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| 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-m