Regulation of cosmetic

medical and surgical

procedures

Sarah Lark, Special Counsel

MinterEllison, Sydney

Overview

Part 1 – Topical issues arising from incidents involving cosmetic surgical and medical procedures & examples

Part 2 – Regulatory & statutory review process

Part 3 – National Regulation of practitioners who perform cosmetic procedures

Part 4 – Regulation of facilities where cosmetic procedures are carried out in New South Wales

Cosmetic surgery – Issues

• Historically, no specialist training required - any doctor could perform cosmetic procedures/ surgery

• Any doctor can could themselves a ‘cosmetic surgeon’ - misleading to lay people?

• Commonly performed outside hospitals in clinics, doctors’ rooms – use of local anaesthesia/ conscious sedation; questionable post op care (infection and narcotic analgesia management)

• Unregistered/ unqualified persons performing procedures & administering injectables in homes and hotel rooms (unaccredited and unsafe environments)

Adverse outcomes Inquest into death of Lauren James (Vic)

26 year old, fit, healthy, no significant medical history

Liposuction on 19 January 2007 – day surgery at accredited clinic

Nurse gave information about procedure and recovery period

Discharged home same day

Nurse – post op phone contact on 20 January – mild discomfort controlled by analgesia

21 January – Lauren left house briefly; felt unwell in the afternoon; mother called clinic doctor – advised further analgesia & call in morning if not better

22 January – reviewed by doctor and discharged half an hour later following Pethidine and Endone. Plan for further review that afternoon

Family concerned. Several attempted calls to clinic

Doctor called at 6:30pm – advised clinical presentation normal & for review in the morning if no improvement

Continued deterioration

Falls during the evening

000 call at 9pm

45 minute resuscitation – died in hallway of her home

Coronial Findings:

Cause of death – complications from liposuction: sepsis, decreased respiratory function, microthrombi, fat emboli, inhalation of gastric contents, central nervous system depression due to narcotic analgesia

Death preventable – doctors and clinic failed to provide adequate post-operative care

Inquest into death of Lauren Edgar (SA)

28 year old following liposuction on 5 March 2008 at the rooms of Dr Kerry, cosmetic surgeon

Multiple incisions – hips, thighs, legs. Compressions stockings for 6 months

Discharge immediately following procedure – by taxi

No post op examination by Dr Kerry

No protocol for post op examination or monitoring of post op complications

Patients were phoned the day after discharge

Follow up phone call made. Lauren alluded to having removed compression stockings but no follow up enquiry made

Lauren’s condition deteriorated over several days – extreme pain, skin blisters, wound discharge, discomfort, large amounts of pain relief (up to 16 Panadine Forte < 24 hours)

8 March 2008 – parents took Lauren to Flinders Medical Centre

9 March 2008 – transferred to Royal Adelaide Hospital

10 March 2008 – passed away

Cause of death – multiple organ failure due to infection (Clostridium perfringens infection – gas gangrene affecting legs and pelvis), contributed to by paracetamol and codeine toxicity

Found – more likely than not bacteria introduced on a surgical instrument during the procedure (as opposed to during the post op period)

Clostridium found in soil. Often present in bowel and vagina normal flora – inadequate infection control in doctor’s rooms during procedure

HCCC complaint – 2014

RN guilty of unsatisfactory professional conduct and professional misconduct

Botox and cosmetic injections without prescription or medical supervision

Doctor’s surgery and day spa

Amy Rickhuss

Cardiac arrest in January 2015 while undergoing breast augmentation at the Cosmetic Institute

Several subsequent incidents at this clinic

HCCC complaint – May 2016

Deregistered cosmetic physician – licence removed > 15 yrs ago

Pretending to be a doctor – performing cosmetic procedures at Sydney clinic

Injected Botox in wrong area, injected air into forehead, removed incorrect part of patient’s nose

June 2016 – Unregistered person caught performing cosmetic procedures at apartment in Melbourne

July 2016

Mabel Liu caught administering cosmetic injectables not approved for use in Australia at apartment in Five Dock

NSW Health issued warning to Ms Liu’s patients – seek blood testing for viruses: Hep B & C and HIV

Several cats found roaming around apartment – infection risk

Regulatory & Statutory Review March 2015:

Medical Board of Australia - public consultation paper

Issues relating to medical practitioners performed cosmetic surgery, effectiveness of current regulation and whether further regulation required

Comments that data from insurers showed medical practitioners performing cosmetic surgery faced higher numbers of claims (ranking just behind obstetrics and neurosurgery)

In or around late 2015:

NSW Health reviewed regulation of cosmetic surgery in NSW – whether current regulation appropriate and safe

Noted repeated and serious failures of practitioners to comply with Medical Board Guidelines

Recognised cosmetic surgery can not safely be performed in doctors’ rooms, clinics etc

Explored additional regulation required in relation to facilities where cosmetic surgery performed

Considered whether private health facility licencing was a way to manage the risks

Levels of regulation

Regulation of

facilities where cosmetic surgery is carried out – NSW

only

Regulation of practitioners who perform cosmetic surgery - National

Reformed national regulation of practitioners who perform cosmetic surgery

• The Medical Board of Australia Guidelines for Medical Practitioners who Perform Cosmetic Medical and Surgical Procedures came into force on 1 October 2016

• The Guidelines apply to any medical practitioner who is registered under the Health Practitioner Regulation National Law and who provides cosmetic medical and surgical procedures

• In regards to plastic surgery, the Guidelines apply to plastic surgery that is performed for cosmetic purposes only. They do not apply to reconstructive plastic surgery.

• The Guidelines apply in addition to Good medical practice: A code of conduct for doctors in Australia

Guidelines apply to: • ‘Cosmetic medical and surgical procedures’ – operations & other

procedures revising or changing appearance, colour, texture, structure or position of normal bodily features – dominant purpose of ‘a more desirable appearance/ boosting self esteem’

• ‘Major Cosmetic medical and surgical procedures’ (cosmetic surgery) – cutting beneath the skin eg breast augmentation, rhinoplasty, liposuction

• ‘Minor (non-surgical) cosmetic medical procedures’ – no cutting beneath skin but may involve piercing skin e.g. non-surgical varicose vein treatment, laser skin treatments/ hair removal, injections

The Guidelines – key requirements

• Patient assessment and management – practitioners performing procedure now responsible for management; protocols for managing complications & emergencies now required

• Use of sedation/ anaesthesia – practitioner must now ensure have trained staff & facility adequately equipped

• Cooling off periods for adults and minors prior to undertaking cosmetic procedures

• Mandatory evaluation by a psychiatrist, psychologist or general practitioner, of minors under the age of 18 years prior to undergoing cosmetic procedures

• Prescribing and administering cosmetic injectables

• Mandatory consultations for patients seeking prescription only cosmetic injectables

• New informed consent requirements

• Training and experience – new requirement for necessary training before providing cosmetic medical and surgical procedures

• Qualifications and titles – prohibition on misleading claims about qualifications, skill and experience

• Facilities – procedures to be performed at facility appropriate for level of associated risk & appropriately equipped

Risk – failure to comply

• The Guidelines may be admissible in proceedings under the Health Practitioner Regulation National Law brought by the Medical Board against a practitioner, as evidence of what constitutes appropriate professional conduct or practice

• Repeated or serious failures to comply with the Guidelines may have consequences for a medical practitioners registration

Regulation of facilities where cosmetic surgery is carried out in NSW

• Private Health Facilities Amendment (Cosmetic Surgery) Regulation 2016 – creates new class of private health facility: ‘cosmetic surgery’

• ‘Cosmetic surgery’ defined in clause 3(1) – any cosmetic surgical procedure intended to alter or modify a person’s appearance or body that involves anaesthesia, incl tummy tucks, breast augmentation, implants, fat implants, fat transfer, liposuction, rhinoplasty and others..

• Means from March 2017, all NSW facilities carrying out cosmetic surgery are required to hold a licence under the Private Health Facilities Act 2007 (NSW) and Private Health Facilities Regulation 2010 (NSW)

• In effect, facilities carrying out cosmetic surgery will be subject to the same licensing standards that currently apply to private hospital facilities in New South Wales

• The licencing standards relate to patient safety, clinical care and safety of the premises

• It is an offence for a facility to not comply with the licensing standards

• A facility that does not comply with the licensing standards may risk suspension or cancellation of the facility's licence or conditions being placed on the licence

Examples of standards that apply

• Facilities must have and maintain appropriate anaesthetic and surgical equipment

• Minimum staffing requirements

• Documentation and record keeping

• Procedure register

• Building and design compliance

• Patient transfer protocols

• Incident management

• Accommodation standards

Risk – failure to comply

• Breach of licence requirement or Guidelines may establish breach of duty of care in civil claim

• Non-compliant facilities or medical practitioners may also risk class actions, regulatory investigations or action, and disciplinary action

• A non-registered practitioner who undertakes cosmetic procedures may be found to have committed an offence.

Questions??