Hysteroscopic sterilisation of women in the outpatient department without any anaesthesia with the new Essure device

M.P.H. Vleugels

Riverland Hospital Tiel, Tiel, The Netherlands

Female laparoscopic sterilisation has been offered as the standard last 3 decades. Complication rates of 5/1000 and failure rates meant by pregnancies 5–7/1000 are still very low and accepted. Nevertheless, admission, general anaesthesia, one day stay in clinic is required combined with complaints of nausea, vomiting and abdominal pains and scars of the skin. At least 2 days out off work are the consequences. Keeping these disadvantages in mind a large group of women does not take the decision for a sterilisation by laparoscopy. A new method of hysteroscopic sterilisation has been introduced last 2 years. This method is meant to be performed on the out patient clinic without anaesthesia and admission.

The ‘Essure’ device consists of a tinitol-coil with dacron fibers in the centre, causing a sterile reaction in the intramural part of the tubes within 3 months. We developed a protocol to sterilise patients without any anaesthesia on the out patient department within less then 14 minutes in total. Using a 4.9 mm Bettocchi CF hysteroscope without tenaculum and without a speculum, according to the vagino-approach, the tubal ostia are located and the Essure device is introduced on both sides. Patients, often accompanied with husband or friend follow the procedure on the monitor while the doctor is explaining the procedure. Patients take some tea or coffee and leave the clinic for their work or other activities. After 3 months an ultrasound is performed , immediately followed by a hysterogram to locate the devices and to proof obstructed tubes. During the period of these 3 months additional anticonceptives have to be used or continued. Failure of placement is 3% and after 2 years none pregnancy is found in our group. Pain scores during placement are 2.2 on the VAS ,less then during the menstrual periods. Phase II and III studies as well as world wide follow-up of all correctly treated patients- >15000, did not resulted in one pregnancy.This method is the perfect sterilisation to be performed on the Out Patient Department for all those women who feared the clinical laparoscopic procedure.