Intended Use; Contraindications - Promedon Calistair S Instructions D'utilisation

ENGLISH
INSTRUCTIONS FOR USE
DESCRIPTION
Calistar S is a permanent implant composed of biocompatible type 1
(according Amid-classification
polypropylene mesh with two anterior polypropylene attachment arms and
two posterior mesh arms. The outer part of the implant is composed of
2
lightweight (55 – 69 g/m
mesh. The central part of the implant is composed of ultra-lightweight
2
– 18 g/m ), macroporous (1769 – 3985 µm) polypropylene mesh.
The mesh kit contains:
• 1 Calistar S implant (Ref: CALISTAR-S)
• 3 Tissue Anchoring Systems (Ref.:TAS) attached with polypropylene sutures
• 1 Retractable insertion guide (Ref.: DPN-MNL), disposable, designed for the
placement of the Tissue Anchoring System and provided with a tube in order
to protect surrounding tissues during the surgical procedure.
• 1 Retractable insertion guide (Ref.: DPN-MNC) disposable, designed for the
placement of the Anterior Attachment Arms (Ref.: AAA) of the implant.
• 1 Knot Pusher (Ref: KP), disposable, provided with a protective tube,
designed to be used during the surgical procedure if necessary.
All components are supplied sterile and ready to use.

INTENDED USE

Calistar S is intended for transvaginal reestablishment and reinforcement
of the physiologic anatomy of the female pelvic floor in the defined patient
population.
INDICATIONS
Calistar S is indicated for the treatment of anterior pelvic organ prolapse in
non-fertile women
• recurrent pelvic organ prolapse and
• primary pelvic organ prolapse, when other surgical procedures are
expected to fail (i.e. complex primary prolapse), defined by the presence of
at least two risk factors:
• levator avulsion injury
• family history of pelvic organ prolapse
• enlarged genital hiatus
• advanced stage POP (≥POP-Q stage 3)
• pelvic floor muscle weakness
• multiparity
• younger age (<60 years of age)
• collagen deficiency
• co-morbidities which increase the intraabdominal pressure
such as:
• high body mass index
• chronic obstructive pulmonary disease
• chronic asthma
• chronic constipation.

CONTRAINDICATIONS

Calistar S must not be used in:
• Fertile women
• Patients with active or latent infection of the vagina, cervix or uterus
• Patients with previous or current vaginal, cervical or uterine cancer
• Previous, current or planned pelvic radiation therapy
• Known allergy to polypropylene.
1
PK Amid. "Classification of biomaterials and their related complications in
abdominal wall hernia surgery". Hernia (1997). 1: 15 - 21.
2
Coda A, Lamberti R, Martorana S. "Classification of prosthetics used in
hernia repair based on weight and biomaterial." Hernia (2012). 16(1):9 - 20.
3
Non-fertile women are defined as women in menopause (def: absence of
menstruation for at least one year) or iatrogenic causes (e.g. hysterectomy,
sterilization) which exclude women permanently from becoming pregnant.
1
), macroporous (> 75 µm)
2
), macroporous (117 – 861 µm) polypropylene
3
with or without apical vaginal wall involvement in both,
1
, monofilamentous
2
(14
3