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adverse effects associated with the use of the CYRENE sling.
These include, but are not limited to:
a) linked to the sling:
• Local irritation or even a foreign body reaction.
Foreign body reactions may take the form of infl ammatory granuloma.
• Pain, some of which may become permanent, sexual dysfunction such as dyspareunia.
• As with any foreign body, the polypropylene slings can potentiate the risk of infection or can migrate in
the tissue.
b) linked to the surgical procedure:
• Injury or laceration to the vessels resulting in hemorrhage, hematoma, nerve damage, or damage to the
bladder, urethra, vagina, may occur during the surgical procedure, and may require surgical repair.
• Acute retention, temporary or permanent obstruction of the lower urinary tract if the sling was slung too
tightly under the mid-urethra during implantation.
• Erosion, extrusion, fi stula, dehiscence of the vaginal incision, failure to heal, or necrosis of the vaginal
mucosa.
• Vaginal discharge or bleeding; if this occurs, the patient should consult her physician as soon as pos-
sible.
• Pain, some which may become permanent, dyspareunia.
• As with all suspension surgery, there can be de novo emergency cases, de novo cases of hyperactive
bladder, and sexual dysfunction of the dyspareunia type.
• A recurrence of stress urinary incontinence.
• Neurological and/or neuromuscular symptoms.
• Vaginal extrusion or prosthetic retraction may be the cause of partner discomfort.
Certain adverse effects may disappear or resolve over time. The treatment of certain effects may
require surgical removal of the CYRENE sling.
If the surgery is unsuccessful, it is important to fully reevaluate the patient's case.
WARNINGS AND PRECAUTIONS ASSOCIATED WITH USE OF THE PRODUCT
• Each CYRENE sling must be carefully examined before the surgical procedure and undergo conti-
nuous monitoring throughout the surgical procedure to ensure that the structural integrity of the device
is not compromised in any way. A damaged CYRENE sling should not be implanted or repaired.
• The use of slings in patients who already have an implant or with a history of implant use, or who
have undergone previous surgery in the pelvic fl oor area, should be evaluated with care. These pa-
tients may have a higher rate of complications.
• It is important that each procedure for the implantation of a CYRENE sling be evaluated and adapted
to each individual patient. The use of imaging techniques before and after the procedure may facilitate
the placement of the sling and confi rm the absence of injury to adjacent anatomical structures.
• Before using this type of sling, it is recommended that the surgeon can expertly manage complica-
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