Indication For Use; Patient Information - Promedon STEEMA Instructions For Use Manual

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 finished, 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 deficiency.
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 first 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 difficulty to urinate).
• Vaginal pain.
• Fever.
• Presence of serous, bloody or purulent secretion.
• Hemorrhages or other discomfort.