation and the use of the sling.
The patient must be warned that future pregnancies could invalidate the
surgical effects of the sling implantation, and therefore, she might become
incontinent again.
The patient should be warned that Steema is a permanent implant. Total
or partial removal of the sling due to complications may imply additional
surgeries.
It is recommended for the patient to avoid lifting weights and doing vigorous
exercise involving effort (riding a bicycle, running, etc.), as well as maintaining
sexual intercourse, during at least the rst three or four weeks after surgery.
The doctor should determine when it is appropriate for the patient to resume
her normal activities.
The patient must immediately contact the surgeon in case of:
• Dysuria (pain or difculty to urinate).
• Vaginal pain.
• Fever.
• Presence of serous, bloody or purulent secretion.
• Hemorrhages or other discomfort.

• Vaginal exteriorization of the mesh.
PRECAUTIONS
Steema must be used only by surgeons who are trained in the implantation
technique and the postoperative management.
The sling must be handled with care, avoiding the use of pointed, serrated or
sharp objects. Any damage, perforation or scratch may lead to complications.
Fluff, ngerprints, powder, bacteria or other items contaminating the sling
surface may cause infections or reactions to foreign bodies. Extra precautions
must be taken to avoid contamination.
The surgical approach must be made carefully, avoiding major blood vessels
and organs. Risks are minimized by paying attention to the local anatomy and
passing the needle correctly.
The use of polypropylene in urogynecological procedures has been associated
with cases of erosion, the treatment of which may require the partial surgical
removal of the implant.
Like with all surgical procedures, there are certain known risk factors that may
affect the results on the patient’s pelvic oor and which may include, but are
not limited to, altered vascularization (e.g. smoking status, estrogen status,
previous radiation of the pelvic oor, etc.), or active infections in or near the
surgical site. The patho-physiological conditions previously described must
be considered at the time of determining whether the patient is a suitable
candidate for sling implantation.
Hemorrhages may occur. The patient must be carefully monitored before
leaving the hospital.
The operating room conditions must comply with the local hospital/
administrative/government procedures and regulations.
After use, product and packaging must be disposed of pursuant to the local
hospital/administrative/government procedures and regulations.
SUPPLY AND STORAGE
Steema is supplied sterile and pyrogen-free, in a pouch and/or blister.
Any damage to the sterile barriers renders the product non-sterile.
Storage must comply with the following conditions:
• TEMPERATURE: Room temperature.
DO NOT USE AFTER THE EXPIRATION DATE INDICATED IN PACKAGING.
MAGNETIC RESONANCE (MR) ENVIRONMENT
The Steema sling does not affect and is not affected by magnetic resonance
(MR) environments.
POSSIBLE COMPLICATIONS
The possible complications associated with the use of the sling should be
discussed with the patient prior to the surgery.
The use of this sling may result in complications related to the surgical
procedure.
There may also exist complications associated with the patient’s reaction or
degree of intolerance to any foreign material implanted in her body.
Infections not responding to antibiotic treatment require the partial or total
removal of the implant.
Some complications may require removal of the sling. Such procedure may
involve multiple surgeries. In some cases, total removal of the sling may not be
possible. Performance of multiple surgeries does not ensure the total repair of
complications.
Some patients may experience groin or vaginal pain during the
initial postoperative period. Treatment with ANALGESICS and ANTI-
INFLAMMATORIES may be enough to relieve the pain.
Other complications reported with slings include, but are not limited to:
• Infection.
• Erosion of the urethral mucosa, vaginal mucosa, wall of bladder or other
surrounding tissues.
• Pain or persistent pain (pelvic, vaginal, in the groin or thighs).
• Vaginal pain, discomfort or irritation.
• Dyspareunia.
• Purulent, serous or bloody discharge.
• Inammation.
• Injury of blood vessels or nerves.
• Organ perforation or laceration.
• Bladder instability.
• Urinary obstruction.
• Urinary issues.
• Mesh exposure.
• Recurrence of incontinence.
• Hemorrhage.
• Neuromuscular issues.
• Vaginal healing.
Postoperative formation of a brous tissue capsule around the sling is a normal
physiological response to the implantation of a foreign body.

PROMEDON S.A. requires that all surgeons inform the Company or the
Distributor of any complication observed with the use of Steema.
SURGICAL PROCEDURE
INSIDE-OUT APPROACH
The sling is implanted by a transobturator approach, following the currently
accepted surgical technique, under regional, local or general anesthesia. The
administration of prophylactic therapy with antibiotics should be considered,
according to the procedure approved by the hospital.
The inside-out transobturator technique is summarized in the following steps:
1. Make a punctiform incision where a horizontal line passing at the level of
the clitoris meets the genitofemoral folds.
2. Midline Colpotomy: Perform a sagittal incision, 1.5 cm long, starting about
1 cm from the lower edge of the urethral meatus.
3. Paraurethral Dissection: From the incision, perform a dissection at a
45° angle from the urethral axis, towards the obturator foramen in the
paraurethral space. Take care not to injure the vaginal mucosa. Perform a
minimal vaginal dissection in order to form a tunnel that will allow the passage
of the transobturator needle. Repeat the process in both sides.
4. Thread the end of suture loop into the needle eyelet (see Figure 1).
Figure 1
5. Insert the urethral protector in the dissected area.
6. Enter the needle tip into the dissected area, following the urethral protector
channel. Push the needle forward, slightly passing through and penetrating
the obturator membrane.
7. Once in this position, remove the urethral protector and keep it sterile for
later use in the same patient on the other side.
8. Rotate the instrument on the ischiopubic branch until the needle appears at
the incision previously performed in the skin.
9. When the tip of the needle and the suture loop appear at the opening of
the skin, unthread the loop, clamp it with forceps and remove the needle,
rotating the handle in the opposite direction.
10. Pull the suture loop until it completely passes through the skin, and the
sling with its protective cover appears.
11. Repeat the process in the other side of the patient (step 4 to 10). Make
sure the positioning tab is located under the urethra and the sling is in
horizontal position.
12. Cut the sling and its protective sheaths under the dilator arms. Locate
the sling without tension under the mid-urethra by placing a Metzenbaum
scissors between the sling and the urethra to make tension regulation easier
and prevent the sling from bending. Pull the ends of the mesh until it makes
contact with the scissors.
When the sling is located without any tension under the urethra, remove the
protective sheaths of the sling, without removing the Metzenbaum scissors.
13. Remove the Metzembaum scissors.
14. Remove the positioning tab from the sling by cutting the thread located in
the front. Make sure to take out the positioning tab and the thread from the
vaginal channel.
15. Finally, cut the mesh excess and suture the incisions.
OUTSIDE-IN APPROACH
The sling is implanted by a transobturator approach, following the currently
accepted surgical technique, under regional, local or general anesthesia. The
administration of prophylactic therapy with antibiotics should be considered,
according to the procedure approved by the hospital.
The transobturator technique is summarized in the following steps:
1. Make a punctiform incision where a horizontal line passing at the level of
the clitoris meets the genitofemoral folds.
2. Midline Colpotomy: Perform a sagittal incision, 1.5 cm long, starting about
1 cm from the lower edge of the urethral meatus.
3. Paraurethral dissection: From the incision, perform a dissection at a
45° angle from the urethral axis, towards the obturator foramen in the
paraurethral space. Take care not to injure the vaginal mucosa. Perform a
minimal vaginal dissection in order to form a tunnel that will allow the passage
of the transobturator needle. Repeat the process in both sides.