Promedon Opsys Instrucciones De Uso página 4

preferably smaller, until normal urination is restored. Usual precautions
regarding catheter handling and insertion must be taken in order to prevent
infection.
As with all implants, existing infection could be exacerbated by Opsys.
Opsys components have been designed to be used only ONCE. Therefore,
DO NOT REUSE or RESTERILIZE them, as this can potentially result in
compromised device performance and increased risk of inappropriate
resterilization and cross contamination.
Opsys must not be injected intravascularly.
Viable tissue is required for Opsys to be effective. Cicatricial tissue or
significantly compromised tissue will not heal properly. Patients with a
short urethra who have undergone several surgeries due to stress urinary
incontinence may not be viable candidates for bulking injection treatment.
As to diabetic patients, diabetes must be well controlled before using Opsys.
When urinary continence is not satisfactorily restored with the first
procedure, a second procedure for Opsys implantation may be considered
convenient. The success or failure of the first implant procedure can be
assessed only after 90 days following implantation.
For reimplantation, indications, contraindications, and performance through
cystoscopy are the same as for the first treatment. Reimplantation should
not be performed within 90 days following the first procedure.
MAGNETIC RESONANCE (MR) ENVIRONMENT
The implant does not affect and is not affected by magnetic resonance (MR)
environments.
POSSIBLE COMPLICATIONS
The possible complications regarding the use of Opsys must be discussed
with the patient prior to surgery.
Complications regarding the implantation of an injectable agent into the
proximal urethra include those common to these types of procedures:
• Dysuria
• Urinary infection
• Hematuria
• Voiding pain and pain in injection site
• Acute urinary retention
• Long-term adverse effects with low probability of occurrence: urinary
retention, abscess formation, fibrosis, migration and necrosis.
IMPLANTATION PROCEDURE
NECESSARY MATERIAL
Opsys should be implanted using an endoscope with a transurethral
injection needle.
In order to perform the procedure using an endoscope, the following
elements are necessary:
• Opsys syringes (Code: BAI-5J)
• 1 injection needle with 21-G tip or larger
• 1 cystoscope with 6-Fr working channel or larger and 0º to 30º optics.
Short cystoscopes with small diameters should be used for better and
simpler Opsys implantation.
TRANSURETHRAL ENDOSCOPIC TECHNIQUE
1. Administer general, regional or local anesthesia. The administration of
prophylactic therapy with antibiotics should be considered, according to the
procedure approved by the hospital.
2. Check the free flow through the injection needle using saline solution.
3. Connect the syringe to the injection needle passing the material through
it until the substance appears at the needle tip.
NOTE: In order to reduce the number of syringes to be changed during the
procedure, the syringe used for needle pre-filling should be disconnected
and kept in reserve within the sterile field. Then, connect a full Opsys
syringe.
Insert the injection needle into the cystoscope.
When the tip of the needle is seen, rotate it positioning the bevel of the
needle toward the urethral lumen.
4. Move the cystoscope forward toward the bladder. Move the needle
forward until its tip is seen. Remove the cystoscope and move the tip of
the needle backward, about 2.5 cm distal to the bladder neck. Locate the
6 o'clock position, and inject at a 30º-45º angle with regard to the urethral
mucosa. Insert the needle into the urethral submucosa up to an approximate
depth of 4 mm.
Place the cystoscope at a 0º angle (parallel to the urethra) and move
the needle forward until the catheter is touched; the needle end will be
fully introduced into the urethral submucosa at a depth of 8 mm. If a
different type of injection needle is used, check that the insertion depth is