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.