Treatment of Myoma’s by GIB : suspension of ESMYA treatment

Symptomatic  uterine myoma’s need  treatment.  Symptoms can be discomfort and/or pain especially when larger.  Submucous myoma’s can contribute to infertility.

The etiology of most –if not all- myoma’s are genetic or epigenetic incidents to the myometrial cells, similar to the etiology of endometriosis. This explains  racial and hereditary differences in prevalence. It also suggest that similar to endometriosis myoma’s can be heterogeneous and that all myoma’s do not react in a similar manner to estrogens and progestogens.

 Surgical treatment

Being a benign tumour the primary treatment is surgery which can be

Hysteroscopic myomectomy

for intracavitary or submucous myoma’s.  We explain the possibilities and relative benefits of a 2 step surgery  when these myoma’s are bigger than 4-5 cm or intramural. This permits a personal choice by the individual woman.

Laparoscopic myomectomy .

• The relative benefits and possibilities of a laparoscopic myomectomy,  of eventually multiple myomectomies  and of a subtotal hysterectomy will be explained. This will permit women to take personal decisions after taking into account age, and fertility.
• Also for very large myoma’s  it will be discussed beforehand when we consider that a mini-laparotomy is preferable  to extensive laparoscopic suturing
• Also the risk and benefits of morcellation  and the risk of sarcoma spreading  are discussed  in order to permit individual choices.

Medical treatment

Until the recent introduction of ESMYA there was no effective medical treatment of myoma’s. Results have been promising especially for bleeding.

ESMYA an antiprogestin.  Recently serious liver injury, including liver failure leading to transplantation was reported. Therefore the European medicines agency recommended 

• Do not start new patients on Esmya or new treatment courses in patients who have already completed a previous one.
• Perform liver function test s at least once a month for all patients taking Esmya
• If the patient develops transaminase levels more than 2 times the upper limit of normal, stop treatment and
• monitor the patient closely.  Liver test should be repeated 2 to 4 weeks after stopping treatment
• For any patient with signs or symptoms consistent with liver injury, check transaminase levels immediately. If transaminase levels are more than 2 times the upper limit of normal, stop treatment and closely monitor the patient.
• Advise your patients about the signs and symptoms of liver injury

Conclusion : Considering that the development of other antiprogestins has been hampered by liver function problems in the past, and considering the AGES GCP recommendation we decided that

Gruppo Italo belga will therefore no longer use ESMYA