Promedon Ophira Instrucciones De Uso página 2

ENGLISH
INSTRUCTIONS FOR USE
DESCRIPTION
Ophira is a kit for the treatment of stress urinary incontinence, containing:
• 1 Ophira Mini Sling (Ref: S-38-AF), manufactured with biocompatible
synthetic materials with two fixation arms, a center mark and 2 blue sutures.
• 1 retractile insertion guide (Ref: DPN-MN), disposable, designed to be used
together with the sling for implantation.
All Ophira components are supplied sterile and ready to use.
The Ophira Mini Sling is a permanent implant consisting of two
polypropylene fixation arms and a type I polypropylene monofilament central
mesh which supports the urethra, producing a posterior support which
allows coaptation of the urethra during stress. The fixation arms attach
themselves to the internal obturator muscle, fixing the sling.
INDICATIONS
The Ophira sling is intended to be used for the treatment of female stress
urinary incontinence resulting from urethral hypermobility and/or intrinsic
sphincter deficiency.
CONTRAINDICATIONS
Ophira should not be prescribed if there are infectious processes, especially
in the genital system or in the urinary tract.
Ophira should not be used for patients
• on anticoagulant therapy,
• with current urinary infection or,
• during pregnancy,
• with known sensitivity or allergy to polypropylene products,
• with pre-existing conditions that pose an unacceptable surgical risk.
WARNINGS
Ophira should be used only by surgeons familiar with the procedures and
techniques for implanting Ophira.
Careful patient selection and complete diagnostic evaluation are essential
prior to surgery.
Maximum precautions must be taken to avoid contamination.
The surgical approach must be performed carefully so as not to injure large
vessels, the bladder or other organs. Risks are minimized if attention is paid
to perineal anatomical details and if the needle is passed correctly.
It is established that the surgical technique is safe, but in the case of very
severe deviations from this and/or very marked anatomic variations, when
passing the retractile insertion guide, perforation or injury may occur to
blood vessels, organs or nerves, and repair surgery may then be necessary.
Implantation with tension may lead to problems of urinary retention and
urethral erosion.
As with all foreign bodies, the polypropylene mesh and fixation arms could
exacerbate a pre-existing infection.
Ophira should be used cautiously in patients with:
• diabetes
• coagulation problems
• superior urinary tract obstruction
• renal insufficiency
• autoimmune diseases affecting connective tissues
Ophira components are supplied sterile. Do not use the product if the
package is open or damaged.
Ophira components have been designed to be used only ONCE. Therefore,
DO NOT REUSE or RESTERILIZE, as this can potentially result in compromised
device performance and increased risk of inappropriate resterilization and
cross contamination.
The patient must be warned that future pregnancies could negate the
surgical effects of the mini sling implantation, and therefore, incontinent
might recur.
It is recommended that patients avoid heavy lifting and intensive exercise
(e.g., riding a bicycle, jogging, etc.) during the first three or four weeks after
surgery, as well as sexual intercourse for at least a month after the surgery.
Patients must be advised to immediately contact the surgeon if any of the
following occur:
• Dysuria
• Vaginal pain
• Fever
• Presence of serous, bloody or purulent secretion
• Hemorrhage or other discomfort
PRECAUTIONS
The implant must not be manipulated with pointed, serrated or sharp
objects, since any damage, perforation or tear may cause subsequent
complications.
Maximum precautions must be taken to avoid contamination.
2