Permanent Contraception: Eligibility and Consent

Permanent contraception is surgical interruption of the fallopian tubes in women (tubal occlusion, also called bilateral tubal ligation) or of the vas deferens in men (vasectomy). Both are intended to be irreversible and are very effective. Neither alters hormones, sexual desire, sexual performance or breastfeeding, and neither protects against sexually transmitted infections or HIV. Because the decision cannot be reliably undone, assessment covers voluntariness and informed choice as much as surgical fitness.

Classification. Female procedures are done at interval, postpartum, postabortion, or during caesarean section or other abdominal surgery, by minilaparotomy or laparoscopy. Male procedures are scalpel or no-scalpel vasectomy under local anaesthesia.

Mechanism. Tubal occlusion prevents sperm reaching the ovum. Vasectomy prevents sperm entering the ejaculate, which still contains seminal fluid.

Effectiveness. First-year pregnancies for tubal occlusion are 0.5 per 100 women with typical use and 0.5 per 100 women with perfect use. For vasectomy they are 0.15 per 100 women with typical use and 0.1 per 100 women with perfect use. Tubal occlusion protects at once. Vasectomy protects only after 3 months, so a backup method is needed until then.

Return to fertility. None is expected. Reversal surgery cannot be guaranteed to succeed.

Reversible alternatives. First-year typical use pregnancies per 100 women are 0.05 for implants, 0.2 for the levonorgestrel intrauterine device and 0.8 for the copper T 380A. When future fertility is uncertain, a long-acting reversible method often serves the patient better.

Ideal candidates. Adults who have completed their desired family size, understand that the procedure is permanent, and request it voluntarily after reversible alternatives have been offered.

Patients who should not have the procedure. Patients uncertain about future fertility, patients who have not given voluntary informed consent, and men who cannot withstand surgery, for example with a bleeding disorder.

Extra care in counselling. Nulliparous women, young patients, men who have not fathered a child, and patients with illness including depressive disorders. Age alone does not bar the procedure. Young age with no living children carries the highest risk of regret, and the procedure may be delayed by up to one month to secure a settled decision. Multiple caesarean sections and grand multiparity are not absolute indications.

Eligibility classes. No condition absolutely excludes a patient, but conditions fall into four classes.

Women, examples.

• Accept: any parity, breastfeeding, mild pre-eclampsia, past ectopic pregnancy, smoking, past venous thromboembolism, migraine, HIV clinical stage 1 or 2, high risk of HIV, uncomplicated postabortion state, postpartum under 7 days or over 42 days.
• Caution: obesity, hypertension controlled with blood pressure under 160/100, past ischaemic heart disease or stroke, uncomplicated valvular disease, epilepsy, depressive disorders, uncomplicated diabetes, hypothyroidism, fibroids, anaemia, kidney disease, previous abdominal or pelvic surgery.
• Delay: young age with no living children, postpartum or postabortion sepsis, severe haemorrhage, severe pre-eclampsia or eclampsia, current pelvic inflammatory disease, haemoglobin under 7 g/dL, sickle cell disease, current deep vein thrombosis or pulmonary embolism, unexplained vaginal bleeding, pelvic cancer, active viral hepatitis, abdominal skin infection, acute respiratory or systemic infection.
• Special: blood pressure 160/100 or higher, hypertension with vascular disease, complicated valvular disease, diabetes with vascular complications, coagulation disorders, venous thromboembolism on anticoagulants, hyperthyroidism, endometriosis, severe cirrhosis, known pelvic tuberculosis, fixed uterus, uterine perforation, abdominal wall or umbilical hernia, chronic respiratory disease, AIDS, allergy to local anaesthetics.

Men, examples.

• Accept: reproductive age with completed family and voluntary consent, including high risk of HIV, HIV clinical stage 1 or 2 and sickle cell disease.
• Caution: single men, no living children, age under 18, depressive disorders, diabetes, past scrotal injury, large varicocele or hydrocele.
• Delay: local skin infection, active sexually transmitted infection, balanitis, epididymitis, orchitis, systemic infection, scrotal filariasis, intrascrotal mass.
• Special: coagulation disorders, HIV clinical stage 3 or 4, scrotal injury or large varicocele or hydrocele needing extensive surgery, cryptorchidism, inguinal hernia (vasectomy can be done at the time of hernia repair).

History and examination. Obstetric and gynaecological history, contraceptive history, comorbidity, medicines, anaesthetic allergy, bleeding tendency, blood pressure, abdominal and pelvic examination in women, scrotal and spermatic cord examination in men.

Investigations. None are routine beyond blood pressure and exclusion of pregnancy in women. Check haemoglobin when anaemia is suspected, coagulation tests only with a bleeding history, and offer HIV testing with counselling.

Consent. Written signed consent is required for every procedure. Spousal consent is not mandatory, but counselling both partners and obtaining consent from both is encouraged where appropriate. The patient may change their mind at any time before the procedure. No incentive may be offered to the patient or to the provider. Where a patient has an intellectual disability, written consent may be obtained from a parent or guardian after consultation with a professional colleague. Under 18 years give assent, with consent in line with the law.

Sequence.

1. Explore reproductive intentions and offer all reversible long-acting options with their efficacy.
2. State clearly that the procedure is permanent, that reversal is not assured, that it does not protect against sexually transmitted infections and that vasectomy takes 3 months to work.
3. Confirm the patient understands, then obtain written consent on a separate occasion from any labour or acute distress.
4. Assess eligibility class and apply the action for that class.
5. Exclude pregnancy in women, then perform the procedure with local anaesthesia where possible.
6. Counsel before and after the procedure.

Pregnancy exclusion. A woman is reasonably certain not to be pregnant if she has not had intercourse since her last menses, has used a reliable method consistently, is within 7 days of the start of menses, is within 4 weeks postpartum, is within 7 days of an abortion, or is fully breastfeeding, amenorrhoeic and under 6 months postpartum. Otherwise do a pregnancy test and delay if positive.

Timing in women. Within 7 days of birth, at interval, after uncomplicated abortion, or at caesarean section or other abdominal surgery. Between 7 and 42 days postpartum, delay until at least 42 days.

Switching from another method.

Backup. None after tubal occlusion once the procedure is done. For vasectomy, condoms or another method for 3 months.

Provider and facility. Doctors, or reproductive health clinical officers with post-basic training, may perform the procedure. A minor theatre, appropriate equipment, infection prevention, emergency drugs and equipment, and a working referral system are required. One surgeon should not exceed 15 procedures in a day, and one operating room should not exceed 30.

Follow up. Wound check within 2 weeks, with return at any time for pain, fever, wound discharge, missed menses or abdominal pain. Men return for semen analysis or confirmation of clearance after 3 months.

Expected effects. Short-lived incisional pain, bruising and, after vasectomy, scrotal swelling.

Complication rate. After female procedures overall complications occur in 0.4 to 2.0% of patients.

Complications. Anaesthetic reaction, bleeding, haematoma, wound infection, bladder or bowel injury in women, scrotal haematoma, infection and chronic pain in men, and ectopic pregnancy if the female procedure fails.

Regret. Risk is highest with young age at the procedure, few or no living children, decisions made around childbirth or abortion, relationship change and pressure from a partner or provider. Manage with non-judgmental counselling, confirmation of the facts, and referral for reversal assessment or assisted reproduction.

Failure. Any pregnancy after tubal occlusion is ectopic until proved otherwise. Failure after vasectomy is confirmed by serial semen analysis.

Referral and escalation. Refer any patient in the Special class when the team and equipment are not available, any patient with bladder or bowel injury, and any patient with suspected ectopic pregnancy.