The Essure method is the only available hysteroscopic sterilisation method. A 4-cm device is placed in the fallopian tubes, which then induces an inflammatory reaction that causes occlusion. The method has a high successful placement rate and high effectiveness, and it can be performed in an office setting without anaesthesia. Three months after the procedure, a confirmation test has to be conducted to assure a correct position of the micro-inserts and tubal occlusion. This test can be performed by hysterosalpingography (HSG), plain X-ray or ultrasound. Pregnancies reported after Essure sterilisation are, in a majority, related to non-adherence to the follow-up protocol or misreading of the confirmation test. A majority of the pregnancies occurred after HSGs that were determined to have been misinterpreted, including missed expulsion or perforation of the micro-insert. Other complications such as ectopic pregnancy and allergic reaction to the micro-inserts seem to have been described to be of low incidence.
Highlights
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The Essure sterilisation method has a high placement rate and effectiveness.
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A confirmation test 3 months after the procedure is indicated.
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Pregnancies after Essure sterilisation are related to non-compliance of the follow-up protocol and incorrect placements of micro-inserts.
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Essure can be used for pre-in vitro fertilisation (IVF) closure of hydrosalpinges.
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Global endometrium ablation techniques can be used in patients with micro-inserts in situ.
Introduction
Female sterilisation, by tubal ligation or tubal occlusion, is the most commonly used method of family planning in the world. Overall, in developed regions, 8.1% of women between the ages of 15 and 49 years, married or in a union, currently use female sterilisation for contraception, compared with 22.3% of those in less developed regions. More than 180 million couples rely on tubal sterilisation for contraception . Approximately 75% of these people live in Asia (China and India). The majority of procedures are abdominal, performed by laparotomy or laparoscopy.
Approximately 50% of all female sterilisations are performed during caesarean section or in the puerperal period. The other 50%, which is called ‘interval sterilisation’, is performed at least 6 weeks after the last pregnancy or delivery . Pomeroy in the 1930s made tubal sterilisation well known but, because a laparotomy was needed, it was still considered a major procedure. The mini-laparotomy, an abdominal incision 2–3 cm in length, was first described by Uchida and colleagues in 1961, offering a reduced recovery time and a better cosmetic result . Colpotomy, a technique that dates back to the early 19th century, began to attract new interest in the 1970s. Through a small incision in the anterior or posterior vaginal fault, a modified Pomeroy technique or fimbriectomy was performed. Surprisingly, the complication rates in Europe and the US were much higher than those in India, and the method was abandoned.
Laparoscopic sterilisation
The techniques and settings of sterilisation have progressively changed since the 1960s with the introduction of minimally invasive surgery. While in developing countries mini-laparotomy remains the most common approach, in developed countries nearly all interval sterilisations and an increasing proportion of post-partum sterilisations are performed by laparoscopy . Various laparoscopic methods have been introduced since 1936. Unipolar coagulation was the first method of laparoscopic tubal occlusion to achieve widespread use. Although highly effective, it was associated with early reports of thermal injuries, including thermal bowel lesions and deaths. In 1972, bipolar electrocoagulation of the tubal isthmus was first introduced, which eliminated the need for a ground plate and was safer for the patient . Several alternative laparoscopic techniques were introduced in the early 1970s. The elastic rubber band was developed by Yoon. The band is introduced with a specially designed laparoscopic applicator. The application of the band onto a tubal loop is associated with a 2–3% incidence of haemorrhage from stretching the vessels underneath the tube or tearing the tube itself . Approximately 3 cm of the constricted tube undergoes necrosis. An advantage of the spring/Hulka clip was that it only compresses 3 mm of the mid-isthmus of the tube. As a result, anastomosis for reversal of sterilisation is fairly successful. Another technique, described by Filshie and colleagues, uses a silicone rubber-lined titanium clip applied to the mid-isthmus and necessarily including the entire circumference of the tube . The Filshie clip has been used around the world for the past 20 years, and it was approved by the Food and Drug Administration (FDA) in the United States in 1996.
All methods currently in use are highly effective when performed properly, although pregnancy can occur in spite of optimal application. Such failures are often due to tubo-peritoneal fistula formation. When pregnancies do occur, they are much more likely to be ectopic than pregnancies during use of other methods or when no method is used. The risk of pregnancy persists during the fecund period, and it is therefore important to consider the long-term cumulative probability of pregnancy with any contraceptive method – or methods – over time. Unfortunately, there are no controlled trials comparing the different laparoscopic techniques with a follow-up period long enough to provide evidence on long-term failure rates . Pregnancies can and do occur even many years after sterilisation, as has been documented by the US Collaborative Review of Sterilisation (CREST study) in which pregnancies occurred in the 10 years after each of the four methods of laparoscopic sterilisation studied (unipolar coagulation, bipolar coagulation, silicone rubber-band application and spring-clip application). An analysis of the experience of 10,685 women followed up prospectively for up to 8–14 years in the CREST study identified 143 sterilisation failures (pregnancies other than luteal-phase pregnancies) and found that the risk of pregnancy after sterilisation varied by age at sterilisation and method of tubal occlusion. The 10-year cumulative probability of pregnancy was low for most women aged 34–44 years at sterilisation, but it was as high as 5% for women aged 18–27 years with two methods (bipolar coagulation and spring-clip application). Another noteworthy finding from this analysis is that the risk of pregnancy accumulated over time. The timing of sterilisation failures varied by method; for example, a high proportion of pregnancies after clip application occurred in the first 3 years after the procedure, whereas pregnancies after bipolar coagulation occurred at approximately the same rate year after year. A total of 47 (32.9%) of the 143 pregnancies identified were ectopic. The cumulative probability of ectopic pregnancy, like that for pregnancies overall, increased over time and varied by method of occlusion and age at sterilisation . The findings from this review of sterilisation techniques should be interpreted with some precaution, keeping in mind that they were based on procedures performed >20 years ago and that a substantial number of the procedures were performed shortly after the introduction of laparoscopic sterilisations in the USA. A subgroup analysis of women undergoing bipolar tubal coagulation showed that the cumulative failure rate during the period 1978–1982 (19.5 per 1000) was three times higher than during the period 1985–1987 (6.3 per 1000). In addition, those women who had three or more sites coagulated had a very low probability of pregnancy (3.2 per 1000) compared to women with fewer sites coagulated (12.9 per 1000) .
The Filshie clip was not available in the United States until 1996 and it was not included in the US CREST study. However, published data suggest that the clip is, similar to the other methods of tubal occlusion, highly effective. Four studies from the Family Health International (FHI) were designated pivotal evaluations: all were prospective, randomised and multicentre investigations of interval sterilisations. A 12-month cumulative pregnancy rate of 0.1–0.2 per 100 women for the Filshie clip was reported . Long-term follow-up data for the Filshie clip such as those obtained by CREST are limited. A 5-year follow-up study from Kovac and Krins involving 30,000 women revealed a failure rate of 73 per 30,000 (2.4 per 1000) .
Laparoscopic sterilisation
The techniques and settings of sterilisation have progressively changed since the 1960s with the introduction of minimally invasive surgery. While in developing countries mini-laparotomy remains the most common approach, in developed countries nearly all interval sterilisations and an increasing proportion of post-partum sterilisations are performed by laparoscopy . Various laparoscopic methods have been introduced since 1936. Unipolar coagulation was the first method of laparoscopic tubal occlusion to achieve widespread use. Although highly effective, it was associated with early reports of thermal injuries, including thermal bowel lesions and deaths. In 1972, bipolar electrocoagulation of the tubal isthmus was first introduced, which eliminated the need for a ground plate and was safer for the patient . Several alternative laparoscopic techniques were introduced in the early 1970s. The elastic rubber band was developed by Yoon. The band is introduced with a specially designed laparoscopic applicator. The application of the band onto a tubal loop is associated with a 2–3% incidence of haemorrhage from stretching the vessels underneath the tube or tearing the tube itself . Approximately 3 cm of the constricted tube undergoes necrosis. An advantage of the spring/Hulka clip was that it only compresses 3 mm of the mid-isthmus of the tube. As a result, anastomosis for reversal of sterilisation is fairly successful. Another technique, described by Filshie and colleagues, uses a silicone rubber-lined titanium clip applied to the mid-isthmus and necessarily including the entire circumference of the tube . The Filshie clip has been used around the world for the past 20 years, and it was approved by the Food and Drug Administration (FDA) in the United States in 1996.
All methods currently in use are highly effective when performed properly, although pregnancy can occur in spite of optimal application. Such failures are often due to tubo-peritoneal fistula formation. When pregnancies do occur, they are much more likely to be ectopic than pregnancies during use of other methods or when no method is used. The risk of pregnancy persists during the fecund period, and it is therefore important to consider the long-term cumulative probability of pregnancy with any contraceptive method – or methods – over time. Unfortunately, there are no controlled trials comparing the different laparoscopic techniques with a follow-up period long enough to provide evidence on long-term failure rates . Pregnancies can and do occur even many years after sterilisation, as has been documented by the US Collaborative Review of Sterilisation (CREST study) in which pregnancies occurred in the 10 years after each of the four methods of laparoscopic sterilisation studied (unipolar coagulation, bipolar coagulation, silicone rubber-band application and spring-clip application). An analysis of the experience of 10,685 women followed up prospectively for up to 8–14 years in the CREST study identified 143 sterilisation failures (pregnancies other than luteal-phase pregnancies) and found that the risk of pregnancy after sterilisation varied by age at sterilisation and method of tubal occlusion. The 10-year cumulative probability of pregnancy was low for most women aged 34–44 years at sterilisation, but it was as high as 5% for women aged 18–27 years with two methods (bipolar coagulation and spring-clip application). Another noteworthy finding from this analysis is that the risk of pregnancy accumulated over time. The timing of sterilisation failures varied by method; for example, a high proportion of pregnancies after clip application occurred in the first 3 years after the procedure, whereas pregnancies after bipolar coagulation occurred at approximately the same rate year after year. A total of 47 (32.9%) of the 143 pregnancies identified were ectopic. The cumulative probability of ectopic pregnancy, like that for pregnancies overall, increased over time and varied by method of occlusion and age at sterilisation . The findings from this review of sterilisation techniques should be interpreted with some precaution, keeping in mind that they were based on procedures performed >20 years ago and that a substantial number of the procedures were performed shortly after the introduction of laparoscopic sterilisations in the USA. A subgroup analysis of women undergoing bipolar tubal coagulation showed that the cumulative failure rate during the period 1978–1982 (19.5 per 1000) was three times higher than during the period 1985–1987 (6.3 per 1000). In addition, those women who had three or more sites coagulated had a very low probability of pregnancy (3.2 per 1000) compared to women with fewer sites coagulated (12.9 per 1000) .
The Filshie clip was not available in the United States until 1996 and it was not included in the US CREST study. However, published data suggest that the clip is, similar to the other methods of tubal occlusion, highly effective. Four studies from the Family Health International (FHI) were designated pivotal evaluations: all were prospective, randomised and multicentre investigations of interval sterilisations. A 12-month cumulative pregnancy rate of 0.1–0.2 per 100 women for the Filshie clip was reported . Long-term follow-up data for the Filshie clip such as those obtained by CREST are limited. A 5-year follow-up study from Kovac and Krins involving 30,000 women revealed a failure rate of 73 per 30,000 (2.4 per 1000) .
Hysteroscopic sterilisation
The idea of utilising hysteroscopy for tubal occlusion goes back for more than a century. In the last 100 years, transcervical approaches were studied and promoted during four separate periods, beginning in the early 1920s. During World War II, in 1942, Clauberg started his criminal research in Auschwitz on thousands of imprisoned Jewish and Gypsy women, looking for a cheap and efficient method to sterilise women. He injected acid liquids into their uterus without the use of anaesthetics. After the war, Lindemann continued sterilisation experiments with the Clauberg technique of coagulating the fallopian tubes . The fourth period started at the beginning of this century . Hysteroscopic sterilisation techniques have been sought because they avoid the risks of the laparoscopic route, they allow women a quicker return to normal activities and they are especially useful in women for whom laparoscopy is contraindicated. The methods for tubal closures include chemical applications, mechanical devices and thermal methods where electrosurgery, cryocoagulation, radiofrequency and laser are used.
Thermal
In 1934, the first hysteroscopic sterilisation with electrocoagulation was performed in two patients. Both procedures were unsuccessful. In the 1970s, an overall bilateral tubal occlusion rate of 83% was achieved, but pregnancies including ectopics were reported . Finally, the method did not prove to be reliable, and the patients suffered from serious complications due to bowel injury . Other methods with cauterisation of the tubal openings have not been developed further .
Chemical
Quinacrine sterilisation is used in many developing countries because of good results and low costs. The technique requires two insertions of quinacrine into the uterine cavity. This can be done ‘blind’ or by hysteroscopic guidance and direct tubal instillation by a specially developed catheter . The procedure is reported to have a 1–2% failure rate, although the rates for ectopic pregnancy and serious complications are equal to or less than those for transabdominal sterilisation . The drawbacks of the procedure include the need for multiple applications and the problem of reliably confirming tubal occlusion. A hysterosalpingogram (HSG) is not recommended, because of the risk of blowing out the delicate occluding scars . The need to make this procedure simple, safe, inexpensive and thereby more acceptable, even in countries with limited surgical facilities, is well recognised. Use of quinacrine pellets has become the most widely adopted method of non-surgical female sterilisation . The FHI has recently decided not to pursue further research on quinacrine, partly because of the relatively high pregnancy rates after quinacrine compared to other contraceptive methods . The 10-year pregnancy probability is approximately four times higher than after laparoscopic tubal sterilisation (bipolar coagulation) as reported by CREST.
Mechanical
To avoid the risk of complications of thermal and chemical methods, many different devices were developed and tested during the second half of the last century. Most of the devices were unsuccessful . Three devices became commercially available and they were introduced to the European market.
Ovabloc intratubal device
The concept of blocking the fallopian tubes with silicone was first introduced by Crofman . The first studies performed on rabbits proved an efficacy of 100% if the silicone material was applied up to the isthmic part of the tubes. Erb developed a technique for hysteroscopic intratubal administration of liquid silicone, mixed with a catalyst and a ‘cure in place’ to form rubbery implants, with the aim of producing a non-incisional, non-scarring method for permanent contraception with minimal discomfort for the patient .
This Ovabloc method has been in use since 1978. Phase II and III studies were performed in the late 1970s and early 1980s in Belgium and the USA . These FDA trials were stopped when the initially assumed reversibility was poor . In 1985, the Ovabloc procedure became commercially available in the Netherlands (Ovabloc Europe BV, Alphatron Medical Systems, Rotterdam, later Advanced Medical Grade Silicones BV, Beverwijk, the Netherlands), where its use has mainly been confined to a few centres . A Conformité Européene (CE) mark for the European market was achieved in 2001.
The insertion is an outpatient procedure. The procedure involves high-pressure injection of viscous silicone into the ostium with a catheter placed in the tubal ostium through a hysteroscope with a 7-French working channel. The silicone conforms to the shape of the ampoule of the tube and solidifies in approximately 5 minutes. The silicone contains radiopaque silver powder, which enables a radiological check for correct placement at completion of the procedure. Bilateral placement takes around 30 min. The woman is asked to use contraception for 3 months, at which point a second plain X-ray is performed to exclude migration and expulsion. Published data report a high failure rate, expulsion to the abdominal cavity and complete expulsions. The method never became very popular, probably because it was too complicated. It was stopped in 2009. In 2012, CE approval was obtained for Ovalastic (Urogyn BV, Nijmegen, the Netherlands), which is the result of a technical upgrade of Ovabloc. With this upgrade, the manufactory claims a less time-consuming, more reliable and safe procedure.
Adiana
The complete transcervical sterilisation procedure of Adiana (Adiana Inc., Redwood City, CA purchased by Hologic, USA) is a two-stage procedure. First, a superficial lesion of the epithelium of the intramural part of the tube is created with bipolar radiofrequency energy. The second step is placement of a 3.5-mm porous, silicone, non-biodegradable implant (matrix) into the tubal lumen. The implant provokes a fibrous reaction that occludes the tube over a period of weeks. Patients must use alternative contraception for 3 months until an HSG is performed. A CE mark for the European market was obtained in December 2008, and the FDA approved the application in July 2009. The Evaluation of Adiana System (EASE trial) was completed in 2005 . It was stated that 611 women were treated, with a 95% bilateral insertion rate. Almost half of the patients (47%) received conscious sedation with an intravenous agent. The HSG confirmation test after 3 months showed tubal patency of one or both tubes in 8.8% of the patients. During the first 4 years of this trial, 15 pregnancies were reported. Five of the pregnancies occurred while subjects were instructed to rely on an alternate contraceptive: two pregnancies following placement failure and three pregnancies after successful placement, but during the waiting period (patient non-compliance). Ten pregnancies occurred following successful placement and HSG showing tubal occlusion. Six of these pregnancies occurred in the first year of reliance on the device. A retrospective review of HSGs for three of these subjects suggests that the diagnosis of tubal occlusion was in error (misread). The six pregnancies contributed to a 1-year failure rate of 1.1%. In March 2012, the manufactory decided Adiana was not generating the expected revenue, hence stopping the manufacture of Adiana. At that moment, a long-standing battle over patent infringement between the company and Conceptus (Essure) was taking place.
Essure
In November 2002, the FDA approved the Essure sterilisation while it has been available on the European market since 2001 (Conceptus Inc., Mountain view, CA, USA). The device is a dynamically expanding insert that consists of a stainless steel inner coil, a nickel titanium (nitinol) expanding outer coil and polyethylene terephthalate (PET) fibres. The device, with a length of 4 cm, is placed into the fallopian tube using a modern standard hysteroscope with a 5-French working channel. After placement, the device is anchored in the tubo-cornual junction by the expanded nitinol coil. The PET fibres induce an inflammatory reaction that causes scarring and occlusion of the tubes. The exact time that it takes for tubal occlusion of the tubes to allow the patient to rely on the devices as permanent contraception is unknown . Obliteration of the tubal lumen was demonstrated histologically in four of nine tubes removed within 4 weeks after device placement and five of five tubes removed within 4–8 weeks after placement. Functional occlusion confirmed by HSG was already confirmed 1 week after placement . Patients are instructed to use alternative contraception until a 3-month confirmation test has shown adequate bilateral localisation and tubal occlusion. In the US, an HSG is required for confirmation according to the FDA approval, while in other countries scout X-ray or transvaginal ultrasound (TVU) is used for confirmation. The ESS205, a modification of the former ESS 105 device, with higher insertion rates was introduced in 2004. In 2007, the ESS 305 with an automatic-release mechanism of the introducer catheter and a special introducer was presented.
Successful placement is achieved in 95–99% of the cases in an office setting . Worldwide, >750,000 women rely on Essure sterilisation. The cumulative 9-year failure rate is 0.2% on the basis of follow-up data from 449 women included in Phase II and pivotal trials . More than 700 unintended pregnancies are reported in the first 10 years of use . Data analysis of patient files shows that 44% of the pregnancies are attributed to patient non-adherence to the protocol or misreading of the confirmation test. Shavell reported a 12.7% compliance with the 3-month HSG in a general clinic population in an urban environment, despite both preoperative and post-operative counselling and a follow-up rate of 70% for the 1-week post-operative control . Of the 508 evaluable pregnancies in the study of Munro , 32 (6.3%) gestations were categorised as luteal-phase pregnancy, which means that the gestation already existed at the time of Essure placement. Of the 508 women who became pregnant , 41.7% of HSGs were determined to have been misinterpreted, including missed expulsion (4.7%) or perforation of a micro-insert (18.7%). Five percent of the HSGs were categorised as ‘inadequate’, including HSGs that failed to demonstrate adequate filling of the endometrial cavity and cornual regions or inadequate views or image resolution, rendering determination of satisfactory micro-insert location and bilateral tubal occlusion impossible or equivocal. In 45% of the evaluable post-Essure pregnancies, the patient failed to use additional contraception after the procedure or did not return to the confirmation test. A likely diagnosis of ectopic pregnancy was found in 30 cases.
In a systematic review, Cleary reported 102 pregnancies . Few pregnancies occurred in women with confirmed bilateral occlusion, with the longest follow-up being 7 years. Again, a large percentage of failures after complete or incomplete confirmatory testing, and the importance of correct intratubal position and occlusion cannot be underemphasised (see confirmation test).
Al-Safi et al. examined the Manufacturer and User Facility Device Experience (MAUDE) database for complications related to Essure hysteroscopic sterilisation during the 10-year period 2002–2012. There were 457 reported adverse events, including events that occurred during the procedure, symptoms the patient experienced afterward and findings diagnosed later. The most frequent reported adverse events were pain (47.5%) followed by delivery catheter malfunction (26.4%), perforation (19.7%), pregnancy (13.3%), abnormal bleeding (9.6%), device malposition (7.2%) and allergic reaction (5.3%). There seems to be no relation between the experience of the physician and the frequency of misplacement, perforation and expulsion of Essure micro-inserts. Twenty-nine of the 61 post-operative pregnancies were ectopic pregnancies. This high occurrence suggests that there is a high risk of ectopic pregnancy in women who become pregnant following the Essure procedure. The CREST showed already that there is a high incidence of ectopics after failure of tubal ligation, but this conclusion cannot be made on the data from the MAUDE database because they cannot be used to establish rates of adverse effects. In the study by Munro et al. of 749 reported pregnancies, only 30 were ectopic, a rate of 0.006% using the number of kits distributed as the denominator.
Of the 20 reported cases of allergic reactions in the MAUDE database, only four had been confirmed by allergy testing. There were 16 reports of concomitant use of Essure with endometrial ablation techniques. The most frequent symptom was pain, which in two cases was the reason for hysterectomy. The instructions for use of the Essure procedure state that it should not be performed concomitantly with any endometrial ablation technique, although according to the FDA it can be safely and effectively performed with the Essure micro-inserts in place .
In 2013, complications related to Essure hysteroscopic sterilisation gained media attention and online exposure via women’s social networks.
In a systematic review in 2014, Adelman et al. summarised the complications of Essure placement, with focus on management strategies that have been reported in the literature and recommendations as to how management strategies should be applied. Besides, 90 cases of perforations and 33 malpositions not otherwise specified were reported. The rate of tubal perforation was 2.6% in the Phase II trial and 0.9% in the Phase III trial . In many case reports, difficult insertion was associated with subsequently identified malposition or perforation. Two serious complications occurred 4 weeks after placement as a result of perforation causing a bowel obstruction due to a band of adhesions resulting in a closed-loop obstruction and a strangulation of the bowel. Laparoscopic removal should be considered after perforation of a micro-insert especially when it is discovered within 3 months after placement and accompanied by pain and abdominal distension.
Several case reports and case series have documented adverse events due to suspected nickel hypersensitivity, some with confirmed sensitisation at skin patch testing and others with normal results. In four cases with manifestations of contact allergic reaction and confirmed nickel hypersensitivity, the symptoms improved shortly after removal of the devices and resolved within 3–12 months after removal.
In women with symptoms without any obvious alternative cause, it may be reasonable to remove the devices if conservative management is ineffective. Universal patch testing before placement of Essure is not cost-effective and is not recommended. When patients exhibit symptoms post-operatively, patch testing should be performed to confirm sensitivity, and if results are positive the threshold to remove should be low. There is no single method by which appropriately placed devices may be removed. If the patient is still seeking sterilisation, laparoscopic removal and salpingectomy may be indicated.
Hysteroscopy for sterilisation
Between the 1970s and 1980s, modern hysteroscopy was introduced. Procedures for distending the uterine cavity were introduced, with carbon dioxide and high molecular weight fluids allowing visualisation of the uterine cavity and tubal ostia . The Ovabloc ITD procedure was performed using a single-flow hysteroscope with an Alberan deflexion bridge, initially with Hyskon (32% dextran 70 in 10% glucose) or carbon dioxide as the distension medium. From 1991, a continuous-flow 8.0-mm hysteroscope with a 2.2-mm (7-French) working channel and an Alberan deflexion bridge, fitted with a 4-mm 30° fore-oblique telescope, was used with sorbitol for uterine distension .
Pain regimen
At the beginning of the 1990s, scopes were used with operative sheaths with a diameter ≤5.5 mm with a working channel of 1.7 mm (5 French) and telescopes with a diameter ranging between 1.2 and 3 mm. With the use of these smaller instruments, the use of a speculum and tenaculum and dilatation of the cervix were no longer necessary: the vaginal cavity can be distended with a distension medium to facilitate location of the cervical canal. The anatomy can be followed by gentle movements of the hands that correctly drive the hysteroscope into the cervix and through the internal cervical os . This method has been defined as the ‘vaginoscopic approach’, and the patient discomfort associated with the traditional approach to the uterus is eliminated .
As anaesthesia and analgesia are not required for hysteroscopy, women now have the option of permanent contraception while avoiding the risk associated with laparoscopy and general anaesthesia. Some physicians are still hesitant to perform the procedure in an office setting, most commonly citing patient discomfort as the major concern, but several studies support high tolerability and satisfaction with an office approach .
One study indicates that patients undergoing hysteroscopic sterilisation experience significantly less pain than those undergoing laparoscopic sterilisation .
Paracervical block with 1% lidocaine provides effective pain relief for cervical manipulations during office hysteroscopic sterilisation, but it does not reduce the pain associated with upper uterine/tubal manipulation when placing the devices .
Pain scores were associated with procedural time. A likely explanation for this is that procedural time is a marker for difficulty of the procedure or skills of the hysteroscopist. In general, the more difficult the Essure placement, the longer will it take to achieve correct placement, and the more frequent the additional manipulations needed to assist in appropriate placement, the more cramping of the fallopian tubes will be induced. An important finding is that the largest difference in observed pain scores was 2.3 on the visual analogue scale (VAS). Although for the purposes of this study a relatively conservative difference of 0.9 on the VAS was used to be clinically relevant to prevent underpowering, some studies indicate that the clinically relevant VAS difference is around 2.5. Therefore, although a difference was observed and found to be statistically significant, this may not represent a clinically relevant difference. When examining the placebo group, we observed that pain was not significantly greater than reported menstrual pain. This is critical when counselling patients regarding the pain from the Essure procedure, as well as likely other office hysteroscopy procedures that require less manipulation than Essure. Because pain is one of the most common patient concerns when choosing to undergo an office procedure, the ability to tell a patient that the pain will be similar or less than a typical menstrual period can be very reassuring for many patients .
According to a Cochrane review from 2012, the available literature is insufficient to determine the appropriate pain regimen for outpatient sterilisation by hysteroscopy. Neither paracervical block with lidocaine nor conscious sedation significantly reduced overall pain scores during sterilisation by hysteroscopy with Essure. Although paracervical block with lidocaine did not reduce overall patient-reported pain, it did reduce pain during some portions of the procedure, particularly with injection into, or manipulation, of the cervix. As paracervical anaesthesia is safe and inexpensive, it may be a reasonable option. The provision of intravenous conscious sedation did not reduce the total pain score, but it did significantly reduce pain at the time of insertion of the second tubal insert; this is one of the most painful parts of the procedure. Thus, it may have some benefit .
Confirmation test
In the late 1970s, the HSG was abandoned as a routine follow-up after laparoscopic sterilisation because of discordance between tubal patency and pregnancy rate. In a study of 250 women with laparoscopic tubal fulguration, the patency rate with HSG was 3.6% while the pregnancy rate was only 0.62%. A review of additional contemporary studies confirmed discordant patency and pregnancy rates .
The results of the CREST review did not change the policy of confirmation of laparoscopic sterilisation. The CREST review reported an overall cumulative failure rate of 1.9%. This was more than double of what has been accepted as the standard failure rate for tubal sterilisation. This failure rate contrasted sharply with previous studies of common tubal occlusion techniques that cited figures lower than 1%. Until then, comparisons of contraceptive failure rates had reported the probability of failure during the first year after sterilisation to range between 0% and 0.4% . These failure rates, however, were based on investigations having only 1 or 2 years of follow-up. Alternative diagnostic tests for confirmation of laparoscopic sterilisation have not been described.
For all hysteroscopic techniques, initially, an HSG was recommended. For the Ovabloc method, finally, two X-ray images were required to evaluate the effectiveness of the device: one X-ray immediately following instillation to check the integrity and shape of the plug and a second X-ray at 3 months post instillation to check the proper location of the Ovabloc devices. This decision that patients could not rely on the sterilisation for 3 months was an arbitrary point in time .
The first and only study with available data for the Adiana method reports 53 of 604 patients with unilateral or bilateral tubal patency with the 3-month HSG. By 6 months post procedure, 26 still showed at least unilateral patency. With TVU, 598/604 subjects had devices visualised bilaterally. There have been a total of 10 pregnancies among 553 women who were told to rely on Adiana for contraception based on the 3-month HSG, two pregnancies of which were ectopic. It is unclear how the TVU imaging correlates with these unintended pregnancies. The devices are not radiopaque; therefore, pelvic X-ray is not useful for the confirmation .
In the US, according to the FDA, an HSG is required after hysteroscopic sterilisation with Essure, while in Europe and other countries initially X-ray was an accepted alternative. In February 2011, the CE mark approved the use of TVU to confirm the proper placement of the micro-insert, 3 months following the procedure. Available data confirm that the proper location of the micro-inserts correlates very well with tubal occlusion and high effectiveness . Evaluation of data from 745 patients with unintended pregnancies showed a high incidence of misreading of the HSGs and patient non-compliance to the HSG confirmation test . In an urban clinic population in Michigan, the compliance to a protocol with HSG revealed only 12.7%, despite correct counselling and a 70% follow-up rate for the post-operative visit . Studies with confirmation tests other than HSG report higher patient compliance .
There is a need for other tests to confirm the proper position and tubal occlusion after sterilisation. HSG is still the gold standard. The procedure is invasive and uncomfortable for the patient. In addition, it is associated with infection, vasovagal reaction and anaphylactic shock. In addition, uterine bleeding and perforation may occur.
Alternative ideas are suggested and are the subject of research: In contrast infusion sonography (CIS) or saline infusion sonography (SIS) , NaCl infusion in the uterine cavity is carried out while inspecting for real-time flow within the tube or unequivocal dye spill in the adnexa . Hysterosalpingo-contrast sonography (HyCoSY) uses an ultrasound contrast agent to examine tubal patency. Volume contrast three-dimensional (3D) ultrasound produces a 5-mm-thick image in the C-plane (VCI-C) similar to HSG. The images yield more detail with regard to the relationship of the device to the uterine cavity than conventional (two-dimensional (2D)) ultrasound or HSG. Like 2D US, it gives information about the position of the micro-insert but not about the integrity of the fallopian tubes. A classification has been developed to assess the position of the micro-insert. Four positions are described: perfect, proximal, distal and very distal. Only the last position is associated with a higher chance of tubal patency on HSG .
Global endometrial ablation and hysteroscopic sterilisation
The transcervical approach of hysteroscopic sterilisation and endometrial ablation makes it very attractive to women to combine both procedures at one time but the instructions for use of the Essure procedure state that it should not be performed concomitantly with any endometrial ablation technique.
The FDA approved three types of third-generation methods of global endometrial ablation for use with Essure in situ: Novasure (Hologic, Bedford, MA, USA), hydrothermal ablation (HTA) and Thermachoice (Ethicon, Somerville, MA, USA). Several studies have reported data about the safety and efficacy of performing an endometrial ablation with Essure coils in situ and that HSG was not compromised by post-ablation intrauterine adhesions . Peri-hysterectomy studies showed that the depth of ablation was not altered by the presence of micro-inserts in tubes. No thermal or electrical conduction extend to the serosa .
In a case report, a patient with Essure micro-inserts in situ developed bilateral abscesses 3 months after thermal balloon ablation. She was treated with doxycycline and metronidazole, and she underwent a laparotomy with bilateral salpingectomy. Micro-inserts were located in the centre of each abscess. The patient recovered without further complications. The authors discuss the possibility of asymptomatic endometritis and consequent bilateral abscess formation at the site of foreign bodies after the endometrial ablation, and they advise prophylactic antibiotics for patients with Essure coils in situ, undergoing a global endometrial ablation.
Pre-in vitro fertilisation closure of hydrosalpinx with micro-inserts
Patients with hydrosalpinges have been identified as a subgroup with significantly poorer outcomes of in vitro fertilisation embryo transfer (IVF-ET) compared to tubal factor patients without hydrosalpinges . Laparoscopic salpingectomy before IVF-ET has been shown to restore IVF-ET outcomes in patients with hydrosalpinges )). Proximal occlusion of a hydrosalpinx by hysteroscopic placement of an Essure device has been used successfully as an alternative to laparoscopic surgery in these patients. A significant concern is the trailing of Essure coils into the uterine cavity and its possible effects on implantation as well as on pregnancy. Therefore, it is advised to limit the number of coils remaining in the cavity to three . The results of several reports support the idea that it is unlikely that the presence of Essure micro-inserts interferes with implantation and the developing amniotic sac and foetus .
