Information for physicians

General
The Ovabloc is a very non-intrusive, outpatient alternative to laparoscopic sterilisation. Ovabloc is a method of sterilisation for women, whereby liquid siloxane is inserted into both Fallopian tubes, with the aid of hysteroscopic vision (or X ray), after which the siloxane polymerizes.

Ovabloc offers a number of advantages when compared to standard sterilisation methods. There is no need for a general anaesthetic. Due to it being an outpatient treatment, the woman can generally go home directly after treatment. There are no wounds or scars involved because the method makes use of natural access routes. Complications seldom occur. There may be a slight pain resembling menstrual pain for the first few hours after treatment and there may be some vaginal bleeding in the first week.

Procedure
Here you can view a presentation (770kB) of the Ovabloc procedure, intended for medical professionals.

The Ovabloc procedure is carried out shortly after the menstruation. Sometimes a local anaesthetic (paracervical block) is needed. An Ovabloc catheter is inserted into the cavum uteri via the working channel of an operation hysteroscope. The liquid siloxane material is then inserted into the tubal orifice.

Within five minutes, the Ovabloc material has polymerized into a soft rubber. The catheter tip adheres to the material and remains behind when the catheter is withdrawn. Thus a plug is formed which seals off the tube. The procedure takes 20 to 40 minutes in total for both tubes. The patient can follow the procedure via the monitor if she likes. In order to assess the quality of the plugs, an X ray of the pelvic area is made directly after the treatment.

Target group
Ovabloc is intended for women looking for permanent contraception. It is possible to remove the Ovabloc material from the tubes again if required. Although it involves surgery, the tubes will then be unblocked again, the chances of the woman getting pregnant are minimal. Ovabloc must therefore be seen as a permanent form of contraception. The woman must have two healthy, easily accessible tubes. Prior to the Ovabloc procedure, the woman will therefore undergo a gynaecological and physical check-up. Approximately 10% of women prove not to be suitable for the Ovabloc method. The main reasons for this are blocked tubes and anatomical deviations of the uterus, which prevent insertion of the Ovabloc catheter.

Reliability

The Ovabloc method is a reliable method of sterilisation. The reliability is comparable to that of laparoscopic sterilisation: there is a chance of 4-8 in 1000 that women who have had the treatment accidentally get pregnant. Dislocation occurs in less than 2% of the cases and the occasional ectopic pregnancy can occur. The material used is completely safe. It has been used for applications in the human body for many decades and has been used safely for Ovabloc sterilisation procedures since 1978. Allergic reactions to the Ovabloc material are a rarity. Studies have shown that Ovabloc is both reliable and safe.

Literature/Studies

De Blok, S. (1989) Permanente geboorteregeling zonder weefselschade. De Vrouwelijke Patiënt, nr. 5

De Blok, S. (1991) Is sterilisatie met Ovabloc verantwoord? Vademecum. Permanente nascholing huisartsen.

De Maeijer, J. (1988) Permanent Birth Control with formed-in-place silicone implants. Report on a series of 271 patients, treated in a trial from 1978-1885 in Belgium up until July 1987. Antwerpen, Belgium

Franklin, D, e.a. (1988) Hysteroscopic tubal occlusion with the use of formed-in-place silicone devices.

Ligt-Veneman, N.G.P., e.a. (1999) The efficacy of intratubal silicone in the Ovabloc hysteroscopic method of sterilization. Acta Obstetricia et Gynecologica Scandinavica

Reed, T.P. (1989) Permanent birth-control with the use of formed-in-place silicone devices.

Soebadi, D.M., e.a. (1995) Intravasal injection of formed-in-place medical grade silicone rubber for vas occlusion. International Journal of Andrology, 18, suppl. 1: 45-52

Van der Leij, G. (1997) Hysteroscopic sterilization. Study of the siloxane intratubal device application method.

Van der Leij, G. / Lammes, F.B. (1996) Office hysteroscopic tubal occlusion with siloxane intratubal devices (the Ovabloc method). International Journal of Gynecology & Obstetrics 53, 253-260

Van der Leij, G / Lammes, F.B, (1997) Radiographic aspects of office hysteroscopic tubal occlusion with siloxane intratubal devices (the Ovabloc method). International Journal of Gynecology & Obstetrics 59, 123-131

Van der Leij, G. / Van Krimpen, M.D. (1995) Impact of Ovabloc intratubal polymer on the morphology of the fallopian tube. International Journal of Gynecological Pathology, New York

Wamsteker, K. / De Blok, S. (1990) Clinical Expert report. Ovabloc cured in place silicon device for permanent birth Control.

Wamsteker, K., e.a. Novel techniques in tubal contraception. Reprinted form. The fallopian tube. Clinical and surgical aspects.
 

Intructions for Use
Download here the Instructions for Use.