Current and emerging female endoscopic sterilisation techniques

Location of Adiana® implants in the fallopian tubes.

Introduction
Laparoscopic tubal occlusion is the most common method of female sterilisation worldwide but this operation is now being performed less frequently due to the advance of long acting reversible contraception and hysteroscopic methods. The first laparoscopic tubal occlusion operation was performed in 1936.

Following this, monopolar and bipolar cautery was used. In the 1970s, a number of mechanical devices were introduced to overcome the associated thermal and electrical injuries associated with cautery. These included the Falope ring, Hulka clip, Bleier clip, Tupla clip and the widely recognised Filshie clip. These procedures can now be performed in day case settings and have a low risk of complications. Recent studies have shown an overall complication rate of between 4.6 to 5.5 per 1000 laparoscopic sterilisations.^1,2

Hysteroscopic sterilisation has been used for a number of years. Methods such as silver nitrate cautery, cryocautery and corneal plugs have been used.³ The most promising developments in female sterilisation in the last ten years have been in hysteroscopic sterilisation. Two techniques, the Essure and Adiana methods will be described in more detail later in this article.^4,5

The perfect contraceptive
The search for the perfect contraceptive goes on but it should include the following qualities.

• Safe
• 100% effective
• Immediate
• Outpatient setting
• Not painful
• No impact on day to day activities
• Permanent
• Reversible

Counselling
Counselling for female sterilisation procedures is hugely important. To make an informed decision about laparoscopic sterilisation, for example, the failure rate and risks of the procedure should be made available to the woman. Other methods available such as male sterilisation and long acting reversible contraception should be discussed. The RCOG has up to date evidence-based guidelines on male and female sterilisation which are readily available.⁶ The patient should be aware of the small risk of ectopic pregnancy and laparotomy.

The emphasis on the irreversibility of the procedure is important to avoid subsequent regret. The two most common factors associated with regret are young age and unpredictable life events.^7,8 Women under the age of 30 years at the time of sterilisation were twice as likely to seek reversal than those aged 30 to 349. Reversal of clip sterilisation does have a high success rate over 80% but does involve a mini laparotomy.^8,9,10

Laparoscopic sterilisation
In the UK, approximately 50,000 women undergo this procedure every year.¹¹ Around one in four women or their partners rely on sterilisation for family planning.¹²

The Filshie clip is a mechanical device approved by the Food and Drug Administration (FDA) in 1996. It is made of titanium and lined with silicon rubber. Application involves placement of the Filshie clip on the mid isthmic portion of the Fallopian tube using an applicator.

Tubal necrosis then occurs and the silicon rubber expands to maintain occlusion of the lumen. When a Filshie clip is used only about 4mm of Fallopian tube is destroyed thus enhancing possible reversal if desired.¹⁰ The Filshie clip has a failure rate after ten years of 2-3 per 1000 procedures.

Hysteroscopic sterilisation
The most exciting advances in recent years have been the development of hysteroscopic methods. The use of microinserts into the Fallopian tubes to occlude the tubal lumen have been used. The two methods are Essure and Adiana techniques. The Essure system (Conceptus, San Carlos, CA, USA) consists of two microinserts comprising a dynamic outer coil (nickel titanium alloy) and an inner stainless steel coil. Between the two, runs a layer of polyethylene terephthalate (PET) fibres. The outer coil is responsible for expanding to anchor the microinsert within the intramural and proximal isthmic portion of the fallopian tubes. The PET fibres give rise to a benign tissue reaction resulting in inflammation and fibrosis.

The Adiana technique (Hologic Inc, Bedford, MA) is a two step process. Firstly, radiofrequency energy is applied to the Fallopian tubes to destroy epithelial cells. Then a porous, non-biodegradable matrix plug is inserted into the cauterised lumen. Both techniques lead to tubal occlusion after three months. Currently there is more published data on the efficacy and safety of Essure than Adiana.

The optimal time for hysteroscopic sterilisation is during the early proliferative menstrual phase (days 7-14) as this enables better visualisation of the tubal ostia. The National Institute for Health and Clinical Excellence (NICE) guidance issued in September 2009 states that the evidence to support hysteroscopic sterilisation by tubal cannulation and placement of intrafallopian implants is satisfactory provided that normal arrangements are in place for clinical governance and audit. NICE endorses imaging by pelvic X-ray, ultrasound or HSG.¹³

Advantages
The main advantage of hysteroscopic sterilisation is that a general anaesthetic is not required. Premedication with simple analgesics and use of paracervical anaesthesia +/- sedation is all that is required. Most published studies use a combination of NSAIDs (eg diclofenac) and co-codamol. In studies using Essure sterilisation, the mean time taken for procedure ranged from 6.8 to 14 minutes.^14,15 Whilst this is no doubt important, the procedure also needs to be acceptable to patients. Reassuringly, 84% of women felt little or no discomfort.¹⁴ The procedure was described as more painful than normal menses in 3.8% and of equal discomfort in 12.1%.¹⁴

The majority of women (83.9%) were able to resume normal activities on the same day. Complications were found in 5% of women, five of these being minor self-limiting vasovagal reactions and one being uterine perforation.¹⁵ All these women were discharged the same day with no long term problems. A small number of women after Essure sterilisation would have preferred a general anaesthetic with the benefit of hindsight (12%).¹⁵ However, avoiding a general anaesthetic is an obvious advantage in obese patients and those with significant co-morbidities.

Efficacy
In the development of the Essure, the multicentre trials underwent three phases. In the Phase III trial, successful bilateral placement was achieved in 92% of women, Correct device placement was confirmed in 96% of women.¹⁶ Bilateral successful device placement range from 81% to 95%.^17,18 Optimal device placement is defined as three to ten coils remaining visible in the uterine cavity following insertion. In a minority of cases, two procedures were required to achieve bilateral placement.

The Adiana technique was approved by the FDA in 2009. In a multicentre prospective trial, successful bilateral placement was achieved in 94.8% of patients and bilateral occlusion confirmed in 88.4%. Pregnancy prevention rate at one year was 98.4%.¹⁹ Average treatment time is 12 minutes. The manufacturers recommend HSG as the test of choice to confirm tubal occlusion at three months.

Concerns
It is of some concern that in one study, in 70 women who had a choice between laparoscopic or hysteroscopic sterilisation, an overwhelming majority preferred a laparoscopic approach (77%).²⁰ This study was performed ten years ago but for hysteroscopic sterilisation to become accepted practice, it has to be wanted by patients.

One of the concerns regarding hysteroscopic sterilisation is that it is not effective. immediately and contraception has to be used for at least three months until a follow-up test has shown satisfactory occlusion of both Fallopian tubes.

Location of Adiana® implants in the fallopian tubes.

Follow-up
Follow-up to confirm satisfactory tubal blockage and effective contraception takes place three months after the procedure. The investigations that have been used include pelvic X-ray, hysterosalpingogram (HSG) and pelvic ultrasound. A pelvic ultrasound is obviously more preferable to an HSG and has been proven to correlate with HSG results in all 37 cases followed over a two year period.²¹ Compliance with hysteroscopic sterilisation extends beyond the treatment itself and this needs to be considered in the counselling process. Both manufacturers of Essure and Adiana recommend HSG as the test of choice to confirm tubal occlusion.

An accepted success rate of 99.74% after five years of follow-up has been accepted by the FDA in cases of successful placement.²² Sixty four pregnancies have been reported in an estimated 50000 procedures. The majority of these pregnancies resulted in patients who did not have appropriate follow-up. This again illustrates the importance of follow-up in hysteroscopic sterilisation.

Data comparing hysteroscopic and laparoscopic sterilisation is scarce. However, in one comparative study patients completed a self-assessment diary post-operatively.¹⁷ Patient satisfaction at 90 days postoperatively was 94% in the Essure group compared to 80% in the laparoscopic sterilisation group. Also, at 90 days, 100% of women in the Essure group were very satisfied with their recovery compared to 80% in the laparoscopic sterilisation group. The Essure group also had less pain and less problems in the post operative period.

Not all women with satisfactory bilateral placement of either device have confirmed tubal occlusion at three months. In the phase three trial for Essure, 8% of women undergoing HSG at three months still had tubal patency.¹⁶ The comparison figure for the Adiana technique is 11.6%.²¹ In such cases, HSG is repeated three months later at six months post procedure.

Pitfalls
The main pitfalls of hysteroscopic sterilisation is failure of insertion and expulsion of device. In the phase III trial performed for the Essure device, out of 518 women enrolled to the study microinsert placement was not attempted in 11 women. The reasons being polyps blocking the tubal ostia, inability to see or reach tubal ostia and cervical stenosis.¹⁶ In the same study, nine women had microinsert expulsion because of too proximal placement of the device in the fallopian tube. They had a second procedure that was successful bilaterally in all nine cases.²³

Costs
The Essure and Adiana procedures have higher disposable costs than laparoscopic sterilisation. However, this is offset by savings on costs of day surgery units and need for an anaesthetist. The procedures do require skilled operators and to undergo training recommended by the manufacturers before being able to use their products. Nine of ten participating physicians in the Essure study reported that the procedure was either simple or moderately simple.¹⁶ Cost analysis between hysteroscopic and laparoscopic methods has not been fully analysed in a large randomised trial.

Other gynaecological procedures
For cases of menorrhagia and proposed endometrial ablation, the Gynecare Thermachoice System has been approved by the FDA for women with the Essure system.²³ Bipolar radiofrequency and microwave ablation is not advised with Essure. However, bipolar radiofrequency ablation has been licensed for use in patients with the Adiana system following a confirmatory HSG.

The future
Chemical methods offer hope for the future as they can be introduced blindly through the cervical canal using no more than a modified intrauterine device inserter. They have been studied for a number of years but there have been ongoing concerns over toxicities and high failure rates.

Quinacrine offers the most promise and was first used as a technique for female sterilisation in Chile in the 1970s.²⁴ Quinacrine is introduced into the uterus in pellet form on two occasions, one month apart. Ten year cumulative pregnancy rates have been reported as 8.9 per 100 patients.²⁵ At present, quinacrine is not used in developed countries due to concerns over long-term safety. However, as it is inexpensive and readily available it may prove a safe option for permanent contraception, especially in developing countries.

Summary
The uptake of hysteroscopic sterilisation in the United Kingdom is behind the United States at present. Outpatient hysteroscopy clinics are established in UK practice but laparoscopic sterilisation remains the most common form of permanent contraception in the UK. No surveys of current practice have been undertaken in the UK. The author expects the numbers of hysteroscopic sterilisation to rise given that outpatient hysteroscopy clinics are established with expert operators. Hysteroscopic sterilisation offers obvious advantages to patients. It avoids the need for general anaesthetic, the need for incisions and the inherent dangers of laparoscopic surgery. The disadvantages are that it does not offer immediate contraception, relies on compliance with follow-up and the need for an uncomfortable procedure (HSG) to confirm tubal occlusion. Even if hysteroscopic sterilisation becomes more popular, laparoscopic sterilisation will still be required in cases where it is not possible to place microinserts into the fallopian tubes.

The search for the perfect permanent form of contraception goes on but hysteroscopic microinsert sterilisation offers a safe, quick, ambulatory approach which will develop further in years to come.

References

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