Idoman Teoranta Thermablate EAS Instrucciones De Uso página 4

PATIENT SELECTION
Excessive uterine bleeding can be caused by a variety of underlying problems
including but not limited to endometrial cancer, myomas, polyps, and drugs.
Patients should al w ays be evaluated to determine if there are underlying
causes of their excessive uterine bleeding before any treatment option is
initiated.
The patient selection criteria are:

Documented diagnosis of excessive uterine bleeding with no
underlying causes

Completed childbearing

Pre-menopausal

Normal uterine cavity wi t h sounding between 8 cm and 12 cm,
inclusive

Normal Pap Smear and endometrial biopsy

Does not present any of the contraindications
RECOMMENDED PRE ASSESSMENT OF UTERUS AND CAVITY
Assessment of the cavity for patient selection can include
Transvaginal or Transabdominal Ultrasound, Saline / Gel Infusion
Sonography (SIS) / (GIS), and Hysteroscopy. Sounding length of
uterine cavity can be taken during office biopsy or requested with the
ultrasound.
CONTRAINDICATIONS
Thermablate EAS is contraindicated for use in:
•
A patient with a uterine sounding less than 8 cm or in excess of
12cm (external os to fundus)
•
A patient with active pelvic inflammatory disease
•
A patient with known or suspected endometrial carcinoma
(uterine cancer) or pre-malignant change of the endometrium,
such as unresolved complex (adenomatous) hyperplasia
•
A patient with history of pelvic malignancy within the past 5
years.
•
A patient with submucous / intramural myomas greater than 3.0
cm such that the uterine cavity is significantly distorted
•
A patient with intracavitary lesions (Type 0 or 1 myoma or
polyps of any size) as documented by hysteroscopy, saline
infusion sonohysterogram (SIS), or MRI performed in the last
six months. Ablation can be performed if polyp is removed prior
to procedure.
•
A patient with a septate uterus
•
A patient with an IUD currently in place
•
A patient with any anatomic or pathologic condition in which
weakness of the myometrium could exist, such as history of
previous classical caesarean section or transmural
myomectomy
•
A patient that has had three or more, lower segment C
sections and where the linear scar thickness in those patients
is less than 8mm.
•
A patient who is pregnant or who wants to become pregnant in
the future
•
A patient with active genital or urinary tract infection at the time
of procedure (e.g. cervicitis, vaginitis, endometritis, salpingitis,
or cystitis)
•
A patient less than 6 months post-partum.
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