Office hysteroscopic sterilization using the Essure micro-insert device

Office hysteroscopic sterilization using the Essure micro-insert device

M. Martinho, J. Bernardes

Unit of Endoscopy, Department of Gynaecology and Obstetrics, Hospital S.

João, Faculty of Medicine, University of Porto, Portugal

Objective: The Essure permanent birth control (pbc) device is a

minimally invasive transcervically placed micro-insert that occludes the

Fallopian tubes, resulting in permanent female sterilization. This device is, as

far as we know, the first medical device to obtain the FDA approval, for

hysteroscopic sterilization. The author’s report their experience using this

device in an office setting and present data about the safety, effectiveness and

tolerance of the procedure.

Methods: The method was presented to women seeking permanent birth

control that met the patient selection criteria recommended. Associated

pathologies increasing operative risk were a taken in consideration and favoured

the choice of this method. After an exhaustive explanation of the procedure,

women gave their written informed consent and the procedure was scheduled.

Essure pbc micro-inserts were inserted in the proximal portion of the Fallopian

tubes under hysteroscopic visualisation with paracervical block or no local

anaesthesia, in an office setting. The procedure was performed preferentially in

the follicular phase of the cycle and women were advised to use an effective

contraception method. The patients were evaluated 1 month after the procedure

and a hysterosalpingogram scheduled at 3 months. We analysed retrospectively all

clinical files and evaluated, the safety of the procedure, the tolerance and

recovery from the procedure, tubal occlusion and device placement.

Results: From May 2002 to January 2004, 37 women aged 26- 47 (38,75)

were submitted to the procedure; 20 (54,05%) had associated pathology increasing

the operative risk. Bilateral device placement was achieved in 33 (89,19%) women.

In 2 (5,40%) women a second procedure was required to accomplish bilateral

placement. In 1 (2,70%) only unilateral placement was possible. In 1 case

(2,70%) expulsion of one device occurred. 32 (86,49%) women found the procedure

to be highly acceptable. 31 (83,78%) women received diazepam, 5mg, orally prior

placement and N butil bromide of hioscine i.v. during procedure; 14 (37,84 %)

patients had paracervical block and 21 (56,76%) needed analgesic medication

during or immediately after the procedure but no patient complaint from

post-procedure pain at the moment of discharge. No major complications occurred.

All patients but two had a correct device location and bilateral tubal occlusion

3 month after procedure as confirmed by HSG. These two women achieved it at 6th

months post-procedure. 26 women were able to rely on Essure for permanent birth

control and no pregnancies occurred until now.

Conclusion: According to our experience this method can be performed

safely and with minimal patient’s discomfort in an office setting. It was

associated with a rapid recovery, high patient satisfaction and low rate of

complications. Data presented are similar to those in the literature and suggest

that this procedure may be an effective alternative to women seeking

sterilization without requirement of incisions and general anaesthesia and

especially to women with increased operative risk.

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