Potential Adverse Events - Idoman Teoranta Thermablate EAS Instrucciones De Uso

REPEAT B ALLOON ABLATIONS ARE CONTR AIND ICATED
As the endometrial cavity following any kind of endometrial ablation is
most likely distorted, repeat ablations should not be attempted with
Thermablate EAS. Patients requiring further treatment after thermal
balloon ablation should be treated medically, by resectoscopic
endometrial ablation, or by hysterectomy. Repeat resectoscopic ablation
resection should be attempted only by experienced hysteroscopists since
the complications may be severe.

POTENTIAL ADVERSE EVENTS

The following adverse events are potentially associated with endometrial
ablation:
Pelvic cramping
•
Nausea and vomiting
•
Perforation of the uterus
•
Rupture of the uterus
•
Thermal injury to adjacent tissues/organs
•
Heated liquid escaping into the cervix, vagina, or fallopian
•
tubes
Infection
•
Post-ablation tubal sterilization syndrome (PATSS)
•
Hematometra.
•
RECOMMENDED PRE-TREATMENT OF ENDOMETRIUM
• Oral Contraceptives (Recommended for minimum 21 days until day of
treatment)
• An estrogen/progesting combined preparation may be administered daily
by mouth or monthly per vagina
• Timing of the Menstrual Cycle
• Suction Curettage (If necessary)
• GnRH analogues recommended only for patients with a uterine
sounding ≥ 10 cm.
PATIENT COUNSELLING
As with any procedure, the physician needs to discuss the risks, benefits, and
alternatives with the patient prior to performing endometrial ablation.
The device is intended for use in women who do not desire to bear children
because the likelihood of pregnancy is significantly decreased following this
procedure.
Patients of childbearing capability should be counselled that endometrial
ablation is not a sterilization procedure and should be provided with an
appropriate birth control method. These patients should be cautioned of the
potential complications that may ensue if they should become pregnant.
Vaginal discharge is typically experienced during the first few days following
ablation and may last as long as a few weeks. Generally, the discharge is
described as: bloody during the first few days; serosanguineous by
approximately one week; then profuse and watery thereafter. Excessive pain,
heavy bleeding, foul smelling discharge or fever should be reported to the
physician.
WARNING
Endometrial ablation using the Thermablate EAS system is not a
sterilization procedure. Pregnancies after ablation can be dangerous
for both mother and foetus.
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