Download Treatment injury case study

Treatment injury case study
July 2012 – Issue 46
Sharing information to enhance patient safety
EVENT: Surgery to prevent risk of
ovarian cancer
INJURY: Unnecessary surgery
Case Study
Anne, a 57-year-old, underwent elective prophylactic bilateral oophorectomy
to remove both ovaries, as prophylaxis against ovarian cancer.
Anne had a history of two episodes of pre-menopausal
breast cancer and ductal carcinoma in situ (DCIS). In
view of this history, Anne and her daughters had seen
the medical geneticist.
Anne was referred to a gynaecological oncologist to
discuss prophylactic treatment against ovarian cancer
and was advised that she should consider elective
prophylactic bilateral oophorectomy.
A breast cancer susceptibility gene (BRCA) analysis
was done but it did not identify any gene mutations.
However, the geneticist advised Anne that, given her
history, she had an increased risk of ovarian cancer.
After meeting the gynaecological oncologist, Anne
chose to undergo an elective prophylactic bilateral
oophorectomy, and four months later underwent
uncomplicated surgery and was discharged home
the next day. A sample sent for histology showed no
evidence of abnormal cells or malignancy.
Key points
• Pre-menopausal bilateral oophorectomy
is recognised as a common practice
for surgical prophylaxis against the
recurrence of oestrogen-dependent
breast cancer
• In someone deemed to be at high risk for
the occurrence of ovarian cancer, bilateral
oophorectomy is considered a sub-optimal
prophylaxis
• To prevent the occurrence of ovarian
cancer, bilateral salpingo-oophorectomy
is recommended
• Routine consent should include informing
the patient of the technical nature of the
procedure, its role in risk reduction and
any long-term side-effects
• Pre-menopausal patients should be
informed of options for managing
menopausal symptoms and other longterm side-effects post risk-reducing
surgery, including the use of hormone
replacement therapy.
About two weeks after surgery, Anne’s case was
discussed at a multidisciplinary meeting that included
the oncologists, surgeons and pathologists. At the
meeting it was agreed that, rather than the bilateral
oophorectomy that she had already had, bilateral
salpingo-oophorectomy was recommended as a
standard technical procedure for surgery to prevent
the risk of ovarian cancer. This was also noted in the
histology report.
The new recommendation was discussed with Anne
and her husband during her follow-up visit. Anne
agreed for her name to be placed on the waiting list
for bilateral salpingectomy to remove her fallopian
tubes, and surgery was performed. The histology of
the samples from this surgery also showed no adverse
pathology.
In discussion with her surgeon Anne lodged a
treatment injury claim for unnecessary surgery,
as she had undergone two operative procedures
when one would have sufficed. ACC sought a report
from the surgeon and external clinical advice from
a gynaecologist. Whilst the decision to remove the
ovaries was reasonable, more recent knowledge
recommends a bilateral salpingo-oophorectomy to
prevent the risk of ovarian cancer.
Case study
After assessing the information, ACC accepted the claim
and was able to assist Anne with her treatment costs and
temporary loss of income while she recovered from the
surgery.
Expert commentary
Dr Sylvia K Rosevear, BA MB ChB, MD, FRCOG,
FRANZCOG
This case is interesting because there were no clinical
complications either intra-operatively or subsequently.
The patient had been referred by the clinical geneticist
who had discussed with her the degree of risk for ovarian
cancer given her early-onset breast cancer at the age of
25 and subsequent DCIS at age 38. She wished to have a
procedure that reduced that risk even though there was
no BRCA1 and BRCA2 mutation identified. In retrospect,
it was acknowledged that a less-than-optimal surgical
procedure had been performed for risk prophylaxis for the
occurrence of ovarian cancer in someone deemed to be
high risk.
Despite being seen by two consultant gynaecologists
and a registrar, bilateral oophorectomy was performed.
Common practice is for bilateral oophorectomy to be
done pre-menopausally as surgical prophylaxis for the
recurrence of breast cancer as an oestrogen-dependent
tumour. The standard technical procedure for prophylaxis
for ovarian cancer is a salpingo-oophorectomy because
it is now considered that ovarian epithelial cancer is of
extra-ovarian origin1-5. It arises in the ampullary section
of the tube. This was raised by the pathologist at the
clinic-pathological departmental meeting subsequent
to her initial surgery. It was corrected with the patient
undergoing a further laparoscopic procedure for removal
of the tubes.
The need for salpingo-oophorectomy represents a
paradigm shift in understanding of which gynaecological
oncologists have been aware for about three years, but it
may not be part of general gynaecological understanding.
It illustrates the necessity to be familiar with accessing
How ACC can help your patients following treatment injury
Many patients may not require assistance following their treatment injury.
guidelines in specialty areas. These need to be up to date.
For instance, recommendations for the management of
women at high risk of ovarian cancer are well documented
in a clinical practice guideline developed by the Australian
National Breast and Ovarian Cancer Centre.
The gynaecologist, in addition to informing the patient
of the technical nature of the procedure and confirming
the intentions of the surgery for risk reduction6, in terms
of informed consent should discuss the issues of the
management of menopausal symptoms (should the
woman be pre-menopausal) and other long-term sideeffects post risk-reducing surgery, including the use of
hormone replacement therapy. Other issues are factors
influencing psychosocial wellbeing post risk-reducing
salpingo-oophorectomy (RRSO). The evidence for the
benefit of RRSO is level 3 (cohort studies)7. The Royal
Australian and New Zealand College of Obstetricians and
Gynaecologists (RANZCOG) statement on prophylactic
oophorectomy is due for review in July 2012. It is useful for
the consideration of ancillary issues associated with the
removal of tubes and ovaries8.
References
1.http://guidelines.nbocc.org.au/guidelines/high-risk-ovarian/ch0s11.php.
2. Crum CP, Drapkin R, Kindelberger DW, Medeiros F, Miron A, Lee Y. Lessons from
BRCA: The tubal fimbria emerges as an origin for pelvic serous cancer. Clin Med
Res. 2007 5 (1):35-44.
3. Kurman RJ, Shih IM. Pathogenesis of ovarian cancer: lessons from morphology
and molecular biology and their clinical implications. International Journal
Gynaecology Pathology 2008 27 (2):151-60.
4.Kurman RJ, Shih IM. Molecular pathogenesis and extraovarian origin of
epithelial ovarian cancer – shifting the paradigm. Human Pathology 2011 42
(7):918-31.
5. Kuhn, E, Kurman RH, Shih IM. Ovarian cancer is an imported disease: Fact or
Fiction? Curr Obstet Gynecol Rep. 2012 Mar; 1(1):1-9.
6. Rebbeck TR, Kauff ND, Domchek SM. Meta-analysis of risk reduction estimates
associated with risk-reducing salpingo-oophorectomy in BRACA1 or BRCA2
mutation carriers. J Natl Cancer Inst. 2009 Jan 21;101(2):80-7.
7. National Health and Medical Research Council. NHMRC additional levels
of evidence and grades for recommendations for developers of guidelines.
Canberra: Commonwealth of Australia; 2009.
8.RANZCOG College Statement C-Gyn 25. Prophylactic oophorectomy at the time
of Hysterectomy for Benign Conditions (C-GYn 25).
Claims information
Between 1 July 2005 and 15 June 2012 ACC received 13 claims for unnecessary
surgery relating to bilateral oophorectomies and salpingo-oophorectomies.
Of the 13 claims lodged, eight were accepted and five were declined. The most
common reason for declining was that the surgery was a necessary part of
treatment.
However, for those who need help and have an accepted ACC claim, a
range of assistance is available, depending on the specific nature of the
injury and the person’s circumstances. Help may include things like:
About this case study
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This case study is based on information amalgamated from a number of
claims. The name given to the patient is therefore not a real one.
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contributions towards treatment costs
weekly compensation for lost income (if there’s an inability to
work because of the injury)
help at home, with things like housekeeping and childcare.
No help can be given until a claim is accepted, so it’s important to
lodge a claim for a treatment injury as soon as possible after the
incident, with relevant clinical information attached. This will ensure
ACC is able to investigate, make a decision and, if covered, help your
patient with their recovery.
ACC6447 Jul 2012 ©ACC 2012
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The case studies are produced by ACC’s Treatment
Injury Centre, to provide health professionals with:
•
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an overview of the factors leading to treatment injury
expert commentary on how similar injuries might be avoided in
the future.
The case studies are not intended as a guide to treatment injury cover.
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