Names have been removed to protect privacy. Identifying letters are assigned in alphabetical order and bear no relationship to the person’s actual name.
A Decision by the Deputy Health and Disability Commissioner
- This report is the opinion of Deborah James, Deputy Health and Disability Commissioner, and is made in accordance with the power delegated to her by the Commissioner.
- The report discusses the care provided to Ms A by general practitioner (GP) Dr B and Clinical Practice Manager Ms C at a medical centre.
- On 5 September 2020, Ms A was provided with Botox treatment at the medical centre. Following treatment, Ms A experienced adverse reactions.
- Ms A raised concern about the informed consent process. She stated that she was not made aware of the risks and side effects prior to treatment, and she was not provided with any written information about the treatment.
- The following issues were identified for investigation:
- Whether Dr B provided Ms A with an appropriate standard of care in September 2020.
- Whether Ms C provided Ms A with an appropriate standard of care in September 2020.
- Whether the medical centre company provided Ms A with an appropriate standard of care in September 2020.
Details of providers
Medical centre company
- In 2020, both Dr B and Ms C worked at the medical centre, which was owned and operated by Dr B. Dr B is the sole director of the medical centre company.
- Dr B was responsible for the day-to-day activities, and any appearance medicine activities at the medical centre. Dr B stated that appearance medicine was a ‘tiny part’ of the medical centre’s range of services, and these services were offered only by himself. He stated that the treatments offered included Botox injections for the correction of wrinkles, injectable fillers, chemical peels, and Platelet Rich Plasma (PRP).
- Dr B told HDC that he was not doing any clinical work at the time of the events due to health issues. Currently Dr B is not practising, and his practising certificate expired in August 2020.
- Ms C was the Clinical Practice Manager of the medical centre at the time of the events of the complaint.
- The employment agreement between the medical centre and Ms C dated 13 May 2013 described Ms C’s position as a ‘Health Care Assistant/Administration Support Officer’.
- Ms C was a member of an overseas nursing organisation, but she was not registered with the Nursing Council of New Zealand to practise as a nurse, and she did not hold a practising certificate in New Zealand.
- Ms C told HDC that she was responsible for managing the medical centre’s operations, and for overseeing the day-to-day clinical and administrative activities. This included leading the clinical staff, human resourcing duties (including the hiring and training of new staff), handling medical records and accounting, ordering equipment and supplies, and developing and implementing strategies to improve the medical centre’s efficiency.
- Ms C told HDC that in addition to these duties, she also assisted Dr B with clinical activities from time to time, specifically when the medical centre was short-staffed. Ms C stated:
‘This included assisting [Dr B] while he was doing [minor] surgery and administering Botox injections on his standing order (after [a] few years of assisting him and completing the comprehensive training he gave me) …
As per [Dr B’s] request I was helping him and the practice and [cosmetic nurse] (also trained by [Dr B]), from time to time if they were busy on his standing order.’
- Ms C told HDC that currently she works in a job ‘which does not include any type of clinical activities or cosmetic treatments’.
Botox treatment on 5 September 2020
Delegation of treatment
- On 5 September 2020, Ms A arrived at the medical centre with two of her friends for her first Botox treatment. Ms A stated that a friend had made the appointment for himself, his partner, and for Ms A.
- Dr B told HDC that at the time when Ms A’s friend had made the appointment, the staff member making the appointment was under the impression that Ms A would only be observing. Dr B stated that the staff member making the appointment did not realise that Ms A also wanted to receive treatment as a new patient.
- Dr B said that as he was away from the medical centre on that day, appointments were to be made for follow-up patients only, and not any new patients. He said that when Ms C realised that Ms A was a new patient, she telephoned him and asked what she should do. Dr B stated:
‘I then made an error of judgement and informed her, given the circumstances, to do an initial assessment as I would normally do and if there are no contraindications, to proceed with treatment.’
- Ms C injected Ms A with a total of 30 units of Botox.
- Dr B said that Ms A and both of her friends went into the treatment room together, which placed ‘undue pressure’ on Ms C. Dr B stated:
‘Overwhelmed by an extended audience to witness her actions and their enthusiastic encouragement of [Ms A] to go ahead, [Ms C] made an error of judgement to forego most of the steps for an initial assessment and proceed with the treatment for [Ms A]. She checked the medical questionnaire for any contraindications and explained the most common side-effects.’
- Ms C stated:
‘I did the Botox injection for [Ms A’s friend] first and while I was doing the Botox for them I was explaining the common side effect of Botox injection such as ptosis, droopy eyelid, etc. for example I explained how the treatment is different for a patient with a long forehead and someone with the short forehead …
I have checked [Ms A’s] consent form and looked for any history or current disease or allergy and I found none. I did the facial assessment and told [Ms A] that for the first treatment I will go with the minimum standard dose for each area of her concern as we don’t know how her facial muscles will react to Botox and she can come back after two weeks for follow up, she agreed.’
- On 5 September 2020, Ms A signed a consent form for the Botox treatment, which Ms C signed as the ‘Doctor’.
- The consent form states: ‘I, [Ms A] have requested that [Dr B] improve my facial expression lines with Botox …’
- The consent form lists the following risks and side effects:
‘Botox treatment of frown lines can cause minor temporary droop of an eyebrow or eyelid in 3% of injections. This could last 2–3 weeks. Occasionally, slight swelling or bruising can occur and last for a few days.’
- Ms A stated:
‘There was no discussion prior to the treatment of the contents of the consent form, nor any discussion on possible risks, side effects, or post treatment protocols. I was not told how many units I was getting. The only question asked was “what was I hoping for” (in regard to my wrinkles) and I explained I’d rather have less the first time to see whether I liked it. Then the Botox was injected.’
- Ms A said that she was also not provided with any advice on the aftercare. She stated that as she walked out of the treatment room, Ms C ‘called out’ that she should not rub her face, but she was not provided with any other aftercare advice.
- Ms A said that subsequently she did her own research, and she believes that she should have avoided lying down for at least four hours after treatment, and she was not to carry out any physical exercise for a few days after treatment.
- Ms C acknowledged that she did not discuss with Ms A the possibility of adverse reactions and apologised for this.
- Dr B stated that in this case, the standard procedure for administering Botox was not followed, as Ms A was not provided with the opportunity to have an individual discussion of her treatment goals and consider all possible side effects before consenting to the treatment. Dr B also stated that Ms A was not provided with any written instructions on aftercare.
Events following treatment
5 September 2020
- Ms A stated that when she got into her car after the treatment, she noticed some post-injection bleeding at one of the injection sites, which she wiped off with a dampened tissue.
6 September 2020
- Ms A said that on 6 September 2020, the day following treatment, she felt very tired and ‘slightly off’. She said that she had taken great care not to rub her face, and she had not done any physical exercise.
- Ms A stated that around 10.30pm, she started to experience several symptoms, which she described as:
‘Racing heart rate, feeling of dread, shaking, sweating, inability to fall asleep (I was awake the entire night), body felt like it was on fire and I had electrical surges through my arms and legs, heavy legs, feeling [off-balance].’
7 September 2020
- Ms A stated that on 7 September 2020, she continued to experience symptoms, which she described as:
‘Feeling [off-balance] (a sense of falling to the left when I walked), heavy legs (like I was conscious of walking), severe brain fog, inability to concentrate, tight feeling around my head like a rubber band, loss of feeling down my cheeks, anxiety, extremely dry eyes, heavy eyelids, feeling like something is pressing on my left eye in particular, slightly blurred vision, aching face.’
- On the same day, Ms A emailed the medical centre advising that she had been experiencing adverse effects from the Botox treatment. In response, Ms C asked Ms A to attend the medical centre for a full assessment.
8 September 2020
- On 8 September 2020, Ms A was assessed by a GP at the medical centre, Dr D. Dr D noted that Ms A presented with multiple symptoms following her Botox treatment but was feeling better than she had felt two days previously. Dr D also noted that Ms A had been treated for anxiety 15 years prior to her Botox treatment, which had been ‘completely resolved’.
- On examination, Dr D found that Ms A was clinically stable. Her neurological examination was normal, as were her ears, nose, and throat. Dr D’s impression was one of a mild reaction to Botox, with an ‘overlay of severe anxiety’.
- Dr D discussed Ms A’s condition with the National Poisons Centre, and with the on-call neurologist at the public hospital, who advised that the Botox dosage Ms A had received was unlikely to cause any significant adverse effects, and it was possible that she had had a minor reaction to the treatment, which could have triggered a severe anxiety reaction.
- Dr D managed Ms A’s condition conservatively and advised her to present to the Emergency Department (ED) if any new symptoms emerged, or if her condition deteriorated. Dr D provided Ms A with a referral letter for this purpose.
- Dr D also instructed Ms C to telephone Ms A daily to monitor her condition.
- Dr D stated that he heard nothing further and understood from Ms C that Ms A had recovered well a few days after his assessment.
9 September 2020
- At 3.45pm on 9 September 2020, Ms C sent Ms A a text message to monitor her condition, to which Ms A replied: ‘No change, feeling exhausted.’
- At 6.23pm, Ms C sent Ms A another text message to see if she had any new symptoms, to which Ms A replied ‘no’.
- Ms A stated that from this point, there was no further follow-up or monitoring from Ms C.
10 September 2020
- Ms A said that on 10 September 2020, she had a consultation with ‘a practitioner who specialises in supporting the body with detoxing and immune system reactions’, after which her neurological symptoms began to alleviate.
11 September 2020 to 9 October 2020
- Ms A stated that on 11 September 2020, she continued to experience symptoms and ‘a general feeling of dizziness’. The dizziness was on-going, and on 3 October 2020 she started to experience vertigo.
- Ms A said that on 8 October 2020, she started to experience neurological pain in her right arm, which lasted for three days, and on 9 October 2020, she had a ‘brief episode of inability to swallow, followed by [a] lump sensation in [her] throat’.
- Dr B stated that Ms A did not inform the medical centre of her new symptoms that emerged on 3 October, 8 October, and 9 October 2020, nor did she seek treatment for these symptoms from the ED, as per Dr D’s advice.
- Dr B said that it was clear that Ms A had experienced several side effects that can commonly occur with Botox treatment, but it was difficult to determine which of her symptoms were injection-related, toxin-related, or due to other factors. Dr B stated that had Ms A been informed about what to expect after the treatment, she may not have experienced such a wide range of side effects.
- Dr B expressed his utmost regret for not being able to deliver the services Ms A contracted from the medical centre at an appropriate standard and level of care.
- Ms C told HDC:
‘[A]fter this incident … [Dr B] mentioned to me that he did some additional research to improve the quality for appearance medicine clinic and he [thinks] that it is better if I don’t administer Botox any longer as I am not a registered nurse in [New Zealand]. I was [quite] upset that I have been placed in such a compromised and vulnerable position although [Dr B] mentioned that he was not aware of that … as an employee, I was following my employer’s instructions and helping him without knowing that my qualification, skills and nursing registration from [overseas] was not sufficient to carry out the Botox procedure. Considering that in many countries such as [my home country], [United States of America] and [United Kingdom] anyone with [a] clinical background or beauty therapists are able to [administer] Botox by physician standing order after proper training.
I always [know] my work limitation and I would never go beyond that, for example I was never involved in any immunisation program, vaccine administration or other clinical activities required to be performed by [a] registered nurse although I was capable to do those activities. Since then, I have not been involved in any clinical activities … after I left [the medical centre].’
- Ms C apologised to Ms A for her experience with Botox treatment. Ms C told HDC:
‘I assured [Ms A] that I didn’t have any intention to compromise her health or provide her with inadequate information. I understand that her experience was less than satisfactory, and I am deeply sorry for that.’
Medical Council of New Zealand
- The Medical Council of New Zealand’s statement ‘Informed Consent: Helping patients make informed decisions about their care’ (issued in September 2019) (the Informed Consent statement) notes:
‘The doctor undertaking treatment is responsible for the overall informed consent process …
Sometimes, it could be practical to delegate a patient’s care to another doctor or health practitioner. When deciding whether to delegate, you should consider the nature of the treatment or intervention, and how any risks and complications will be managed … whether your patient or anyone else involved in the decision to delegate has been given enough information and time to think it over and to express their views …
You should also consider whether the person you delegate to has the right skills and experience to treat your patient, understands the risks and benefits of the treatment they are providing, understands the patient’s needs and their clinical history … is clear about which doctor or health practitioner is responsible for obtaining consent from the patient and for checking that the patient is clear about their decision.’
- The Medical Council of New Zealand’s ‘Statement on cosmetic procedures’ (issued in November 2017) outlines the standards expected of doctors who perform cosmetic procedures, including the following:
‘A patient’s informed written consent should be obtained at a pre-procedure consultation within a reasonable time period before the day of the procedure and consent must be reconfirmed on the day the procedure occurs. Obtaining informed consent is the responsibility of the doctor treating the patient …
The operating doctor is responsible for all aspects of preoperative, operative and post operative care. Delegation of care must be appropriate and arranged in advance of any procedure.’
Nursing Council of New Zealand
- The Nursing Council of New Zealand told HDC:
‘Botox is a prescription medicine and can only be given by a medical practitioner, a dentist, a registered nurse or nurse practitioner working under standing orders. Any nurse would have to be practising within their scope of practice and have the relevant training and education in its administration before administering it.’
New Zealand Society of Cosmetic Medicine
- The New Zealand Society of Cosmetic Medicine (NZSCM) is the only organisation recognised by the Medical Council of New Zealand to regulate and train doctors in cosmetic medicine.
- NZSCM states that injected treatments, such as Botox and dermal fillers, are prescription medicines, and that only a doctor or registered nurse working under the doctor’s supervision can perform them.
Standing Order Guidelines
- In August 2016 the Ministry of Health published Standing Order Guidelines to provide guidance for health professionals working with standing orders, and to assist people administering and/or supplying medicines under standing orders.
- The Standing Order Guidelines state that a standing order is a written instruction issued by a medical practitioner, dentist, nurse practitioner or optometrist, authorising a specified person or class of people (such as paramedics or registered nurses) who do not have prescribing rights, to administer and/or supply specified medicines and some controlled drugs.
- The Standing Order Guidelines state that the issuer retains overall responsibility to ensure that the legislative requirements for the standing order are met, and to ensure that anyone operating under the standing order has the appropriate training and competency to fulfil the role.
Royal New Zealand College of General Practitioners (RNZCGP)
- Standard 15.2 of the RNZCGP Foundation Standards states that all clinicians, including doctors and nurses, require an annual practising certificate (APC). If a clinician operates without an APC, lawfully they cannot practise.
- The RNZCGP Foundation Standards also state that the practice is to ensure that health practitioners/clinical team members maintain their APC.
- The medical centre’s policy and procedure on Botox at the time of events (dated 18 March 2019) stated:
‘[A] cosmetic Nurse, or Physician Assistant shall be able to assess, consult, and treat clients with Botox …
The cosmetic Nurse or Physician Assistant shall function under the general supervision of the Medical Director [Dr B] who is immediately available for consultation by phone and is physically available as medically necessary …
The Medical Director, Cosmetic Nurse and/or Physician assistant shall document (on the appropriate form) the initial evaluation and final determination recording satisfactory completion of training and competence.’
- Ms A was given an opportunity to respond to the ‘Introduction’, ‘How matter arose’, ‘Relevant legislation and standards’, ‘Policies and procedures’, and ‘Changes made since events’ sections of the provisional decision.
- Ms A did not provide any comments.
- Dr B was given an opportunity to respond to the provisional decision as it relates to him. Dr B did not provide any comments.
Medical centre company
- The medical centre company was given an opportunity to respond to the provisional decision. The medical centre company did not provide any comments.
- Ms C was given an opportunity to respond to the provisional decision as it relates to her.
- Ms C has provided a formal written apology to Ms A.
- First, I acknowledge the distress that these events caused Ms A. It is evident that she experienced a range of symptoms and significant anxiety following her treatment, and it is understandable that she sought an independent review of the care she received.
- Having reviewed the matter, I am concerned that Dr B, as the director and supervising practitioner, allowed Botox to be provided by Ms C, who did not hold the appropriate registration and practising certificate to do so.
Delegation to unqualified person
- On 5 September 2020, Dr B directed Ms C to administer Ms A’s Botox injections, when Ms C was not registered with the Nursing Council of New Zealand (ie, she was not a registered nurse), and did not hold an APC.
- This was inappropriate, as Ms C was not qualified to perform nursing services in New Zealand.
- As stated by NZSCM and the Nursing Council of New Zealand, Botox is a prescription medicine that only a doctor or a registered nurse working under the doctor’s supervision can administer. Standard 15.2 of the RNZCGP Foundation Standards states that nurses cannot lawfully operate without an APC.
- As set out in the Standing Order Guidelines, the responsibility rested with Dr B to ensure that the legislative requirements for any standing order were met, and to ensure that Ms C had the appropriate training and competency to fulfil the role.
- Dr B, as the registered health practitioner, was responsible for ensuring that he delegated his clinical work to appropriately qualified and trained staff.
- I am concerned that it is apparent that Dr B asked Ms C to assist with Botox treatments for other consumers as well, when she was not qualified to do so.
- I find that that Dr B breached Right 4(2) of the Code of Health and Disability Services Consumers’ Rights (the Code) by directing Ms C to administer Ms A’s Botox injections when she was not qualified to do so (as she was not registered with the Nursing Council of New Zealand and did not hold an APC).
Provision of information and informed consent
- Right 6(1) of the Code states that every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive.
- Right 7 of the Code states that services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any enactment, or the common law, or any other provision of the Code provides otherwise.
- On 5 September 2020, Ms A signed a consent form for Dr B to provide her with Botox treatment. The treatment was provided by Ms C, who signed the consent form as the ‘Doctor’.
- The only risks and side effects listed on the consent form are a minor, temporary drooping of the eyebrow or eyelid, and slight swelling or bruising.
- Ms A was not provided with adequate information as part of the informed consent process, and there was not a proper discussion about the risks and side-effects before treatment was provided. Dr B accepts that Ms A was not provided with adequate information to give informed consent.
- While the consent process was delegated to Ms C, ultimate responsibility to ensure that the risks were discussed, and appropriate informed consent was obtained rested with Dr B as the medical professional who remained responsible for the treatment.
- Accordingly, I find that Dr B breached Right 6(1) of the Code. By failing to ensure that such information was provided, Dr B also breached Right 7(1) for failing to ensure that Ms A’s informed consent was obtained before treatment was provided.
- On 5 September 2020, on the direction of Dr B, Ms C administered Ms A’s Botox injections when she was not registered with the Nursing Council of New Zealand (ie, she was not a registered nurse) and did not hold an APC in New Zealand.
- As stated by NZSCM and the Nursing Council of New Zealand, Botox is a prescription medicine that only a doctor or registered nurse working under the doctor’s supervision can administer. Standard 15.2 of the RNZCGP Foundation Standards states that nurses cannot lawfully operate without an APC.
- Ms C was not a registered nurse and did not hold an APC. Therefore, she was not qualified as a health practitioner, and not entitled to perform health services in New Zealand.
- I am critical that Ms C administered Botox injections when she was not qualified to do so. I am also critical that Ms C signed the consent form as the ‘Doctor’, and that she did not provide Ms A with adequate information to give informed consent. However, I acknowledge that Ms C was following Dr B’s directions, and that she may have been unaware that her qualifications, skills, and nursing registration from an overseas jurisdiction were insufficient to carry out the Botox procedure (although, as Practice Manager, I would have expected her to have been familiar with the appropriate requirements). As Ms C was not registered with the Nursing Council of New Zealand, she would not have been familiar with the Nursing Council of New Zealand’s requirements. This mitigates individual accountability on the part of Ms C.
- Accordingly, I find that Ms C did not breach the Code.
- As a healthcare provider, the medical centre company was responsible for providing services in accordance with the Code.
- In addition to Ms A, it is apparent that Ms C was administering Botox injections for other consumers as well. Ms C stated that she administered the Botox injection for Ms A’s friend. Ms C also stated that she assisted Dr B with clinical activities from time to time, which included Botox injections.
- I am concerned that the medical centre had a practice of allowing non-practitioners such as Ms C to administer Botox treatment when they were not qualified to do so.
- The medical centre’s policy on Botox at the time of events provided that a cosmetic nurse or ‘physician assistant’ was able to assess, consult, and treat clients with Botox. The term ‘physician assistant’ is unclear and seems on its face to contradict the requirement that only a doctor or registered nurse can provide Botox treatment. I am concerned that a description of the competencies was not included to clarify that only appropriately registered health professionals fulfilling the competency requirements were able to administer Botox injections.
- Further, while the policy was adequate with respect to the administration process, I am mildly critical about the lack of detail around the pre-administration assessment process.
- I note that the medical centre has made some changes to its policy since events, and I have recommended that further changes be made.
- Overall, I consider that the issues in this case primarily related to the clinical decision-making by an individual (Dr B, as the director and supervising practitioner), and I consider that the medical centre company’s failures did not amount to a breach of the Code.
- Since the events, the medical centre has reviewed and updated its consent form and its policy and procedure on Botox. The revised policy (dated 23 November 2020) states:
‘A Registered Nurse or Physician Assistant with appropriate training shall be able to consult and treat clients with Botox following the guidelines set herein. All new patients require an assessment and examination by the medical director prior to the use of Botox …
The Registered Nurse or Physician Assistant will only treat patients with Botox after completing clinical training …
The Registered Nurse or Physician Assistant must complete the [medical centre’s] clinical training program. Advanced Practice Nurses experienced in this procedure, or a teaching institution [specialising] in this procedure, may perform this training and certification.’
- The revised policy lists the risks of Botox injections and also includes Botox post-treatment instructions.
- Ms C told HDC that after these events, the medical centre changed its practice by providing all clients with the Botox pamphlet, discussing all possible side effects of Botox with clients prior to treatment, and inviting no more than two clients into the treatment room ‘to avoid any distraction for the client and injector’.
- Dr B told HDC that all appearance medicine services, including for existing clients, have been suspended, and that a decision to continue this service will be made if and when his state of health is such that he can return to the office.
Current status of Dr B and the medical centre company
- While Dr B and the medical centre company initially engaged with HDC in response to the complaint, they have not engaged since HDC notified them of this investigation. The provisional opinion was delivered to an address that HDC reasonably believes belongs to Dr B.
- No response to the provisional opinion was received from Dr B or the medical centre company.
- Currently Dr B is not practising, and his practising certificate expired in 2020.
- Taking into account the changes made by Dr B since the events, I recommend that Dr B undertake a competence review, with the assistance of the Medical Council of New Zealand, should he return to medical practice.
- Taking into account the changes made by the medical centre since events, if the medical centre decides to continue its appearance medicine services, I recommend that the medical centre review and update its policy to ensure that only a doctor or registered nurse can provide Botox treatment, and not a ‘physician assistant’.
- Ms C has provided Ms A with a formal written apology, as recommended in my provisional opinion. Given Ms C’s apology and taking into account the changes made by Ms C since the events, I recommend that Ms C familiarise herself with the requirements to practise as a registered nurse in New Zealand and provide HDC with a statement confirming this within three months of the date of this report. I also recommend that Ms C ensure that she does not sign any documentation or consent forms as a ‘Doctor’ in future.
- A copy of this report with details identifying the parties removed will be sent to the Medical Council of New Zealand, and it will be advised of Dr B’s name in the cover letter.
- A copy of this report with details identifying the parties removed will be sent to the Royal New Zealand College of General Practitioners and the New Zealand Society of Cosmetic Medicine, and placed on the Health and Disability Commissioner website, hdc.org.nz, for educational purposes.
 An injectable cosmetic treatment that temporarily relaxes muscles to soften wrinkles and lines.
 A non-surgical regeneration and rejuvenation treatment that uses cells and chemistry from a person’s own blood.
 Ms C told HDC: ‘[E]very time I was promoted I asked for my contract to be revised, however, [Dr B] mentioned that as long as both parties are [okay] with [the] agreement there is no need for [a] new contract.’
 The Botox was injected into Ms A’s forehead, around her eyes (crow’s feet), and between her eyebrows.
 When the upper eyelid droops over the eye.
 Dr D told HDC that he had no involvement with the Botox service at the medical centre.
 A sudden internal or external spinning sensation.
 The medical practice.
 Section 7(2) of the Health Practitioners Competence Assurance Act 2003 states that no person may claim to be practising a profession as a health practitioner of a particular kind or state or do anything that is calculated to suggest that the person practises or is willing to practise a profession as a health practitioner of that kind unless the person — (a) is a health practitioner of that kind; and (b) holds a current practising certificate as a health practitioner of that kind.
 Every consumer has the right to have services provided that comply with legal, professional, ethical, and other relevant standards.
 The risks listed are: ‘Pain/Discomfort, Bruising/Swelling, Infection, Treatment Failure, Long-term Effects, Pregnancy, Lactation, Asymmetry, Functional Problems, General Body Symptoms.’