Sterilisation (Counselling and Complications)

Sterilisation is an operation and hence requires informed consent. The nature and extent of informed consent is discussed in medical ethics. 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, dictates 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.

• 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 indicate poor surgical technique or clinical negligence.
• Sterilisation must be seen as an irreversible procedure. Reversal operations are performed. The 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.
• A woman is sterile immediately after operation although she can get pregnant in her menstrual cycle before operation but a man must not consider himself to be clear until he has produced 2 consecutive semen samples with no spermatozoa seen. This is usually 8 to 12 weeks after the operation.
• These points must be recorded in the records as they may be crucial if subsequent pregnancy occurs and litigation follows.

The trend since 2000 has been that the rate of female sterilisation is static at between 10% and 11% with male sterilisation rising from 11% to 12% annual uptake.¹ Between ages 40 to 49 men were more likely than women to have had an operation to become sterile (30% of men compared with 19% of women aged 40 to 44, and 32% of men compared with 21% of women aged 45 to 49). 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.²

Ideally the couple should be seen and counselled together but in reality this may not be possible. They must both see sterilisation as irreversible and appreciate that even if tragedy were to befall their family that they would be unable to replace lost children. It is inevitable that no matter how diligently couples are counselled that regret will sometimes occur but there are certain situations where the risk is such that the doctor should proceed with caution.

• Young people, especially under 25, are more likely to regret. Over 35, especially if the operation is on a woman, the risk of regret is much less.
• Couples with less than 2 children are more likely to regret.
• If the relationship is unstable there is a risk that they may part, meet someone new and the one who has been sterilised will be unable to have any more children with the new partner.
• Vasectomy in the partner's pregnancy should be approached with care. The current pregnancy may have been unplanned but stillbirth and neonatal death still occur. It may be wiser to wait for a healthy child to be delivered and to be several weeks old.
• Tubal ligation can be performed at caesarian section. The obstetrician will always ascertain that the paediatrician is happy with a healthy baby before proceeding but problems may not be apparent immediately.
• Sterilisation at the time of a termination of pregnancy (TOP) should be addressed with a degree of circumspection. The woman may feel that she needs to offer her fertility as the price for termination.

Nowadays many couples share responsibility and feel that whilst the woman takes care of contraception in the first part of the marriage that the man should do so once the family is complete.⁵ This is reflected in the great upsurge of vasectomy.

Vasectomy is a less major procedure than female sterilisation as it does not require access to the abdomen but the cynic's definition of a minor operation is "an operation performed on someone else". 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. The operation must be entered into freely and willingly, not under duress. It should be mentioned that the man will perform and ejaculate in exactly the same way except that he will be "firing blanks". There is no evidence that libido is affected, or that there is an increased risk of getting heart disease, prostate cancer or testicular cancer.
If a woman is having menstrual problems and is likely to require hysterectomy it is probably wise to let this be the sterilisation procedure, although it should be borne in mind that the advent of the Mirena coil and endometrial laser ablation are making hysterectomy a less popular option.

Vasectomy is usually performed under local anaesthesia although the less robust may prefer to be unconscious at the time. Female sterilisation is almost invariably performed under general anaesthetic and the risks of general anaesthetic (GA) should not be under-estimated.

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 contraindicated. Because of the risk to the woman posed by GA it may be tempting to opt for vasectomy instead. However, the disease has such a poor prognosis that this could leave the husband widowed and infertile at an age when the prospect of re-marriage and further children are not unreasonable. Laparoscopic sterilisation can be performed under local anaesthesia.

Whilst sterilisation was once considered a solution to the long-term risks of hormonal contraception, the increasing number of reversible options for the mature woman makes this concern less of a problem.
These include:

• Combined Oral Contraception (COC) This is suitable for women over the age of 35 with no other risk factors providing they have not smoked within the last year. It is also suitable for women over the age of 40 providing they have no history of cardiovascular disease, stroke or migraine. If a woman over 40 is prescribed the COC, a monophasic pill with ≤30μg ethinylestradiol with a low dose of norethisterone or levonorgestrel is a suitable first-line option.
• Progestogen-Only Methods There is no apparent increase in risk of myocardial infarction (MI), venous thromboembolism (VTE)) or stroke with progestogen-only pills. 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 progestogen-only pills, implants or the Mirena IUD.⁷
• Barrier Methods Male condoms and caps are more frequently used than female condoms or spermicides, but none are particularly reliable or popular.
• Copper IUDs These can be used at any age, but women identified at being at higher risk for sexually transmitted infection should have an endocervical swab for Chlamydia trachomatis as a minimum, together with an endocervical swab for Neisseria gonorrhoea depending on local prevalence.

This is usually performed under local anaesthesia as a day case, outpatient procedure or even in a GP surgery. However, post-operative discomfort must not be under-estimated and the man must 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. Nevertheless, even the most fortunate tend to describe it as "like having been kicked by a mule". Failure to rest increases the risk of haematoma.

A variety of vasectomy techniques are 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.⁸ Fascial interposition has a lower failure rate, particularly if combined with thermal cautery, but is technically more difficult.⁹

Methods

Laparoscopic Tubal Occlusion
Laparascopic tubal occlusion involves inserting a needle into the abdomen to insufflate and then the laparoscope is inserted "blind" so that there is a risk of damage to bowel or blood vessels in the procedure. This risk is raised by obesity, an inexperienced operator and abdominal adhesions, usually from previous surgery. The cosmetic results of laparoscopy are excellent. Unipolar diathermy burns the entire tube and so is rarely used nowadays. Bipolar diathermy may burn a small portion and it is then divided and sealed. A more popular option is to use Filshie clips or rings to occlude the tubes.
Mini-laparotomy
A small Pfannensteil 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. 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.

Choosing the Method¹⁰

Laparoscopy using Filshie clips is, statistically, the most effective option and the method least likely to cause complications. The exceptions are post-partum, when a mini-laparotomy may be preferable, and during caesarian section.

Timing of the Procedure

The Royal College of Obstetricians and Gynaecologists (RCOG) published some useful guidance concerning sterilisation issues in 2005. Their main recommendations are as follows¹⁰:

• Laparascopic 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. General anaesthesia is usually used in the UK for a laparoscopy, but local anaesthesia is possible. Otherwise the operation should be deferred until the follicular phase of a subsequent cycle. The woman should be advised to use effective contraception until her next menstrual period.
• 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.
• When a mini-laparotomy is used as the method of approach for an interval sterilisation (performed between pregnancies and not in the puerperium or after caesarian), any effective surgical or mechanical method of tubal occlusion can be used.

Vasectomy

Patients should be warned of the following complications:

• Failure rate - this is approximately 1 in 2000 after two negative tests have been received.
• Chronic scrotal pain - this affects almost 1 in 7 patients. It can last for some months but is usually mild and self-limiting.¹¹
• Granuloma formation - this is a common finding but rarely causes problems.¹²

Female Sterilisation

Patients should be warned of the following complications:

• Failure rate - the lifetime failure rate in general is approximately 1 in 200. The longest follow-up study using the most popular method (Filshie clips) suggested a failure rate after 10 years of 2-3 per 1000 procedures.
• If tubal occlusion fails, there is a chance that the pregnancy could be ectopic.
• If technical difficulties arise during a laparoscopy, a laparotomy is a possibility. The risk 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.
• Before 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 is limited.