Sterilisation (Female Sterilisation and Vasectomy)

Sterilisation is a surgical means of obtaining permanent contraception by occluding the fallopian tubes in women and the vas deferens in men (hence vasectomy). Compared to many surgical procedures, sterilisation is fraught with cultural, religious, psychosocial, psychosexual, and psychological issues despite being an effective method of contraception for those in stable relationships who are certain they have completed their child-bearing.

The history of sterilisation is controversial, not least the abuses of Nazi Germany's eugenics programme,¹ but infringements on reproductive rights continue around the world today.^2,3,4 This makes it essential that we ensure that decisions regarding sterilisation should be freely made and that there should be no coercion by any partner, family, health or social welfare professional.

• The popularity of tubal occlusion appears to be on the decline in the UK: in one study, the annual incidence of female sterilisation fell by a third over an 8-year study period from 1992-1999. Vasectomy rates remained unchanged and, since 1996, the UK has been one of the few countries where the incidence of sterilisation in men exceeds that in women.⁵
• A report on contraception and health in 2002 showed that, overall, 18% of men between the ages of 16-69 had had a vasectomy. 69% had had their operation on the NHS, compared to 94% of women.⁶
• Worldwide, sterilisation is the most frequent form of contraception with over 190 million couples relying on female tubal occlusion and 33 million couples on vasectomies for contraception.⁷

Sterilisation is an operation and hence requires informed consent. The nature and extent of informed consent is discussed in medical ethics. If there is any question of a person not having the mental capacity to consent to a procedure that will permanently remove their fertility, the case should be referred to court for judgment.⁸ From a legal perspective, only the patient who submits to operation needs give consent and the operation can be performed without knowledge of the partner. Good practice, however, is that both partners should sign a form to give informed consent.

As well as the usual topics to be covered in informed consent, there are specific matters that must be made clear in counselling both in primary and secondary care:

• Failure rate - no operation is perfect and there is a small but finite failure rate for sterilisation. The rate varies between procedures and surgeons and failure of an operation does not necessarily indicate poor surgical technique or clinical negligence.
• Irreversibility - sterilisation must be seen as an irreversible procedure. Reversal operations are performed: best results are achieved with microsurgery but success rate as defined by successful pregnancy is very limited and the operation is not available on the NHS.
• Time constraints - a woman is sterile immediately after the operation although she can conceive in the pre-operative menstrual cycle and thus must be counselled to avoid sex or use effective contraception until the menstrual period following the operation, as very early pregnancy may be undetectable. A man must not consider himself to be sterile until he has produced 2 consecutive semen samples with no spermatozoa seen. This is usually 8 to 12 weeks after the operation.⁸

These points must be recorded in the records as they may be crucial if subsequent pregnancy occurs and litigation follows.

Ideally the couple should be seen and counselled together but in reality this may not be possible. They must understand that sterilisation is irreversible and appreciate that, even if tragedy were to befall their family, they would be unable to replace lost children. Provide clear written guidance to accompany any discussion.

• Additional care must be taken when counselling people under 30 years of age or people without children who request sterilisation.
• Tubal occlusion should be performed after an appropriate interval following pregnancy, wherever possible.
• Women who request tubal occlusion postpartum or following abortion should be made aware of the increased regret rate and the possible increased failure rate.
• If tubal occlusion is to be performed at the same time as a Caesarean section, counselling and agreement should have been given at least one week prior to the procedure.

Whilst statistically vasectomy is 30 times less likely to fail and 20 times less likely to have post-operative complications than female sterilisation,¹⁰ the choice of which member of a couple should undergo sterilisation is not always so clear-cut.

• Vasectomy is a less invasive surgical procedure than female sterilisation, as it does not require access to the abdomen.
• Vasectomy is usually performed under local anaesthesia, although the less robust may prefer to be unconscious at the time. This allows it to be done as a day case, outpatient procedure or even in a GP surgery. Female sterilisation is almost invariably performed under general anaesthetic (GA) and the attendant risks should not be under-estimated. Female laparoscopic sterilisation can be performed under local anaesthesia.
• Some men, and also some women, may feel that irreversible curtailment of their fertility is an affront to their manhood or womanhood. If this is so, it must not be ignored or psycho-sexual problems may ensue. It should be mentioned that the man will perform and ejaculate in exactly the same way except that he will be "firing blanks".
• Where a woman has an indication for hysterectomy (e.g. fibroids, menorrhagia, prolapse, ovarian mass), this will provide definitive sterilisation. The use of the intrauterine system (IUS) and endometrial laser ablation have reduced the use of hysterectomy for menorrhagia however.
• A particular problem is where sterilisation is required for the health of the woman. Primary pulmonary hypertension is an example where pregnancy will cause deterioration and can even be fatal, and oral contraceptives are contra-indicated. With the risk to the woman posed by GA, it may be tempting to opt for vasectomy instead but the disease has such a poor prognosis that, potentially, the male partner may be widowed and infertile at an age when the prospect of re-marriage and further children is not unreasonable.

Whilst sterilisation was once considered the only solution to the long-term risks of hormonal contraception or repeated pregnancies, the increasing options, particularly of long-acting reversible contraception (LARC), make this concern less problematic.

• Combined oral contraception (COC) can be used with older women provided they do not have significant or multiple risk factors for cardiovascular disease or other contra-indications.
• Progestogen-only methods include progestogen-only pills (POPs), depot injections, implants (Implanon®), the Mirena® IUS. There is no apparent increase in risk of myocardial infarction (MI), venous thromboembolism (VTE)) or stroke with POPs. The exception is women over 40 with current VTE (but not women with a previous history of VTE). Women with a history of MI or stroke should avoid progestogen-only injectables but can take the POP, have implants or the IUS.¹¹
• Barrier methods used most commonly are male condoms and caps but their reliability and acceptability can be poor.
• Coils - copper intrauterine devices (IUDs) can be used at any age, but women identified at being at higher risk for sexually transmitted infection should be screened prior to insertion. The IUS is increasingly chosen for reliable, long-term and reversible contraception combined with its ability to reduce menstrual bleeding, making it particularly suitable in women prone to menorrhagia. Its increasing use may be reducing the incidence of female sterilisation.

A variety of vasectomy techniques is used including various vas occlusion techniques of excision and ligation, thermal or electrocautery, mechanical and chemical occlusion methods, as well as vas irrigation and fascial interposition. A Cochrane review was unable to draw definitive conclusions about the effectiveness, safety, acceptability and costs of vas occlusion technique or vas irrigation as studies were of low quality.¹² Fascial interposition has a lower failure rate, particularly if combined with thermal cautery, but is technically more difficult.¹³

Technique¹⁴

• Sterilise the skin and palpate for the vas near the neck of the scrotum and move it as near to the skin as possible.
• Holding the vas in this position, infiltrate the skin and tissue with 1-2 ml lidocaine around the vas and in a proximal direction.
• Make a small incision vertically in the skin down to the vas.
• Draw a 5 cm loop of vas through the incision and clamp both proximally and distally. Cut and remove a short segment and send it off for histology to confirm that a segment of vas has been removed.
• Ligate the upper end of the vas with a non-absorbable ligature.
• Ligate the lower end as above and tie back on itself to minimise the risk of re-anastomosis.
• Some surgeons interpose a layer of fascia between the two cut ends. This further minimises the risk of failure.
• Confirm haemostasis and close with an absorbable suture.
• Confirmation of success requires at least two successive negative sperm counts at least one month apart after 20-25 ejaculations. Advise the patient to continue with alternative methods of contraception during this time.

Other techniques include:

• No-scalpel vasectomy where the vas deferens is delivered via a puncture made in the scrotum, and then divided. Clamps rather than sutures are often used to seal the wound.^15,16 There is some evidence that this method results in fewer side-effects, and may be more aesthetically acceptable to some patients.¹⁷
• Intraluminal cautery,¹⁷ either electric or thermal, without separation of the vasa is the current method of choice at Marie Stopes International health centres.

Failure rate

• Ligation of the vas, cauterisation of the ends and fascial interposition has the lowest failure rate of 0.3%.¹⁷
• The no-scalpel technique has a similar failure rate.¹⁸
• The failure rate of intraluminal cautery is quoted as 'less than 1%'.¹⁷
• Late recanalisation causes failure in 0.2% of vasectomies.¹⁹

Vasectomy complications¹⁴

• Bleeding into the scrotum (minor bleeding 1:400, major bleeding 1:1,000)
• Infection (1:100)
• Epididymitis (1:100)
• Sperm granuloma, a tender scrotal swelling near proximal end of vas, requires further excision (1:500)
• Persistent pain (1:1,000)

There is no evidence that vasectomy increases the risk of:

• Testicular or prostate cancer
• Immune complex disease
• Ischaemic heart disease
• Libido problems

Despite being considered a more 'minor' operation than female sterilisation, post-operative discomfort must not be under-estimated and the man should arrange to take a few days off work if it is sedentary and probably a week if manual. A firm scrotal support should be worn after the operation and the degree of pain is highly variable. Failure to rest increases the risk of haematoma.

This can be performed laparoscopically or as an open procedure. Laparoscopy using Filshie® clips is, statistically, the most effective option and the method least likely to cause complications. The exceptions are postpartum, when a mini-laparotomy may be preferable, and during Caesarean section.⁸ Laparoscopic tubal occlusion can be performed at any time during the menstrual cycle provided that the clinician is confident that the woman has used effective contraception up until the day of the operation.⁸ Otherwise defer until the follicular phase of a subsequent cycle.

There is also increasing interest in and evaluation of hysteroscopic approaches with potential advantages, including minimal requirement for anaesthesia, patient acceptability and cost-saving associated with an outpatient procedure.²⁰

Laparoscopic tubal occlusion

Laparoscopic tubal occlusion involves inserting a needle into the abdomen to insufflate and then the laparoscope is inserted. Bipolar diathermy burns a small portion of tube which is then divided and sealed. A more popular option is to use Filshie® clips or rings to occlude the tubes. There is a risk of damage to bowel or blood vessels, which is increased by obesity, an inexperienced operator and abdominal adhesions. The cosmetic results of laparoscopy are excellent.

Mini-laparotomy

A small Pfannenstiel incision is made just above the pubis at the level of the pubic hairline. Forceps can be used to pull up the tubes that are identified, divided and tied. It is usual to remove a small piece for histology to prove that the Fallopian tube was identified correctly. The cut ends are tied back to assure separation. Reversibility is no worse than with other techniques and the resulting scar is small, neat and scarcely visible.

Failure rate

The lifetime failure rate is approximately 1:200. The longest follow-up study using the most popular method (Filshie® clips) suggested a failure rate after 10 years of 2-3:1,000 procedures. However, patients should be aware that when tubal occlusion fails, there is an increased risk of ectopic pregnancy.

Complications⁸

• If technical difficulties arise during a laparoscopy, the operation may need to be converted to an open procedure. The risk of laparotomy is increased if the patient is obese or has had previous abdominal surgery.
• After tubal occlusion, women should be advised to seek medical advice if they have abdominal pain or vaginal bleeding or if they think they might be pregnant, due to risk of ectopic pregnancy.
• After the age of 30, sterilisation is not associated with heavier or more irregular periods. It is associated with an increased rate of hysterectomy, although the reasons for this are unknown. The data on women younger than 30 are limited.

Tubal sterilisation is not associated with significantly altered risks of subsequent all-cause death or cancer.²¹

1. Reis SP, Wald HS; Learning from the past: medicine and the Holocaust. Lancet. 2009 Jul 11;374(9684):110-1.
2. Moszynski P; Rwanda denies plan to forcibly sterilise people with learning difficulties. BMJ. 2009 Jul 6;339:b2712. doi: 10.1136/bmj.b2712.
3. Krosnar K; Civil rights group urges Czech government to act on report on sterilisation of Gypsies. BMJ. 2006 Mar 25;332(7543):688.
4. Mallet J, Kalambi V; Coerced and forced sterilization of HIV-positive women in Namibia. HIV AIDS Policy Law Rev. 2008 Dec;13(2-3):77-8. [abstract]
5. Rowlands S, Hannaford P; The incidence of sterilisation in the UK. BJOG. 2003 Sep;110(9):819-24. [abstract]
6. National Statistics; Contraception and sexual health 2002 Series OS no.23. ISBN 1 85774 555 8
7. Pile JM, Barone MA; Demographics of vasectomy--USA and international. Urol Clin North Am. 2009 Aug;36(3):295-305. [abstract]
8. Male and female sterilisation, Royal College of Obstetricians and Gynaecologists (2004)
9. Hillis SD, Marchbanks PA, Tylor LR, et al; Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999 Jun;93(6):889-95. [abstract]
10. Adams CE, Wald M; Risks and complications of vasectomy. Urol Clin North Am. 2009 Aug;36(3):331-6. [abstract]
11. Backman T; Benefit-risk assessment of the levonorgestrel intrauterine system in contraception. Drug Saf. 2004;27(15):1185-204. [abstract]
12. Cook LA, Vliet H, Pun A, et al; Vasectomy occlusion techniques for male sterilization. Cochrane Database Syst Rev. 2004;(3):CD003991. [abstract]
13. Labrecque M, Hays M, Chen-Mok M, et al; Frequency and patterns of early recanalization after vasectomy. BMC Urol. 2006 Sep 19;6:25. [abstract]
14. Vasectomy; WHO Essential Surgical Care Manual
15. Reynolds RD; Vas deferens occlusion during no-scalpel vasectomy. J Fam Pract. 1994 Dec;39(6):577-82. [abstract]
16. Vasectomy; Encyclopedia of Surgery: A Guide for Patients and Caregivers 2007
17. Dassow P, Bennett JM; Vasectomy: an update. Am Fam Physician. 2006 Dec 15;74(12):2069-74. [abstract]
18. Clenney TL, Higgins JC; Vasectomy techniques. Am Fam Physician. 1999 Jul;60(1):137-46, 151-2. [abstract]
19. Awsare NS, Krishnan J, Boustead GB, et al; Complications of vasectomy. Ann R Coll Surg Engl. 2005 Nov;87(6):406-10. [abstract]
20. Sinha D, Kalathy V, Gupta JK, et al; The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilisation. BJOG. 2007 Jun;114(6):676-83. [abstract]
21. Iversen L, Hannaford PC, Elliott AM; Tubal sterilization, all-cause death, and cancer among women in the United Kingdom: evidence from the Royal College of General Practitioners' Oral Contraception Study. Am J Obstet Gynecol. 2007 May;196(5):447.e1-8. [abstract]

• Sheynkin YR; History of vasectomy. Urol Clin North Am. 2009 Aug;36(3):285-94. [abstract]
• Contraception, Clinical Knowledge Summaries (2008)
• Zurawin R, Sklar AJ; Tubal Sterilisation. eMedicine, October 2009.