abiss CYRENE Instrucciones De Uso página 9

WARNING
The patient must be informed of the risks / benefi ts of the operation and accept the benefi ts and
risks after a period of refl ection.
The CYRENE sling is a permanent implant. The prescribing physician must inform their patient
that the use of a permanent implant may result in complications whose treatment may require
a surgical procedure.
Certain complications may persist even after treatment.
PRODUCT DESCRIPTION
The CYRENE sling is composed of polypropylene prosthetic sling, whose extremities are capped with
stainless steel in the premium version. This cap is used to clip the sling to the tunnelling device.
Three models are available:
- CYRENE ref. 102313: transobturator approach
- CYRENE premium ref. 112313: Out-In transobturator approach
- CYRENE premium In-Out ref. 122313: In-Out transobturator approach
INDICATIONS
The CYRENE sling is designed to provide urethral support in the surgical treatment of female stress
incontinence.
CONTRAINDICATIONS
It is the surgeon's responsibility to inform the patients or their representatives of the contraindications
associated with the use of this product. All of the usual contraindications that apply to the use of urethral
slings also apply to the implantation of the CYRENE sling.
These include, but are not limited to, patients with the following conditions:
● Pregnancy or desire for future pregnancy
● Breast-feeding
● Potential for further growth (e.g. adolescents)
● Genitourinary infections (urinary infection, vaginal infection, etc.)
● Perioperative injuries of the urethra (fi stula, diverticula)
● Pelvic radiotherapy
● Auto-immune disease, compromised immune system or other conditions that could compromise
healing
● Hypersensitivity to synthetic derivatives of the polypropylene type
● Fibromyalgia
ADVERSE EVENTS
The potential adverse events are those associated with the implantation of biomaterials.
It is the surgeon's responsibility to inform the patient or her family, prior to the operation, of the possible
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