Names have been removed to protect privacy (except Health NZ Lakes, Rotorua Hospital and the advisors). Identifying letters are assigned in alphabetical order and bear no relationship to the person’s actual name.

Health New Zealand|Te Whatu Ora Lakes

General Surgeon, Dr B

A Report by the Health and Disability Commissioner

Contents

Executive summary

Complaint and investigation

Information gathered during investigation

Opinion: Introduction

Opinion: Health NZ Lakes — breach

Opinion: Dr B — breach

Changes made

Recommendations

Follow-up actions

Appendix A: Independent clinical advice to Commissioner

Appendix B: ACC treatment injury advice

Appendix C: Independent clinical advice to Commissioner

Executive summary

1. This report relates to the care provided to a woman in 2018 by a general surgeon and Health New Zealand|Te Whatu Ora (Health NZ) in relation to her breast cancer. Primarily the woman was concerned about the standard of reconstruction surgery undertaken following a double mastectomy. However, as the investigation progressed, other issues emerged, including whether the woman had received appropriate advice regarding her treatment options. The woman’s care was managed through the breast service, but because of the structure of the service, no clinician had overall responsibility for her care prior to her planned surgery. As a result, on the morning of surgery, the general surgeon questioned the woman’s treatment plan, which included whether she should proceed with the planned procedure that day.
2. The report also discusses the adequacy of the general surgeon’s preoperative discussions with the woman about the risks and benefits of a prophylactic double mastectomy in light of her risk of cancer recurrence or life expectancy.

Findings

3. The Commissioner considered that the system in place to guide the woman through her breast cancer treatment was inadequate, in that during the stages of diagnosis and forming of the initial treatment plan, no clinician held ultimate responsibility for her care. The Commissioner found Health NZ in breach of Right 4(5) of the Code for the lack of cooperation among providers to ensure that the woman received continuity of care.
4. The Commissioner considered that the woman was not counselled adequately on the benefits and risks of prophylactic double mastectomy and the alternative treatment options available to her in light of her circumstances. The Commissioner found the general surgeon in breach of Right 6(1) of the Code for failing to provide appropriate information to the woman to allow her to make a fully informed decision on her treatment. Accordingly, the surgeon was also found in breach of Right 7(1) of the Code for failing to obtain the woman’s informed consent for the double mastectomy.

Recommendations

5. The Commissioner recommended that Health NZ provide an apology to the woman and update HDC on its new guidelines around prophylactic mastectomies, including a prompt for clinicians to consider a referral for patient counselling and multidisciplinary consideration. The Commissioner also recommended that Health NZ use an anonymised version of this report for staff training.
6. The Commissioner recommended that the general surgeon provide an apology to the woman; complete the HDC online learning modules; and undertake an audit of his clinical documentation and advise HDC of the remedial actions taken for any identified deficiencies.

Complaint and investigation

7. The Health and Disability Commissioner (HDC) received a complaint from Ms A about the services provided to her by Dr B and Health New Zealand|Te Whatu Ora (Health NZ) Lakes (formerly Lakes District Health Board).[1]
8. The following issues were identified for investigation:

• Whether Health New Zealand|Te Whatu Ora provided Ms A with an appropriate standard of care in 2018.

• Whether Dr B provided Ms A with an appropriate standard of care in 2018.

9. The parties directly involved in the investigation were:

Ms A                                                                     Consumer

Dr B                                                                       Consultant general surgeon/provider

Health NZ Lakes                                                Provider

10. Further information was received from the Accident Compensation Corporation (ACC), Dr C (a consultant general surgeon), Dr D (a general surgeon), CNS E (a clinical nurse specialist), and Dr F (a general surgeon).
11. Independent advice was obtained from Dr Sally Langley, a plastic and reconstructive surgeon (Appendix A), and Dr Erica Whineray Kelly, a general surgeon (Appendix C).
12. Treatment injury advice obtained by ACC from Dr G, an oncoplastic breast and general surgeon, is included as Appendix B.

Information gathered during investigation

Diagnosis and initial appointments

13. On 26 March 2018, Ms A had a tissue biopsy of her left breast. A report dated 29 March identified a small tumour. On 4 April 2018, Ms A was told that she had breast cancer.
14. A record of a Health NZ multidisciplinary meeting (MDM) dated 4 April 2018 states that Ms A was diagnosed with a Grade 1[2] invasive[3] carcinoma. It records the recommended surgery as a wide local excision (WLE)[4] and sentinel node biopsy (SNB[5]), and that for the right breast, no treatment was required at that stage. A handwritten comment states: ‘Family H[is]t[ory] post-menopausal Breast Ca[ncer].’ A general surgeon, Dr D, said that family history is considered at the MDMs.
15. Health NZ provided HDC with nursing notes recording discussions between Ms A and a clinical nurse specialist (CNS), CNS E. The 4 April 2018 note records their discussions about the diagnosis and treatment options, including breast reconstruction. Ms A was given the opportunity to ask questions.
16. Dr D also saw Ms A on 4 April after the MDM (which he attended). Dr D told HDC that he would have discussed the MDM treatment recommendations with Ms A, all surgical options, the complications of the therapy, and the required postoperative need for radiotherapy. However, HDC was not provided with any clinical notes specifically recording that these issues were discussed with Ms A on 4 April.
17. An outpatient clinic letter[6] prepared by Dr D stated:

‘[Ms A] has had an opportunity to discuss this with her friend and her mother who has had breast cancer and a number of other individuals and is very keen to head for a conservative approach.’

18. The clinic letter did not contain any further details about Ms A’s mother’s cancer. However, Ms A told HDC that in respect of her family history, she had been questioned about it and had provided her mother’s history of bilateral[7] breast cancer to both general surgeon Dr C and CNS E.
19. General surgeon Dr B (who had not yet met Ms A) told HDC that on 6 April, his breast cancer nurse also obtained the family history of bilateral breast cancer (and nil else) and asked Dr B to refer Ms A to the genetic services for testing, which he did. Dr B told HDC that this was requested prior to Ms A being allocated to his care and onto his operating list, and that he had no knowledge of Ms A as a patient at this point. Dr B stated: ‘I progressed the referral as part of the shared administrative tasks that take place in the operation of the Breast Service.’
20. In response to the provisional opinion, Dr B told HDC that CNS E informed him that the referral to the genetic services had not been made by the clinician responsible for Ms A ‘despite her request’ (it is unclear who this clinician was) and therefore she asked Dr B to do it. He said that, as far as he was aware, the clinicians concerned ‘knew about this [genetic] referral’ and his belief was that the other clinicians were ‘dealing with the situation’.
21. Dr B told HDC that no notification is received when patients are transferred on to a particular surgeon’s surgical list until the surgeon receives the theatre list for the day in question (usually 24–48 hours prior to the day of surgery). He said:

‘The shared-care service, in the context of full workloads in a busy provincial hospital, relies on accurate and appropriate care provided at each patient interaction, prior to surgical procedures taking place. This is required where workloads and scheduling often make it impossible to arrange a clinic appointment to address any “missing information” at short notice.’

Excision and biopsy

22. On 3 May 2018, Ms A attended Rotorua Hospital to undergo a WLE with SNB to remove the tumour. She met with Dr B for the first time at this appointment.
23. Ms A’s mother attended the hospital with her. Dr B told HDC that during discussions with him about family history, Ms A’s mother explained that in addition to her own breast cancer,[8] other family members had suffered various cancers, including breast cancer. Ms A said that prior to 3 May 2018, she had not told breast clinic staff about any family cancers other than her mother’s because she had been unaware of them. Accordingly, at this point none of the other clinicians involved in Ms A’s care were aware of this additional history.

Dr B

24. In respect of what information Dr B was aware of prior to meeting Ms A and her mother on 3 May, Dr B said that he had reviewed Ms A’s clinical file and noted a comment by another clinician about Ms A’s mother’s breast cancer. He said that he was unaware of the nature of Ms A’s mother’s breast cancer or of the additional family history. Dr B said that the information he was aware of prior to 3 May ‘raised some questions’, and he considered there to be evidence of some familial risk factors. He said that it was unclear to him at this stage how far these risk factors had been explored. In response to the provisional opinion, Dr B said that if he had been aware that this history of the additional family cancers had not been taken at all, he would have informed the other clinicians (in the service) about this new finding.
25. Dr B said that he considered some of the information learned on 3 May to be ‘significant’, including ‘the extent of the family history of cancer [and] the nature of [Ms A’s] mother’s cancer as triple negative’.
26. Dr B told HDC that patients with triple negative cancer (such as Ms A’s mother) are recommended to have genetic testing done, as certain types of genetic abnormalities can be passed down from mother to daughter, meaning that Ms A’s mother’s history[9] of cancer may have increased the risk of cancer in Ms A. At this stage, Ms A had not yet completed her genetic testing, although, as noted above, a referral for that testing had been made on 6 April. Dr B explained that if Ms A’s testing had revealed a genetic link, it could have changed the recommendation for surgery, so that breast conservation was no longer the preferred option, and instead a mastectomy[10] may have been recommended.
27. Dr B advised that definitive surgery undertaken in a single sitting typically results in better outcomes, as there is less chance of swelling due to prior surgery or infection, the surgeon is going through native tissues (ie, the patient’s own breast tissue), and the incision position is not constrained by previous surgery.

Health NZ

28. In a letter from Dr F, Health NZ Lakes explained why Ms A met Dr B for the first time only on the morning of her surgery (3 May 2018). Dr F said that the breast clinic is held once per week, and the three consultant surgeons (Dr B, Dr C, and Dr D) see patients on a rotational basis. Patients are seen and treated by ‘the service’ rather than a particular clinician. Dr F noted that the clinical nurse specialist ensures that when a patient is managed through the breast service, they are kept up to date with care plans (which provides continuity of care). The clinical nurse specialist also arranges further surgical consultations preoperatively or postoperatively depending on the patient’s needs.
29. Dr F commented that Health NZ has not found this approach to be a concern for patients. He said that any confusion around Ms A (referring here to the fact that her full and significant family history was discovered only on the day of her scheduled surgery) was the result of a family history that was not fully appreciated at the time of her MDM discussion to determine the appropriate surgical recommendations.

Discussions about procedure

30. Ms A told HDC that on learning of the additional family history on 3 May, Dr B gave her the option to reconsider the excision and biopsy procedure she was scheduled to have that day, as additional surgery might be required to minimise the chance of reoccurrence. Ms A said that at this point she was fully prepped for surgery, including having had a radioactive dye[11] injected the previous day and a hook wire[12] inserted that morning.
31. Dr B said that he advised Ms A that if she elected to wait, the wire in situ would be removed, and they could consider using agents like Tamoxifen[13] to stop the development of the tumour.
32. Dr B said that he also explained to Ms A the implications of significant family history, the heightened risk of further cancer if a genetic link was established, and the ways in which this could be managed. He said that he advised Ms A of the possible implications/risks of proceeding with the WLE and SNB (being that future reconstructions may be more complicated). Dr B said that he also discussed with Ms A the potential benefits of going ahead with the WLE and SNB procedure, and that it was open to her to continue with the procedure and afterwards they ‘could expedite the family history assessment so that an appropriate way forward could be ascertained’. He told HDC:

‘I made it clear to [Ms A] that in light of the new information, it was open to her to delay the operation until we had the results of the genetic testing, and better understood what we might be dealing with.’

33. Dr B said that Ms A had not had these discussions previously.
34. In response to the provisional opinion, Dr B said that he believed that the other clinicians were ‘dealing with the situation’ (see paragraphs 20–21 above) and that this is why he did not bring Ms A back to the clinic to take a more detailed history following the appointment on 3 May.
35. The information that Dr B said he discussed with Ms A (as noted in paragraphs 30–32) is not recorded in the clinical notes.
36. Dr B said that he offered Ms A some time to consider her options, but Ms A elected to proceed with the surgery for which she had been prepared, and Dr B performed the WLE and SNB.
37. Dr B documented that the type of incision he used in the WLE was a ‘concentric mastopexy type incision’, although later he advised HDC that this was an error, and the incision should have been described as a ‘crescentic’ mastopexy.

Post-excision

38. A nursing note from 4 May 2018 by CNS E records the postoperative care discussions with Ms A, including that Ms A was ‘full of questions’ about next steps and the possibility of a mastectomy. The note also records a discussion about mastectomy and that Ms A was provided with related information.
39. On 16 May 2018, Ms A attended a postoperative appointment with Dr B. The results of the biopsy showed that the operation had been successful, and Ms A was referred for radiotherapy and drug therapy[14] to complete her treatment.
40. The results of the genetic testing were still not available at that time, but Dr B provided Ms A with a pamphlet titled ‘Royal Marsden NHS foundation Trust: A Beginner’s Guide to the BRCA1 and BRCA2[15]’. In response to the provisional opinion, he said that he drew Ms A’s attention specifically to a section that deals with available options that do not involve surgery, a section that details different surgical approaches used, and a section that deals with the mechanisms of screening and risk reduction. Dr B said that he discussed these sections in detail with Ms A, and he provided this pamphlet because the nature of Ms A’s mother’s breast cancer was highly suggestive of BRCA abnormalities. Dr B also provided Ms A with the BAPRAS[16] guide to breast reconstruction, and the Aotearoa New Zealand Ministry of Health guidelines on Management of Early Breast Cancer.[17]
41. An MDM record from 16 May 2018 notes details of the WLE and SNB surgery and the biopsy result and records the family history as: ‘Patient’s mother has had x2 breast cancer triple negative post-menopausal and grandmother bowel ca[ncer].’ The treatment recommendation was for radiation therapy, endocrine therapy (with the note, ‘[Ms A] not keen on endocrine therapy but willing to discuss’), and a further referral to genetics.
42. Dr B told HDC that he saw Ms A again on 18 May 2018 with her mother present, at which time they discussed genetic defects and the implications of these, including that a negative result (in respect of the genetic testing) would be only in respect of known genetic abnormalities, and that it did not mean that Ms A was not at risk from unknown genetic cancer risks.

Mastectomy

Initial discussions: 18–28 May 2018

43. A nursing note from 18 May 2018 made after the meeting with Dr B records CNS E’s telephone advice that Ms A needed only a radiotherapy referral at this point, and that she should await the genetics results to determine whether a bilateral mastectomy was required. In response to the provisional opinion, CNS E told HDC: ‘Despite our best efforts to dissuade her from undertaking further surgery, we were unable to change her mind.’ No detail has been provided regarding the efforts made, and such discussions are not noted in the clinical record.
44. Ms A saw Dr B again on 28 May 2018. A telephone note (made by a Health NZ breast cancer nurse) records that this clinic appointment was initiated by Ms A, and that she had specifically asked to discuss a bilateral mastectomy because she was concerned about reoccurrence of her breast cancer. At this time, the results of the genetic testing were still not available, but they discussed a bilateral mastectomy and immediate reconstruction. Dr B explained to HDC that it was Ms A who wished to discuss a prophylactic bilateral mastectomy. He said that he provided her with information on reconstruction, explaining the different possible procedures, and the pros and cons of each. He said that he gave Ms A the opportunity to ask any questions and advised her to review the printed resources he had provided previously.
45. A letter written by Dr B to Ms A’s GP dated 28 May 2018 records the discussions at the appointment that day. The letter notes:

‘We went into details about [if she should] undergo reconstruction, what would be best for her. [Ms A] has agreed to undergo bilateral implant-based reconstruction after also considering latissimus dorsi and bilateral DIEP, TRAM reconstructions.[18] She was measured up and implants were ordered today.’

46. In response to the provisional opinion, Dr B told HDC:

‘It is my usual discussion with patients that prophylactic mastectomy removes 95% of breast tissue, but not all and a small risk still persists. I am sure that this discussion was undertaken with [Ms A].’

47. There is nothing in the clinical notes to indicate that this information was discussed with Ms A.
48. There is also nothing in the clinical notes that documents a discussion about whether the surgery was appropriate in light of the lack of information about genetic testing, or whether the surgery would be beneficial in terms of preventing cancer recurrence/reducing Ms A’s risk of death from cancer. Ms A stated that she could not recall whether anyone spent time with her exploring her reasons for choosing mastectomy, and she told HDC that she does not recall discussing the possibility of a single mastectomy rather than a contralateral mastectomy.
49. In response to the provisional opinion, Dr B told HDC that all his discussions with Ms A about options, risks, and benefits of surgery were supplemented by detailed discussions between CNS E and Ms A. He said that this is why he did not take detailed notes of these discussions. He said: ‘[CNS E] informed me that [Ms A] could not be dissuaded from proceeding to more radical surgery.’ In addition, Dr B said that the evidence that prophylactic mastectomy does not offer a survival benefit over alternative options was not current at the time of the events, and that ‘[r]eports of a significant reduction in occurrence of second breast cancers were available [at that time]’.
50. Ms A opted for a bilateral mastectomy with immediate reconstruction. She told HDC that she opted for implant-based reconstruction, as she did not have the fat volume available for reconstruction and, as a very physical person, she did not want to use either shoulder or abdominal muscles. She was advised to have the implants inserted under the pectoral muscles to help cover them.

Results of genetic testing — 11 June 2018

51. The results of the genetic testing were communicated to Ms A in a telephone call on 11 June 2018 and a follow-up letter on 12 June 2018. The tests revealed no recognised genetic abnormality. The 12 June letter records Ms A’s mother’s cancer, and that ‘[o]ther reported cancer history includes, bowel, brain, prostate and additional breast cancers’. Based on the test results, the letter predicted between a 4% and 18% chance of contralateral breast cancer for Ms A over the following 5 to 25 years respectively. The letter also states:

‘[I]t is difficult to predict what [your cancer] risks are likely to be. It is possible that there is a genetic risk in your family, but that you have not inherited it and your diagnosis of breast cancer is not genetically linked to your mother’s diagnosis. However, there is also a chance that there is a genetic link in your family in a gene that we have not done testing in.’

Further discussions/consent for mastectomy — 13 June 2018

52. Ms A saw Dr B again on 13 June 2018. By that time, Ms A was aware of the results of the genetic testing. Dr B told HDC that at the 13 June clinic appointment, he worked through the consent form for the mastectomy and reconstruction surgery with Ms A.
53. A letter from Dr B to Ms A’s GP of 14 June 2018 records the discussions, including the benefits and risks of the surgery (including the risk of implant loss, bleeding, and infection), scars, possible effects of the chosen incision type, and a likely loss of feeling in Ms A’s nipples. It was also discussed that Dr B could not guarantee that the breasts would be perfectly symmetrical. A 2cm nipple lift was also planned to match the mastopexy carried out on the left-hand side in the earlier operation.
54. Dr B told HDC that he advised Ms A that further surgery might be required in the future, and he discussed with her the reduction in risk of cancer recurrence arising from the mastectomy.
55. Ms A told HDC that she spent considerable time educating herself on the relative risks and benefits of mastectomy versus radiation therapy, including a visit to another hospital’s Radiation Oncology Department to learn about the risks of radiation therapy. She said that she chose mastectomy mainly because she was concerned about the potential long-term risks of radiation damage. Ms A also told HDC that no clinicians attempted to dissuade her from choosing mastectomy over radiation therapy, and she could not recall whether anyone spent time with her exploring her reasons for choosing mastectomy.
56. Dr B told HDC that Ms A had communicated anxiety about developing further cancers and was motivated to preserve her health. He said that he considered that it was appropriate to take Ms A’s preferences into account and undertake the requested procedure. Dr B said that despite the results of the genetic testing, he did not consider the risk associated with Ms A’s family history of cancer to be minimal. He said that the genetics team confirmed that Ms A had a higher risk of developing breast cancer than the normal population ‘and were not definitive that the family history described prompted no risk’. Dr B referenced an email of 11 June 2018 from the genetic counsellor, which confirmed that uncertainty remained regarding Ms A’s risk for bilateral breast cancer and that the possibility of a genetic link to her mother’s cancer could not be excluded.
57. In view of the WLE and the genetic results, and following her own research, Ms A decided not to undergo radiation therapy and endocrine therapy (which was the recommended next step after a WLE and SNP), instead opting for a mastectomy.
58. There is no evidence that other treatment options were considered further following receipt of the genetic test results, nor that the benefits of the surgery or Ms A’s reasons for wanting the surgery were explored. Dr B told HDC:

‘Ultimately, I did not consider it was my role to persuade or dissuade/discourage [Ms A] from a particular choice. I considered my role … was to provide her with information relevant to the procedure, including the risks, benefits and alternatives — and leave it to [Ms A] to decide what she wished to do.’

59. In response to the provisional opinion, Dr B said: ‘The alternative treatment options available to [Ms A] following the results of genetic testing are the same options we already had discussed.’
60. The consent form signed by Ms A on 13 June 2018 states the risks discussed as bleeding, infection, ‘not a perfect match’, ‘?secondary surgery’, and a handwritten comment that is illegible. The form also states:

‘I agree that I have been able to discuss the proposed treatment/procedure with the Health Professional named below who has explained the possible benefits and risks to me of the treatment/procedure(s) relating to my clinical history and condition.’

Rationale for bilateral mastectomy and reconstruction

61. In respect of the decision to perform a mastectomy on Ms A’s left breast, Dr B told HDC that he considered radiotherapy was the ‘opportune course’ to pursue in the circumstances, while the genetic information was awaited. However, following this and Ms A’s decision not to undergo radiotherapy, Dr B said the surgical management option of mastectomy ‘was entirely appropriate and indicated (where radiotherapy was not taking place) for the [left breast]’. He said that the WLE is ‘complete’ only if accompanied by postoperative radiotherapy, and (following the WLE & SNB on 3 May) Ms A chose not to undergo radiotherapy. Dr B said that even in the absence of significant family history, all patients with breast cancer have the surgical option of either a WLE or a mastectomy.
62. In respect of the decision to perform a mastectomy on Ms A’s right breast, Dr B initially said that prophylactic contralateral mastectomy[19] is offered to all patients, should they request it — which Ms A did, after the option was explained to her. Dr B said that it is not unusual for prospectively high-risk patients to ask for a contralateral prophylactic mastectomy, and the treatment option is not reserved for patients with aggressive disease.
63. However, in a later response to HDC, Dr B said that he wishes to make clear that it was not (and is not) common or usual practice to offer contralateral prophylactic mastectomy, and that the above comments were made only in respect to Ms A’s case. Dr B said that while it is clear from his initial management recommendations that he did not propose contralateral mastectomy as the preferred course, prophylactic mastectomy is an available procedure in New Zealand in such qualifying circumstances.[20] He stated:

‘[W]hen faced with an anxious patient, and documented evidence of some risk, a prophylactic mastectomy can be proposed as an option. Sometimes, patients proactively [propose] it themselves … If patients asked me about it, I provided them with information and recommendations appropriate to their particular circumstances.’

64. In explaining the rationale of performing the bilateral mastectomy, Dr B also referenced the results of the genetic testing and that he did not consider the risk associated with Ms A’s family history of cancer to be ‘minimal’ (discussed further at paragraph 56 above).
65. In responding to Ms A’s complaint, Health NZ included a letter from another consultant general surgeon, Dr C. Dr C had seen Ms A earlier in her treatment journey on 28 March 2018. In the letter, Dr C commented:

‘Looking through this patient’s notes, I am perplexed by two issues:

1. Why this patient refused radiotherapy treatment immediately after her initial surgery.

2. Why this patient was ultimately offered extensive surgery in the form of bilateral mastectomy including a prophylactic contralateral mastectomy given this patient’s essentially minimal risk factors pertaining to her family history and tumour characteristics. This surgical option was not discussed at any of our breast cancer MDM’s.’

66. Dr B told HDC that the therapeutic decisions made at the MDMs were made without appreciation of Ms A’s ‘very significant risk of developing familial breast cancer’.
67. A report obtained by ACC from Dr G, an oncoplastic breast and general surgeon, following a later treatment injury claim by Ms A, commented on whether a bilateral mastectomy was indicated in Ms A’s case. Dr G’s report is annexed to this report (Appendix B). Dr G wrote:

‘[T]his small cancer, if managed with the standard method of WLE followed by Radiotherapy, would have likely been the only cancer episode in this patient’s lifetime … Based on documentation provided by ACC, there is no compelling evidence to support double mastectomy in [Ms A’s] case. The long-term outcome for small early breast cancers is equivalent for breast conservation followed by Radiotherapy, compared to mastectomy alone. In other words, there is no survival advantage by undergoing a mastectomy with small breast cancers.’

Procedure — 21 June 2018

68. On 21 June 2018, Ms A underwent a bilateral mastectomy and implant reconstruction. The procedure used Mentor brand silicone implants[21] placed underneath the pectoral muscles, and a synthetic mesh[22] to cover the lower part of the implant, attached to the muscle by sutures. Thin skin flaps were raised to cover the new material. The nipples were preserved using a ‘lollipop’ type vertical incision.
69. The theatre report for the operation records the indications for the surgery as: ‘Previous wide local excision plus sentinel lymph node biopsy. Family history +++. After genetic testing patient chose to have a bilateral mastectomy and reconstruction.’
70. Ms A told HDC that the procedure appeared to go well but, on waking, she was concerned about the asymmetrical size and position of the breasts. She also said that she had read that it was best practice to review the colour of the nipples post-surgery to ascertain if there are any issues with blood supply, but the dressings were opaque and did not allow for this to be done. She said that she raised the issue with a nurse in the recovery ward but was told that they were following standard practice.

Postoperative recovery

71. When the dressings were removed on 29 June 2018 by a community nurse, necrosis[23] was noticeable on both nipples.
72. On 1 July 2018, Ms A attended the Rotorua Hospital outpatient clinic and saw another consultant. The visit took place because Ms A had a cough, and the cough had triggered pain around the site of the recent surgery. The clinical record of the visit states that the pain could be sharp in nature, felt somewhat muscular, and was associated with movement.
73. On 4 July 2018, Ms A saw Dr B again. At that appointment, Dr B debrided[24] both nipples. There was a small amount of necrosis on the left nipple, but the right nipple contained a larger patch with no nipple protruding. Ms A told HDC that she was not prepared for the outcome of the debridement and had driven herself to the appointment and had no support person present. In response to the provisional opinion, she said that she was prepared for a ‘few millimeters’ of dead tissue to be removed, ‘not the entire protruding nipple … All that was left was a large hole that took several months to heal. This remains to be a very traumatic memory.’
74. Dr B told HDC that prior to the 4 July appointment, he had explained to Ms A what the procedure would involve — specifically that he proposed to undertake a partial edge debridement, which required the removal of a few millimeters of dead tissue from the nipple for the purpose of avoiding infection. Dr B explained that prevention of infection is paramount in these cases as, if the implant gets infected, this will lead to its removal.
75. The nursing notes record that at an appointment on 10 August 2018 for a dressing change, Ms A told CNS E that she had been having difficulty with her mental and emotional health post-treatment. Ms A was referred to a cancer psychologist to assist with coming to terms with cancer recovery. It was noted at that appointment that the nipples were healing.
76. The nipples healed eventually, and a letter from Dr B to a main centre hospital (Hospital 2) dated 12 December 2018 recorded the result. The letter states:

‘[Ms A] unfortunately suffered from partial nipple necrosis, bilaterally, right more than the left. This recovered in due course and she had a reasonable result on the left side.’

Breast deformities

77. On 29 August 2018, at the Breast Clinic at Rotorua Hospital, Ms A raised concerns with Dr B about the obvious lack of symmetry in her breasts. Dr B advised Ms A to give it more time for the implants to settle.
78. Ms A also raised concerns about the deformities at subsequent follow-up appointments with CNS E. A nursing note dated 25 September 2018 records Ms A’s concerns around the asymmetry of her breasts, rippling on the left breast, and the right breast sitting higher than the left. The note records that Ms A was scheduled for review in December 2018 once there had been several more months of healing, and at that time there could be discussion around improvements, with the possibility of lipomodelling.[25]
79. Ms A saw Dr B again on 31 October 2018 and raised the lack of symmetry and a rippling effect that was evident on the left breast. Ms A told HDC that Dr B advised that following debridement, the healing process required for the wound would have slowed down the settling of the implants, and they should allow approximately six months from the surgery date before making any further decisions.
80. Dr B became concerned that the deformities were caused by ‘flipping’ of the implants, and so he referred Ms A for an ultrasound. The ultrasound on 11 December 2018 showed that the implants had not flipped.
81. On 12 December 2018, Dr B told Ms A that he did not think the outcome of the surgery was acceptable and referred her for possible remedial surgery. The referral letter recorded Ms A’s concerns as ‘[r]ippling of the implant (especially when she exercises), slightly high riding right implant, [and] slight lateralisation of the left nipple’.
82. Dr B discussed the cause of some of the deformities in a letter to HDC, explaining that at the time of the surgery, he did not fully appreciate how physically active Ms A was, and the associated possibility of a rupture of the join between the mesh and pectoral muscle.
83. On 17 December 2018, Ms A was seen by a private plastic surgeon, whose findings were as follows:

‘We can see some obvious discrepancies, the first is that she has had some partial necrosis of the right nipple with what appears to be a circumvertical scar completed at the same time as the mastectomy. The breasts differ in position of the device and also that there is difference in height. There is a suggestion that she may have a rotation of one or both devices and the right breast seems to sit higher on the chest wall. I have put a tape measure around her neck and we can see that the left nipple areolar complex is sitting eccentric on the breast mound. She has a 13cm wide implant but this sits about 8cm from the medial border of the implant and only 4cm from the lateral border. The rippling is quite evident in the upper poles. She is able to contract the pec major muscles and give a very strong and obvious animation deformity. Her scars look slightly hypertrophic[26].’

84. Ms A told HDC that as of 25 August 2022, she had had three further remedial surgeries to correct the defects with the breast reconstruction, and she may need further surgery in the future.

Further information

Information provided to Ms A

85. HDC asked Dr B and Health NZ what information was provided to Ms A before she decided to proceed with the bilateral mastectomy and reconstruction. Some of the information and the associated discussions are noted above. In addition, CNS E provided HDC with a long list of pamphlets and other documents that were given to Ms A.
86. CNS E also told HDC:

‘There were conversations had post first surgery, around genetics and determining family history, as you would expect [Ms A] was very motivated about future health and reducing her risks of recurrence. At this stage referral to radiotherapy was completed. Support given to [Ms A] for her choices in surgery, providing information in print form and verbal. Risks, complications, healing times and recovery, the used of breast [sic] to help support reconstruction and follow up. I had many conversation[s] and t[e]xt messaging with [Ms A], where [I] offered information, referrals and support.’

87. In relation to the results of the genetic testing and the biopsy, Dr B provided HDC with detailed pamphlets he said were given to Ms A and advised that it is his usual practice to use these to supplement discussions with patients.
88. In relation to the implants, Dr B provided a copy of the BAPRAS guide to breast reconstruction and told HDC that his normal practice is to ask patients to read the relevant information on the implants in the guide. He said that this information then forms the basis of a discussion on the implants in the consultation.
89. In addition to other information about breast reconstruction, the BAPRAS guide states:

‘Look and feel: It can be difficult to get a natural breast shape with an implant alone and so these kinds of reconstructions are best for women with relatively small breasts that do not droop at all, or if both breasts are being removed.

…

Potential problems: Implants are prone to hardening, deflation, visible folds and creases, and do not give good results if you have to have radiotherapy either before or after the reconstruction is carried out.’

90. The BAPRAS guide also includes some basic information about silicone implants, including:

‘If your breast is reconstructed using an implant on its own, a silicone prosthesis is inserted under the skin and muscle of the chest to replace the volume of breast tissue that has been removed at the time of mastectomy. This is quite a simple operation that does not involve scars elsewhere on your body. The implant will be very like one that is used in cosmetic surgery.’

91. In relation to the information discussed at the consultations, Dr B told HDC:

‘I would discuss the type of implants: round/tear drop (anatomical) shaped. We would also discuss the implant placement, position after mastectomy and that reconstructed breasts look different to normal breasts and have less ptosis (droop). We also inform the patients that the final outcome will be evident after 3 to 6 months.

We address possible complications, specifically the small risk of infection and thereafter removal (4–6%). Long term, there is a risk of capsular contracture[27] and second surgery (in about 30% of patients). I would have discussed a small risk of BIA-ALCL — breast implant associated-anaplastic large cell lymphoma[28] (about 1 in 3000). We have now changed to using Motiva implants that do not have this risk.

The patients are then measured up for implants and sizes are discussed (option of going smaller or larger) and their wishes are taken into consideration when ordering them.

The patients have the option to discuss things further with the breast care nurse and in the normal course he/she will have a sample implant for the patients to see and feel. All patients have direct contact numbers to the breast care nurse to contact and discuss their doubts and concerns. Additional appointments are made by the breast care nurse with her and with me as required.

[Ms A] had the opportunity to re-confirm her choice on implants on 13 June 2018 — and again on the day of the (second) surgery.’

92. In relation to post-surgery activity, three pamphlets were provided to HDC that were given to Ms A. These pamphlets contain information about post-surgery activities and exercises. One of the pamphlets contains the warning:

‘If you’ve recently had a breast reconstruction, talk to the surgeon who did the operation or your physiotherapist before you start or continue with any exercises, and follow their advice.’

93. Dr B also told HDC that the breast care nurse (in this case CNS E) would discuss the contents of these documents, and possibly the physiotherapy team would also. He said that the information is provided either during the preoperative consultation, where the patient is consented for the surgery, or on discharge.
94. CNS E told HDC that Ms A had a tough time in the healing process, and she was an ‘active relaxer’. CNS E said that generally she encourages mobility and gentle exercise for at least the first six weeks and advises patients to pace themselves and allow their bodies to heal, while supporting emotional wellbeing. In response to the provisional opinion, CNS E told HDC:

‘Post-surgery care and exercise restrictions had been discussed with [Ms A]. I clearly remember her coming back to ask if she could use the exercise bike. [Dr B] and I told her to avoid heavy exercise and to gradually build up over the next 6 months. Driving was only to be undertaken after 3–4 weeks.’

95. Ms A’s clinical records note that she was seen by a physiotherapist on 22 June 2018, the day after the surgery, and that she was given a handout, advised to do ‘Stage 1 exercises’ until the drain had been removed, and advised that she should do no heavy lifting for 6–8 weeks.
96. A breast nurse note from 23 June 2018 records: ‘[E]xercises covered.’

ACC

97. An application by Ms A to ACC for a treatment injury claim was successful, and ACC agreed to cover the injury that led to the migration and rotation of the implants, and the superficial nipple necrosis.
98. The ACC documents provided to HDC include a report by an oncoplastic breast and general surgeon, Dr G (see Appendix B). Dr G’s report included discussion about the post-surgery advice normally given to breast reconstruction patients. Dr G advised:

‘Patients need to be given very clear instructions about the restrictions in activities after surgery and to avoid any lifting/pulling/pushing for at least 3 months to try and prevent these complications. Patients need to be advised against driving for at least 8–10 weeks after surgery …’

Ms A

99. In respect of the information provided on post-surgery activity, Ms A said that she was surprised by Dr G’s report. She does not recall being told anything as specific as the restrictions suggested by Dr G, and said that she limited her activity, but not to that extent. She stated that she is a physical person and did a lot of exercise at the time. She said that no information was given to her about not driving, and she would not have done so had she been advised not to drive. She recalls that the plastic surgeon who carried out her remedial surgery explained that a rupture between the mesh and the pectoral muscles had occurred, but Ms A said that she does not believe it was because of physical activity.
100. In January 2020, Ms A told HDC:

‘I’m still facing major surgery to fix the reconstruction that took place in June 2018 … I no longer feel like I got off lightly, in fact I regret my decision to have a double mastectomy due to the complications that were caused by it and the effect that it’s had on my life … I’m upset that what I have been going through since the double mastectomy wouldn’t likely have been required if best practice methods had been used. The impact for myself and my family has been significant and ongoing. I have not come to terms with my body post-surgery and have been seeing a psychologist since August 2018.’

Responses to provisional report

101. Ms A was given the opportunity to respond to the ‘information gathered’ section of the provisional report. Where relevant, her comments have been incorporated into this report.
102. Health NZ was given the opportunity to respond to relevant sections of the provisional report. Where relevant, Health NZ’s comments have been incorporated into this report.
103. Dr B was given the opportunity to respond to relevant sections of the provisional report. Where relevant, his comments have been incorporated into this report. In addition, Dr B said:

‘I again wish to express my apologies for the cosmetic outcomes and reiterate my previous responses … My team and I have reflected deeply on the care provided to [Ms A] and how we can use this experience as a learning opportunity to improve our practice … We are deeply apologetic that [Ms A] felt the care provided to her was not adequate and I do not believe this to be a reflection of my usual practice.’

104. Regarding why Ms A was not offered psychological support prior to her decision to undergo a mastectomy, Dr B told HDC:

‘I do agree that a clinical psychologist is useful in such matters. Unfortunately, there has not been a consistent availability of such a person at the DHB. In their absence, [CNS E] does discuss all options independently and ensure[s] patients are well informed … In [Ms A’s] case time was a critical consideration and referring her to the Breast Cancer Foundation was not reasonably practical when breast care nurses are trained to help patients make decisions like this.’

Opinion: Introduction

105. The issues for me to determine are:

1. Whether there was appropriate continuity of care — noting in particular that Ms A met her surgeon, Dr B, for the first time on the day of her initial surgery;
2. Whether there was adequate consideration of Ms A’s family history of cancer prior to treatment options being offered and considered;
3. Whether Ms A was counselled adequately on the rationale for, and risks/benefits of, the double mastectomy surgery;
4. Whether Ms A’s surgery was conducted with reasonable care and skill; and
5. Whether Ms A was counselled adequately in respect of her postoperative exercise.

106. I obtained independent advice from a general plastic and reconstructive surgeon, Dr Sally Langley. I have relied on this advice to determine these issues in relation to Dr B and Health NZ. In addition, I obtained independent advice from a general surgeon, Dr Erica Whineray, who has provided further advice on the care provided by Dr B.

Opinion: Health NZ Lakes — breach

Knowledge of family history and preoperative discussion before WLE

107. On the day of her first surgery, Ms A was put in an extraordinarily difficult position. Specifically, she was asked to re-consider the proposed surgery having prepared mentally and physically for a particular treatment of her cancer, including having had dye injected and a hook wire inserted into her breast. This was, in my opinion, an unacceptable and avoidable situation.
108. HDC asked Health NZ why Ms A met Dr B for the first time only on the day of her first surgery, and what steps were in place to promote continuity of care.
109. Dr F (on behalf of Health NZ) advised that the breast clinic is held once per week, and the three consultant surgeons (Dr B, Dr C, and Dr D) see patients on a rotational basis. He said that patients are seen and treated by ‘the service’ rather than a particular clinician and are booked as appropriate for their needs. Dr F said that any confusion around Ms A (referring here to the fact that her full and significant family history was discovered only on the day of her scheduled surgery) was the result of a family history that was not fully appreciated at the time of her MDM discussion to determine the appropriate surgical recommendations.
110. Dr B told HDC that no notification is received when patients are transferred on to a particular surgeon’s surgical list until the surgeon receives the theatre list for the day in question (usually 24–48 hours prior to the surgery). He said:

‘The shared-care service, in the context of full workloads in a busy provincial hospital, relies on accurate and appropriate care provided at each patient interaction, prior to surgical procedures taking place. This is required where workloads and scheduling often make it impossible to arrange a clinic appointment to address any “missing information” at short notice.’

111. Dr Whineray was asked to comment on whether Dr B should have been aware of Ms A’s additional family history of cancer (the family history in addition to her mother’s history of breast cancer) prior to his meeting with her on the morning of the surgery on 3 May 2018. Dr Whineray advised that possibly Dr B should have been aware of this history, but as Ms A was a ‘pool patient’, Dr B was reliant on the assessment by the two other surgeons who met with Ms A in clinic prior to 3 May (Dr D and Dr C).
112. Dr Whineray advised that even prior to a known diagnosis, during a standard breast clinic appointment the initial surgeon should have elicited the family history of Ms A’s mother’s bilateral breast cancer. Dr Whineray said that additional history of other cancers is not always known by the patient at the time of diagnosis and becomes apparent with subsequent appointments. However, Dr Whineray advised that it is standard practice to ask the patient specifically about the risk factors for breast cancer, including family history of breast or ovarian or related cancers, and to document the presence or absence of these risk factors. Dr Whineray advised that the failure to do so in this case constitutes a moderate departure from accepted standards.
113. I accept Dr Whineray’s advice. In my view, when several different clinicians are involved in a patient’s care journey, there is an inherent risk of important information being missed. Accordingly, it is the responsibility of Health NZ to have processes in place to mitigate this risk. I am concerned that the full details of Ms A’s mother’s cancer do not appear to have been elicited prior to the first surgery (they are not documented) and there do not appear to have been any further enquiries made as to further family history. The comments made by Dr B and the other breast surgeons relating to discussions about family history show that there was uncertainty and confusion about what information had already been elicited, and whose responsibility it was to obtain that information.
114. I have also considered the appropriateness of Dr B’s discussion with Ms A about other options prior to her undergoing the WLE surgery on 3 May (discussed in paragraphs 116–118 below) and, if considered inappropriate, where responsibility lies.
115. Dr B is clear that the genetics referral he made on 6 April was an administrative task, and that he did not have any knowledge of Ms A prior to her being placed on his surgical list (around 24–48 hours prior to the surgery on 3 May). As I have found below, it is my view that Dr B was in a difficult position on the morning of 3 May, having no knowledge of Ms A nor the additional family history of cancer, and that in the circumstances of him discovering additional information that in his view was relevant to the treatment plan, he provided Ms A with the information that she needed to make an informed decision about whether to proceed with the WLE procedure that day. Although this was undertaken at an inappropriate time and in a less-than-ideal environment, I do not consider this wholly the fault of Dr B.
116. In my view, Dr B was operating within a system that did not allow for appropriate continuity of care. This stemmed from a failure in earlier appointments to elicit the full history of Ms A’s mother’s cancer, although sufficient clinical history was established to warrant a genetics referral one month prior to Ms A’s surgery. Regrettably, there was also no clinical consideration given to the significance of this referral (with the potential to gather further relevant family history, and the results of genetic testing), and therefore, no consideration was given to how the missing history/genetic results might impact on the treatment plan. The genetic referral alone should have prompted a discussion with Ms A and possibly the MDM before her proposed surgery date.
117. In this respect, I note Dr Whineray’s advice that once Ms A’s mother’s general history of breast cancer had been established and the genetics referral made, ‘the threshold for considering a familial syndrome was reached’. This means that the options that Dr B discussed with Ms A on 3 May could have been discussed with her prior to the morning of her procedure if adequate procedures had been in place to facilitate those discussions.
118. Right 4(5) of the Code stipulates that every consumer has the right to co-operation among providers to ensure quality and continuity of services. In Ms A’s case, the system in place to guide her through her breast cancer treatment was inadequate in that in the stages of diagnosis and forming of the initial treatment plan, no clinician held ultimate responsibility for her care. This resulted in a wholly unsatisfactory situation where on the morning of her planned WLE procedure on 3 May, the treatment plan was questioned in a manner that placed unnecessary stress on Ms A. Accordingly, I find that Health NZ Lakes failed to ensure cooperation among providers to ensure that Ms A was provided continuity of care, in breach of Right 4(5) of the Code.

Opinion: Dr B — breach

Preoperative discussion before WLE & SNB — adverse comment

119. Prior to Ms A undergoing the WLE & SNB on 3 May 2018, she met with Dr B for the first time. Ms A’s mother was present at this appointment and advised Dr B of the nature of her cancer as well as additional familial cancer information. On learning this information, Dr B gave Ms A the option to reconsider the WLE & SNB procedure she was scheduled to have that day.
120. Dr B explained his rationale for raising alternative treatment options just before the scheduled surgery:
     1. Prior to 3 May 2018 he was unaware of Ms A’s family history of cancer other than that Ms A’s mother had had breast cancer previously (information that he had learned on reading Ms A’s clinical notes from another clinician);
     2. He considered that the additional family history he elicited and the fact that Ms A’s mother’s cancer was ‘triple negative’ was significant to the treatment options;
     3. That a genetic defect or significant family history could come with a risk of recurrence that could change his advice around management and interventions (including that a mastectomy may have been recommended); and
     4. That if further surgery was required, definitive surgery undertaken in a single sitting typically results in better outcomes.
121. In relation to what Dr B discussed with Ms A prior to the procedure, he said that he advised Ms A that if she elected to wait, the wire in situ would be removed and they could consider using agents to stop the development of the tumour in the meantime. He said that he explained to Ms A the implications of significant family history, the heightened risk of further cancer if a genetic link was established, and ways in which this could be managed. Dr B said that he advised Ms A of the possible implications/risks of proceeding with the WLE & SNB (being that future reconstructions may be more complicated), and the potential benefits of going ahead with the procedure. He said that he also explained that it was open to her to proceed with the procedure and afterwards look to expedite the genetic testing. However, there is no record in the clinical notes of the details of this discussion. Dr B said that he offered Ms A time to consider her options, but she elected to proceed with the WLE & SNB procedure that day.
122. My independent advisor, Dr Whineray, advised that the additional familial history that Dr B became aware of on 3 May was (in her view) not clinically significant, in that once Ms A’s mother’s history of breast cancer had been established and the genetics referral made, ‘the threshold for considering a familial syndrome was reached’. This meant that the options that Dr B discussed with Ms A on 3 May could have been discussed with her prior to the morning of her procedure.
123. In particular, Dr Whineray’s opinion is that on receiving some family history and making the genetics referral on 6 April 2018, Dr B should have brought Ms A back to the clinic at that stage, to take a more detailed family history and to discuss the implications of the family history on her treatment options (including whether or not she should proceed with the planned WLE & SNB and radiotherapy or wait for the genetic results and decide on her treatment options then). Dr Whineray advised:

‘It is not uncommon to proceed with the cancer treatment for the cancer a patient already has, and attend to the genetic assessment and risk reduction options later if a pathologenic variant is detected. In this case, [Ms A’s] primary cancer was small and low-grade — there was enough time to wait for the genetics result to come through whilst counselling her on the treatment options and providing time to decide.’

124. Dr B said that the genetics referral was requested by him prior to Ms A being allocated to his care and onto his operating list, and that he had no knowledge of Ms A as a patient at this point. As outlined above, he also said that he progressed the referral as part of the shared administrative tasks that take place in the operation of the breast service. In addition, Dr B said that no notification is received when patients are transferred onto a particular surgeon’s list, until the surgeon receives the theatre list for the day in question (usually about 24–48 hours prior to the surgery).
125. In response to Dr B’s comments, Dr Whineray said that a doctor is responsible for the referrals they make and the tests they order. She said that irrespective of the fact that Ms A had not yet been allocated to his surgical list on 6 April (when the genetics referral was made), having personally referred Ms A for genetics assessment he was responsible for the outcome. Dr Whineray maintained her criticism of Dr B’s decision to alert Ms A to the potential change of plan on the day of surgery and considered this to be a moderate departure from accepted standards.
126. I also note Dr Langley’s advice that the discussion was carried out at an inappropriate time. She said that raising the possibility of alternative treatment just before Ms A was to be anaesthetised was inappropriate, as this is not a good way to enter general anaesthetic (with concern or doubt about the procedure about to be done).
127. Dr Langley advised that discussion of a different course of treatment immediately prior to an operation would be acceptable if it was serious, major, and with significant consequences. She considered that in Ms A’s circumstances, the concern about family history could have been assessed and addressed later. The alternative operation, bilateral mastectomy with or without reconstruction, could also have been discussed later. Dr Langley also considered that the WLE and SNB was the standard requirement for Ms A’s breast cancer at that stage and may well have been the only operation that she required. In addition, Dr Langley does not believe that undergoing the operation would have affected the consideration of Ms A’s family history of breast cancer and its consequences, or subsequent mastectomies and reconstructions. Dr Langley also disagreed with Dr B that a single operation has more acceptable or predictable results.
128. I note that Dr G’s advice also supports the view that it was inappropriate for Dr B to conduct the discussion regarding other treatment options with Ms A immediately prior to her planned WLE & SNB procedure.
129. I acknowledge the advice from Dr Langley, Dr Whineray, and Dr G, and I agree that it was inappropriate for Ms A to be notified of other treatment options immediately prior to her planned WLE & SNB procedure. I also accept that Ms A’s mother’s general history of breast cancer was enough to meet the threshold for considering familial syndrome as it prompted the genetics referral. In my view, Ms A was placed in this unacceptable position as a consequence of the system of care (as discussed in the previous section).
130. Dr B was in a difficult situation on 3 May, in part owing to the way the breast service operated — and in particular that a ‘service’ model of patient management did not enable clinical ownership and responsibility for Ms A’s care. This issue is addressed above in relation to Health NZ Lakes (and is relevant to this discussion). All clinicians, including Dr B, were unaware of Ms A’s additional family history prior to the morning of 3 May. Unfortunately, the additional information about Ms A’s mother’s cancer had either not been elicited by previous clinicians who had seen Ms A or was not offered when requested. The results of the genetic testing were also unavailable at this time, and Dr B regarded his referral to genetics as an ‘administrative’ task.
131. In my view, Dr B had limited options available to him at the time. Dr B could have proceeded with the surgery without having a discussion about the potential significance of the family history on the treatment recommendations, thereby not subjecting Ms A to extra stress or worry. With this option, a later appointment could have been made at a time when Ms A was in the right frame of mind to be considering treatment options in light of the benefits and risks of each.
132. Dr B’s other option was to give Ms A all the relevant information and ask her to make a decision based on full information, but subject her to the extra stress and worry. This extra stress and worry had the potential to affect her response to the operation she was about to undergo or affect her recovery. Ms A could also have chosen to abort the scheduled operation, either to take time to consider her options fully, or to opt for a prophylactic mastectomy instead.
133. Despite the comments of my advisors and the additional advice from Dr G, I cannot be overly critical of Dr B in this situation. He had a difficult judgement call to make, with disadvantages to any option he chose. In previous decisions, I have stressed that central to the effectiveness of informed consent is that a patient should have all the relevant information to consider before making any treatment decisions. If relevant information is withheld from a patient, consent is not informed.
134. Taking all this context into account and noting the recent allocation of Ms A’s surgery to Dr B, and that he obtained new information that in his clinical judgement affected the potential treatment pathway, I am satisfied that Dr B acted reasonably in advising Ms A accordingly. I have also considered that by providing Ms A with additional information about alternative treatment options, Dr B respected the key principle of informed consent.
135. Notwithstanding this, I am mildly concerned that Dr B did not identify Ms A’s mother’s cancer history prior to Ms A being prepared for surgery (ie, when Ms A was placed on his surgical list 24–48 hours prior to the surgery) given that this history met the threshold for considering familial syndrome. In addition, I am concerned that Dr B did not think critically at the time of the genetics referral, particularly as he has acknowledged that the family history and genetic risk could have been significant to the treatment plan. Although he regarded the referral as an administrative task, and may have assumed that others were managing Ms A’s care, he had the opportunity, as the clinician making the referral (noting also that usually a referrer would have responsibility to manage the results), to consider its implications for the patient, and consider whether the referral and treatment plan should be re-considered and discussed with the patient, other clinicians, and/or at an MDM.

Decision to perform mastectomy and information provided — breach

Summary of facts

136. On 16 May 2018, Ms A was advised that the result of the SNB showed that her cancer had likely not spread, and that it was therefore likely that the WLE had removed all the cancer. Ms A saw Dr B on 28 May and records show that Ms A requested this appointment as she wanted to discuss a bilateral mastectomy because she was concerned about recurrence of her breast cancer. At this time, the results of the genetic testing were still not available. Dr B told HDC that he provided Ms A with information on reconstruction, explaining different possible procedures, and the pros and cons of each. He said that he gave Ms A the opportunity to ask any questions and advised her to review the printed resources he had provided previously.
137. In response to the provisional opinion, Dr B said that it is his usual practice to advise patients that a prophylactic mastectomy removes 95% of breast tissue, but not all, and a small risk of recurrence still persists. He told HDC: ‘I am sure that this discussion was undertaken with [Ms A].’ Dr B also said that the evidence that prophylactic mastectomy does not offer a survival benefit over alternative options was not current at the time of the events, and that ‘[r]eports of a significant reduction in occurrence of second breast cancers were available [at that time]’.
138. Dr B said that all his discussions with Ms A about options, risks and benefits of surgery were supplemented by detailed discussions between CNS E and Ms A, and that is why he did not take detailed notes of these discussions. He said that CNS E told him that Ms A could not be dissuaded from proceeding to more radical surgery. Nothing in the clinical notes from this appointment documents a discussion about whether the surgery was appropriate, noting that, at this point, the genetic testing had not been concluded, or whether the surgery would be beneficial in terms of preventing cancer recurrence/reducing Ms A’s risk of death from cancer. In addition, Ms A stated that she could not recall whether anyone spent time with her exploring her reasons for choosing mastectomy or whether anyone discussed with her the possibility of removing only the breast that had been affected by cancer (a single mastectomy).
139. On 11 June, Ms A was advised of the result of the genetic testing, which revealed that there were no recognised genetic abnormalities. Dr G’s report for ACC (which Dr Langley had not seen before she prepared her advice) explains in detail what the results mean in practice. Dr G advised:

‘[Ms A] had a small 10mm low grade (Grade 1) invasive cancer … [Ms A’s] 5- and 10-year survival was calculated at 98% with surgery alone; with less than 1% survival benefit from Endocrine therapy. This tool does not account for [r]adiation therapy, which is a local treatment to the breast. In other words, this small cancer, if managed with the standard method of WLE followed by Radiotherapy, would have likely been the only cancer episode in this patient’s lifetime.

[Ms A’s] genetic testing was also negative and therefore [she] was not a high-risk patient, despite family history. One clinic letter suggests “strong family history” but without any details. Preoperative clinic letter by another SMO indicates patient’s mother had postmenopausal breast cancer but without any other breast or ovarian cancer history in the family and would not be categorised as significant family history. Variation in clinician assessment can often result in erroneous risk stratification, unnecessary anxiety for the patient, excessive screening measures or unnecessary risk-reducing surgery.

…

Based on documentation provided by ACC, there is no compelling evidence to support double mastectomy in [Ms A’s] case.

The long-term outcome for small early breast cancers is equivalent for breast conservation followed by Radiotherapy, compared to mastectomy alone. In other words, there is no survival advantage by undergoing a mastectomy with small breast cancers.’

140. Ms A saw Dr B again on 13 June 2018, by which time the results of the genetic testing were available. Dr B told HDC that at this appointment, he worked through the consent form for the mastectomy and reconstruction surgery with Ms A.
141. Dr B told HDC that Ms A had communicated anxiety about developing further cancers and was motivated to preserve her health. He said that he considered that it was appropriate to take Ms A’s preferences into account and undertake the requested procedure. He commented:

‘Ultimately, I did not consider it was my role to persuade or dissuade/discourage [Ms A] from a particular choice. I considered my role to was to provide her with information relevant to the procedure, including the risks, benefits and alternatives — and leave it to [Ms A] to decide what she wished to do.’

142. Dr B said that despite the results of the genetic testing, he did not consider the risk associated with Ms A’s family history of cancer to be minimal.
143. A letter from Dr B to Ms A’s GP of 14 June records the discussions between Ms A and Dr B, including the benefits and risks of the surgery (including the risk of implant loss, bleeding, and infection), scars, possible effects of the chosen incision type, and a likely loss of feeling in Ms A’s nipples. It was also discussed that Dr B could not guarantee that the breasts would be perfectly symmetrical, and that Ms A might require further surgery in the future.
144. The consent form signed by Ms A on 13 June 2018 states the risks discussed as bleeding, infection, ‘not a perfect match’, ‘?secondary surgery’, and a handwritten comment that is illegible. There is no evidence that other treatment options were considered further following receipt of the genetic test results, nor that the benefits of the surgery or Ms A’s reasons for wanting the surgery were explored. I note both Dr B’s and CNS E’s responses to the provisional opinion, in which they describe being unable to change Ms A’s mind about the procedure. Dr B describes setting out the options and risks with reference to a leaflet that was provided to Ms A. However, as noted elsewhere in this opinion, there is no documented evidence of such discussions, and this evidence must be viewed in light of Dr B’s further evidence that there were reports of a significant reduction in occurrence of second breast cancers with prophylactic mastectomies, as well as, in his view, benefits to her proceeding with the surgery in the absence of radiotherapy.
145. Ms A said that she chose mastectomy mainly because she was concerned about the potential long-term risks of radiation damage. She also told HDC that no clinicians attempted to dissuade her from choosing mastectomy over radiation therapy.

Psychology input

146. ACC advisor Dr G commented that in cases where a patient requests a prophylactic mastectomy despite no evidence of increased cancer risk, time should be taken to allay any fears the patient has about reoccurrence or personal biases around treatment complications. Dr G also noted that it is advisable to seek a formal assessment by a clinical psychologist in this setting, and that the patient should be counselled adequately against having a double mastectomy (my emphasis). She advised that there is little evidence of these steps having been carried out in Ms A’s case. Dr G commented that if there is no survival advantage or benefit from a bilateral mastectomy, she would expect to see clear and detailed discussion about the issue documented in the patient notes.
147. Similarly, Dr Whineray considered that Ms A was not counselled adequately regarding the risks and benefits of preventative surgery. Dr Whineray also advised that it may have been warranted to refer Ms A to a clinical psychologist, as it is common to see decision regret following preventative surgery in an active woman of Ms A’s age. Dr Whineray noted:

‘If [Ms A] [was] still keen on surgery at that point after being presented with all the possible things that could go wrong, then you have an informed patient who is likely to be satisfied with the outcome.’

148. In response, Dr B said that he agrees that psychological input in such a decision would be helpful, but the breast service in Rotorua is limited in its availability to offer this. Dr B stated:

‘Through the relevant period and in the years since, there hasn’t consistently been a psychologist that is able to provide this service.’

149. Dr Whineray advised that in the absence of an available psychologist in the service, a referral could be made to organisations such as the Breast Cancer Foundation. She said that another option is using time delay and speaking to other clinicians, ‘as a means to ensure that a patient is not making the decision out of the usual anxiety associated with a breast cancer diagnosis as further surgery may not address the underlying concern’.
150. Dr Whineray advised that as there is limited access to a psychologist in Rotorua, she would consider the failure to seek psychological input to be a mild departure from acceptable practice.

Discussion

151. On the evidence before me, it is clear that Ms A had educated herself on both the radiotherapy option and the mastectomy procedure, and that she wished to proceed with a prophylactic double mastectomy. I acknowledge that Dr B considered the prophylactic mastectomy to be a reasonable treatment option for Ms A in light of her clear wishes for the procedure, her choice not to undergo radiotherapy following the WLE (making the WLE procedure ‘incomplete’), and her family history of cancer. Considering the above reasoning, and that Ms A had clearly educated herself on the prophylactic mastectomy and wished to proceed, I accept that the mastectomy may have been a reasonable treatment option to consider. However, despite Ms A taking all steps to educate herself on the treatment options, Dr B still had a responsibility to ensure that Ms A had all the relevant information prior to consenting to the procedure. I will discuss this in detail below.
152. Dr Whineray identified that the genetic testing had shown no pathological genetic variant, and, whilst it was an ‘inconclusive result’ (consistent with the time), it would now be declared not a carrier. Dr Whineray advised that in light of the inconclusive result, the surgeon would then review the risk profile according to the genetic tree.
153. The genetics team had counselled Ms A that the risk of another breast cancer was up to 18% at 25 years compared to the normal population at 11%. There was therefore an 82% chance that Ms A would not develop another cancer. In relation to whether or not Ms A was fully informed of the meaning of the risk profile, Dr Whineray advised:

‘Patients consistently over-estimate their risk of contralateral breast cancer so it is important that time is spent explaining what these numbers mean; for every patient like [Ms A], less than 1 in a group of 100 would develop another breast cancer each year. And whilst bilateral mastectomy would reduce the chance of her developing another breast cancer, there is NO survival benefit. It will not reduce breast cancer death.’

154. I note that although Dr B advised this Office that he discussed with Ms A the reduction of risk of cancer recurrence arising from the mastectomy, there is nothing in the clinical notes to illustrate that this occurred. I also note Ms A’s comments that she does not recall anyone exploring with her the reasons for choosing mastectomy, and that she does not recall anyone dissuading her from undergoing the procedure.
155. In response to the provisional opinion, Dr B said that the evidence that prophylactic mastectomy does not offer a survival benefit over alternative options was not current at the time of the events, and that ‘[r]eports of a significant reduction in occurrence of second breast cancers were available [at that time]’.
156. Dr Whineray was asked to comment on this submission, specifically whether in 2018, at the time of events, it was known that prophylactic mastectomy does not offer a survival benefit over alternative options. Dr Whineray advised that in 2018 it was in fact known that prophylactic mastectomy does not offer a survival benefit. Dr Whineray provided references to the research, which I have reviewed. I accept Dr Whineray’s advice.
157. It is clear that Ms A was provided information about the mastectomy. Dr B and CNS E provided Ms A with relevant printed materials and had discussions with her about risks (Dr B notes that he discussed implant loss, bleeding, infection, scars, possible asymmetry and loss to nipple sensation), complications, healing times, recovery, genetic factors, details of the implants and the surgical procedure, cosmetic outcomes, and the risk that further surgery would be required.
158. However, whilst it is clear that Ms A was aware of less aggressive treatment options (such as WLE and radiation), there is nothing in Ms A’s patient notes or in Dr B’s evidence to suggest that the risks of cancer recurrence and long-term survival with the various treatment options were discussed with her adequately to allow her to make an informed choice about prophylactic mastectomy. That is, there is no evidence of discussion about the relative future cancer risks between having the mastectomy (including that having the mastectomy would not lower the risk of death from breast cancer), having no treatment, or completing an alternative course of treatment (ie, the radiotherapy and drug therapy). Whilst CNS E did advise Ms A to wait until the genetic testing had been completed before making a decision, Ms A has stated that on receipt of the results of the genetic testing, she does not recall whether anyone spent time with her exploring her reasons for choosing a mastectomy. There is also no evidence in the clinical documentation that this occurred, and I note Dr B’s comment that he did not regard it as his role to attempt to dissuade her.
159. Based on the information available to me, I find it more likely than not that Dr B did not counsel Ms A adequately on the risks and benefits of the mastectomy procedure and alternative treatment options, particularly in relation to future cancer risks.
160. Dr Whineray advised that if Ms A did not understand that the mastectomy procedure would reduce but not eliminate her chance of developing another breast cancer, and would not change her life expectancy, then she would consider the failure of Dr B to counsel on these points to be a moderate departure from accepted standards.
161. I agree. Whilst I appreciate that clinicians must respect a consumer’s wishes on medical decisions, in my view, if a consumer requests treatment that has little clinical evidence for its use over less aggressive treatments, I would expect to see greater care taken to explore the reasons why the consumer is electing those treatments, and clear documentation of that process. I also note that there were no MDM discussions about a prophylactic mastectomy either before or after the WLE. Although I accept that ultimately it is the treating clinician who, in consultation with the patient, determines the best course of treatment, the inclusion of other voices and opinions in the process may have produced a more satisfactory outcome for Ms A. Dr C’s letter suggests that he, at least, would have counselled against a prophylactic mastectomy had it been discussed at an MDM. Ultimately, I am concerned that Dr B did not counsel Ms A adequately on the risks and benefits, including her future cancer risk, before proceeding with the double mastectomy.

Conclusion

162. Right 6(1) of the Code states that all consumers have the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including an explanation of the options available, including an assessment of the expected risks, side effects, and benefits. In my view, by failing to counsel Ms A adequately on the benefits and associated risks of the mastectomy and alternative treatment options, particularly in light of the results of the genetic testing, Dr B failed to provide appropriate information to Ms A to allow her to make a fully informed decision on her treatment. It follows that Dr B also breached Right 7(1) of the Code, which states that services may be provided to a consumer only where that consumer has made an informed choice and given informed consent. As I have found that Ms A was not provided with the appropriate information by Dr B, it is my view that she was not in a position to give informed consent to the mastectomy procedure.
163. I do not consider the failure to refer to a clinical psychologist to be a serious failing, in light of the service limitations at Rotorua. That said, it is important to acknowledge the value of counselling and support in these circumstances and, accordingly, recommendations and comment on this issue are made below at paragraph 193b).

Outcome of bilateral mastectomy and reconstruction

Whether surgery was performed with reasonable care and skill — no breach

164. Ms A’s main complaint relates to the outcome of the bilateral mastectomy and reconstruction. She told HDC that she regrets the decision to have a bilateral mastectomy due to the complications caused by it, and the effect it has had on her life. She believes that best practice methods were not used in the reconstruction, and therefore she is facing major revision surgery and the associated recovery. At the time of writing, Ms A had had five surgeries.
165. In this respect, Ms A’s complaint stems from findings by Dr G in the ACC report relating to the rippling effect evident, especially on her left breast post-reconstruction, and to nipple necrosis and positioning of the implants.
166. In relation to the rippling effect, Dr G advised that this was most likely caused by the use of soft implants combined with the thin mastectomy skin flaps at the time of surgery. In addition, the sutures along the pectoral muscle and TIGR mesh had snapped before the TIGR mesh had integrated with the host tissue, probably due to early use of the muscle or the very thin muscle flap.
167. In respect of the nipple necrosis, Dr G listed several factors that can contribute to the appearance of necrosis following surgery. She noted that superficial necrosis is a recognised complication in 10–15% of mastectomy cases, and complete nipple necrosis is seen in 3–5% of cases where a mastopexy-type incision is used with nipple-sparing and implant-based reconstruction.
168. Regarding the position of the implants, Dr G noted:

1. 1. The difference in implant height is often caused by inaccurate mark-up prior to surgery and intraoperative assessment during implant placement.
   2. The lateral displacement of the implant could be caused by the early breaking of the sutures holding the pectoral muscle to the flaps, or by the pocket being too large for the implant. In Ms A’s case, the implant pocket may have been too large.

169. Dr Langley also commented on the reasons for the post-surgery deformities. She advised that a relatively poor cosmetic result is not unusual after implant reconstructive surgery. She said that it is reasonably common to need a further procedure to excise skin along the line of the inframammary fold,[29] and it is also not unusual to have asymmetry and poor attachment/definition of those folds. This can require further surgery to reattach the folds. She also said that it is not unusual to have some grooving and rippling of the breast skin. This may be improved by careful fat grafting, which should be available in the public hospital. Lastly, she advised that it is not unusual to have early and late asymmetry despite the surgeon’s best endeavours, and further surgery to try to improve this is often required.
170. Dr Langley is not critical of Dr B’s surgical technique, nor is she directly critical of the cosmetic outcome of the bilateral mastectomy and reconstruction.
171. Considering the advice of both Dr Langley and Dr G, I am not critical of the skill and care with which Dr B performed the surgery. Although Dr G listed several factors that could have contributed to the deformities, it is far from clear whether any blameworthy conduct by Dr B resulted in the deformities. I note that Dr G’s report was produced for the specific purpose of determining whether there was a treatment injury for ACC claim purposes, and not to determine whether Dr B departed from the standard of care expected of him. I accept Dr Langley’s advice that a poor cosmetic result is not unusual in breast reconstruction surgery, and often remedial surgery is required to correct this.

Information provided before surgery about possible deformities and implant types — no breach

172. Throughout the clinical documentation there are references to the advice provided to Ms A about potential asymmetry, and the possibility of further surgery being required to correct defects in the future. Both Dr B and CNS E described discussions they had with Ms A at various points, including discussions on cosmetic outcomes. However, I cannot see any specific discussion about the possibility of a rippling effect following the surgery.
173. Dr Langley commented that although Dr B provided Ms A with considerable information, he appears not to have given her details about the silicone gel breast implants themselves, and the specific outcome concerns and complications related to them. However, Dr Langley did not identify any departure in respect of the information given to Ms A about the possibility of unsatisfactory outcomes from the surgery. Dr B told HDC that the BAPRAS guide to breast reconstruction does contain details on silicone breast implants, and he uses that as a basis for discussions in the consultation.
174. Although it is not clear whether the specific risk of rippling with the type of implant used in Ms A’s reconstruction was discussed, I note that Ms A was warned of the risk of deformities and the potential need for corrective surgery, and was provided with substantial printed material, including information about silicone implants. The BAPRAS guide specifically mentions that implants are prone to visible folds and creases. Ms A had the opportunity to ask questions of Dr B. Accordingly, whilst I acknowledge the advice of my independent advisor, I consider that Ms A was provided with sufficient information by Dr B before her mastectomy and reconstruction, except in the area of post-surgery physical activity.

Information provided before surgery about physical activity — adverse comment

175. Dr G noted the importance of limiting physical exertion in the weeks after surgery. She counsels her patients to avoid lifting, pushing, or pulling anything heavier than a cup of tea for six weeks after surgery. She stated:

‘Patients need to be given very clear instructions about the restrictions in activities after surgery and to avoid any lifting/pulling/pushing for at least 3 months to try and prevent these complications. Patients need to be advised against driving for at least 8–10 weeks after surgery; provided there are no wound complications; and longer, if there are any wound problems. Preoperative education by Breast Care Nurses and detailed Patient information leaflets specific to type of reconstruction, can help minimise these complications.’

176. Ms A said that she was surprised by Dr G’s report. She cannot recall being told anything as specific as the restrictions suggested by Dr G, and said that she limited her activity, but not to the level suggested by Dr G. She stated that she is a physical person and did a lot of exercise at that time. Ms A said that no information was given to her about not driving, and that she would not have driven to her appointment less than two weeks after the surgery if she had been advised not to drive.
177. In response to the provisional opinion, CNS E told HDC:

‘Post-surgery care and exercise restrictions had been discussed with [Ms A]. I clearly remember her coming back to ask if she could use the exercise bike. [Dr B] and I told her to avoid heavy exercise and to gradually build up over the next 6 months. Driving was only to be undertaken after 3–4 weeks.’

178. However, there is nothing in the clinical record about specific activity restrictions being provided to Ms A. Dr Langley similarly commented that she was not provided with information about the activity restrictions given to Ms A.
179. Dr B and CNS E provided information to HDC about the advice and printed material they gave Ms A in respect of the level of physical activity she should undertake post-surgery. The printed materials comprise three pamphlets detailing the exercises and physiotherapy that a breast surgery patient should carry out in the weeks post-surgery. The pamphlets focus on the exercises that should be carried out rather than on details of specific limitations on physical activity. However, the pamphlets note that patients should build up gradually to moderate and regular activity, avoid uncomfortable exercises, go at a pace at which they feel comfortable, and avoid heavy lifting.
180. There is an absence of information about what level of activity might be harmful or might cause the kinds of deformities suffered by Ms A. I suspect that this is because it is dependent on the patient and/or the type of surgery. I note that the Breast Cancer Care document ‘Exercises after Breast Cancer Surgery’ contains the warning:

‘If you’ve recently had a breast reconstruction, talk to the surgeon who did the operation or your physiotherapist before you start or continue with any exercises, and follow their advice.’

181. In terms of the specific advice provided by Dr B, he said that it was the breast cancer nurse who discussed the contents of the pamphlets, and perhaps also the physiotherapy team. CNS E told HDC that Ms A was an ‘active relaxer’ and that she had a tough time during the healing process. CNS E said that generally she encourages mobility and gentle exercises for the first six weeks, and she advises patients to pace themselves. I can find no specific mention of discussions around post-surgery activity in the nursing documentation, except a note by the breast nurse on 23 June 2018, which states: ‘[E]xercises covered.’
182. The clinical notes by a physiotherapist on 22 June 2018 record that Ms A was given a handout advising her to do ‘Stage 1 exercises’[30] until the drain had been removed, and that she should do no heavy lifting for 6–8 weeks.
183. I note also that on 1 July 2018 Ms A attended the Rotorua Hospital outpatient clinic with a cough that had triggered pain around the site of her recent surgery.
184. The cause of Ms A’s breast deformities is not entirely clear, particularly the rupture of the sutures attaching the TIGR mesh to Ms A’s pectoral muscles. Regardless of how the deformities occurred, I find it concerning that other than the advice to avoid heavy lifting, there is no specific mention of how Ms A should limit her physical activity following the surgery. Dr G noted that she advises her patients on activity restrictions in much greater detail than appears to have occurred in Ms A’s case, including that patients should avoid lifting, pushing, or pulling anything heavier than a cup of tea for six weeks after surgery, and that patients should avoid driving for eight to ten weeks after surgery. I note with concern that Ms A drove herself to her appointment on 4 July 2018 (at which the necrosis on her nipples was debrided). That appointment was only two weeks after her surgery, and Ms A commented that she did not feel prepared for the outcome of the debridement, and no one had advised her to avoid driving.
185. I am also concerned that more care was not taken by Dr B, as the responsible clinician, to ensure that Ms A understood both the level of physical activity to which she should limit herself in the weeks after her surgery, and also the potential consequences of undertaking too much physical activity. Although Dr B may rely on the clinical nurse specialist and the physiotherapy department to an extent, as the operating consultant it remained his responsibility to ensure that Ms A understood the particular risks of any reconstruction method. Ms A was an active person, and her level of activity in the weeks following surgery may have increased the risk of rupturing her sutures.

Changes made

186. Dr F told HDC that a guideline around prophylactic mastectomies is under development.
187. I note with approval that Health NZ Lakes has made changes to its MDM form to include specific discussions about family history. Dr B told HDC that the Health NZ Lakes MDM form was amended on his prompting to include family history as a compulsory discussion topic. He said that now that it is a required discussion point, and further and appropriate detail is collected by clinicians and presented to the full team to inform discussions on treatment plans. I am reassured by these process improvements.
188. In response to the provisional opinion, Health NZ Lakes said that it has agreed on a ‘rotating roster’ whereby an agreed consultant surgeon would accept responsibility for referrals, and therefore the outcomes of patients referred to the service. The roster has been set up on a two-weekly rotation among the four surgeons in the service, and the responsible surgeon ensures that appropriate outcomes and management plans are instituted for each patient.
189. In response to the provisional opinion, Health NZ Lakes advised HDC of its current pathway for patients presenting to Rotorua Hospital requesting or wishing to explore the option of a prophylactic mastectomy (based on a genetic test). Health NZ Lakes said that the patient would meet with a surgeon, and, if prophylactic mastectomy is an option, a referral is made to a tertiary institution for review.
190. Dr B also told HDC that he now always asks patients for breast reconstruction whether they are in the habit of performing very heavy exercises. If they answer yes, he does not advise retro-pectoral reconstruction, and instead considers them for a pre-pectoral reconstruction (which does not produce the ‘window shading’ effect, as the pectoral muscle is not separated from the chest wall).
191. Dr B also told HDC that since early 2019, when they became available, patients have been given the option of using form-stable anatomical implants, and all patients are now warned about the possibility of rippling when considering the use of ergonomic implants.
192. In response to the provisional opinion, Dr B told HDC that he has implemented a tick-box sheet that documents the discussions had between clinicians and patients, and a list of the leaflets provided. He also said that he has implemented a process whereby discussions on reconstruction are part of a separate appointment. Dr B said: ‘A brief discussion on reconstruction will be held initially and a specific reconstruction appointment will be scheduled for a week later.’

Recommendations

Health NZ Lakes

193. I recommend that Health NZ Lakes:

1. Provide a written apology to Ms A for the failings identified in this report. The apology is to be provided to HDC within three weeks of the date of this report, for forwarding to Ms A.
2. Provide an update to HDC on the new guideline around prophylactic mastectomies and, in the event that the following is not included in the guideline, consider including a prompt for clinicians to consider (1) a referral for patient counselling, and (2) MDM consideration for such patients, within three months of the date of this report;
3. Use an anonymised version of this report as a basis for staff training at Health NZ Lakes for staff involved in breast surgery, focusing particularly on:
   1. discussions with patients about alternative treatment options and how the risks of each option are quantified to patients (and documentation of those discussions); and
   2. discussions with patients about limitations on physical activity following surgery, and the risks associated with overexertion (and documentation of those discussions);

and provide HDC with evidence of the training within six months of the date of this report.

Dr B

194. I recommend that Dr B:
     1. Provide a written apology to Ms A for the failings identified in this report. Dr B is to provide the apology to HDC within three weeks of the date of this report, for forwarding to Ms A.
     2. Complete the HDC online learning modules and provide HDC with the certificate of completion within three months of the date of this report.
     3. Undertake an audit of his clinical documentation covering the three-month period prior to the date of this report, in order to identify:
        1. any patients who have not been provided with details of the relative risks and benefits of different treatment options;
        2. any patients who have not been provided with sufficient information to enable them to understand both the levels of physical activity to which they should limit themselves in the weeks after surgery, and also the potential consequences of undertaking too much physical activity; and
        3. in respect of both paragraph i and ii above, to identify whether such discussions have been documented adequately.

I recommend that Dr B report back to HDC with the results of the audit, and any steps taken to resolve any deficiencies, within three months of the date of this report.

Follow-up actions

195. A copy of this report with details identifying the parties removed, except Health NZ Lakes, Rotorua Hospital, and the advisors on this case, will be sent to the Medical Council of New Zealand, and it will be advised of Dr B’s name.
196. A copy of this report with details identifying the parties removed, except Health NZ Lakes, Rotorua Hospital, and the advisors on this case, will be sent to Breast SurgANZ.
197. A copy of this report with details identifying the parties removed, except Health NZ Lakes, Rotorua Hospital, and the advisors on this case, will be placed on the Health and Disability Commissioner website, www.hdc.org.nz, for educational purposes.