Mechanism Of Action - Promedon Opsys Instrucciones De Uso

INSTRUCTIONS FOR USE
DESCRIPTION
Opsys is a manually injectable, non-absorbable, permanent tissue bulking
substance to treat female Stress Urinary Incontinence.
Opsys consists of particles of polyacrylate polyalcohol copolymer immersed
in a glycerol and saline solution carrier. Opsys is made up of pyrogen-free
particles, highly deformable by compression, which may be extruded with
21-gauge needles.
The carrier is a glycerol solution. Once implanted, the carrier is eliminated
unmetabolized by the reticuloendothelial system and excreted through the
kidneys, while the particles remain to ensure permanent bulking.
INDICATION
The physicochemical properties of Opsys make it suitable to treat female
Stress Urinary Incontinence (SUI).

MECHANISM OF ACTION

When injected into soft tissues, this material produces tissue bulkiness that
remains stable throughout time.
When implanted, Opsys produces urethral coaptation, given the bulkiness
effect on the urethral submucosa, and restores urinary continence.
HOW SUPPLIED
Opsys is supplied as follows:
Opsys Kit (Code: BAI-5J)
• 5 Opsys syringes (Code: BAF), each containing 1 ml of material
and
Spare Opsys (Code: BAI-1J)
• 1 Opsys syringe (Code: BAF) containing 1 ml of material
Injection needles with 21-G tip or larger are recommended for injecting Opsys.
Opsys is supplied sterile and ready to use. The syringe is sterilized with moist
heat.
Handling and Storage Precautions:
Packaging includes a cardboard box containing the syringes.
The syringes are contained in a double pouch and protected by an aluminum
pouch. Neither the outside pouch (aluminum) NOR the intermediate pouch
must be in contact with the sterile surgical field. IF ANY OF THE 3 POUCHES
IS DAMAGED, DO NOT IMPLANT Opsys.
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.
INFORMATION FOR PATIENTS
The Surgeon is responsible for informing the patient, or their representatives,
before surgery, of the possible complications regarding Opsys implantation.
STORAGE
Opsys should be stored under the following conditions:
• TEMPERATURE: Room temperature
DO NOT USE AFTER THE EXPIRATION DATE ON THE PACKAGING.
CONTRAINDICATIONS
• Untreated idiopathic detrusor hyperactivity
• Neurogenic detrusor hyperactivity
• Functional or obstructive overflow incontinence
• Urogenital infections
• Vulvar vestibulitis
• Interstitial cystitis
• Pregnancy
• First year postpartum
• Urethritis
• Narrowing of the urethra or the bladder neck
PRECAUTIONS / WARNINGS
The technique and the instruments necessary for injecting Opsys
should follow the same precautions as in other similar urogynecological
interventions, endoscopy practices and endourological procedures.
Opsys must be used by qualified surgeons experienced in endoscopy
practices and trained in urethral injection procedures.
Excessive repair could lead to urinary retention or inability to urinate. If
urinary retention occurs within the immediate period following implant
surgery, a catheterization should be performed using a 12-Fr catheter, or