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Background
The Essure Miro-Insert System is an Food and Drug Administration (FDA)-approved hysteroscopic approach to tubal sterilization. The primary advantages of the Essure System over other techniques of female sterilization are that the Essure System is non-incisional and sterilization can be performed without general anesthesia.
Using a hysteroscopic approach, 1 Essure micro-insert is placed in the proximal section of each fallopian tube lumen. The micro-insert expands upon release, acutely anchoring itself in the fallopian tube. The micro-insert subsequently elicits a benign tissue response. Tissue in-growth into the micro-insert anchors the device and occludes the fallopian tube, resulting in sterilization. According to the labeling, a hysterosalpingogram is necessary three months after surgery to verify micro-insert placement and tubal occlusion.
Approval of the Essure System by the FDA was based on the results of a phase III clinical trial involving 518 sexually active reproductive-age women who underwent a placement procedure. The Essure System was reported to be 98 % effective in preventing pregnancy after 2 years follow-up.
The primary endpoints of the phase III study of Essure were pregnancy prevention, safety of the placement procedure, and safety of long-term use. Secondary endpoints included patient satisfaction and bilateral placement rate. Bilateral placement rate was 86 % on 1st attempt and 90 % on 2nd attempt. Average hysteroscopy time was 13 minutes, and average procedure time was 35 minutes.
Nichols et al (2006) compared hysteroscopic female sterilization with the Essure system performed in-office versus a hospital operating room (OR) among newly trained physicians. Procedure time (scope in/scope out time), device placement rates, and incidence of complications and adverse events were compared. There was no significant difference in scope time between the 2 settings. There was no significant difference in placement rates, although the placement rate was somewhat higher in-office (91 % versus 88 %). There were no complications among any of the procedures, and the incidence of minor adverse events was extremely low in both settings (OR = 2 %, in-office = 1 %). The authors concluded that thereis no clear advantage to performing hysteroscopic sterilization with the Essure system in a hospital operating room. Hysteroscopic sterilization can be performed safely and efficiently in an office setting.
In an observational, multi-center, 6-month study, Panel and Grosdemouge (2008) evaluated a new hysteroscopic method of tubal sterilization; specifically, to examine the factors associated with placement failure of Essure implants. A total of 7 gynecology clinics, including 5 public hospitals and 2 private clinics; and a total of 495 women who provided informed consent were included in this study. All procedures were done by a vaginoscopic approach with a 5-mm operating hysteroscope. Data collected were age, parity, type of anesthesia, pre-medication, endometrial aspect, ostia visualization, duration of the procedure, pain during the procedure, and associated procedures. Unilateral and bilateral placement rates were assessed. Adverse events at 3 months (e.g., expulsion, migration, perforation) were also recorded. Mean parity was 2.45; 20 women were nulliparous. In 56.3 % of cases (n = 277), none or local anesthesia was used for the placement procedure. Overall, 86 % of the women (n = 423) had non-steroidal anti-inflammatory drug (NSAID) pre-medication, and 8.1 % (n = 40) had another intra-uterine surgical procedure performed at the same time. In 24 cases, at least one of the tubal ostia could not be visualized well during hysteroscopy. The authors concluded that the failure rate for Essure micro-insert placement was 6 % at first attempt and 3.3 % after 2 attempts. Success rate was not significantly associated with parity, mode of analgesia, NSAID pre-medication, or combination with another procedure. The only factor significantly associated with the failure rate was poor visualization of the tubal ostia.
An assessment by the National Institute for Health and Clinical Excellence (NICE, 2009) concluded that current evidence on the safety and efficacy of hysteroscopic sterilization by tubal cannulation and placement of intra-fallopian implants is adequate to support the use of this procedure.
Vancaillie and colleagues (2008) evaluated placement efficacy and reliability of a an intra-tubal occlusion device, the Adiana System for Transcervical Sterilization, for permanent contraception and assessed tolerability and overall satisfaction. A total of 770 women with known parity were recruited to participate in a prospective, multi-center study. Bipolar, low-level radiofrequency energy delivery and porous silicon inserts were used. Inserts were placed bilaterally in the fallopian tube lumen. Subsequent bilateral occlusion was assessed with hysterosalpingography. Overall, bilateral placement success was achieved in 611 of 645 women (95 %). Bilateral occlusion was confirmed in 570 of 645 (88.4 %). The 1-year pregnancy prevention rate as derived with life-table methods was 98.9 %. The authors concluded that this transcervical sterilization system offers an effective contraceptive method, which was well-tolerated and had a high satisfaction rate.
Palmer and Greenberg (2009) compared the available data on transcervical sterilization procedures (Essure and Adiana) to study the strengths and weakness of each system. The authors reported that the Essure implants have been offered to women in the U.S. for 7 years and have proved to be safe, effective, and well-tolerated. On the other hand, the experience with the Adiana system is limited (with only 12-month data). However, results from the pivotal study provided important clinical information. As with the Essure implants, the Adiana system appears to be well-tolerated with low rates of side effects, although more data are clearly needed. The overall bilateral placement rates for both systems are similar (94 % to 95 %), and the rates of tubal occlusion following hysterosalpingography are comparable. There have been no reported pregnancies after Essure implantation from the phase II and pivotal clinical trials.
Results from the Evaluation of the Adiana System for Transcervical Sterilization study (Vancaillie et al, 2008) indicated that the cumulative failure rate of the Adiana system using life-table methods was 1.07 % at the primary endpoint of 1 year, which falls within the range of other sterilization methods (0 to 2.4 %).
On July 6, 2009, the FDA approved the Adiana Permanent Contraception System for women who desire permanent birth control by occlusion of the fallopian tubes.
In a prospective comparative study, Darwish and El Saman (2007) examined whether hysteroscopic tubal occlusion will produce the same efficacy as laparoscopic tubal occlusion of functionless hydrosalpinx prior to in vitro fertilization (IVF)/intra-cytoplasmic sperm injection (ICSI). A pilot safety phase included 10 uteri removed by hysterectomy in peri-menopausal women subjected to roller ball coagulation of the peritubal bulge. The study phase included 27 patients with unilateral or bilateral functionless hydrosalpinges, who were randomly divided into 2 groups: (i) group A comprised 14 patients who were randomly allocated for laparoscopic occlusion, and (ii) group B included 13 patients scheduled for a hysteroscopic approach. Laparoscopic occlusion of the isthmic part of the fallopian tube was performed using bipolar diathermy in 9 (64 %) cases or clips in 3 (21.4 %) cases in group A. Roller ball electrode of the resectoscope was utilized for occlusion of the tubal ostium under local, spinal, or general anesthesia in group B. Second-look office hysteroscopy was performed in group B whenever possible. In both groups, hysterosalpingography or sonohysterography was carried out 1 month later to confirm tubal occlusion. Main outcome measures included safety phase aimed at confirming tubal occlusion with minimal harm to adjacent tissues as well as confirmed tubal occlusion of the functionless hydrosalpinx. The safety phase resulted in bilateral complete occlusion of the proximal part of the tubes with secondary coagulation less than 8 mm, as indexed in the histopathological sections. The suspected main cause of functionless hydrosalpinges was iatrogenic (pelvic surgery) in 9 (64 %) and 8 (61.5 %) cases in both groups, respectively. The mean number of abdominal scars/patient was 1.4 and 1.5 in both groups, respectively. Unilateral functionless hydrosalpinx was encountered in 7 (50 %) and 5 (38 %) cases in both groups, respectively. In group A, the procedure was possible and successful in 10 cases (76.9 %), while in group B, hysteroscopic access and occlusion were achieved in 12 (85.7 %) and 9 (64.2 %) cases, respectively. In group B, diagnostic hysteroscopy showed fine marginal adhesions in 2 cases (15 %), and a small polyp in 1 case (7.7 %). Hysteroscopic tubal occlusion showed shorter operative time (9 +/- 2.8 versus 24 +/- 4.8 mins, p = 0.0001) and hospital stay (2 +/- 1.8 versus 5 +/- 1.1 hrs, p = 0.0001). Second-look office hysteroscopy was performed in 8 cases in group B and revealed no significant corneal lesions at the site of hysteroscopic occlusion. The authors concluded that this preliminary study demonstrated the feasibility of hysteroscopic tubal occlusion of functionless hydrosalpinx in all cases with acceptable efficacy. It has the advantage of adding a valuable evaluation of the endometrial cavity prior to IVF/ICSI. It should be an option for treatment protocol in cases of functionless hydrosalpinges. They stated that further large sample-sized studies are needed to test its impact on the implantation rate and clinical outcome.
In a retrospective case-series study, Hitkari et al (2007) described the use of Essure microinsert placement in patients with hydrosalpinges before IVF. A total of 5 women with unilateral or bilateral hydrosalpinges on transvaginal ultrasound, laparoscopy, or hysterosalpingogram who were planning further fertility therapy were included in this study. In all patients, laparoscopy was felt to be relatively contraindicated because of previous extensive abdominopelvic surgery. Hysteroscopic placement of the Essure microinsert was carried out in 4 patients under general anesthesia. One patient underwent fluoroscopically guided placement. Main outcome measures included placement rates and post-operative recovery, technical challenges in Essure placement, and results of subsequent treatment with IVF when available. Successful bilateral Essure placement was confirmed in 2 of 5 patients. Unilateral placement was achieved in 2 of 5. There were no post-operative complications. No pregnancies have occurred thus far. The authors concluded that hysteroscopic placement of the Essure microinsert is a minimally invasive option for proximal tubal occlusion. In patients requiring occlusion of hydrosalpinges before IVF and with contraindications to abdominal surgery, this technique may offer a safer alternative. Pre-operative documentation of proximal tubal patency helps predict placement success. They stated that further research into this unique clinical scenario is needed.
In a prospective, single-arm, clinical study, Mijatovic and colleagues (2010) examined the success rate of proximal tubal occlusion with Essure devices in sub-fertile women with hydrosalpinges, and observed the results of subsequent treatment with in IVF. A total of 10 women with unilateral or bilateral hydrosalpinges prior to IVF were included in this trial. In all patients laparoscopy was felt to be contraindicated. Hysteroscopic placement of Essure devices were carried out in an office setting. Main outcome measures were placement rate, successful proximal tubal occlusion, and pregnancy rate after IVF. All patients had successful placement of the Essure devices without any complications. Proximal tubal occlusion was confirmed by hystero-salpingography in 9 out of 10 patients. A 40 % ongoing pregnancy rate was achieved with 20 % life births after one IVF cycle and/or frozen embryo transfer. The authors concluded that proximal occlusion of hydrosalpinges with Essure devices before IVF is a successful treatment for patients with a contraindication for salpingectomy. The findings of this small study need to be validated by well-designed studies.
In a Cochrane review on surgical treatment for tubal disease in women due to undergo IVF, Johnson et al (2010) concluded that surgical treatment should be considered for all women with hydrosalpinges prior to IVF treatment. Previous evidence supported only unilateral salpingectomy for a unilateral hydrosalpinx (bilateral salpingectomy for bilateral hydrosalpinges). This review provided evidence that laparoscopic tubal occlusion is an alternative to laparoscopic salpingectomy in improving IVF pregnancy rates in women with hydrosalpinges. They stated that further research is needed to evaluate the value of aspiration of hydrosalpinges prior to or during IVF procedures and also the value of tubal restorative surgery as an alternative (or as a preliminary) to IVF. Hysteroscopic tubal sterilization was not mentioned as an option.
Oligbo and colleagues (2010) compared the failure rate (pregnancies) of a Pomeroy procedure and Filshie clips tubal occlusion at the time of Caesarean section. This was a retrospective observational study done in a district general hospital in the United Kingdom. There were 290 sterilizations performed at the time of Caesarean section over the period of 1994 to 2007. Studied population included 203 Pomeroy procedures and 87 Filshie clips applications. Follow-up period ranged from 2 to 15 years. A birth register and an operating theatre database were used to identify patients who underwent Caesarean section with a tubal occlusion. These patients' names were checked against the antenatal booking database, the early pregnancy assessment unit database, the operating theatre database in case of ectopic pregnancies, and a termination of pregnancy database to recognize failed sterilization. There was no failure of tubal occlusion with a Pomeroy procedure (0/203). The failure rate of Filshie clips tubal occlusion was 1.15 % (1/87) (p = 0.3). The length of the follow-up period ranged from 2 to 15 years (for Pomeroy procedure, median was 9 years and inter-quartile range (IQR) was 7; for Filshie clip, median was 8 years and IQR was 7). The authors concluded that Pomeroy technique appears to carry a lower risk of a failed sterilization than Filshie clips tubal occlusion at the time of Caesarean section. However, Pomeroy procedure needs to be balanced against the speed and simplicity of Filshie clips tubal occlusion.
In a Cochrane review, Lawrie et al (2011) compared the different tubal occlusion techniques in terms of major and minor morbidity, failure rates (pregnancies), technical failures and difficulties, and women's and surgeons' views. Originally MEDLINE and The Cochrane Controlled Trials Register were searched. For the 2010 update, searches of Popline, Lilacs, PubMed and The Cochrane Controlled Trials Register were performed. Reference lists of identified trials were searched. All randomized controlled trials (RCTs) comparing different techniques for tubal sterilization, regardless of the route of Fallopian tube access or the method of anesthesia were include in the analysis. Trials under consideration were evaluated for methodological quality and appropriateness for inclusion. A total of 9 relevant studies were included and the results were stratified in 5 groups: tubal ring versus clip, modified Pomeroy versus electrocoagulation, tubal ring versus electrocoagulation, modified Pomeroy versus Filshie clip and Hulka versus Filshie clip. Results were reported as odds ratio for dichotomous outcomes and weighted mean differences for continuous outcomes. Tubal ring versus clip: Minor morbidity was higher in the ring group (Peto OR 2.15; 95 % confidence interval [CI]: 1.22 to 3.78). Technical difficulties were found less frequent in the clip group (Peto OR 3.87; 95 % CI: 1.90 to 7.89). There was no difference in failure rates between the 2 groups (Peto OR 0.70; 95 % CI: 0.28 to 1.76). Pomeroy versus electrocoagulation: Women undergoing modified Pomeroy technique had higher major morbidity than those with the electrocoagulation technique (Peto OR 2.87; 95 % CI: 1.13 to 7.25). Post-operative pain was more frequent in the Pomeroy group (Peto OR 3.85; 95 % CI: 2.91 to 5.10). Tubal ring versus electrocoagulation: Post-operative pain was more frequently reported in the tubal ring group. No pregnancies were reported. Pomeroy versus Filshie clip: In the only trial comparing the 2 interventions only 1 pregnancy was reported in the Pomeroy group after follow-up for 24 months. No differences were found when comparing Hulka versus Filshie clip in the only study that compared these 2 devices. The authors concluded that electrocoagulation was associated with less morbidity including post-operative pain when compared with the modified Pomeroy and tubal ring methods, despite the risk of burns to the small bowel. The small sample size and the relative short period of follow-up in these studies limited the power to show clinical or statistical differences for rare outcomes such as failure rates. Aspects such as training, costs and maintenance of the equipment may be important factors in deciding which method to choose.
Madari et al (2011) noted that the modified Pomeroy procedure is currently the most widely used method for post-partum sterilization. Alternative options are Filshie clips, Hulka-Clemens clips and Falope rings. In this systematic review these researchers pooled the available evidence in order to compare the failure rates, complications, technical difficulties, and reversibility of the Pomeroy method and Filshie clips when resorted to for post-partum sterilization. These investigators gathered data from MEDLINE, EMBASE (1970 to 2010), the Cochrane database, and reference lists of RCTs and observational studies. They extracted information on study design, sample characteristics, interventions, and outcomes. These investigators search yielded 294 citations of which 43 were retrieved for detailed evaluation. A total of 14 studies were included in the systematic review; 1 RCT and 3 observational studies compared failure rates of the Pomeroy method versus Filshie clips. A random-effects analysis of the pooled studies showed no difference in the failures rates between these 2 methods (odds ratio 0.76 [95 % CI: 0.30 to 1.95]). Complication rates were similar although the Filshie clip technique was reported to be easier. The authors concluded that Filshie clip application is easier to perform. The failure and complication rates are comparable to those of the modified Pomeroy method, when performed in the post-partum period.
In a systematic review, Rodriguez et al (2011) examined the effectiveness of the titanium clip in post-partum sterilization. These investigators searched the Medline and Cochrane databases from their inception through January 2011 for all articles in any language pertaining to the titanium clip use in post-partum sterilization. Reference lists and device registration files were also searched. They identified 13 articles for this review -- 10 observational trials and 3 reports from 1 single RCT. Studies were included if they used the titanium clip for sterilization during the post-partum period and reported subsequent pregnancy as an outcome. Studies of the Hulka clip (spring-loaded) without a titanium comparison group or of the post-abortion population were excluded. Data abstraction was independently performed by 2 authors. Standard data abstraction templates were used to systematically assess and summarize the data. Quality of the evidence was rated with the U.S. Preventive Task Force System. Effectiveness of the titanium clip was estimated from the only RCT identified. This trial found a significantly increased risk of pregnancy at 24 months with clip sterilization post-partum (cumulative rate 1.7 compared with 0.04, p = 0.04) compared with post-partum partial salpingectomy. The authors concluded that based on limited data, the titanium clip has reduced effectiveness than partial salpingectomy in the post-partum population. They stated that routine use of the titanium clip during the post-partum period should not be recommended.
Appendix
Hysteroscopic tubal sterilization is contraindicated in any woman who:
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Can have only occlusion device placed (including members with apparent contralateral proximal tubal occlusion and members with a suspected unicornuate uterus); or
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Has previously undergone a tubal ligation; or
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Is uncertain about her desire to end fertility.
Hysteroscopic tubal sterilization is also contraindicated for women with any of the following conditions:
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Active or recent upper or lower pelvic infection; or
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Delivery or termination of a pregnancy less than 6 weeks before occlusion device placement; or
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Known allergy to contrast media; or
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Pregnancy or suspected pregnancy.
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