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EURO-7970; No. of Pages 4 European Journal of Obstetrics & Gynecology and Reproductive Biology xxx (2013) xxx–xxx
Contents lists available at SciVerse ScienceDirect
European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb
Review
Essure1 permanent birth control effectiveness: a seven-year survey S. Jost a,*, C. Huchon b, G. Legendre c, A. Letohic a, H. Fernandez c, P. Panel a a
Department of Obstetrics and Gynecology, Centre Hospitalier de Versailles, 177 rue de Versailles, 78150 Le Chesnay, France Department of Obstetrics and Gynecology, Centre Hospitalier Inter-Communal de Poissy, Poissy, France c Department of Obstetrics and Gynecology, Hoˆpital Biceˆtre, Assistance Publique Hoˆpitaux de Paris (APHP), Le Kremlin-Biceˆtre, France b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 26 July 2012 Received in revised form 24 November 2012 Accepted 27 December 2012
Essure appears to be a safe reliable contraception. The aim of this study is to report French pregnancies after Essure hysteroscopic sterilization. This study is a retrospective national survey between January 2003 and September 2010. Data were collected in two ways: – a mail-in questionnaire addressed to all surgeons performing Essure procedures in France
Keywords: Essure Pregnancy Sterilization failure Hysteroscopic sterilization
– pregnancies reported directly to the manufacturer. The surgeons contacted in our study were responsible for 63.4% of all Essure procedures in France. Fifty-eight cases of unintended pregnancies after Essure sterilization in France were reported during the study period. Factors associated to unintended pregnancies were patient’ non compliance with followup (22 pregnancies, 38% of cases) and misinterpretation at the 3rd-month confirmation test (19 cases, 33%). Other causes were physician’s deviation from protocol (10 cases) and undetected pre-procedure pregnancy (3 cases). Three pregnancies happened before the 3-months confirmation test. Based on the number of kits sold during the period, the estimated pregnancy rate was between 1.07 and 1.09/1000 procedure. The pregnancy risk after hysteroscopic sterilization may be reduced by improving patient education and physician knowledge concerning the 3rd month confirmation test. ß 2013 Published by Elsevier Ireland Ltd.
Contents 1. 2. 3. 4.
Introduction . . . . . . . . . Materials and methods Results . . . . . . . . . . . . . Comments . . . . . . . . . . Acknowledgements . . . References . . . . . . . . . .
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1. Introduction Tubal ligation is a birth-control method used throughout the world by 17% of women of child-bearing age [1]. Seven hundred thousand sterilizations are conducted every year in the United States, and between 30,000 and 75,000 in France [2–4]. More than
* Corresponding author at: Centre Hospitalier de Versailles, Le Chesnay, 177 rue de Versailles, 78157 Le Chesnay cedex, France. Tel.: +33 6 84 94 76 36; fax: +33 1 39 63 97 32. E-mail address:
[email protected] (S. Jost).
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450,000 Essure procedures have been done worldwide and more than 70,000 in France (Conceptus SAS data December 2010). Essure hysteroscopic sterilization is non-surgical and nonhormonal and provides physicians and patients a favorable alternative to tubal ligation. The technique of tubal sterilization by the Essure procedure is increasingly chosen over traditional laparoscopic tubal sterilization. This method has indeed many advantages: no incision, high successful bilateral placement rates [4], non-mandatory use of anesthesia [5], in office procedures, a low level of pain, and low-risk surgery [6]. Recently, the French Authority for Health (HAS) recommended that the Essure procedure should be offered as a first line alternative for women
0301-2115/$ – see front matter ß 2013 Published by Elsevier Ireland Ltd. http://dx.doi.org/10.1016/j.ejogrb.2012.12.042
Please cite this article in press as: Jost S, et al. Essure1 permanent birth control effectiveness: a seven-year survey. Eur J Obstet Gynecol (2013), http://dx.doi.org/10.1016/j.ejogrb.2012.12.042
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EURO-7970; No. of Pages 4 S. Jost et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology xxx (2013) xxx–xxx
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over 40 years who request permanent birth control [7,8]. A recent study on Essure procedures in France found a placement success rate of 97%, with 93% of patients satisfied or very satisfied [9]. Despite the large number of international publications on Essure, few are aimed at measuring the rate of pregnancy following Essure sterilization [10–14]. According to Conceptus SAS, France is the world’s second-largest consumer of Essure devices. We therefore decided to conduct a national survey of pregnancies following Essure sterilization in France.
2. Materials and methods In this retrospective review we assessed pregnancies that occurred between January 1, 2003 and September 30, 2010. The data were collected in two different ways: (1) data directly reported by practitioners or patients to the ConceptusTM Company and (2) by means of a mail-in questionnaire addressed by name to all surgeons performing Essure procedures. According to HAS all surgeons are required to complete at least five supervised cases before performing Essure procedures. Conceptus SAS France organized surgeon training sessions prior to the sale of the micro-inserts to each institution, to ensure procedure accuracy. All surgeons were asked to report known pregnancies that occurred after an Essure procedure. If they were aware of such cases, they were asked to specify the time lapsed between the procedure and the pregnancy, the type of confirmation test used (3 months post-procedure), the supposed cause for the sterilization failure and the pregnancy outcome. Practitioners were given the possibility of replying either by post or by email. The data were cross-checked in order to avoid double-counting. The national number of procedures was evaluated based on the number of kits sold between January 1, 2003 and December 31, 2009. The Essure procedure includes a 3-month confirmation test, which in France takes the form of a pelvic X-ray. If the micro-insert placement appears to be unsatisfactory a second confirmation test by a hysterosalpingography (HSG) is recommended [15]. Until bilateral tubal occlusion and correct micro-insert placement are positively verified, the patient has to continue the use of her regular contraception method. X-ray criteria for proper positioning of the inserts are presented in Table 1. Pregnancies following an Essure procedure were classified in five categories: misinterpretation of the 3-month X-ray, patient non-compliance (no follow-up or failure to continue using contraception until the confirmation test), luteal phase pregnancy, deviation from protocol, and other.
Table 1 X-ray’s interpretation criteria. Criteria of proper placement of the micro-inserts – 2 inserts (if two inserts posed) – 2 symmetrical inserts – distance during the implants smaller or equal to 4 cm (length of the implant) – 4 radio-opaque markers in line AND data from the report – uterine cavity – number of expanded outer coils on each side (between 3 and 8) – fallopian tubal ostia in view during the procedure – difficulties to insert implants – others difficulties – length of the procedure (must be under 15 min) – pain during procedure (if no anesthesia) If one of the criteria is not respected, indication to proceed to hysterosalpingography.
3. Results Thirty-four pregnancies were spontaneously reported to Conceptus SAS France. The mail-in questionnaire was sent to 1268 surgeons performing the Essure procedure, and 287 surgeons (22.5%) from 206 institutions replied either by post or by email. Most of them also reported data of procedures conducted by their colleagues working in the same institution. The surgeons contacted in our study were responsible for 63.4% of all Essure procedures in France. During the study period, an estimated 53,003 kits were sold by Conceptus SAS France, of which 33,611 (63.4%) were to institutions that answered the questionnaire. After cross-checking, 58 pregnancies were reported in France between January 1, 2003 and September 30, 2010. Participating institutions reported 36 pregnancies, demonstrating a pregnancy rate of 1.07 pregnancies per 1000 Essure procedures. Considering all pregnancies (58), the total pregnancy rate in France was 1.09/1000. The causes of pregnancies are detailed in Table 2. The primary cause identified was patient non-compliance with follow-up (22 patients): no confirmation test at 3 months (16 patients), no contraceptive use during the 3-month post-procedure period (5 patients) and one patient who did not undergo the HSG requested by the physician after the X-ray confirmation test. The second cause of unintended pregnancies was misinterpretation of the 3-month confirmation test (18 pregnancies). Retrospective interpretation of the pelvic radiographs was possible in 10 cases: in 9 cases only one implant was found to be wellpositioned, while the tenth showed that the two implants were implanted on the same side. The third cause of unintended pregnancy was deviation from protocol (10 pregnancies). In four cases, the 3-month confirmation test was performed by ultrasound only. In four cases, HSG was not performed despite being required in cases of past salpingectomy, doubtful radiography, or difficulties during Essure procedure. In two cases, there was a lack of information about the necessity of for 3 months’ contraception and a confirmation test. Three cases of luteal pregnancy were reported. No obvious cause was identified in the remaining five cases. One case was interpreted as ‘‘real failure’’ of Essure implants by the performing surgeon. Pregnancy occurred 18 months after the Essure procedure. The confirmation test (X-ray) was considered as correct. After a miscarriage, a bilateral salpingectomy revealed two well-positioned implants in the tubes (data from the performing surgeon). Two pregnancies were reported after a unilateral procedure in patients with a past history of a contralateral salpingectomy for ectopic pregnancy: in both cases, an HSG was performed before surgery proving the unilateral occlusion, but no operative reports of the performed salpingectomies were available. In the two last cases, no obvious cause was found but the confirmation test was not reviewed. One case of ectopic pregnancy is reported (X-ray misinterpretation).
Table 2 Causes of reported pregnancies. Reason pregnancy occurred
No.
% of total
Patient non-compliance Misread X-ray Deviation from protocol Others Pregnant at time of placement
22 18 10 5 3
38 31 17 9 5
Total
58
Please cite this article in press as: Jost S, et al. Essure1 permanent birth control effectiveness: a seven-year survey. Eur J Obstet Gynecol (2013), http://dx.doi.org/10.1016/j.ejogrb.2012.12.042
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EURO-7970; No. of Pages 4 S. Jost et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology xxx (2013) xxx–xxx
The delay between the Essure procedure and pregnancy is shown in Fig. 1. Three pregnancies occurred before the 3-month confirmation test. In two of the three cases, the micro-inserts were found to be well-positioned. Twenty-nine pregnancies (50%) led to induced abortion, and eight pregnancies (13.7%) were carried to term. Nine pregnancies ended in miscarriage while one pregnancy was medically interrupted because of Down syndrome. In 18 cases, a secondary laparoscopic tubal ligation was conducted. In three cases, patients underwent a second Essure procedure. 4. Comments The first cases of Essure tubal sterilization were performed in Australia in 1999. This procedure spread to the USA in 2000 and France in 2002. Four hundred and fifty thousand procedures have been performed worldwide as at the end of 2010 (Conceptus SAS data). No pregnancy was reported from the 2001 pilot study [16]. Nevertheless, some sporadic cases were reported in the literature or during congresses. The first publication regarding unintended pregnancies was written by Levy et al. [11]. Sixty-four pregnancies were reported to the device manufacturer by the patient or the surgeon worldwide. At the time of this first publication, the estimated worldwide number of Essure procedures performed was 50,000. The study was based only on declared cases, and might underrate the number of pregnancies. Verseema et al. reported unintended pregnancies after Essure sterilization in The Netherlands [12]. Ten cases were reported between 2002 and 2008 for 6000 procedures performed in 45 institutions. The study was also based only on declared cases, but the data may still be used because of the small number of institutions concerned and the centralized training. We tried to estimate the real number of unintended pregnancies after Essure sterilization. Only 34 pregnancies were reported by the manufacturer whereas we reported 58 cases. In addition we found that participating surgeons were the ones who performed the greater number of Essure procedures, accounting for 2/3 of Essure procedures done in France during the period. The main bias in this study is a declarative bias, as patient or physicians might not declare their pregnancies. Furthermore, only 22.5% of physicians responded to the survey, and those physicians and their institutions performed 63.4% of the cases. An argument could be made that these surgeons who perform a lot of cases will have a lower failure rate because of their experience while the failure rate may be higher among the physicians who did not respond, who are the low frequency performers of this procedure. This might lead a falsely low pregnancy rate.
100% 90%
Pregnancies
80% 70% 60% 50% 40% 30% 20% 10% 0% before 3 3-6 6-12 12-18 18-24 24-30 30 -36 months months months months months months months Fig. 1. Delay between Essure procedure and pregnancy.
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The survey includes procedures from January 1, 2003 to December 31, 2009. Before January 2003, the number of procedures was anecdotal in France. The number of procedures is an estimate from the number of micro-inserts sold during the survey period. As the study lasted seven years, the stock impact was low; thus rendering this approximation accurate. This was because implants were delivered on demand, thus ensuring a precise approximation of the number of implants used. On average, two implants are used for each patient (data from Panel et al. [9]). Implant contamination or error of implantation can sometimes lead the surgeons to use more than two implants while, on the other hand, a history of a previous unilateral salpingectomy requires the use one implant, thus keeping the approximate number of implants used constant. The 58 pregnancies reported out of 53,003 kits conclude a pregnancy rate of 1.09/1000. When specifically interpreting data collected from institutions involved in our study, the pregnancy rate was found to be 1.07/1000 (36 pregnancies and 33,611 kits). These figures are close to the worldwide estimated rate of 0.15/ 100 [10]. We can compare these results with those obtained from other methods of tubal sterilization. The CREST study compared different methods of sterilization excluding ESSURE and Filshie clips (Hulka clips, bipolar coagulation, monopolar coagulation, partial salpingectomy). The reported cumulative failure rate at five years for women between 35 and 44 years old was from 1.8/ 1000 for unipolar coagulation to 18.7/1000 for partial interval salpingectomy [2]. In France, more than 95% of Essure procedures are done on patients over 35 years [9]. In our study the majority of pregnancies occurred in the first two years (Fig. 1). We therefore think that pregnancy occurs due to failure of the procedure and not because of a possible spontaneous recanalization. The main cause of pregnancy found in this study is patient non-compliance with follow-up (22 cases out of 58 pregnancies). In most cases, the patient was lost from follow-up after the procedure and re-consulted once pregnant. This is a problem also found in the studies of Levy et al. (24 pregnancies out of 64 charged to non-compliance) [11] and Verseema et al. (3 cases out of 10 pregnancies) [12]. A U.S. study [17] observed the compliance of patients with the 3-month confirmation test done by HSG: 79 patients underwent Essure procedures and only 10 (12.7%) underwent the confirmation test. It is important to inform patients at the first consultation, before and after the procedure, regarding the need for contraception for 3-months following the procedure. Even if the procedure goes well, migration or expulsion is possible in 1–5% of cases [18]. In our study, we found seven cases of migration or expulsion out of the 38 pregnancies for which radiographic confirmation is available. It is interesting to analyze the countries’ choice of the 3-month confirmation test. In the USA, a successful Essure procedure is said to have occurred if complete tubal occlusion and correct microinsert placement is found using HSG as the confirmation test, whilst in France a successful Essure procedure is when a satisfactory micro-inserts position is found at the 3-month confirmation pelvic X-ray. Although differences between the two countries exist, the causes and number of unintended pregnancies does not seem to differ [9]. The second cause of pregnancy found in this study is misinterpretation of the 3-month confirmation test. In France the standard protocol is that the patient undergoes pelvic radiography to check the correct position of the implants [2]. In our study, we found 19 cases of misinterpretation at the checkup, including 14 cases of misinterpretation of the pelvic
Please cite this article in press as: Jost S, et al. Essure1 permanent birth control effectiveness: a seven-year survey. Eur J Obstet Gynecol (2013), http://dx.doi.org/10.1016/j.ejogrb.2012.12.042
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radiography. In clinical practice, many surgeons reported difficulty in interpreting the pelvic radiography. Some of them almost always supplement their review by an ultrasound, and others request confirmation by HSG. Many authors prefer to combine ultrasound and pelvic radiography [19–22]. The use of ultrasound confirmation was studied by Verseema et al., who found a sensitivity of 50% and a specificity of 95% for ultrasound diagnosis of intraluminal position at the horn and the proximal portion of the tube [20]. Legendre et al. [21] concluded that 3D ultrasound was a simple and reproducible method of checking the position of the Essure implants, showing a very good correlation with the HSG. Moreover, in The Netherlands, the ‘‘Dutch protocol’’ has been established, completing the Essure procedure with endovaginal ultrasound, supplemented in cases of doubt by an HSG [12]. In our study we reported cases of failure of the ultrasound confirmation test. We cannot draw any conclusions as the techniques used were various (3D ultrasound, 2D ultrasound, abdominal or vaginal ultrasound). The third cause for unintended pregnancy we observed was deviation from protocol by the surgeon (10 pregnancies out of 58). Three cases of luteal pregnancy were identified in this study. The recommendation of the HAS is to systematically perform the Essure procedure during the follicular phase and to conduct a preprocedure pregnancy test. For the first time, three cases of early pregnancy (i.e. patients becoming pregnant in the 3-month interval) are reported in this study. In two cases, correct implant placement and tubal obstruction were confirmed by HSG after the abortion. These cases prove that the 3-month interval contraception is necessary until complete tubal occlusion has occurred. It is interesting to discuss two particular cases. In this survey, we reported a case of pregnancy where the protocol was wellconducted with both implants well-positioned (laparoscopically verified). This seems to be the first case reported in literature. We also report a case of ectopic pregnancy after Essure tubal sterilization, which is rarely described [23]. Cases of unilateral procedures have to be discussed. In our survey, we reported two cases of unintended pregnancies after unilateral implantation in patients with a contralateral salpingectomy due to an ectopic pregnancy. In both cases, an HSG was performed before the procedure, as recommended. Confirmation of the salpingectomy by means of the surgical postoperative notes was not performed in either of the cases. For our part, we conclude that without a confirmatory surgical report a laparoscopy has to be performed to verify that a salpingectomy was performed. If not, a laparoscopic tubal sterilization is recommended instead of the Essure procedure. According to this study the estimated pregnancy rate after Essure sterilization is about 1 in 1000. Most of the pregnancies are avoidable. In our opinion, a standardized nationwide protocol is obligatory but the type of confirmation test does not seem to impact pregnancy risk.
Conflicts of interest The authors declare conflicts of interest with Conceptus, Inc., Mountain View, CA.
Acknowledgments Thanks to our colleagues who allowed this data collection and to the ConceptusTM France Company who gave us all the information required for this work. References [1] Mackay AP, Kieke Jr BA, Konnin LM, Beattie K. Tubal sterilization in the United States, 1994–96. Family Planning Perspectives 2001;33:161–5. [2] Peterson HB, Xia Z, Hughes J, Wilcox L, Tylor L, Trussell J. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. American Journal of Obstetrics and Gynecology 1996;174:1161–70. [3] Chandra A. Surgical sterilization in the United States: prevalence and characteristics, 1965–95. Vital and health statistics, Series 23, No 20. Washington, DC: Government Printing Office; 1998(DHHS Publication no. (PHS) 98-1996). [4] Kerin JF, Cooper JM, Price T, et al. Hysteroscopic sterilization using a microinsert device: results of a multicentre Phase II study. Human Reproduction 2003;18:1223–30. [5] Vleugels M, Veersema S. Hysteroscopic sterilisation in the outpatient department without anaesthesia. Gynecological Surgery 2005;3:155–8. [6] Franchini M, Boeri C, Calzoari S, et al. Essure transcervical tubal sterilization: a 5-year X-ray follow up. Fertility and Sterility 2011;95:2114–5. [7] Strate´gies de choix des me´thodes contraceptives chez la femme. Recommandations pour la pratique Clinique. Service des recommandations professionnelles de l’ANAES, De´cembre 2004. [8] HAS. Re´fe´rentiel de bon usage hors GHS. ESSURE Dispositif pour ste´rilisation tubaire par voie hyste´roscopique. Octobre 2007. www.has-sante.fr (consulted on 29.05.2011). [9] Grosdemouge I, Engrand JB, Dhainault C, et al. Essure implants for tubal sterilisation in France. Gynecologie Obstetrique et Fertilite 2009;37:389–95. [10] Levy B, Munro MG, Veersema S, Vleugels M. Reported pregnancies after ESSURE hysteroscopic sterilization: a retrospective analysis of pregnancy reports worldwide: 2001–2010. Journal of Minimally Invasive Gynecology 2011;18(6 Suppl):S20–1. [11] Levy B, Levie MD, Childers ME. A summary of reported pregnancies after hysteroscopic sterilization. Journal of Minimally Invasive Gynecology 2007;14:271–4. [12] Verseema S, Vleugels M, Moolenaar L, Janssen C, Brolmann H. Unintended pregnancies after Essure sterilization in the Netherlands. Fertility and Sterility 2010;93:35–8. [13] Kerin JF. Pregnancies in women who have undergone the Essure hyteroscopic sterilization procedure: a summary of 37 cases. Journal of Minimally Invasive Gynecology 2005;12:S28. [14] Moses AW, Burgis JT, Risinger J. Pregnancy after Essure placement: report of two cases. Fertility and Sterility 2008;89:724.e9–724.e11. [15] Essure Permanent Birth Control Instructions for Use. Mountain View, CA: Conceptus, Inc. http://www.fda.gov/ohrms/dockets/ac/02/briefing/ 3881b1_03.pdf (consulted on 15th July 2011). [16] Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first EssureTM PBC clinical study. Australian and New Zealand Journal of Obstetrics Gynecology 2001;41:364–70. [17] Shavell VI, Abdallah ME, Diamond MP, Kmak DC, Berman JM. Post-Essure hysterosalpinography compliance in a clinic population. Journal of Minimally Invasive Gynecology 2008;15:431–4. [18] Kulier R, Boulain M, Walker DM, De Candolle G, Campana A. Minilaparotomy and endoscopic techniques for tubal sterilization. Cochrane Database of Systematic Reviews 2004;3:CD001328. [19] Teoh M, Meagher S, Kovacs G. Ultrasound detection of the Essure permanent birth control device: a case series. Australian and New Zealand Journal of Obstetrics 2003;43:378–80. [20] Verseema S, Vleugels M, Timmermans A, Brolmann H. Follow-up of successful bilateral placement of Essure micro inserts with ultrasound. Fertility and Sterility 2005;84:1733–6. [21] Legendre G, Gervaise A, Levaillant JM, Faivre E, Deffieux X, Fernandez H. Assessment of three-dimensional ultrasound examination classification to check the position of tubal sterilization micro insert. Fertility and Sterility 2010;94:2732–5. [22] Kerin JF, Levy BS. Ultrasound: an effective method for localization of the echogenic Essure sterilization micro-insert: correlation with radiologic evaluations. Journal of Minimally Invasive Gynecology 2005;12:50–4. [23] Bjornsson HM, Graffeo CS, Davis SS. Ruptured ectopic pregnancy after previously confirmed tubal occlusion by the Essure procedure. Annals of Emergency Medicine 2011;57:310–1.
Please cite this article in press as: Jost S, et al. Essure1 permanent birth control effectiveness: a seven-year survey. Eur J Obstet Gynecol (2013), http://dx.doi.org/10.1016/j.ejogrb.2012.12.042
