Is it time to abandon traditional laparoscopic sterilisation?

With the increase in the use of the Mirena Intrauterine System, female sterilisation in the UK has fallen from 40,500 in 1998/1999 to just over 12,000 in the last year (NHS 2010). In the UK, female sterilisation is still performed through the laparoscopic route in over 95% of cases and mostly by intermediate trainees. Although this is deemed the ‘gold standard’, the lifetime failure rate of laparoscopic sterilisation using the Filshie clip is 1 in 2–300 (RCOG 2004) and known complications include bowel perforation (1:1,000), vascular injuries (1:3,000) and death (1:12,000). In fact, in the 5-year period between 1977 and 1981, 29 deaths had been reported to the Centres for Disease Control and Prevention in the USA following laparoscopic tubal ligation, of which three were attributed to vascular injuries sustained during laparoscopy (Peterson et al. 1983). The need to simplify female sterilisation by avoiding general anaesthesia and laparoscopy (thus reducing the anaesthetic and surgical risks as well as the duration of recovery) has led to the development of sterilisation through the transcervical route.

Currently, two main hysteroscopic sterilisation techniques are licenced for use in the UK:

1. Essure Permanent Birth Control System (Conceptus Inc, San Carlos, CA, USA) has received approval from the Food and Drug Authority (FDA) of the USA and the Conformite Europeenne (CE); NICE Interventional Procedure Guidance 44 published in 2009 also supported its use provided ‘arrangements are in place for clinical governance and audit’. The Essure system involves hysteroscopic placement of a nickel-titanium (Nitinol) alloy inserted into the intramural portion of the fallopian tube, which then occludes the tube by inducing a gradual fibrous reaction.

2. Adiana Permanent Contraceptive System (Adiana Inc, Redwood City, CA, USA) markets a two-stage procedure, which involves treating the intramural portion of the tube with radiofrequency energy followed by insertion of a matrix into the fallopian lumen, which causes fibrosis. It has licence for use in the European Union and is awaiting FDA approval.

There have been over 500,000 Essure procedures performed worldwide and the FDA accepted data quote a 99.8% efficacy with usage over 5 years (Conceptus 2010). While the aim of this editorial is not to compare the two systems of hysteroscopic sterilisation, Essure does have more long-term data (with over 200 publications in the literature), is simpler to use, requires less invasive confirmatory tests and appears to be more effective (Palmer and Greenberg 2009). At least 600 gynaecologists have been trained in the use of Essure in Europe, including some 100 or so in the UK. Correct placement requires the skill of a good hysteroscopist in order to visualise the tubal ostia and insert the device: those currently doing outpatient hysteroscopy will probably have the shortest learning curve (a ‘no touch’ vaginoscopy technique is extremely useful).

The global uptake of hysteroscopic sterilisation in the UK does have manpower implications however, as this is not a generic skill as in laparoscopic sterilisation and cannot be performed independently by intermediate trainees at the moment: consultant-led lists will have to be planned. As the procedure takes less than 15 minutes and can be conducted in the outpatient setting with minimal analgesia, it is more cost-effective than laparoscopic sterilisation (bearing in mind that the cost of theatre use alone is £1,000/hour even before the addition of staff and drug costs).

Patients do need to be counselled that a confirmatory test at 3 months to ensure device location and/or bilateral occlusion is mandatory, before this could be relied upon as the primary form of contraception. The hysteroscopic route, therefore, will not be the method of choice for someone requesting immediately effective tubal occlusion. The compliance of post-procedural confirmatory tests, moreover, can be as low as 12.7% in some patient populations (Diamond et al. 2008).

Having said all this, we have sufficient data to accept the emergence of a simpler and more effective technology in female sterilisation, in the same way that retropubic and transobturator tapes have gradually replaced open colposuspension in the treatment of stress urinary incontinence. While there will always be slow adopters, we should remind ourselves that when two surgical options are available, we should offer the one that is safer, more effective, less painful, more cost-effective and with a quicker recovery. Is it time now to switch to the hysteroscopic route for female sterilisation?

Declaration of interest: The first author has been using Essure Permanent Birth Control System for the past 15 months but receives no financial renumeration from Conceptus, Inc.