A new method of hysteroscopic sterilization: Essure
S. Moros (1), E. Cayuela (1), F. Heredia (2), R. Cos (2)
Department of Obstetrics and Gynaecology, Hospital General de Vic,
Barcelona, Spain (1); Department of Obstetrics and Gynaecology, Hospital de
Sabadell, Barcelona, Spain (2)
Introduction: Essure is an irreversible method of permanent
contraception. The device is a dynamically expanding micro- insert which is
placed in the proximal section of the Fallopian tube using a hysteroscopic
approach. This micro-insert induces a local fibrous tissue in-growth that
occludes the tubal lumen in a period of three months.
Design & Methods: We present our experience with 162 cases. They
proceed from two prospective clinical trials and from clinical use. On the 3rd
of March 2000 Phase II clinical trial started with 25 cases, on the 7th of
October 2001 pivotal clinical trial started with 37 cases and on the 5th of
October 2001 after the CE approved this method, we started its clinical use with
100 cases. The protocol followed has been: information about the method, medical
history, gynecologic exploration, Pap Smear and transvaginal ultrasound if
pathology was detected. The patients signed an informed consent and the
preoperative exams consisted on a blood test. The placement procedure was
programmed on the follicular phase of the cycle and it took place in an
Ambulatory Surgery Unit. The equipment we used was an Olympus hysteroscope with
a 5 Fr working channel. Only paracervical block was used, but an
anesthesiologist was available if the patient was stressed or felt pain. The
patient had to use an alternative contraception method until we demonstrated, 3
months later, that both tubes were occluded by an hysterosal pingogram (HSG) or
a pelvic X-Ray.
Results: The successful bilateral placement was achieved in 93,2% of
the cases. This number changed between 90.3% during the clinical trial and 95%
on clinical use. The procedure time oscillated between 8 and 10 minutes.
Regarding the anesthesia used, 58% of the patients of Phase II and Pivotal and
47,5% of the clinical use only needed paracervical block. Adverse events: 6
cases of vasovagal reaction during the procedure. 5 cases of vaginal expulsion
that had had unsuccessful placement, four out of these five underwent a second
procedure which was successful and one case of tubal perforation, in a
assymptomatic woman, which was diagnosed at the moment that the HSG was
performed, she underwent a laparoscopy we removed the micro-insert and
sterilized her. As of February 2004, 3275 women-months of effectiveness data
have been accumulated and there are no pregnancies reported. Regarding the
comfort of this procedure it was rated as good, very good or excellent by 95% of
the patients. At 6 and 12 months the satisfaction was close to the superior
grade.
Conclusions: Hysteroscopic sterilization is an effective permanent
contraception method, safe and acceptable to women. High patient tolerability
and satisfaction. Feasible for 95% of the women with few side effects.
