CONSENT ADVICES SUMMARY

1.DIAGNOSTIC HYSTEROSCOPY UNDER GA

Serious risks
Serious risks include:3
● The overall risk of serious complications from diagnostic hysteroscopy is approximately two women in every
1000 (uncommon)
● Damage to the uterus (uncommon)
● Damage to bowel, bladder or major blood vessels (rare)
● Failure to gain entry to uterine cavity and complete intended procedure (uncommon)
● Infertility (rare)
● three to eight women in every 100 000 undergoing hysteroscopy die as a result of complications
(very rare).
Frequent risks
Frequent risks include:
● infection
● bleeding.

2.DIAGNOSTIC LAPAROSCOPY
Serious risks
Serious risks include:
● the overall risk of serious complications from diagnostic laparoscopy, approximately two women in every 1 000
(uncommon)
● damage to bowel, bladder, uterus or major blood vessels which would require immediate repair by laparoscopy
or laparotomy (uncommon). However, up to 15% of bowel injuries might not be diagnosed at the time of
laparoscopy
● failure to gain entry to abdominal cavity and to complete intended procedure
● hernia at site of entry
● death; three to eight women in every 100 000 undergoing laparoscopy die as a result of complications (very
rare).
Frequent risks
Frequent risks include:
● wound bruising
● shoulder-tip pain
● wound gaping
● wound infection.
3.FEMALE STERLIZATION

Significant risks
These include:
_ Failure resulting in unplanned pregnancy: the lifetime failure rate for laparoscopic tubal occlusion
with clips is up to 2–5 in 1000 procedures at 10 years (uncommon).9 The long-term failure rate of
hysteroscopic sterilisation may be similar to other methods, but long-term data are limited.
The failure rate of hysteroscopic sterilisation is quoted as 2 in 1000 (uncommon). These failure rates
are higher than for the most effective long-acting reversible contraception methods; for example
implant and intrauterine system (IUS).10
_ Sterilisation failure that results in a greater risk of an ectopic pregnancy. (This is a recognised risk but

there is no robust data to quantify the risk.)

_ Visceral or blood vessel injury at the time of laparoscopy (2 in 1000; uncommon).
_ Death as a result of the procedure (1 in 12 000; very rare).
_ Regret, leading to a request for reversal of female sterilisation which is usually unavailable on the

National Health Service. Regret is common, and more common if sterilisation is undertaken below
30 years of age, if the woman is childless, or if there is conflict between the woman and her partner.
Regret is also more common when sterilisation is undertaken at the time of an abortion. 5
_ Failure to complete the procedure. (This is a recognised risk but there is no robust data to quantify the

risk.)
Frequent risks
Changes in menstruation may occur following discontinuation of reversible hormonal contraception,
especially with the combined oral contraceptive or levonorgestrel-releasing intrauterine system (LNGIUS).
Female sterilisation itself does not adversely affect menstrual function.

4.ABDOMINAL HYSTERECTOMY FOR BENIGN DISEASES

Serious risks
Serious risks include:
● the overall risk of serious complications from abdominal hysterectomy is approximately four women in every 100
(common)
● damage to the bladder and/or the ureter (seven women in every 1000) and/or long-term disturbance to the
bladder function (uncommon)
● damage to the bowel: four women in every 10 000 (rare)
● haemorrhage requiring blood transfusion, 23 women in every 1 000 (common)
● return to theatre because of bleeding/wound dehiscence, and so on: seven women in every 1000 (uncommon)
● pelvic abscess/infection: two women in every 1000 (uncommon)
● venous thrombosis or pulmonary embolism, four women in every 1000 (uncommon)
● risk of death within 6 weeks, 32 women in every 100 000 (rare).
The main causes of death are pulmonary embolism and cardiac disease.
Frequent risks
Frequent risks include:
● wound infection, pain, bruising, delayed wound healing or keloid formation
● numbness, tingling or burning sensation around the scar (the woman should be reassured that this is usually
self-limiting but warned that it could take weeks or months to resolve)
● frequency of micturition and urinary tract infection
● ovarian failure.

5.VAGINAL SURGERY FOR PROLAPSE

Serious risks
● damage to bladder/urinary tract, two women in every 1000 (uncommon)
● damage to bowel, five women in every 1000 (uncommon)
● excessive bleeding requiring transfusion or return to theatre, two women in every 100 (common)
● new or continuing bladder dysfunction (variable – related to underlying problem)
● pelvic abscess, three women in every 1000 (uncommon)
● failure to achieve desired results; recurrence of prolapse (common)
● although venous thrombosis (common) and pulmonary embolism (uncommon) may contribute to
mortality, the overall risk of death within 6 weeks is 37 women in every 100 000 (rare).

Frequent risks

Frequent risks include:

● urinary infection, retention and/or frequency
● vaginal bleeding
● postoperative pain and difficulty and/or pain with intercourse
● wound infection.

6.AMNIOCENTESIS & CVS

Serious risks
include:
! failure to obtain a sample of amniotic fluid.An experienced operator is likely to obtain success at the
first attempt in 94% of procedures.
! An experienced operator is likely to obtain blood stained samples in approximately 0.8% of procedures
assuming the use of continuous ultrasound guidance.
! miscarriage.A rate of 1% over the norm is usually quoted during counselling.A rate lower than 1% should
be quoted only if it is supported by robust local data.
! fetal injury.This is rare and has been described only in case reports.This complication may be minimised
by the now standard use of continuous ultrasound guidance.
1 of 2 Consent Advice 6
! maternal bowel injury. This is also rare and, again, the risk is minimised by the use of continuous
ultrasound guidance at the time of needle insertion.
! amniotic fluid leakage – temporary or prolonged and with the added risk of preterm delivery
! chorioamnionitis. Severe sepsis, including maternal death, has been reported but the risk of severe sepsis
is likely to be less than 1/1000 procedures. Standards for control of infection should conform to those for
any invasive diagnostic radiological procedure.
! failure of cell culture in the laboratory.

Frequent risks
include:
mild discomfort at needle insertion site. This is estimated to be equivalent to the experience of
venepuncture.

7.CESAREAN SECTION
Serious risks

Serious risks include:

Maternal:

● emergency hysterectomy, seven to eight women in every 1000 (uncommon)

● need for further surgery at a later date, including curettage, five women in every 1000 (uncommon)
● admission to intensive care unit (highly dependent on reason for caesarean section), nine women in
every 1000
(uncommon)
● thromboembolic disease, 4–16 women in every 10 000 (rare)
● bladder injury, one woman in every 1000 (rare)
● ureteric injury, three women in every 10 000 (rare)
● death, approximately one woman in every 12 000 (very rare).
Future pregnancies:
● increased risk of uterine rupture during subsequent pregnancies/deliveries, two to seven women in
every 1000 (uncommon)
● increased risk of antepartum stillbirth, one to four woman in every 1000 (uncommon)
● increased risk in subsequent pregnancies of placenta praevia and placenta accreta, four to eight
women in every 1000 (uncommon).

Frequent risks
Frequent risks include:
Maternal:
● persistent wound and abdominal discomfort in the first few months after surgery, nine women in
every 100(common)
● increased risk of repeat caesarean section when vaginal delivery attempted in subsequent
pregnancies, one
woman in every four (very common)
● readmission to hospital, five women in every 100 (common)
● haemorrhage, five woman in every 1000 (uncommon)
● infection, six women in every 100 (common).
Fetal:
● lacerations, one to two babies in every 100 (common).

8.LAPAROSCOPIC MANGEMNET OF TUBAL ECTOPIC

Serious risks
● damage to bowel, bladder, uterus or major blood vessels which would require immediate repair by
laparoscopy or laparotomy (uncommon); however, up to 15% of bowel injuries might not be diagnosed
at the time of laparoscopy
● failure to gain entry to abdominal cavity and complete intended procedure laparoscopically, requiring
laparotomy instead
● the overall risk of serious complications from diagnostic laparoscopy is approximately two in 1000
● three to eight women in every 100 000 undergoing laparoscopy die as a result of complications (very
rare)

Frequent risks
● inability to identify an obvious cause for presenting complaint
● bruising
● shoulder-tip pain
● wound gaping
● wound infection
● persistent trophoblastic tissue, when salpingotomy performed (4–8 in 100)
● hernia at site of entry.
Any extra procedures which may become necessary during the procedure

● Laparotomy.
● Salpingectomy.
● Repair of damage to bowel, bladder, uterus or blood vessels.
● Blood transfusion.
● Oophorectomy.

9..REPAIR OF 3RD & 4RTH DEGREE PERINEAL TEARS

Serious risks

Some of these complications are a result of the tear and not necessarily the repair. However, these
complications will be more significant if the repair is not performed.
Common:
● Incontinence of stools and/or flatus.
Uncommon:
● Delivery by caesarean section in future pregnancies may be recommended if symptoms of
incontinence persist or investigations suggest abnormal anal sphincter structure or function.

Rare:

● Haematoma.

● Consequences of failure of the repair requiring the need for further interventions in the future such as
secondary repair or sacral nerve stimulation.

Very rare:
● Rectovaginal fistula.

Frequent risks

Frequent risks include:

● fear, difficulty and discomfort in passing stools in the immediate postnatal period
● migration of suture material requiring removal
● granulation tissue formation
● faecal urgency, 26/100 (very common)
● perineal pain and dyspareunia, 9/100 (common)
● wound infection, 8/100 (common)
● urinary infection.

10. SURGICAL EVACUATION OF THE UTERUS FOR EARLY PREGNANCY LOSS

Serious risks
Serious risks include:
● uterine perforation, up to five in 1000 women (uncommon)
● significant trauma to the cervix (rare)
● There is no substantiated evidence in the literature of any impact on future fertility.

Frequent risks

Frequent risks include:

● bleeding that lasts for up to 2 weeks is very common but blood transfusion is uncommon (1–2 in 1000
women)
● need for repeat surgical evacuation, up to five in 100 women (common)
● localised pelvic infection, three in 100 women (common).
5. Any extra procedures which may become necessary during the procedure
● Laparoscopy or laparotomy to diagnose and/or repair organ injury or uterine perforation.
6. What the procedure is likely to involve, the benefits and risks of any available alternative
treatments, including no treatment ??

The cervix may need to be dilated to allow emptying of the uterine contents. If tissue is sent for
histology, the reasons (to exclude ectopic or molar pregnancy) should be explained.

The alternatives are:

❍ medical management (with mifepristone, prostaglandins)

❍ expectant management, particularly for women without an intact sac.

Non-surgical methods are associated with longer and/or heavier bleeding and a 15–50% possibility of
eventually needing surgical evacuation for clinical need or the woman’s preference. However, non-
surgical methods are also associated with a lower risk of infection compared with surgery.

11.OPERATIVE VAGINAL DELIVERY

Serious and frequently occurring risks

It is recommended that clinicians make every effort to separate serious from frequently occurring
risks.Higher rates of failure and serious or frequent complications are associated with:

● higher maternal body mass index

● ultrasound-estimated fetal weight greater than 4000 g or clinically large baby
● occipitoposterior position
● mid-cavity delivery or when 1/5 fetal head palpable abdominally.

Serious risks

Serious risks include:

Maternal:
● third- and fourth-degree perineal tear, 1–4 in 100 with vacuum-assisted delivery (common) and 8–12
in 100 witH forceps delivery (very common)
● extensive or significant vaginal/vulval tear, 1 in 10 with vacuum 1 and in 5 with forceps.

Fetal:

● subgaleal haematoma, 3–6 in 1000 (uncommon)

● intracranial haemorrhage, 5–15 in 10 000 (uncommon)
● facial nerve palsy (rare).

Frequent risks

Frequent risks include:

Maternal:
● postpartum haemorrhage, 1–4 in 10 (very common)
● vaginal tear/abrasion (very common)
● anal sphincter dysfunction/voiding dysfunction.

Fetal:

● forceps marks on face (very common)

● chignon/cup marking on the scalp (practically all cases of vacuum-assisted delivery) (very common)
● cephalhaematoma 1–12 in 100 (common)
● facial or scalp lacerations, 1 in 10 (common)
● neonatal jaundice /hyperbilirubinaemia, 5–15 in 100 (common)
● retinal haemorrhage 17–38 in 100 (very common).

12.C/SECTION FOR PLACENTA PREVIA

Serious risks

Serious risks include:

Maternal

In all women with placenta praevia:

● emergency hysterectomy, up to 11 in 100 women (very common)
● need for further laparotomy during recovery from the caesarean, 75 in 1000 women (common)
● thromboembolic disease, up to three in 100 women (common)
● bladder or ureteric injury, up to six in 100 women (common)
● future placenta praevia, 23 in 1000 women (common)
● massive obstetric haemorrhage, 21 in 100 women (very common).

In women with placenta praevia and previous caesarean section:

● emergency hysterectomy, up to 27 in 100 women (very common).

In women with an abnormally adherent placenta (e.g. placenta accreta):

● the woman should be advised that hysterectomy is highly likely.

If the placenta is found to be abnormally adherent to the wall of the uterus, it may be safer to leave the
placenta inside the uterus or to perform a planned caesarean hysterectomy to avoid heavy bleeding
than to attempt removal. Excessive bleeding may require blood transfusion and other procedures,
including emergency hysterectomy, to control it. Admission to a critical care unit may then be necessary.

Frequent risks

Frequent risks include:

Maternal

● Admission to intensive care.

● Infection.
● Blood transfusion.

Fetal

● Admission to neonatal intensive care.

5. Any extra procedures which may become necessary during the procedure

● Repair of damage to bowel, bladder or blood vessels.

● Specifically, where placenta praevia accreta is suspected owing to the combination of placenta praevia
and previous caesarean section and/or imaging information, discussion concerning the following (where
available)

should take place:

◆ Cell salvage: this reduces the small risk of transmission of infection and transfusion reactions
associated with the use of donated blood; however, there is a theoretical risk of maternal sensitisation
to the baby’s blood and, rarely, amniotic fluid embolism. Neither of these complications has yet been
confirmed by published research.

◆ Interventional radiology: this occludes the uterine blood vessels by cannulation of the femoral artery
under X-ray screening. Foam plugs, balloons or coils are passed through these cannulas to block the
vessels and control bleeding, either temporarily or permanently. The risks of this intervention should be
discussed with the woman by the radiologist in advance.

6. What the procedure is likely to involve and the benefits and risks of any available alternative
treatments, including no treatment

The procedure is likely to involve delivery of the baby/babies and placenta/placentas through an open
approach using an abdominal incision and an incision into the uterus. Both incisions are usually
transverse. If either a midline abdominal incision or a classic uterine incision is being considered, the
woman must be informed of the reasons and the added risks. Sometimes forceps are used to deliver the
head, especially with breech presentations. The reason for the caesarean section must be clearly
discussed and documented, as must the great risk to mother and baby of not performing the caesarean
section. An informed, competent pregnant woman may choose the no-treatment option, i.e. she may
refuse caesarean section, even when this would be detrimental to her own health or the wellbeing of
her fetus. In such a situation every attempt must be taken to ensure the woman and her birth partner
realise the critical importance of the caesarean section in this specific situation.

DR.ZAIB QURESHI