The NSW government is considering whether there should be a new class of “cosmetic surgery” included in current laws, so that cosmetic procedures could only be undertaken in a licensed private health facility or hospital.

In light of recent patient safety concerns, as headlined in the mainstream media, NSW Health Minister Jillian Skinner released a discussion paper canvassing new regulations on facilities carrying out cosmetic surgery.

Currently cosmetic surgery practices only need to be licensed by the Private Health Facilities Act if patients are administered sedation that renders a patient unconscious or use certain types of anaesthetic.

“The discussion paper will enable stakeholders and industry groups as well as the general public to make submissions which will help inform any future legislative changes,” Health Minister Skinner said: “Patient safety is paramount. The discussion paper will assess whether current licensing requirements for facilities are adequate to protect patients.”

Submissions, which were open to the public, stakeholders and industry, closed 29 January, 2016.

Excerpt from discussion paper, Cosmetic Surgery and the Private Health Facilities Act 2007: The Regulation of Facilities Carrying Out Cosmetic Surgery

Cosmetic surgery in NSW

Recently there have been increased concerns about the safety and regulation of cosmetic surgery in NSW and Australia. Cosmetic surgery can be carried out by different medical practitioners,from specialist plastic surgeons to general practitioners… Further, procedures that in the past would have been undertaken in a hospital under general anaesthesia are, in some cases, now undertaken in cosmetic clinics using local anaesthetic or conscious sedation. There have also been a number of reported cases of serious incidents, including cardiac arrests, arising in relation to cosmetic surgery.

Regulation of cosmetic surgery in NSW

There are two main levels of regulation in NSW that can apply to cosmetic surgery:
• Those that apply to the practitioner involved in cosmetic surgery, and
• Those that apply to the facilities where cosmetic surgery is carried out.

In respect of regulation at the practitioner level, all medical practitioners and other registered health practitioners must be registered under the Health Practitioner Regulation.

National Law (NSW) and comply with the standards and guidelines issued by the relevant health professional Board of Australia, such as the Medical Board of Australia.

However, it is recognised that some procedures cannot be safely carried out in a medical practitioner’s room and that additional regulation is required. As such, at the facility level, some health or medical clinics where practitioners work are subject to additional regulation.

In NSW, private health facilities that meet specific requirements are subject to licensing under the Private Health Facilities Act 2007 and the Private Health Facilities Regulation 2010. The Act has 18 classes of private health facilities, including a surgical class and an anaesthesia class.

With respect to cosmetic surgery, not all facilities that carry out these procedures are licensed under the Private Health Facilities Act. There is no specific class of “cosmetic surgery”. While there is a surgical class and anaesthesia class, the definition of these classes require procedures to involve the use of general, epidural or major regional anaesthetic or sedation resulting in more than conscious sedation. Many of the cosmetic surgical procedures that are currently carried out do not use general, epidural or major regional anaesthetic or sedation resulting in more than conscious sedation. Rather, many cosmetic surgical procedures, such as breast augmentation, may be carried out under conscious sedation or local anaesthetic.

This means that while the medical practitioners performing cosmetic procedures are subject to relevant standards and guidelines issued by the Medical Board of Australia, the facilities carrying out the procedures are not always subject to the standards required by the Private Health Facilities Act and Regulation.

Should cosmetic surgery be a new class of private health facilities?

The Ministry is considering whether facilities carrying out cosmetic surgery should be required to be licensed under the Private Health Facilities Act. Licensing such facilities will help ensure that appropriate standards in relation to the safety of the premises and clinical care apply to such clinics.

However, it is important that the Ministry only regulates in this area where there is a public health and safety risk that can only be appropriately mitigated by way of requiring facilities to be licensed. Some cosmetic surgical procedures, for example minor surgical procedures such as a mole removal for cosmetic reasons, are likely to be able to be safely carried out in a medical practitioner’s room. On the other hand, it may be more appropriate for major surgical procedures, such as breast augmentation, to only be carried out in licensed private health facilities. The major risks associated with cosmetic surgery relate to:

• The use of anaesthesia or sedation, including risks related to over-sedation under sedation, risk of inadvertent administration of a toxic dose of local anaesthesia, and allergic reactions to the sedation/anaesthesia; and
• The inherent risks attached to certain procedures, regardless of what level of anaesthesia or sedation is used. For example, breast augmentation/reduction surgery carries risk of significant haemorrhage and liposuction carries risks relating to fat embolism and haemorrhage. Other risks can include infection, nerve damage, formation of seromas and excessive scarring.

Where the risks are high, there are concerns that the risks cannot be adequately managed by way of the guidelines that apply to registered medical practitioners alone. Rather, there are good grounds to consider that private health facility licensing is required to manage these serious risks.

Accordingly, the Ministry is considering the need to provide further regulatory oversight in this area by creating a new class of private health facilities of “cosmetic surgery”. However, a key issue with creating a “cosmetic surgery” class is ensuring that the class is properly defined to ensure that high risk procedures are appropriately captured in the definition while not including low risk surgical procedures that can be safely carried out in unlicensed premises.

To that end, a possible definition of the new class is a facility that is licensed to:

• Undertake cosmetic surgery, being any surgical procedure (other than a dental procedure) that is intended to alter or modify a person’s appearance or body, and
– that involves the administration of a general , epidural, spinal or major regional anaesthetic (including Biers Block) or sedation resulting in more than conscious sedation; OR
– that involves one of the following procedures (however named): breast augmentation/ reduction, mastopexy or mastopexy augmentation, buttock augmentation/reduction/ lift, pectoral implants, penis augmentation, abdominoplasty (tummy tuck), liposuction, belt lipectomy, large volume fat transfer, brachioplasty (armlift), rhinoplasty, facelift, necklift, facial implants, lower eyelid blepharoplasty, canthoplasty.

This definition focuses on the use of anaesthesia and sedation and certain types of specific procedures. The procedures listed are high risk procedures that are preliminarily considered should only be undertaken in a licensed facility regardless of the level of anaesthesia or sedation that is used…

As a preliminary view, the Ministry considers that a definition that relies both on the use of anaesthesia or sedation and specific procedures, as outlined above, is preferable… However, in considering any definition, it is important to ensure that the definition only covers those areas where the risks associated with the procedure can only be adequately mitigated by way of requiring the facility to be licensed. That is, the definition should not cover low risk cosmetic surgical procedures that can be safely carried out in a medical practitioner’s room.

To read the full discussion paper, go to http://www.health.nsw.gov.au/legislation/Documents/discussion- paper-cosmetic-surgery.pdf

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