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Hysteroscopic sterilization: away with the laparoscope?
International Congress Series 1279 (2005) 184 – 188
www.ics-elsevier.com
Hysteroscopic sterilization: away with the laparoscope? Andreas L. Thurkow* St. Lucas Andreas Ziekenhuis, J. Tooropstraat 164, 1061 AE, Amsterdam, the Netherlands
Abstract. In a review of the literature the history, present state of the art and possible future developments of hysteroscopic sterilization is given. In the Netherlands two systems are now available: OvablocR and EssureR. Although not yet as extensively evaluated as laparoscopic sterilization the pregnancy rate does not seem to be higher and the (major) complication rate appears to be significantly lower. According to this review hysteroscopic sterilization is an attractive alternative method of sterilization and is probably clearly indicated in cases of (relative) contraindications to laparoscopy: obesity, intra-abdominal adhesions, haemorrhagic diathesis and cardiopulmonary disease. As long as X-rays are still advised in hysteroscopic sterilization techniques, this requirement remains the main disadvantage when compared with the laparoscopic approach, but otherwise one could indeed conclude: away with the laparoscope in sterilization! D 2005 Elsevier B.V. All rights reserved. Keywords: Essure; Hysteroscopic sterilization; Ovabloc; Transcervical sterilization; Tubal occlusion
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 [1]. In the Netherlands around 9000 women are sterilized each year [2]. 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 the laparoscopic route and this method developed into the standard technique [3,4]. In rare cases laparoscopy may cause serious complications [5]. Even before the introduction of the hysteroscope in the 19th century, attempts were made to produce tubal occlusion transcervically by a vaginal route [6]. Initially chemical * Corresponding author. Tel.: +3120 5108911; fax: +3120 6853879. E-mail address: [email protected]. 0531-5131/ D 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.ics.2004.12.044
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agents or electrothermic instruments were introduced blindly with poor results. In 1927, for the first time an electrocautery method with hysteroscopic guidance was tested, also without success. Further attempts with electro-, cryo- or Nd–YAG lasercoagulation were equally unsuccessful in achieving bilateral occlusion (in 15% up to a maximum of 60% of cases) [6–8]. In developing countries experiments with the insertion of quinacrine pellets into the uterine cavity have been performed with reasonable success, where the blind insertion has the advantage of low cost. Serious side effects have not been seen, but the mutagenic effects are still under investigation [6]. Since hysteroscopy found its way as a routine diagnostic and interventional technique in the 1970s and 1980s even more methods have been tested, among which are several types of intratubal occlusion devices. All of these initial methods have been abandoned, either due to complications or to lack of effectiveness or both [8–11]. 2. Ovabloc In 1988 OvablocR, a new hysteroscopic sterilization technique was introduced onto the Dutch market after preclinical and clinical studies had been performed dating from 1967 [12,13]. To date it is estimated that around 2000 procedures have taken place in the Netherlands. Ovabloc is a formed-in-place silicone polymer that causes bilateral occlusion in 95% of cases [12,14]. Using a double catheter system the two-component fluid siloxane mixture with a high viscosity is injected in the fallopian tubes, which solidifies within minutes causing occlusion of the tubal lumen. A specially designed siloxane obturatortip, which is preattached to the inner catheter, forms a complex with the intraluminal plug and causes sealing at the uterotubal junction. Causes of failure are tubal spasm, intracavitary pathology, perforation and inability to position the catheter tip in correct alignment with the tubal lumen. This last factor is very operator dependent. Although the chances of success are difficult to assess, some risk factors can be identified, among which are suspicion of intra-uterine pathology and nulliparity [15]. Oral premedication with an NSAID (e.g. NaproxenR) is prescribed the evening before and again 2 h before the procedure. Any hysteroscope with a 7 Fr working channel can be used, with the size range of the outer diameter of the scopes on the market today varying between 4.5 and 8 mm. Whether or not dilatation and local anesthesia are needed depend almost entirely on this outer diameter. With a lower range outer diameter the vaginoscopic route without speculum, tenaculum or anesthesia (the Bettocchi method) is feasible [16]. The whole procedure takes between 15 and 40 min. After completion of the procedure a pelvic X-ray is taken to ensure the integrity and correct position of the Ovabloc and the amount of ampullary filling. If the thickness of the Ovabloc is insufficient (e.g. due to intracavitary reflux of the material) intra-uterine expulsion may occur. The X-ray is then repeated after 3 months to rule out expulsion, which may occur in 3–4% of cases, usually within the first months after placement
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[12,17]. Ultrasound may be used for this second examination as assessment of correct tubal placement is the main goal at this stage and the intramural part of the plug as well as the intra-uterine tip are usually easily visualized sonographically. 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. A multi-center 3 year follow-up study in 398 patients had a cumulative pregnancy rate of 0.99% (Pearl Index 0.13/100 woman-years), which is comparable with the laparoscopic alternative [14,18]. Why the popularity of the method is still limited is not entirely clear. An important factor seems to be the fact that at the time of introduction the routine use of hysteroscopy was not at the level it has reached today, at least in the Netherlands. The highly operator dependant technique, especially at the time of introduction when 8 mm scopes and straight catheters were used, probably contributed considerably to this unfortunate chronological disadvantage. The medical funding system in the Netherlands is another reason for many hospital institutions to either discontinue hysteroscopic sterilization or refrain from starting in the first place. Reimbursement was limited to the fee of the surgeon and the use of the facility, but did not include the rather expensive material when compared with laparoscopic sterilization, which financial burden lies entirely on the overall hospital budget. The system is CE marked, but not FDA approved. 3. Essure 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 EssureR system. The FDA PMA approval followed in November 2002. The EssureR micro-insert (Conceptus), initially called STOP, is a dynamically expanding micro-coil with polyethylene terephthalate (PET) fibers wound in and around the inner coil. 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 produces an additional anchoring and obstructing effect. 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 a vaginoscopic approach. In 92% of cases bilateral occlusion is achieved. After 3 years of follow-up an effectiveness of 99.8% has been shown in a multi-center pivotal study of 518 patients [19]. Complications that have been encountered are rare perforations with no clinical symptoms. More than 35,000 procedures (0 pregnancies) after correct placement of the device have been performed worldwide up to 2004 with a rapid increase in the incidence of the procedure (J.F. Kerin, personal communication). 4. New developments Several alternative methods are in the pipeline and may be introduced in the future.
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Among these are the Adiana system (radiofrequency with fibrosis by matrix ingrowth), the BMES intratubal ligation device (by intraluminal invagination) the Ovion (fiber coated stent) and the Chiroxia intratubal tissue-adhesive, which all are subject to present studies [20]. 5. Conclusion Hysteroscopic sterilization is an elegant alternative to laparoscopic sterilization with the advantage of preventing incisions and general anesthesia and ensuring faster recovery. In women with a (relative) contra-indication to laparoscopy (obesity, intra-abdominal adhesions, haemorrhagic diathesis, cardiopulmonary disease) these features probably form a clear indication for a hysteroscopic approach. The only remaining indication for laparoscopic sterilization seems to exist for those patients who do not wish to have further visits to the gynaecologist. Acknowledgements The author is a member of the advisory board of Chiroxia Medical Device Research and Development in Dublin, Ireland, for research and development in hysteroscopic sterilization. No other potential conflicts of interest exist. Special thanks are due to Gareth Davies, MD, for reviewing the text. References [1] EngenderHealth, Contraceptive Sterilization: Global Issues and Trends, EngenderHealth, New York, USA, 2002. [2] Prismant HCaAI, Landelijke LMR-informatie—Verrichtingen: destructie of afsluiting van tubae faloppii mbv endoscopie, Prismant, Health Care and Advise Institute, Utrecht, the Netherlands, 2004. [3] M.N. Hyams, Sterilization of the female by coagulation of the uterine cornu, Am. J. Obstet. Gynecol. 28 (1934) 96. [4] P. Steptoe, Laparoscopic tubal sterilization—a British viewpoint, IPPF Med. Bull. 5 (2) (1971) 4. [5] F.W. Jansen, et al., Complications of laparoscopy: a prospective multicentre observational study, Br. J. Obstet. Gynaecol. 104 (5) (1997) 595 – 600. [6] G. van der Leij, Hysteroscopic sterilization: study of the siloxane intratubal device application method, Universiteit van Amsterdam, 1997. [7] K. Wamsteker, Hysteroscopie, Rijksuniversiteit Leiden, 1977. [8] J.M. Cooper, Hysteroscopic sterilization, Clin. Obstet. Gynecol. 35 (2) (1992) 282 – 298. [9] S.S. Thatcher, Hysteroscopic sterilization, Obstet. Gynecol. Clin. North Am. 15 (1) (1988) 51 – 59. [10] J. Brundin, Transcervical sterilization in the human female by hysteroscopic application of hydrogelic occlusive devices into the intramural parts of the fallopian tubes: 10 years experience of the P-block, Eur. J. Obstet. Gynecol. Reprod. Biol. 39 (1) (1991) 41 – 49. [11] J. Hamou, et al., Hysteroscopic reversible tubal sterilization, Acta Eur. Fertil. 15 (2) (1984) 123 – 129. [12] F.D. Loffer, Hysteroscopic sterilization with the use of formed-in-place silicone plugs, Am. J. Obstet. Gynecol. 149 (3) (1984) 261 – 270. [13] T.P. Reed, R.A. Erb, Hysteroscopic oviductal blocking with formed-in-place silicone rubber plugs: II. Clinical studies, J. Reprod. Med. 23 (2) (1979) 69 – 72. [14] N.G. Ligt-Veneman, et al., The efficacy of intratubal silicone in the Ovabloc hysteroscopic method of sterilization, Acta Obstet. Gynecol. Scand. 78 (9) (1999) 824 – 825.
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[15] L.G. van der, F.B. Lammes, Office hysteroscopic tubal occlusion with siloxane intratubal devices (the Ovabloc method), Int. J. Gynaecol. Obstet. 53 (3) (1996) 253 – 260. [16] S. Bettocchi, L. Selvaggi, A vaginoscopic approach to reduce the pain of office hysteroscopy, J. Am. Assoc. Gynecol. Laparosc. 4 (2) (1997) 255 – 258. [17] L.G. van der, F.B. Lammes, Office hysteroscopic tubal occlusion with siloxane intratubal devices (the Ovabloc method), Int. J. Gynaecol. Obstet. 53 (3) (1996) 253 – 260. [18] H.B. Peterson, et al., The risk of pregnancy after tubal sterilization: findings from the U.S. collaborative review of sterilization, Am. J. Obstet. Gynecol. 174 (4) (1996) 1161 – 1168. [19] J.M. Cooper, et al., Microinsert nonincisional hysteroscopic sterilization, Obstet. Gynecol. 102 (1) (2003) 59 – 67. [20] Transcervical Methods in the US Pipeline. www.arhp.org/healthcareproviders/cme/onlinecme/cmeclinicalproceedings.cfm?ID=308 (2004).
www.ics-elsevier.com
Hysteroscopic sterilization: away with the laparoscope? Andreas L. Thurkow* St. Lucas Andreas Ziekenhuis, J. Tooropstraat 164, 1061 AE, Amsterdam, the Netherlands
Abstract. In a review of the literature the history, present state of the art and possible future developments of hysteroscopic sterilization is given. In the Netherlands two systems are now available: OvablocR and EssureR. Although not yet as extensively evaluated as laparoscopic sterilization the pregnancy rate does not seem to be higher and the (major) complication rate appears to be significantly lower. According to this review hysteroscopic sterilization is an attractive alternative method of sterilization and is probably clearly indicated in cases of (relative) contraindications to laparoscopy: obesity, intra-abdominal adhesions, haemorrhagic diathesis and cardiopulmonary disease. As long as X-rays are still advised in hysteroscopic sterilization techniques, this requirement remains the main disadvantage when compared with the laparoscopic approach, but otherwise one could indeed conclude: away with the laparoscope in sterilization! D 2005 Elsevier B.V. All rights reserved. Keywords: Essure; Hysteroscopic sterilization; Ovabloc; Transcervical sterilization; Tubal occlusion
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 [1]. In the Netherlands around 9000 women are sterilized each year [2]. 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 the laparoscopic route and this method developed into the standard technique [3,4]. In rare cases laparoscopy may cause serious complications [5]. Even before the introduction of the hysteroscope in the 19th century, attempts were made to produce tubal occlusion transcervically by a vaginal route [6]. Initially chemical * Corresponding author. Tel.: +3120 5108911; fax: +3120 6853879. E-mail address: [email protected]. 0531-5131/ D 2005 Elsevier B.V. All rights reserved. doi:10.1016/j.ics.2004.12.044
A.L. Thurkow / International Congress Series 1279 (2005) 184–188
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agents or electrothermic instruments were introduced blindly with poor results. In 1927, for the first time an electrocautery method with hysteroscopic guidance was tested, also without success. Further attempts with electro-, cryo- or Nd–YAG lasercoagulation were equally unsuccessful in achieving bilateral occlusion (in 15% up to a maximum of 60% of cases) [6–8]. In developing countries experiments with the insertion of quinacrine pellets into the uterine cavity have been performed with reasonable success, where the blind insertion has the advantage of low cost. Serious side effects have not been seen, but the mutagenic effects are still under investigation [6]. Since hysteroscopy found its way as a routine diagnostic and interventional technique in the 1970s and 1980s even more methods have been tested, among which are several types of intratubal occlusion devices. All of these initial methods have been abandoned, either due to complications or to lack of effectiveness or both [8–11]. 2. Ovabloc In 1988 OvablocR, a new hysteroscopic sterilization technique was introduced onto the Dutch market after preclinical and clinical studies had been performed dating from 1967 [12,13]. To date it is estimated that around 2000 procedures have taken place in the Netherlands. Ovabloc is a formed-in-place silicone polymer that causes bilateral occlusion in 95% of cases [12,14]. Using a double catheter system the two-component fluid siloxane mixture with a high viscosity is injected in the fallopian tubes, which solidifies within minutes causing occlusion of the tubal lumen. A specially designed siloxane obturatortip, which is preattached to the inner catheter, forms a complex with the intraluminal plug and causes sealing at the uterotubal junction. Causes of failure are tubal spasm, intracavitary pathology, perforation and inability to position the catheter tip in correct alignment with the tubal lumen. This last factor is very operator dependent. Although the chances of success are difficult to assess, some risk factors can be identified, among which are suspicion of intra-uterine pathology and nulliparity [15]. Oral premedication with an NSAID (e.g. NaproxenR) is prescribed the evening before and again 2 h before the procedure. Any hysteroscope with a 7 Fr working channel can be used, with the size range of the outer diameter of the scopes on the market today varying between 4.5 and 8 mm. Whether or not dilatation and local anesthesia are needed depend almost entirely on this outer diameter. With a lower range outer diameter the vaginoscopic route without speculum, tenaculum or anesthesia (the Bettocchi method) is feasible [16]. The whole procedure takes between 15 and 40 min. After completion of the procedure a pelvic X-ray is taken to ensure the integrity and correct position of the Ovabloc and the amount of ampullary filling. If the thickness of the Ovabloc is insufficient (e.g. due to intracavitary reflux of the material) intra-uterine expulsion may occur. The X-ray is then repeated after 3 months to rule out expulsion, which may occur in 3–4% of cases, usually within the first months after placement
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[12,17]. Ultrasound may be used for this second examination as assessment of correct tubal placement is the main goal at this stage and the intramural part of the plug as well as the intra-uterine tip are usually easily visualized sonographically. 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. A multi-center 3 year follow-up study in 398 patients had a cumulative pregnancy rate of 0.99% (Pearl Index 0.13/100 woman-years), which is comparable with the laparoscopic alternative [14,18]. Why the popularity of the method is still limited is not entirely clear. An important factor seems to be the fact that at the time of introduction the routine use of hysteroscopy was not at the level it has reached today, at least in the Netherlands. The highly operator dependant technique, especially at the time of introduction when 8 mm scopes and straight catheters were used, probably contributed considerably to this unfortunate chronological disadvantage. The medical funding system in the Netherlands is another reason for many hospital institutions to either discontinue hysteroscopic sterilization or refrain from starting in the first place. Reimbursement was limited to the fee of the surgeon and the use of the facility, but did not include the rather expensive material when compared with laparoscopic sterilization, which financial burden lies entirely on the overall hospital budget. The system is CE marked, but not FDA approved. 3. Essure 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 EssureR system. The FDA PMA approval followed in November 2002. The EssureR micro-insert (Conceptus), initially called STOP, is a dynamically expanding micro-coil with polyethylene terephthalate (PET) fibers wound in and around the inner coil. 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 produces an additional anchoring and obstructing effect. 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 a vaginoscopic approach. In 92% of cases bilateral occlusion is achieved. After 3 years of follow-up an effectiveness of 99.8% has been shown in a multi-center pivotal study of 518 patients [19]. Complications that have been encountered are rare perforations with no clinical symptoms. More than 35,000 procedures (0 pregnancies) after correct placement of the device have been performed worldwide up to 2004 with a rapid increase in the incidence of the procedure (J.F. Kerin, personal communication). 4. New developments Several alternative methods are in the pipeline and may be introduced in the future.
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187
Among these are the Adiana system (radiofrequency with fibrosis by matrix ingrowth), the BMES intratubal ligation device (by intraluminal invagination) the Ovion (fiber coated stent) and the Chiroxia intratubal tissue-adhesive, which all are subject to present studies [20]. 5. Conclusion Hysteroscopic sterilization is an elegant alternative to laparoscopic sterilization with the advantage of preventing incisions and general anesthesia and ensuring faster recovery. In women with a (relative) contra-indication to laparoscopy (obesity, intra-abdominal adhesions, haemorrhagic diathesis, cardiopulmonary disease) these features probably form a clear indication for a hysteroscopic approach. The only remaining indication for laparoscopic sterilization seems to exist for those patients who do not wish to have further visits to the gynaecologist. Acknowledgements The author is a member of the advisory board of Chiroxia Medical Device Research and Development in Dublin, Ireland, for research and development in hysteroscopic sterilization. No other potential conflicts of interest exist. Special thanks are due to Gareth Davies, MD, for reviewing the text. References [1] EngenderHealth, Contraceptive Sterilization: Global Issues and Trends, EngenderHealth, New York, USA, 2002. [2] Prismant HCaAI, Landelijke LMR-informatie—Verrichtingen: destructie of afsluiting van tubae faloppii mbv endoscopie, Prismant, Health Care and Advise Institute, Utrecht, the Netherlands, 2004. [3] M.N. Hyams, Sterilization of the female by coagulation of the uterine cornu, Am. J. Obstet. Gynecol. 28 (1934) 96. [4] P. Steptoe, Laparoscopic tubal sterilization—a British viewpoint, IPPF Med. Bull. 5 (2) (1971) 4. [5] F.W. Jansen, et al., Complications of laparoscopy: a prospective multicentre observational study, Br. J. Obstet. Gynaecol. 104 (5) (1997) 595 – 600. [6] G. van der Leij, Hysteroscopic sterilization: study of the siloxane intratubal device application method, Universiteit van Amsterdam, 1997. [7] K. Wamsteker, Hysteroscopie, Rijksuniversiteit Leiden, 1977. [8] J.M. Cooper, Hysteroscopic sterilization, Clin. Obstet. Gynecol. 35 (2) (1992) 282 – 298. [9] S.S. Thatcher, Hysteroscopic sterilization, Obstet. Gynecol. Clin. North Am. 15 (1) (1988) 51 – 59. [10] J. Brundin, Transcervical sterilization in the human female by hysteroscopic application of hydrogelic occlusive devices into the intramural parts of the fallopian tubes: 10 years experience of the P-block, Eur. J. Obstet. Gynecol. Reprod. Biol. 39 (1) (1991) 41 – 49. [11] J. Hamou, et al., Hysteroscopic reversible tubal sterilization, Acta Eur. Fertil. 15 (2) (1984) 123 – 129. [12] F.D. Loffer, Hysteroscopic sterilization with the use of formed-in-place silicone plugs, Am. J. Obstet. Gynecol. 149 (3) (1984) 261 – 270. [13] T.P. Reed, R.A. Erb, Hysteroscopic oviductal blocking with formed-in-place silicone rubber plugs: II. Clinical studies, J. Reprod. Med. 23 (2) (1979) 69 – 72. [14] N.G. Ligt-Veneman, et al., The efficacy of intratubal silicone in the Ovabloc hysteroscopic method of sterilization, Acta Obstet. Gynecol. Scand. 78 (9) (1999) 824 – 825.
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A.L. Thurkow / International Congress Series 1279 (2005) 184–188
[15] L.G. van der, F.B. Lammes, Office hysteroscopic tubal occlusion with siloxane intratubal devices (the Ovabloc method), Int. J. Gynaecol. Obstet. 53 (3) (1996) 253 – 260. [16] S. Bettocchi, L. Selvaggi, A vaginoscopic approach to reduce the pain of office hysteroscopy, J. Am. Assoc. Gynecol. Laparosc. 4 (2) (1997) 255 – 258. [17] L.G. van der, F.B. Lammes, Office hysteroscopic tubal occlusion with siloxane intratubal devices (the Ovabloc method), Int. J. Gynaecol. Obstet. 53 (3) (1996) 253 – 260. [18] H.B. Peterson, et al., The risk of pregnancy after tubal sterilization: findings from the U.S. collaborative review of sterilization, Am. J. Obstet. Gynecol. 174 (4) (1996) 1161 – 1168. [19] J.M. Cooper, et al., Microinsert nonincisional hysteroscopic sterilization, Obstet. Gynecol. 102 (1) (2003) 59 – 67. [20] Transcervical Methods in the US Pipeline. www.arhp.org/healthcareproviders/cme/onlinecme/cmeclinicalproceedings.cfm?ID=308 (2004).