Patient Information; Surgical Procedure - Promedon Ophira Instrucciones De Uso

Handling and Storage Precautions: Ophira is provided sterile and pyrogen-
free. The packaging consists of a cardboard box containing one blister and
one pouch: the pouch contains the Ophira mini sling and the blister contains
the surgical instrument. IF THE POUCH AND/OR BLISTER ARE DAMAGED,
DO NOT IMPLANT THE MINI SLING.
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.
STORAGE
Storage should meet the following conditions:
• TEMPERATURE: Room temperature
DO NOT USE AFTER THE EXPIRY DATE SPECIFIED IN THE PACKAGING.
MAGNETIC RESONANCE (MR) ENVIRONMENT
The implant does not affect and is not affected by magnetic resonance (MR)
environments.
POSSIBLE COMPLICATIONS
The possible complications associated with the use of the mini sling should
be discussed with the patient prior to the surgery.
The use of prosthesis can result in complications related to the specific
degree of intolerance of each patient to any foreign body implanted in the
body. Some complications may require removal of the mini sling.
Infections not responding to antibiotic treatment require the partial or total
removal of the prosthesis.
Some patients may experience vaginal pain during the initial postoperative
period. Treatment with ANALGESICS and ANTI-INFLAMMATORIES may be
enough to relieve the pain.
Other complications reported with this or other slings include:
• Incision infection.
• Urethral or vaginal erosion.
• Vaginal pain.
• Purulent, serous or bloody discharge.
• Vaginal inflammation.
• Injury of blood vessels or nerves.
• Presence of vaginal fistula.
• Bladder instability.
• Urinary obstruction.
The postoperative formation of a fibrous tissue around the mini sling is a
normal physiological response to the implantation of a foreign body.
In the event of vaginal exteriorization of the Mini sling, generally due
to infection, it may be necessary to partially remove the implant. This is
achieved by cutting the part of the polypropylene mesh that is exteriorized.
Promedon requires surgeons to report any complication associated with the
use of Ophira to the Company or to the Distributor.

PATIENT INFORMATION

Surgeon is responsible for informing the patient or her representatives, prior
to the surgery, about the possible complications associated with the implant
of the Ophira mini sling.
The patient must be warned that future pregnancies could negate the
surgical effects of the Mini sling implantation, and therefore, incontinence
may recur. It is recommended for the patient to 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.
The patient must be warned that the sling to be implanted is a permanent
implant, and that any complication associated with the implant may or may
not require additional corrective surgery for the complication.
The patient must immediately contact the surgeon in case of:
• Dysuria (pain or difficulty when urinating)
• Vaginal pain
• Fever
• Presence of serous, bloody or purulent secretion
• Hemorrhage or other discomfort

SURGICAL PROCEDURE

Prepare the patient for surgery in the usual manner and insert a Foley 16 FR
or 18 Fr catheter into the urethra.
The Ophira is implanted via a vaginal approach, under regional or local
anesthesia, by means of a single vaginal incision and is attached to
the obturator internus muscle at a point near the arcus tendineus. The
administration of prophylactic therapy with antibiotics should be considered,
according to the procedure approved by the hospital.
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