Andreas L. Thurkow1, 2, 3
St. Lucas Andreas Hospital, J. Tooropstraat 164, Amsterdam, 1061 AE, The Netherlands
DC Klinieken Lairesse, Valeriusplein 11, Amsterdam, 1075 BG, The Netherlands
MC Amstelveen, Burg. Haspelslaan 131, Amstelveen, 1181 NC, The Netherlands
Andreas L. Thurkow
5.1 Introduction and History
5.5 New Developments
5.1 Introduction and History
Female sterilization is the most frequently used method of permanent birth control: it is estimated that worldwide around 180 million couples rely on this form of contraception (EngenderHealth 2002). In the Netherlands around 9,000 women are sterilized each year (Prismant and Health Care and Advise Institute 2004).
In order to achieve this, from 1930 onwards the fallopian tubes have most commonly been ligated through a (mini) laparotomy, in the 1960s it became possible to do so via laparoscopic route and this method developed into the standard technique (Hyams 1934; Steptoe 1971), although the first laparoscopic sterilization has been described as early as 1936 (Bosch 1936).
Although it is a reliable method of contraception, in the CREST Study, a large multicenter, prospective cohort study in the US, the pregnancy rate after laparoscopic sterilization has shown to be higher than previously reported (Peterson et al. 1996).
In rare cases laparoscopy is known to potentially cause serious complications (Jansen et al. 1997).
In the Netherlands, 54 % of all female sterilizations were performed hysteroscopically in 2010 (Fig. 5.1; Vleugels 2014).
Distribution of methods of sterilization in the Netherlands in 2010 (By courtesy of Michel Vleugels, MD, PhD, personal communication)
Even before the introduction of the hysteroscope in the nineteenth century attempts have been undertaken to ensure a permanent contraception by manipulating the uterus or the fallopian tubes transcervically through a vaginal route in the extent that passage is obstructed (van der Leij 1997). Initially chemical agents or electrothermical instruments were introduced blindly, with tactile feedback only, the effect of which was disappointing. In 1927 for the first time an electrocautery method with hysteroscopic guidance was tested albeit with the same mediocre results. Later attempts with electro-, cryo-, or Nd-YAG laser coagulation were equally unsuccessful in achieving bilateral occlusion (in 15 % up to a maximum of 60 % of cases) (Fig. 5.2a, b; van der Leij 1997; Wamsteker 1977; Cooper 1992; Lindemann and Mohr 1974).
(a) Distal tip of the coagulation probe; (a) insulated tip, (b) coagulation electrode, (c) flexible conduction cable. (b) Thermacoagulator (Wiest KG); (a) Temperature regulator, (b) connection for thermocoagulator probe, (c) timer (a, b Hyst ster Wamsteker: diss Wamsteker)
In developing countries experiments with quinacrine pellets in the uterine cavity have been performed with reasonable success, where the blind insertion has the advantage of low cost (Fig. 5.3). Serious side effects have not been seen, and the mutagen effects however are still under investigation (van der Leij 1997).
Insertion of Quinacrine pellets (Quinacrine: http://www.google.nl/imgres?q=quinacrine&um=1&hl=nl&sa=N&biw=1584&bih=885&tbm=isch&tbnid=xZEELs2hDhkDBM:&imgrefurl=http://panindigan.tripod.com/quinacrine02.html&docid=aFzYbVavfE6b0M&imgurl=http://panindigan.tripod.com/images/quinacrine01.gif&w=300&h=256&ei=luBtULHjHKmc0AWFoICwCw&zoom=1&iact=rc&dur=458&sig=107070023854473941503&page=1&tbnh=156&tbnw=195&start=0&ndsp=28&ved=1t:429,r:6,s:0,i:89&tx=96&ty=58)
Since hysteroscopy found its way as a routine diagnostic and interventional technique in the 1970s and 1980s of the last century even more methods have been tested, among which are several types of intratubal occlusion devices (Fig. 5.4). All of these initial methods have been abandoned, either due to complications or to lack of effectiveness or both (Cooper 1992; Thatcher 1988; Brundin 1991; Hamou et al. 1984).
Various experimental intratubal devices (Various devices: http://www.expert-reviews.com/doi/abs/10.1586/174344188.8.131.523)
From 2003 to 2006 Chiroxia Ltd. (Dublin, Ireland) investigated the hysteroscopic application of a cyanoacrylate-based liquid polymer implant, in which the author of this article performed the study on explanted uteri (Figs. 5.5and 5.6). Although the initial results were promising the investors withdrew their support and the project was discontinued.
Instillation of liquid Chiroxia obstructing material in explanted uterus (Recording of personal explant study)
Extremely firm adhesion of solidified Chiroxia material in intramural tubal lumen of explanted uterus (By courtesy of Chiroxia Ltd.)
In 1988 Ovabloc®, a new hysteroscopic sterilization technique was introduced on the Dutch market after preclinical and clinical studies had been performed since 1967 (Loffer 1984; Reed and Erb 1979).
To date it is estimated that around 2,000 procedures have taken place in the Netherlands.
It is a formed-in-place silicone polymer that causes bilateral occlusion in 95 % of cases (Loffer 1984; Ligt-Veneman et al. 1999).
Through a double catheter system the two component fluid siloxane mixture with a high viscosity is injected in the fallopian tubes, which cures within minutes and hereby causes occlusion of the tubal lumen (Fig. 5.7). A specially designed siloxane obturator tip, which is preattached on the inner catheter, forms a complex with the intraluminal plug and causes sealing in the uterotubal junction.
Ovabloc material injected into right tubal lumen (Ovabloc: http://www.ovabloc.nl/ovabloc/the_treatment, Ovabloc cure: http://web.squ.edu.om/med-Lib/MED_CD/E_CDs/Endoscopic%20Surgery%20for%20Gynecologists/Published/Book_Content/Chapters_51-57/Chapter_57/c57p03/c57p03.html)
Failures are caused by (among others) tubal spasm, intracavitary pathology, perforation and inability to position the catheter tip in correct alignment with the tubal lumen.
Especially the latter makes the procedure quite skill dependent.
Although the exact prediction of failure is not possible, some risk factors can be identified, among which are suspicion of intrauterine pathology and nulliparity (van der Leij and Lammes 1996).
After completion of the procedure a pelvic X-ray is made to ensure the integrity and correct position of the plug and the amount of ampullary filling (Fig. 5.8). If the thickness of the plug is insufficient (e.g. due to intracavitary reflux of the material) intrauterine expulsion may occur. The X-ray is then repeated after 3 months to rule out expulsion, which is stated to take place in 3–4 % of cases, usually within the first months after placement (Loffer 1984; van der Leij and Lammes 1996). The use of ultrasound for this second control may well be equivalent since assessment of correct tubal placement is the main goal at this stage and the intramural part of the plug as well as the intrauterine tip is usually easily visualized sonographically.
X-ray confirmation test after Ovabloc sterilization showing two adequate plugs (Ovabloc X ray: http://web.squ.edu.om/med-Lib/MED_CD/E_CDs/Endoscopic%20Surgery%20for%20Gynecologists/Published/Book_Content/Chapters_51-57/Chapter_57/c57p03/c57p03.html)
As soon as correct position of both plugs has been established the patient can be allowed to rely on Ovabloc as the sole method of contraception.
According to a multicenter 3 years follow-up study in 398 patients the cumulative pregnancy rate is 0.99 % (Pearl Index 0.13/100 woman-years), which is comparable with the laparoscopic alternative (Ligt-Veneman et al. 1999; Peterson et al. 1996).
The use of Ovabloc declined after the introduction of Essure and has virtually disappeared from the market after the introduction of Adiana.
The system is CE marked, but not FDA approved.
A new version of this device with the same material has recently been developed (Ovalastic). Only scarse clinical data are available yet, the only procedures having been performed either by the author or under his supervision. Basically the procedure has not changed, the ease of use however has made a significant step forward in comparison with the original Ovabloc procedure. A clinical study is in preparation.
In November 2001 the European Health Office approved (CE mark) the use of another method of hysteroscopic sterilization which was launched on the Dutch market in 2003: the Essure® system. The FDA PMA approval followed in November 2002.
The Essure® micro-insert (Conceptus Inc., sold to Bayer AG. In 2013), initially called STOP, is a dynamically expanding micro-coil with polyethylene terephthalate (PET) fibers wound in and around the inner coil (Fig. 5.9). It is placed through a 5 Fr working channel of a hysteroscope in the intramural section of the fallopian tube, in which it anchors itself by expansion of the coil. The PET fibers subsequently cause a fibrotic reaction, which renders an additional anchoring and obstructing effect (Fig. 5.10a, b).
Essure device with magnification view showing inner and outer coil with PET fibers (Essure micro: http://download.journals.elsevierhealth.com/pdfs/journals/1553-4650/PIIS1553465009001150.pdf)
(a) Frontal view of uterus with two correctly placed Essure devices after ingrowth of fibrous tissue (Essure sterilization1: http://www.women-health-info.com/88-Sterilization.html). (b) Transection of tubal lumen with Essure and ingrowth of fibrous tissue (Essure fibrosis: http://essuremd.com/Home/AboutEssure/FAQs/tabid/285/Default.aspx, http://ginemartin.blogspot.nl/2011/08/obstruccion-de-trompas-metodo-essure.html)
For an experienced hysteroscopist the technique is simple and fast. The mean procedure time is less than 15 min, partly due to the fact that most cases can be completed without anesthesia by vaginoscopic approach (Bettocchi and Selvaggi 1997).
In 92 % of cases bilateral occlusion is achieved, but in experienced hands rates up to 98.5 % can be attained (Belotte et al. 2011; Povedano et al. 2012). After 3 years of follow-up an effectiveness of 99.8 % has been shown in a multicenter pivotal study of 518 patients (Cooper et al. 2003).
Complications that have been encountered are rare perforations with no clinical symptoms, with the exception of two recent reports of bowel obstruction (Derks and Stael 2011; Belotte et al. 2011).
More than 600,000 procedures have been performed worldwide to date with a rapid increase.
The current confirmation test required by the FDA is HSG (Fig. 5.11), but received CE mark for the use of transvaginal ultrasound in the European market in 2011 (Fig. 5.12), after studies showing the reliability of this modality (Veersema et al. 2011).
HSG confirmation test after Essure showing two correctly placed devices blocking the tubes (Own picture, made at the St Lucas Andreas Hospital)
Essure confirmation test with transversal vaginal ultrasound showing correct position of both devices in intramural portion of the tubal lumen (Own picture, made at the St Lucas Andreas Hospital)
A multicenter phase 4 study has started in the same year with the goal to obtain FDA approval for this change of the standard confirmation method.
In 2009 another hysteroscopic sterilization system, Adiana ®, received CE marking and was approved by the FDA later in the same year.
The device consists of a 1.5 × 3.5 mm silicone matrix that is introduced in the intramural portion of the fallopian tube after superficial radiofrequency coagulation of the tubal mucosa (3 W during 60 s for each side) to stimulate fibrotic tissue ingrowth into the matrix (Fig. 5.13a–d). The system includes a dedicated generator that controls the correct positioning and delivers the energy for the coagulation (Fig. 5.13e).
(a) Adiana in the intramural portion of the tubal lumen; close up of the device (http://www.mayoclinic.com/health/medical/IM04341). (b) Magnification view of the distal tip of the Adiana device showing the matrix, radiofrequency electrode array, position detection array, and optical marker (Adiana: http://www.histeroscopia.es/Adiana.htm). (c) Microscopic and electron microscopic view of Adiana matrix. (d) Scanning electron micrographic cross dissection of Adiana matrix; Human tissue specimen H&E stain (10× magnification) showing ingrowth in matrix (c, d Adiana: Hologic Inc). (e) Adiana inserter and device with proprietary generator (Adiana Generator: http://www.google.nl/imgres?q=adiana&um=1&hl=nl&sa=N&biw=1584&bih=885&tbm=isch&tbnid=W693f0oyf0gYqM:&imgrefurl=http://medgadget.com/2009/07/minimally_invasive_adiana_contraception_device_gets_us_approval.html&docid=Sym6bk0qh5I6_M&imgurl=http://cdn.medgadget.com/img/f34f34ghu6.jpg&w=468&h=218&ei=8PNtUPvSBcXT0QXnqoHACQ&zoom=1&iact=rc&dur=459&sig=107070023854473941503&page=1&tbnh=121&tbnw=259&start=0&ndsp=25&ved=1t:429,r:13,s:0,i:112&tx=120&ty=60)
Although the device is visible on transvaginal ultrasound (Fig. 5.14), the confirmation test required is a HSG after 3 months to ensure blockage of the fallopian tubes.
Adiana devices as seen on transversal transvaginal ultrasound (Own picture, made at the St Lucas Andreas Hospital)
The initial version of the matrix was not radiopaque, in 2011 a radiopaque version was introduced in the European market, which added significantly to the reliability of the confirmation test (Fig. 5.15).
HSG confirmation test after Adiana showing correct placement of both devices in the intramural portion of tubal lumen (Own picture, made at the St Lucas Andreas Hospital)
As with Essure any hysteroscope with a 5 Fr working channel can be used to perform the procedure.
The 3-year pregnancy prevention effectiveness rate is 98.4 % (Anderson and Vancaillie 2009).
Twenty nine thousand five hundred procedures have been performed worldwide, until the Hologic company decided to withdraw the product from the market in May 2012.
5.5 New Developments
Several alternative methods are in the pipeline and may be introduced in the future.
Among these are the Altaseal device (Altascience Ltd.), the ZRO Operculum (Fig. 5.16), and the Daisyclip device (Invectus Biomedical Inc., sold to Hologic Inc. in 2012). It is not clear what the current status of the latter devices is, as far as known to the author neither has been subjected to clinical studies yet. The former is a high grade stainless steel instant blocking device of the fallopian tube that does not depend on tissue ingrowth and therefore might have the advantage of immediate closure (Fig. 5.17). The perihysterectomy pilot study performed by the author of this article has been promising in this respect and further multicenter studies are been performed or in preparation.
ZRO Operculum intratubal device (Operculum: http://www.operculum.net/products.html)
Altaseal device anchored into intramural portion of right tubal lumen (By courtesy of Altascience Ltd.)
Yet other devices are bound to be developed, in view of the interest for minimal invasive sterilization options, specially in the developing countries, where the current devices have not yet shown a large penetration in the market due to the present-day costs of the material.
Hysteroscopic sterilization is an elegant alternative for laparoscopic sterilization with the advantage of preventing incisions and general anesthesia and ensuring faster recovery. In women with a (relative) contraindication for laparoscopy (obesity, intra-abdominal adhesions, hemorrhagic diathesis, cardiopulmonary disease) these features probably form a clear indication for hysteroscopic approach.
The only still standing indication for laparoscopic sterilization seems to exist for those patients who desire not to have to return for a control visit, as long as this remains to be required for hysteroscopic methods.
Author’s Disclosures of Potential Conflicts of Interest
The author is a trainer for Bayer AG (formerly Conceptus Inc.) for Essure sterilization and for Urogyn BV for Ovalastic procedures and has been trainer in the past for Ovabloc and Adiana and is principal investigator in the Altaseal Study for Altascience, Dublin, Ireland. He has been investigator for Chiroxia in the past.
No other potential conflicts of interest exist.
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