Vaginohysteroscopic approach for Essure1 procedure: the experience of 317 cases

Vaginohysteroscopic approach for Essure1 procedure: the experience of 317

cases

A. Ubeda (1), M. Mascaró (2), R. Labastida (1), L. Gijón (2)

Gynecology Endoscopy Unit, Institut Universitari Dexeus, Barcelona, Spain

(1); Gynecology Endoscopy Unit, Hospital Son Dureta, Palma de Mallorca, Spain

(2)

Objective: To analyze the results of 317 cases of Essure1 procedure in

two Spanish hospitals in terms of efficacy, safety and patients’ satisfaction.

Design and methods: Retrospective observational study undergone

between November 2002 and January 2004. Three-hundred and seventeen women

seeking for permanent sterilization were included after normal gynecologic

routine examination, cervical Pap smear and ultrasound. Average age was 35 years

(range 20 – 47). The performance was carried out in an outpatient setting or

the office. A 5-mm diameter continuous-flow hysteroscope with a 5-Fr working

channel was used to deliver the devices. Paracervical block was applied in the

first 81 cases in order to be familiar with the technique, and then abandoned

thanks to the feasibility of the vaginohysteroscopic approach without anesthesia

or any ancillary instrumentation in the last 70% of women. Rates of placement of

the devices, complications, patients’ satisfaction and follow-up were recorded.

Results: Overall successful placement was reached in 302/317 women

(95.3%), both bilateral (295/312) and unilaterally (5/5). Successful delivery in

a second try was achieved in 15 out of 21 women (71.4%). Moreover, the last 158

(49.8%) were all delivered without incidences. Average time of the whole

procedure was 10 minutes (range 1 – 35). To assess the correct intraoperative

placement of the devices, the number of intracavitary loops was recorded, and at

the end of the procedure a mean of 4.1 (range 2 – 16) and 4.3 (range 2 – 11)

loops were seen in the right and the left tubal ostia respectively. Light vagal

reactions took place in 17 out of 299 patients (3.3%), but were medically solved.

Two uterine perforations were averted without bringing further complications.

Patients were discharged in a maximum of 30 minutes time. Abdominal X-ray and/or

hysterosalpingogram follow-up of 236 cases displayed an overall 99.2% rate of

correct placement of the devices. Satisfaction was referred as ‘good’ or ‘excellent’

by more than 94% of the women at third-month visit. At present, no pregnancies

have been recorded.

Conclusions: The hysteroscopist’s experience rather than the use of

anesthesia seems to be the most influential factor in successful placement rate.

The vaginohysteroscopic approach decreases significantly patients’ discomfort,

avoids the need for either general or local anesthesia and allows the procedure

to be safely and routinely carried out in the office.

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