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Insertion of intrauterine device without consent (15HDC01925)
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15HDC01925, 19 December
Private hospital ~ Obstetrician
and gynaecologist ~ Mirena intrauterine device ~ Informed consent ~
A woman, aged 36 years at the time, privately consulted a
gynaecologist for assessment and management of heavy menstrual
bleeding and post-coital bleeding.
The woman signed a consent form for a hysteroscopy, dilatation
and curettage, endometrial biopsy and a Novasure endometrial
ablation, to take place under general anaesthetic. Prior to the
commencement of surgery, a "Time Out" check took place in the
theatre, which included reading out the procedure on the consent
The gynaecologist experienced technical difficulties with the
Novasure machine while attempting to perform the endometrial
ablation, and therefore abandoned the procedure.
At this point, the gynaecologist considered several alternative
procedures, and had devices for these alternatives brought into the
operating theatre. The gynaecologist decided to insert a Mirena
intrauterine device into the woman's uterus, despite the woman
having declined to have a Mirena inserted on a previous occasion,
and not having given consent to have a Mirena inserted on this
occasion. The gynaecologist said that he considered the Mirena to
be the safest and most easily reversible treatment option.
While in the Recovery Room, the woman discovered what had
occurred, and was distressed that a Mirena had been inserted
without her consent. The gynaecologist apologised and removed the
The principle of informed consent is at the heart of the Code.
Pursuant to Right 7(1) of the Code, services may be provided to a
consumer only if that consumer makes an informed choice and gives
informed consent. It is the consumer's right to decide and, in the
absence of an emergency or certain other legal requirements,
clinical judgement regarding best interests does not apply. If the
consumer will be under general anaesthetic, the Code provides an
additional safeguard that consent must be in writing.
It is was considered plainly unacceptable that the gynaecologist
inserted the Mirena without having first obtained the woman's
consent. The woman was particularly vulnerable as she was under a
general anaesthetic. The right to decide was the woman's, and she
was deprived of it. By inserting the Mirena into the woman's uterus
when she had not given informed consent, the gynaecologist breached
Right 7(1) of the Code.
Adverse comment was made about a registered nurse, as she was
aware of what was on the written consent form but did not query the
absence of written consent with the gynaecologist when he began
considering alternative treatment options.
Adverse comment was made about the private hospital, as it was
considered that this case illustrated a missed opportunity to
advocate for the woman when she was under anaesthetic and
vulnerable. Furthermore, the expectation set down by the private
hospital in its informed consent policy, that "[n]o consent should
be presumed", does not appear to have been adhered to.
The Commissioner referred the gynaecologist to the Director of
Proceedings for the purpose of deciding whether proceedings should
be taken, and recommended that the gynaecologist undertake further
education and training on informed consent.
The Commissioner recommended that the private hospital:
a) use an anonymised version of
this case for the wider education of its staff and the surgeons who
use its facilities, with particular emphasis on informed consent
and advocacy for the consumer; and
b) provide HDC with an update of
the corrective actions it has taken since this incident, including
copies of the updated consent form and informed consent policy.
The Commissioner recommended that the Medical Council of New
Zealand consider whether a review of the gynaecologist's competence