- Email: [email protected]
Bipolar hysteroscopic procedures and placement of Essure microinserts for tubal sterilization: a case control study
Bipolar hysteroscopic procedures and placement of Essure microinserts for tubal sterilization: a case control study Pierre Panel, M.D., Isabelle Grosdemouge, M.D., Marie Houllier, M.D., Frederique Renouvel, M.D., Ludovic Friederich, M.D., and Arnaud Le Tohic, M.D. Service de Gynecologie-Obstetrique, Centre Hospitalier de Versailles, H^opital Andre Mignot, Le Chesnay, France
Objective: To assess the effectiveness and complication rate with Essure microinsert placements for tubal sterilization and the concomitant bipolar intrauterine surgical procedure. Design: Case control study. Setting: Department of gynecology and obstetrics of a general hospital in France. Patient(s): 382 women, including 41 undergoing one or several concomitant uterine procedures with Essure placement, and 341 undergoing Essure placement only (controls). Intervention(s): Essure placement with or without bipolar hysteroscopic procedure for polyp, myoma, or endometrial ablation. Main Outcome Measure(s): Success rate for microinsert placement and complications at 3 months. Result(s): Forty-one patients had Essure microinserts placed in combination with a bipolar hysteroscopic procedure: endometrial resection (n ¼ 32), fibroma resection (n ¼ 4), or polyp ablation (n ¼ 5). They were compared with 341 patients who underwent Essure placement only. The success rate for Essure placement was 97.6% in the combination group versus 97.6% in the control group. The complication rate was 4.9% (n ¼ 2) in the combination group versus 2.6% (n ¼ 9) in the control group. The difference in the success and complication rates was not statistically significant. Conclusion(s): Performing intrauterine bipolar resection during hysteroscopy for sterilization is possible without reducing the Essure placement success rate and without increasing morbidity. (Fertil Steril 2011;95:2422–5. 2011 by American Society for Reproductive Medicine.) Key Words: Hysteroscopy, myoma, endometrial ablation, bipolar resection, tubal sterilization
Women of childbearing age consult their healthcare practitioners for the recurring problem of contraception. Among the methods that can be offered to them is tubal sterilization. Since 1998, with the Essure system (Conceptus Inc, Mountain View, California) it has been possible to conduct tubal occlusion by use of hysteroscopy. Its effectiveness seems to be greater than that of sterilization using laparoscopy (1). However, women also may present with menstrual disorders linked to a fibroma, polyp, or endometrial hyperplasia. To date, few studies have examined the possibility of combining the placement of the tubal microinserts with other intrauterine procedures (2–4). Our case control study compared the success rate and hazards of bipolar hysteroscopic procedures combined with Essure placement versus Essure placement alone.
MATERIALS AND METHODS We conducted a prospective observational study in our department between January 2004 and March 2009. All patients who had underReceived August 2, 2010; revised March 13, 2011; accepted March 17, 2011; published online April 16, 2011. P.P. has nothing to disclose. I.G. has nothing to disclose. M.H. has nothing to disclose. F.R. has nothing to disclose. L.F. has nothing to disclose. A.L.T. has nothing to disclose. Essure is manufactured by Conceptus Inc, Mountain View, California. Presented at the 19th Annual Congress of the European Society for Gynaecological Endoscopy (ESGE), Barcelona, September 29–October 2, 2010. cologie-Obste trique, Reprint requests: Pierre Panel, M.D., Service de Gyne ^ pital Andre Mignot, 177 Avenue de Centre Hospitalier de Versailles, Ho Versailles, 78157 Le Chesnay, France (E-mail: [email protected]).
2422
gone tubal sterilization using Essure were included. Patients received complete information on the Essure insert placement technique, including the effectiveness and risks. Patients who were scheduled for bipolar intrauterine resection were fully informed of the operating risks and the uncertainty as to the success of the Essure method when placement is combined with another procedure. All patients signed a consent form, and the study obtained the approval of the CCTIRS. The technique of Essure microimplant placement has been previously described elsewhere (5). When required, a three-channel, 9.5-mm diameter operating hysteroscope was used to achieve the bipolar resection procedures. Irrigation was conducted by use of a pump, with physiologic saline at a constant pressure of 90 mm Hg. According to French recommendations, all patients had a pelvic x-ray as the 3-month confirmation test. The distance between the proximal extremities of the inserts must be less than 4 cm, and the four radiopaque markers should be clearly aligned. In the event of doubt, an ultrasound pelvic scan was performed or a hysterosalpingography (HSG), if necessary. Cases of migration, expulsion, or perforation of the inserts were recorded. Statistical analysis used the Fisher test to compare results. P%.5 was considered statistically significant.
RESULTS Between January 1, 2004, and February 28, 2009, 382 patients underwent Essure placement in our department. In 41 patients (group A), one or several concomitant uterine procedures were conducted. In group B, 341 patients underwent Essure placement only. The
Fertility and Sterility Vol. 95, No. 7, June 2011 Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc.
0015-0282/$36.00 doi:10.1016/j.fertnstert.2011.03.049
TABLE 1 Bipolar hysteroscopic procedures associated with Essure placement.
Procedure
No. of procedures performed
Endometrial ablation Endometrial ablation þ polyp resection Polyp resection alone Myoma resection Myoma resection þ endometrial ablation Total
21 8 5 4 3 41
Panel. Techniques and instrumentation. Fertil Steril 2011.
procedures carried out concomitantly with Essure insert placement are summarized in Table 1. Insert placement occurred during the initial part of the procedure except in one case of a preostial fibroma. The patients’ characteristics and the rates of success and complications of Essure placement are presented in Table 2. In group A, there were no cases of failure of bilateral placement. Three unilateral placement failures occurred during the first attempt. Case 1. During the initial intervention, the insert was placed on the right tube, and two fibroids were excised. The second insert was not placed because the ostium was covered by a fibroid on the left horn. Resection of this fibroid could not be completed. A second intervention was carried out 2 months later to complete the excision of the fibroid and to place the left insert. At the 3-month follow-up evaluation, the HSG showed that the left insert had migrated into the peritoneal cavity. A laparoscopy was carried out to remove the ectopic insert and perform a tubal ligation. Case 2. One patient had the inserts placed in two stages owing to a preostial polyp that required excision. At the 3-month follow-up HSG, the insert placed on the left side was located in the uterine cavity, and the left tube presented a hydrosalpinx. The patient was
treated laparoscopically by bilateral salpingectomy and by removal of the intrauterine implant by hysteroscopy. Case 3. One of the two inserts could not be placed before the endometrial resection. The HSG requested 1 month later showed bilateral tubal occlusion. In group B, there were two cases of bilateral failure. These two patients did not wish to undergo a second attempt. Insertion was unilateral on the first attempt in eight cases: for two patients, placement on the opposite side was conducted on the second attempt with success. In three cases, the HSG check demonstrated a bilateral tubal occlusion. Three patients did not wish to undergo another attempt. At 3 months, we observed in group A one case of insert expulsion and one case of insert perforation with intraperitoneal migration. In group B, there were four cases of migration and five cases of insert expulsion. In group A, three patients did not carry out the 3-month check-up and subsequently were not seen again (7.3%) compared with 24 patients in group B (7%). No cases of pregnancy were reported. The final success rate for sterilization by Essure was 95.1% in group A versus 98.5% in group B: P¼.9; odds ratio 0.96 (95% confidence interval 0.59–1.58).
DISCUSSION Since 2002, the Essure tubal sterilization system has been increasingly because of its effectiveness, safety, and simplicity (1, 6). Since October 2007, the French National Health Authority (Haute Autorite de Sante, HAS) has recommended this technique as the first-line treatment for women around the age of 40 years (7). Around 40 years of age, menorrhagia is frequent. When surgical treatment is indicated and when the patient wishes nonhormonal contraception, we have proposed tubal sterilization during the same operating procedure. In fact, the risk of postoperative synechiae may reduce the chance of inserting an intrauterine device (IUD) or later tubal sterilization (8). The placement success rate found in the literature is between 88% and 99% (Table 3) (9–16). The placement success rate in our series was equal in the two groups studied (97.6%). Valle et al. (3) evaluated the feasibility of Thermachoice after placing inserts in voluntary patients for whom a hysterectomy had
TABLE 2 Population, success rate, and follow-up evaluations at 3 months after Essure placement.
Mean age (y) Mean parity NSAID premedication Bilateral placement at first attempt Unilateral placement on single tube Failure at first attempt Successful placement at second attempt Total successes Microinsert migration or perforation Microinsert expulsion Infection Pregnancy Total complications
Concomitant procedures group (n [ 41)
Control group (n [ 341)
P value
43 (39–49) 2.3 (1–5) 28% 34 4 3 2 40 (97.56%) 1 1 0 0 2 (4.87%)
42 (34–49) 2.5 (0–6) 69% 321 10 10 2 333 (97.65%) 4 5 0 0 9 (2.63%)
NS NS .001 NS NS NS NS NS NS NS NS NS .34
Note: NS ¼ not statistically significant; NSAID ¼ nonsteroidal antiinflammatory drug. Panel. Techniques and instrumentation. Fertil Steril 2011.
Fertility and Sterility
2423
TABLE 3 Success rate of Essure placement in the literature.
Study Cooper et al. 2003 (9) Kerin et al. 2003 (10) Kerin et al. 2004 (11) Vleugels and Veersema 2005 (12) Mino et al. 2007 (13) Sinha et al. 2007 (14) Arjona et al. 2008 (15) Grosdemouge et al. 2009 (16)
No. of patients
Success on first attempt (%)
Success at two or more attempts (%)
507 227 102 175 857 112 1,630 1,061
88 86 98 88.8 96.5 92 NR 94.4
91.5 88 100 94.7 97.2 NR 99 96.6
Note: NR ¼ not recorded. Panel. Techniques and instrumentation. Fertil Steril 2011.
been indicated. They macroscopically analyzed hysterectomy samples obtained after these procedures and concluded that Thermachoice was innocuous in terms of possible tubal thermal lesions. Moreover, no cases of perforation of the Thermachoice balloon by the distal extremities of the inserts occurred. In 2007, Donnadieu et al. (2) reported a retrospective series of 23 patients with Essure and concomitant endometrial ablation. Insert placement was possible in 20 of the 23 cases. No complications were reported, and tubal occlusion was confirmed 3 months later in the 20 patients. In 2007, Jansen et al. (17) reported a case of major infection in a 37-year-old woman who had undergone tubal sterilization by Essure 1 year earlier. This patient presented with persistent menstrual disorders despite hormone therapy, and she underwent an endometrial ablation through thermal destruction. Postoperatively, the patient presented with pelvic inflammatory disease requiring surgery, during which the investigators found bilateral tubal abscesses. We thus can question the benefits of antimicrobial prophylaxis to avoid the occurrence of infectious complications in cases of combined uterine procedures. Nevertheless, in our series we found no infective complications. In a descriptive feasibility study, Hopkins et al. (4) assessed the safety of Essure placement after Novasure global endometrial
ablation (GEA). They also showed that HSG was available for control in 90% of cases. The U.S. Food and Drug Administration (FDA) recommends HSG as the 3-month confirmation test to determine tubal occlusion. However, in most European countries, device location based on x-ray rather than tubal occlusion is used as the end point for a confirmation test. Moreover, three-dimensional ultrasound may replace HSG for the 3-month Essure control (18). In 2004, the U.S. FDA approved Thermachoice endometrial ablation with Essure microinserts in place; however, because endometrial ablation may cause synechia or cervical stenosis, which may prevent the use of HSG, the FDA later retracted this approval, and the labeling information changed (19). The rate of secondary migration or expulsion is between 1% and 5% (9, 13), which may not be increased by concomitant procedures (20). However, despite the increased rate of complications (4.87% vs. 2.63%), our study failed to demonstrate a statistically significant difference. Conor (6) wrote, ‘‘Concomitant global endometrial ablation and hysteroscopic sterilization, although off-label, present a safe, effective, and convenient treatment option for women with menorrhagia and undesired fertility.’’ Our study has supported this conclusion.
REFERENCES 1. Duffy S, Marsh F, Rogerson L, Hudson H, Cooper K, Jack S, et al. Female sterilization: a cohort controlled comparative study of Essure versus laparoscopic sterilization. BJOG 2005;112:1522–8. 2. Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R, Fernandez H. Essure sterilization associated with endometrial ablation. Int J Gynaecol Obstet 2007;97:139–42. 3. Valle R, Valdez J, Wright T, Kenney M. Concomitant Essure tubal sterilization and Thermachoice endometrial ablation: feasibility and safety. Fertil Steril 2006;86:152–8. 4. Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE, Famuyide AO. Radiofrequency global endometrial ablation followed by hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:494–501. 5. Friedrich L, Chis C, Panel P. Comment je fais une hysteroscopie avec pose d’implants Essure par vaginoscopie. Gynecol Obstet Fertil 2008:1239–40. 6. Connor VF. Essure: a review six years later. J Minim Invasive Gynecol 2009;16:282–90.
2424
Panel et al.
7. Haute Autorite de Sante. Evaluation des techniques de sterilisation chez la femme et chez l’homme. May 2005. Available at: http://www.has-sante.fr/ portail/jcms/c_272486/evaluation-des-techniquesde-sterilization-chez-la-femme-et-chez-lhomme. Accessed March 22, 2010. 8. Gervaise A, de Tayrac R, Fernandez H. Contraceptive information after endometrial ablation. Fertil Steril 2005;84:1746–7. 9. Cooper JM, Carigna CS, Cher D, Kevin JF, Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:59–67. 10. Kerin JF, Cooper JM, Price T, van Herendael BJ, Cayuela-Font E, Cher D, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre phase II study. Hum Reprod 2003;18:1223–30. 11. Kerin JF, Munday DN, Ritosssa MG, Pesce A, Rosen D. Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system. J Am Assoc Gynecol Laparosc 2004;11:388–93.
Techniques and instrumentation
12. Vleugels M, Veersema S. Hysteroscopic sterilization in the outpatient department without anaesthesia. Gynecol Surg 2005;2:155–8. 13. Mino M, Arjona JE, Cordon J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilization in an outpatient setting: a prospective study of 857 women. BJOG 2007;114:763–6. 14. Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilization. BJOG 2007;114:676–83. 15. Arjona JE, Mino M, Cordon J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with office hysteroscopic tubal sterilization. Fertil Steril 2008;90:1182–6. 16. Grosdemouge I, Engrand JB, Dhainault C, Marchand F, Martigny H, Thevenot J, et al. La pratique Franc¸aise de la pose des implants de sterilisation tubaire Essure. Gynecol Obstet Fertil 2009;37: 389–95.
Vol. 95, No. 7, June 2011
17. Jansen NE, Vleugels M, Kluivers K, Vierhout M. Bilateral cornual abscess after endometrial ablation following Essure sterilization. J Minim Invasive Gynecol 2007;14:509–11.
Fertility and Sterility
18. Legendre G, Gervaise A, Levaillant JM, Faivre E, Deffieux X, Fernandez H. Assessment of threedimensional ultrasound examination classification to check the position of the tubal sterilization microinsert. Fertil Steril 2010;94:2732–5.
19. Sinclair EJ. Dear Physician letter. Mountain View, CA: Conceptus Inc.; October 2006. 20. Panel P, Grosdemouge I. Predictive factors of Essure implants placement failure: prospective multicenter study on 495 patients. Fertil Steril 2010;93:29–34.
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Objective: To assess the effectiveness and complication rate with Essure microinsert placements for tubal sterilization and the concomitant bipolar intrauterine surgical procedure. Design: Case control study. Setting: Department of gynecology and obstetrics of a general hospital in France. Patient(s): 382 women, including 41 undergoing one or several concomitant uterine procedures with Essure placement, and 341 undergoing Essure placement only (controls). Intervention(s): Essure placement with or without bipolar hysteroscopic procedure for polyp, myoma, or endometrial ablation. Main Outcome Measure(s): Success rate for microinsert placement and complications at 3 months. Result(s): Forty-one patients had Essure microinserts placed in combination with a bipolar hysteroscopic procedure: endometrial resection (n ¼ 32), fibroma resection (n ¼ 4), or polyp ablation (n ¼ 5). They were compared with 341 patients who underwent Essure placement only. The success rate for Essure placement was 97.6% in the combination group versus 97.6% in the control group. The complication rate was 4.9% (n ¼ 2) in the combination group versus 2.6% (n ¼ 9) in the control group. The difference in the success and complication rates was not statistically significant. Conclusion(s): Performing intrauterine bipolar resection during hysteroscopy for sterilization is possible without reducing the Essure placement success rate and without increasing morbidity. (Fertil Steril 2011;95:2422–5. 2011 by American Society for Reproductive Medicine.) Key Words: Hysteroscopy, myoma, endometrial ablation, bipolar resection, tubal sterilization
Women of childbearing age consult their healthcare practitioners for the recurring problem of contraception. Among the methods that can be offered to them is tubal sterilization. Since 1998, with the Essure system (Conceptus Inc, Mountain View, California) it has been possible to conduct tubal occlusion by use of hysteroscopy. Its effectiveness seems to be greater than that of sterilization using laparoscopy (1). However, women also may present with menstrual disorders linked to a fibroma, polyp, or endometrial hyperplasia. To date, few studies have examined the possibility of combining the placement of the tubal microinserts with other intrauterine procedures (2–4). Our case control study compared the success rate and hazards of bipolar hysteroscopic procedures combined with Essure placement versus Essure placement alone.
MATERIALS AND METHODS We conducted a prospective observational study in our department between January 2004 and March 2009. All patients who had underReceived August 2, 2010; revised March 13, 2011; accepted March 17, 2011; published online April 16, 2011. P.P. has nothing to disclose. I.G. has nothing to disclose. M.H. has nothing to disclose. F.R. has nothing to disclose. L.F. has nothing to disclose. A.L.T. has nothing to disclose. Essure is manufactured by Conceptus Inc, Mountain View, California. Presented at the 19th Annual Congress of the European Society for Gynaecological Endoscopy (ESGE), Barcelona, September 29–October 2, 2010. cologie-Obste trique, Reprint requests: Pierre Panel, M.D., Service de Gyne ^ pital Andre Mignot, 177 Avenue de Centre Hospitalier de Versailles, Ho Versailles, 78157 Le Chesnay, France (E-mail: [email protected]).
2422
gone tubal sterilization using Essure were included. Patients received complete information on the Essure insert placement technique, including the effectiveness and risks. Patients who were scheduled for bipolar intrauterine resection were fully informed of the operating risks and the uncertainty as to the success of the Essure method when placement is combined with another procedure. All patients signed a consent form, and the study obtained the approval of the CCTIRS. The technique of Essure microimplant placement has been previously described elsewhere (5). When required, a three-channel, 9.5-mm diameter operating hysteroscope was used to achieve the bipolar resection procedures. Irrigation was conducted by use of a pump, with physiologic saline at a constant pressure of 90 mm Hg. According to French recommendations, all patients had a pelvic x-ray as the 3-month confirmation test. The distance between the proximal extremities of the inserts must be less than 4 cm, and the four radiopaque markers should be clearly aligned. In the event of doubt, an ultrasound pelvic scan was performed or a hysterosalpingography (HSG), if necessary. Cases of migration, expulsion, or perforation of the inserts were recorded. Statistical analysis used the Fisher test to compare results. P%.5 was considered statistically significant.
RESULTS Between January 1, 2004, and February 28, 2009, 382 patients underwent Essure placement in our department. In 41 patients (group A), one or several concomitant uterine procedures were conducted. In group B, 341 patients underwent Essure placement only. The
Fertility and Sterility Vol. 95, No. 7, June 2011 Copyright ª2011 American Society for Reproductive Medicine, Published by Elsevier Inc.
0015-0282/$36.00 doi:10.1016/j.fertnstert.2011.03.049
TABLE 1 Bipolar hysteroscopic procedures associated with Essure placement.
Procedure
No. of procedures performed
Endometrial ablation Endometrial ablation þ polyp resection Polyp resection alone Myoma resection Myoma resection þ endometrial ablation Total
21 8 5 4 3 41
Panel. Techniques and instrumentation. Fertil Steril 2011.
procedures carried out concomitantly with Essure insert placement are summarized in Table 1. Insert placement occurred during the initial part of the procedure except in one case of a preostial fibroma. The patients’ characteristics and the rates of success and complications of Essure placement are presented in Table 2. In group A, there were no cases of failure of bilateral placement. Three unilateral placement failures occurred during the first attempt. Case 1. During the initial intervention, the insert was placed on the right tube, and two fibroids were excised. The second insert was not placed because the ostium was covered by a fibroid on the left horn. Resection of this fibroid could not be completed. A second intervention was carried out 2 months later to complete the excision of the fibroid and to place the left insert. At the 3-month follow-up evaluation, the HSG showed that the left insert had migrated into the peritoneal cavity. A laparoscopy was carried out to remove the ectopic insert and perform a tubal ligation. Case 2. One patient had the inserts placed in two stages owing to a preostial polyp that required excision. At the 3-month follow-up HSG, the insert placed on the left side was located in the uterine cavity, and the left tube presented a hydrosalpinx. The patient was
treated laparoscopically by bilateral salpingectomy and by removal of the intrauterine implant by hysteroscopy. Case 3. One of the two inserts could not be placed before the endometrial resection. The HSG requested 1 month later showed bilateral tubal occlusion. In group B, there were two cases of bilateral failure. These two patients did not wish to undergo a second attempt. Insertion was unilateral on the first attempt in eight cases: for two patients, placement on the opposite side was conducted on the second attempt with success. In three cases, the HSG check demonstrated a bilateral tubal occlusion. Three patients did not wish to undergo another attempt. At 3 months, we observed in group A one case of insert expulsion and one case of insert perforation with intraperitoneal migration. In group B, there were four cases of migration and five cases of insert expulsion. In group A, three patients did not carry out the 3-month check-up and subsequently were not seen again (7.3%) compared with 24 patients in group B (7%). No cases of pregnancy were reported. The final success rate for sterilization by Essure was 95.1% in group A versus 98.5% in group B: P¼.9; odds ratio 0.96 (95% confidence interval 0.59–1.58).
DISCUSSION Since 2002, the Essure tubal sterilization system has been increasingly because of its effectiveness, safety, and simplicity (1, 6). Since October 2007, the French National Health Authority (Haute Autorite de Sante, HAS) has recommended this technique as the first-line treatment for women around the age of 40 years (7). Around 40 years of age, menorrhagia is frequent. When surgical treatment is indicated and when the patient wishes nonhormonal contraception, we have proposed tubal sterilization during the same operating procedure. In fact, the risk of postoperative synechiae may reduce the chance of inserting an intrauterine device (IUD) or later tubal sterilization (8). The placement success rate found in the literature is between 88% and 99% (Table 3) (9–16). The placement success rate in our series was equal in the two groups studied (97.6%). Valle et al. (3) evaluated the feasibility of Thermachoice after placing inserts in voluntary patients for whom a hysterectomy had
TABLE 2 Population, success rate, and follow-up evaluations at 3 months after Essure placement.
Mean age (y) Mean parity NSAID premedication Bilateral placement at first attempt Unilateral placement on single tube Failure at first attempt Successful placement at second attempt Total successes Microinsert migration or perforation Microinsert expulsion Infection Pregnancy Total complications
Concomitant procedures group (n [ 41)
Control group (n [ 341)
P value
43 (39–49) 2.3 (1–5) 28% 34 4 3 2 40 (97.56%) 1 1 0 0 2 (4.87%)
42 (34–49) 2.5 (0–6) 69% 321 10 10 2 333 (97.65%) 4 5 0 0 9 (2.63%)
NS NS .001 NS NS NS NS NS NS NS NS NS .34
Note: NS ¼ not statistically significant; NSAID ¼ nonsteroidal antiinflammatory drug. Panel. Techniques and instrumentation. Fertil Steril 2011.
Fertility and Sterility
2423
TABLE 3 Success rate of Essure placement in the literature.
Study Cooper et al. 2003 (9) Kerin et al. 2003 (10) Kerin et al. 2004 (11) Vleugels and Veersema 2005 (12) Mino et al. 2007 (13) Sinha et al. 2007 (14) Arjona et al. 2008 (15) Grosdemouge et al. 2009 (16)
No. of patients
Success on first attempt (%)
Success at two or more attempts (%)
507 227 102 175 857 112 1,630 1,061
88 86 98 88.8 96.5 92 NR 94.4
91.5 88 100 94.7 97.2 NR 99 96.6
Note: NR ¼ not recorded. Panel. Techniques and instrumentation. Fertil Steril 2011.
been indicated. They macroscopically analyzed hysterectomy samples obtained after these procedures and concluded that Thermachoice was innocuous in terms of possible tubal thermal lesions. Moreover, no cases of perforation of the Thermachoice balloon by the distal extremities of the inserts occurred. In 2007, Donnadieu et al. (2) reported a retrospective series of 23 patients with Essure and concomitant endometrial ablation. Insert placement was possible in 20 of the 23 cases. No complications were reported, and tubal occlusion was confirmed 3 months later in the 20 patients. In 2007, Jansen et al. (17) reported a case of major infection in a 37-year-old woman who had undergone tubal sterilization by Essure 1 year earlier. This patient presented with persistent menstrual disorders despite hormone therapy, and she underwent an endometrial ablation through thermal destruction. Postoperatively, the patient presented with pelvic inflammatory disease requiring surgery, during which the investigators found bilateral tubal abscesses. We thus can question the benefits of antimicrobial prophylaxis to avoid the occurrence of infectious complications in cases of combined uterine procedures. Nevertheless, in our series we found no infective complications. In a descriptive feasibility study, Hopkins et al. (4) assessed the safety of Essure placement after Novasure global endometrial
ablation (GEA). They also showed that HSG was available for control in 90% of cases. The U.S. Food and Drug Administration (FDA) recommends HSG as the 3-month confirmation test to determine tubal occlusion. However, in most European countries, device location based on x-ray rather than tubal occlusion is used as the end point for a confirmation test. Moreover, three-dimensional ultrasound may replace HSG for the 3-month Essure control (18). In 2004, the U.S. FDA approved Thermachoice endometrial ablation with Essure microinserts in place; however, because endometrial ablation may cause synechia or cervical stenosis, which may prevent the use of HSG, the FDA later retracted this approval, and the labeling information changed (19). The rate of secondary migration or expulsion is between 1% and 5% (9, 13), which may not be increased by concomitant procedures (20). However, despite the increased rate of complications (4.87% vs. 2.63%), our study failed to demonstrate a statistically significant difference. Conor (6) wrote, ‘‘Concomitant global endometrial ablation and hysteroscopic sterilization, although off-label, present a safe, effective, and convenient treatment option for women with menorrhagia and undesired fertility.’’ Our study has supported this conclusion.
REFERENCES 1. Duffy S, Marsh F, Rogerson L, Hudson H, Cooper K, Jack S, et al. Female sterilization: a cohort controlled comparative study of Essure versus laparoscopic sterilization. BJOG 2005;112:1522–8. 2. Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R, Fernandez H. Essure sterilization associated with endometrial ablation. Int J Gynaecol Obstet 2007;97:139–42. 3. Valle R, Valdez J, Wright T, Kenney M. Concomitant Essure tubal sterilization and Thermachoice endometrial ablation: feasibility and safety. Fertil Steril 2006;86:152–8. 4. Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE, Famuyide AO. Radiofrequency global endometrial ablation followed by hysteroscopic sterilization. J Minim Invasive Gynecol 2007;14:494–501. 5. Friedrich L, Chis C, Panel P. Comment je fais une hysteroscopie avec pose d’implants Essure par vaginoscopie. Gynecol Obstet Fertil 2008:1239–40. 6. Connor VF. Essure: a review six years later. J Minim Invasive Gynecol 2009;16:282–90.
2424
Panel et al.
7. Haute Autorite de Sante. Evaluation des techniques de sterilisation chez la femme et chez l’homme. May 2005. Available at: http://www.has-sante.fr/ portail/jcms/c_272486/evaluation-des-techniquesde-sterilization-chez-la-femme-et-chez-lhomme. Accessed March 22, 2010. 8. Gervaise A, de Tayrac R, Fernandez H. Contraceptive information after endometrial ablation. Fertil Steril 2005;84:1746–7. 9. Cooper JM, Carigna CS, Cher D, Kevin JF, Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:59–67. 10. Kerin JF, Cooper JM, Price T, van Herendael BJ, Cayuela-Font E, Cher D, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre phase II study. Hum Reprod 2003;18:1223–30. 11. Kerin JF, Munday DN, Ritosssa MG, Pesce A, Rosen D. Essure hysteroscopic sterilization: results based on utilizing a new coil catheter delivery system. J Am Assoc Gynecol Laparosc 2004;11:388–93.
Techniques and instrumentation
12. Vleugels M, Veersema S. Hysteroscopic sterilization in the outpatient department without anaesthesia. Gynecol Surg 2005;2:155–8. 13. Mino M, Arjona JE, Cordon J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilization in an outpatient setting: a prospective study of 857 women. BJOG 2007;114:763–6. 14. Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilization. BJOG 2007;114:676–83. 15. Arjona JE, Mino M, Cordon J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with office hysteroscopic tubal sterilization. Fertil Steril 2008;90:1182–6. 16. Grosdemouge I, Engrand JB, Dhainault C, Marchand F, Martigny H, Thevenot J, et al. La pratique Franc¸aise de la pose des implants de sterilisation tubaire Essure. Gynecol Obstet Fertil 2009;37: 389–95.
Vol. 95, No. 7, June 2011
17. Jansen NE, Vleugels M, Kluivers K, Vierhout M. Bilateral cornual abscess after endometrial ablation following Essure sterilization. J Minim Invasive Gynecol 2007;14:509–11.
Fertility and Sterility
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