05 June, 2008
MEA and Essure - Study Complete
A recent study carried out in Mexico on the safety of MEA following Essure has been completed; an abstract of the study conducted in 2006 by Microsulis Americas Inc and University Hospital Monterey follows -
Objective: To evaluate the safety of microwave endometrial ablation in women following transcervical sterilization with an intratubal insert. Design: Open-label safety study involving Essure (Conceptus) placement followed by MEA (Microsulis) in women previously scheduled for abdominal hysterectomy that meet study eligibility criteria and signed informed consent. Setting: University Hospital in Monterey, Mexico. Patients: Ten women, all requiring hysterectomy for benign uterine bleeding.
Intervention: The patients in the treatment group sequentially underwent unilateral Essure placement, with the contralateral fallopian tube serving as the patient’s own control. Following laparotomy thermocouples for temperature measurements were placed in the serosa of the fundus, uterine tubal junction and isthmical portion of the fallopian tube. Subsequently MEA was performed followed by, abdominal hysterectomy, the expirtated uteri were pathologically examined for Essure device placement and for ablated tissue around the uterine cornua.
Results: All MEA treatments were successfully completed on nine subjects in the treatment group and Essure placement was successful in all subjects. No visual damage or movement of the Essure device was identified. Mean serosal temperatures ranged from 35°C to 36°C during MEA. All Essure devices were carefully dissected from the cornu and proximal fallopian tube and subsequently passesd visual examination and mechanical integrity tests. fallopian tube cross sections from the uterine tubal junction, mid-tube and distal tube locations were macroscopically and microscopically vitality stained for regions of cellular devitalization (TTC-staining). The uterus was bisected in the sagittal plane and macroscopically TTC-stained. Viability assessment of these tissues showed no significant inrease in fallopian tube injury and the expected degree of ablation in the intrauterine cavity. Conclusion: This peri-hysterectomy study provides data to support the safe use of Microwave Endometrial Ablation (MEA) following Essure micro-insert placement. We are now working with the surgeons involved to submit clinical papers which will come to publication in due course. We will also be liaising with the relevant regulatory bodies to update our instructions for use.
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