Contraindications - Promedon ANCORIS POP Repair System Instructions D'utilisation

ENGLISH
INSTRUCTIONS FOR USE
DESCRIPTION
The ANCORIS POP Repair System kit contains:
• 3 TAS anchors (Tissue Anchoring System, Ref: TAS), with the corresponding
sutures, manufactured using polypropylene
• 1 Retractable insertion guide (Ref: DPN-MNL), disposable, designed for the
placement of the anchors, and provided with a tube in order to protect the
tissues during the surgical procedure.
• 1 Knot pusher (Ref: KP), disposable, designed for use during the surgical
procedure if necessary, and provided with a protective tube
• 1 Half circle surgical eye needle (Ref: ESN)
All ANCORIS POP Repair System components provided are sterile and ready
to use.
INDICATIONS
ANCORIS POP Repair System is indicated for surgical treatment of apical
prolapse.

CONTRAINDICATIONS

ANCORIS POP Repair System must not be used in patients:
• Undergoing anticoagulation therapy
• With infectious processes, especially of the genital system or urinary tract
• With vaginal, cervical, or uterine cancer
• During pregnancy
• With a known sensitivity or allergy to polypropylene products
• With pre-existing conditions that pose an unacceptable surgical risk
WARNINGS
ANCORIS POP Repair System must only be used by surgeons and/or
operating room staff who are familiarized with the surgical procedures
for repairing vaginal defects by the transvaginal approach. Promedon
recommends to review the information herein and access an overview of
the implant in the official surgical procedure videos (uploaded to the official
website) prior to performing the surgical procedure.
Careful patient selection and complete diagnostic evaluation are essential
prior to surgery.
Maximum precautions must be taken to avoid contamination of the implant
during the surgical procedure. As with all foreign materials, the anchors
could exacerbate a preexisting infection.
The surgical procedure must be carried out carefully, avoiding damage to
large blood vessels, nerves, and organs. Risks can be minimized by closely
observing the local anatomy and by properly inserting the retractable
insertion guide.
The described surgical technique is considered to be safe, but in the event of
very severe deviations from this and/or extraordinary anatomical variations,
perforation or injury may occur to blood vessels, organs, or nerves when
passing the retractable insertion guide, and repair surgery may then be
necessary.
ANCORIS POP Repair System must be used with caution in patients with:
• Diabetes
• Coagulation difficulties
• Obstruction of the upper urinary tract
• Renal insufficiency
• Autoimmune diseases affecting connective tissue
The patient must be warned that future pregnancies could invalidate the
surgical effects of the implant.
ANCORIS POP Repair System components provided are sterile. Do not use
the product if the package is open or damaged.
ANCORIS POP Repair System components are designed and intended for
SINGLE use only. Therefore, DO NOT REUSE or RE-STERILIZE, since this could
decrease the performance of the device and increase the likelihood of cross-
contamination.
It is advisable that patients avoid heavy lifting, strenuous exercise (cycling,
running, etc.) and sexual intercourse at least during the first four weeks after
surgery. The doctor determines when it is appropriate to resume her normal
activities.
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