FEMIC (Fibromes Embolis�s aux MICrosph�res calibr�es): Uterine Fibroid Embolization using Tris-acryl Microspheres. A French Multicenter Study

Abstract

A French multicenter registry was set up to confirm the safety and efficacy of large calibrated tris-acryl gelatin microspheres for embolization of symptomatic fibroids. Technical recommendations included embolization using large microspheres (>500 microm) with no secondary embolization agent. Postprocedural pain, clinical improvement and adverse events were prospectively evaluated during a follow-up period of at least 6 months. Eighty-five women complaining of fibroid-related symptoms entered the study. In seven women, a secondary embolization agent was used in addition to microspheres. Complete resolution of menorrhagia was achieved in 84% of women at 24 months and significant uterine and fibroid volume reductions were noted after 6 months (37% and 73%, respectively). Three women experienced definitive amenorrhea (4%) and two women required hysteroscopic resection of a fibroid. Eight women were treated by hysterectomy because of treatment failure. In seven of these women, treatment failure was explained by an additional cause of symptoms including diffuse adenomyosis, endometrial hyperplasia or ovarian artery supply to the fibroids. Limited uterine artery embolization using large microspheres has good clinical success rate with low postprocedural pain and complications. Women can expect excellent midterm results with a high level of symptom control and significant fibroid volume reduction. Confidence in the end-point recommended here may require the experience of several cases.