Changes to the Health Practitioner Regulation National Law Act 2009 which is hosted by Queensland – will strengthen the regulation of cosmetic surgery in Australia; increases patient safety and protection and safeguard patients against “cosmetic cowboys”.

The title ‘surgeon’ can only be used by specialist medical practitioners who have completed necessary rigorous surgical training approved by an Australian Medical Council (AMC) accredited College that provides specialist surgical training.

The new ruling follows several years of reports of patients being harmed by underqualified practitioners conducting surgical procedures.  The Health Ministers of Australia came together and worked collaboratively to look at how best to protect the public. 

Nicola Dean, President, ASPS: said: “We welcome Minister Fentiman’s announcement and are 100 percent supportive of the new ruling. Restricting the use of the title ‘surgeon’ is vital for patient safety, so that there is transparency regarding the actual training and qualifications of practitioners.

“To be able to call yourself a ‘surgeon’ is to hold a position of privilege and trust. In the past, there have been too many practitioners in the cosmetic surgery space who have abused that trust and compromised patient safety with appalling consequences. This new ruling will go a long way to help the public understand who is safe to perform surgery.”

In Australia, the only AMC-accredited training for cosmetic surgery is conducted under the umbrella of the Royal Australasian College of Surgeons (RACS) and is one of the components of the Plastic and Reconstructive Training SET (Surgical and Education Training) program delivered by the Australian Society of Plastic Surgeons.

Dr Dean continued: “Specialist Plastic Surgeons have 12 years of training and specific training in cosmetic surgery, but all those doctors who have a FRACS after their names are trained to high standards through the Royal Australasian College of Surgeons. Recently we have been asking patients to “Look for the FRACS title” but now, thanks to this amendment passing, it will be even easier for the public to know who is safe. 

“By working together, the Federal Health Minster, The Hon Mark Butler MP and all the Health Ministers of Australia have demonstrated they are taking the health of women and men undergoing cosmetic surgery seriously and have delivered this great result for patient safety,” Dr Dean concluded.

Practitioners who use the title without having completed the appropriate accredited surgical training will face up to three years in prison and a $60,000 fine.  The Australian Health Practitioners Regulation Agency is also moving to introduce stronger laws around advertising and the use of online influencers and brand ambassadors to promote cosmetic procedures.

Other measures being taken to better regulate the cosmetic surgery industry include new licensing standards for private facilities and establishing a credentialing system to endorse qualified providers.

Australians who are considering cosmetic surgery can check a practitioner’s qualifications via the AHPRA or ASPS websites and make the most informed choice possible.

ENDS

For further information, pls contact Sandra Hogg, Mohr PR on +61 403 823 218

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Minister for Health, Mental Health and Ambulance Services and Minister for Women
The Honourable Shannon Fentiman

• The Health Practitioner Regulation National Law (Surgeons) Amendment Bill 2023 has been passed by Queensland Parliament
• The amendments will strengthen the regulation of cosmetic surgery in Australia and increase public protection
• Penalties for incorrect use of the title “surgeon” include up to three years in prison and a $60,000 fine.

The Queensland Government has passed an amendment to the Health Practitioner Regulation National Law Act 2009 aimed at safeguarding Australians against “cosmetic cowboys”.

Changes to the national law — which is hosted by Queensland — will protect the title of ‘surgeon’ within the medical profession.

These changes mean only qualified doctors with significant surgical training can use the title ‘surgeon’ when promoting and conducting their services.

Doctors who use the title without having completed the appropriate accredited surgical training will face up to three years in prison and a $60,000 fine.

Other measures being taken to better regulate the cosmetic surgery industry include new licensing standards for private facilities and establishing a credentialing system to endorse qualified providers.

The Australian Health Practitioners Regulation Agency is also moving to introduce stronger laws around advertising and the use of online influencers and brand ambassadors to promote cosmetic procedures.

With support from all state and territory Health Ministers, the Bill was introduced to Queensland Parliament in April 2023, before being referred to Queensland Parliament’s Health and Environment Committee for consideration.

Quotes attributable to the Minister for Health, Mental Health and Ambulance Services Shannon Fentiman:

“The passage of this bill is incredibly important. It will help protect Queenslanders, and all Australians, from potentially unsafe cosmetic surgery.

“This amendment was made in response to patient concerns over the lack of regulation and oversight in the cosmetic surgery industry.

“Now that this Bill has passed, it means that medical practitioners are only be able to use the title ‘surgeon’ if they possess the advanced surgical training and qualifications most people would reasonably expect.

“Prior to this amendment, any medical practitioner was able to promote themselves as a cosmetic or aesthetic surgeon, regardless of their qualifications and level of training.

“This is just another way the Queensland Government is protecting the health and safety of all Queenslanders.”

ENDS

For further information, pls contact Sandra Hogg, Mohr PR on +61 403 823 218

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The objective of the “Meet the Master Crafters” campaign is to highlight the specialist training and qualifications of ASPS specialist plastic surgeons and their advocacy for patient safety. Created using generative AI technology – a first for the plastic surgery sector – the campaign launches across paid and owned assets including SEM, Facebook and programmatic Display.

Danny Molyneux, Chief Strategy Officer, Claxon said: “We love a brave client who is prepared to pioneer the integration of AI and design into what is traditionally a more conservative field, in order to get their important messages across to Australians who may be considering or undergoing plastic surgery.

“Meet the Master Crafters is about creating a deeper connection with Australians considering or undergoing plastic surgery. It doesn’t depend on showcasing what ASPS surgeons do; it goes much deeper and tells a compelling story about ASPS’ commitment to excellence and patient safety.”

Meet the Master Crafters turns the microscope onto ASPS surgeons, highlighting their authentic human-side by sharing insight into their lives, passions and experiences outside of the operating theatre. The campaign aims to build trust with consumers and cleverly weaves in ASPS’ messages of higher qualifications and patient safety by building the association that ASPS specialist surgeons are Masters Crafters of their profession and ‘FRACS* is the gold standard’ of qualification.

Victoria Hutchinson, Art Director, Claxon said the innovative campaign reflects a forward-looking approach and vision for the future of plastic surgery.

Hutchinson said: “By embracing AI, humanity and design, the campaign forges a new era in this sector and we are thrilled ASPS has been fearless enough to embrace the technology and lead with a first-of-its-kind initiative for their specialist field. Hutchinson continued: “We have used supplied imagery of the three specialist surgeons who front the campaign, and then used the brilliance of generative AI to place them in simulated environments which talks to their lives outside of their craft, be that as a farmer or theatre or ballet devotee. “

Dr Nicola Dean, President of ASPS, said: “ASPS advocates for patient safety and welfare with transparency of the surgeon’s true qualifications and expertise. “We are delighted this unique digital campaign will help highlight the key differences in surgical training between specialist surgeons and non-specialist practitioners and will help Australians who are considering plastic surgery make more informed choices about the specialist plastic surgeon they choose.”

Meet the Master Crafters launches on July 31 running across digital and social channels for four weeks, with the expectation the campaign will be extended across more channels in future.

For further information, pls contact Sandra Hogg, Mohr PR on +61 403 823 218

Note to editors: *FRACS is a Fellow of the Royal Australian College of Surgeons The Australian Society of Plastic Surgeons is a non-profit organisation with a membership that represents 95% of plastic surgeons in the country, ASPS encompasses professionals practicing in both the reconstructive and cosmetic fields, across private and public hospitals. Surgeons undergo a rigorous training process that spans at least five years of specialised surgical education, culminating in a total of 12 years of medical and surgical training. All ASPS members hold a Fellowship of the Royal Australasian College of Surgeons (FRACS Plast).

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Medical groups response to Ahpra comments in The Australian of 31 March 2023 Ahpra’s implication that all the colleges and societies named are acting solely from financial incentives “there is a lot of money at stake in cosmetic surgery reform” is deeply troubling. It implies that the leading surgeons of the nation are lying about their motivations for raising concerns about Ahpra’s misguided endorsement system.

They clearly do not value specialist surgical training and are condoning lesser standards. It is true that there are non-surgeon doctors in public hospitals in all parts of Australia performing surgical procedures, but they are within the boundaries of strict training and supervision settings. Their supervision is conducted by Fellows of the Royal Australasian College of Surgeons. Ahpra and the Medical Board have lost their way.

To claim that any opposition to an endorsement scheme that does not require the standards expected of all other surgeries in Australia is motivated by money, is an offence to the patients who have been maimed and the brave whistle blowers who have spoken out against cosmetic cowboys. The Royal Australasian College of Surgeons and specialist surgical societies have at their hearts the excellence of surgical training and the safety of patients, and to suggest otherwise is deeply offensive.

Plastic surgeons, who perform the vast majority of cosmetic surgical procedures in Australia, do not have a shortage of patients. Increasingly they are seeing patients who have been harmed by underqualified practitioners and need corrective surgery, and this must stop. These practitioners do not have admitting rights to inpatient services and therefore are often unable and unqualified to look after complications of surgery. This often results in patients being dumped onto the public hospital system. And in response, we see Ahpra showing disdain for their wellbeing and a desire to further weaken standards. Our concerns are about public safety and quality for all.

After all this time, as patients continue to be harmed, the response from Ahpra and the Medical Board is one of deflection and deeply troubling.

We see no issues if general practitioners do a rural generalist course or if a medical practitioner obtains cosmetic surgery or other training that is up to an Australian Medical Council (AMC) standard that achieves competence in a predefined limited scope of practice. However, major surgery, cosmetic or otherwise, needs to be undertaken by specialists who have received appropriate AMC approved training to the highest standards and who have the competence to deal with a much larger scope of practice and range of outcomes and complications.

General practitioners already practice within their scope of competence in rural hospitals that have appropriate governance in place, but as we have seen with cosmetic surgery some medical practitioners don’t professionally practice within a safe scope of practice based on their competence. By undertaking surgery in their own privately owned clinics without proper clinical governance they escape independent scrutiny, and professional audit of outcomes is inaccurate and, in most cases, non-existent.

The AMC accredited training programs cover various specialties that perform cosmetic surgical procedures. These include RACS surgery specialties such as Plastic and Reconstructive surgery; Otolaryngology Head and Neck surgery; General Surgery and Urology, as well as non-RACS specialties that include Ophthalmology and Obstetrics and Gynaecology. All these specialties require five to six years training at a minimum, on top of a primary medical degree. Specialist surgeons are required to participate in annual continued professional development, peer reviews, 2 scrutiny of their cases and provide aftercare with the option of an overnight hospital should complications arise.

This is a matter of patient safety. And in fact, perhaps the underqualified practitioners who are welcoming a lower standard of training, are doing so because they put profits before patients. Ahpra must uphold high standards to put patients before profits.

Ends.

Media enquiries: Abderazzaq Noor (0429 028 9330); Lucy Clark (0420 872 102) or Sandra Renowden (0403 823 218).

Notes to editor Surgeons from the Royal Australasian College of Surgeons (RACS) are highly trained and undergo five or six years of surgical training that is certified by the Australian Medical Council (AMC) or Medical Council of New Zealand (MCNZ). This training is in addition to their medical degree and prevocational training in a hospital. By the time they have finished their surgical training, our surgeons will have completed more than a minimum of 12 years of rigorous training and acquire the post-nominal of FRACS – Fellow of the Royal Australasian College of Surgeons. FRACS surgeons are also trained to provide the physiological, ethical, psychological, pharmacological, surgical and medical expertise to safely diagnose, treat and manage surgical patients. Their training and practice put patient safety at the forefront during consultations, surgery and post-operative care.

RACS, ASAPS, ASOHNS, GSA, BreastSurgANZ, USANZ and ASPS

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Breast implant associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare cancer that can be effectively treated if detected early.

The ASPS and ASAPS are concerned there may be confusion in the community surrounding BIA-ALCL and therefore seeks to clarify the key known facts.

Facts associated with BIA-ALCL

1. It is a cancer of lymphatic cells and a form of Non-Hodgkin’s Lymphoma 2. It is not a breast cancer
3. It occurs in association with breast implants and to date exclusively with exposure to textured implants (i.e. No case has been reported with exposure to smooth implants alone).
4. It occurs in women who have had implants for both cosmetic and reconstructive indications
5. It takes an average of 7-10 years after implant insertion before it develops 6. The commonest presentation is a fluid swelling around the breast implant and in the space between the implant and breast implant capsule – late seroma. The diagnosis of the tumor is made by examination of the seroma fluid.
7. Early stage disease is curative with surgery alone.
8. Disease which has spread through the capsule, forming a mass or which has spread to local lymph glands carries a worse prognosis

Risk

The most accurate risk published to date is from a detailed study of numerator and denominator in Australia and New Zealand. This showed that the risk for implants with high surface area texture (biocell, Alllergan and polyurethane, Silimed) were around 10 times higher (1 in 4000 to 1 in 7000) compared with implants with lower surface area texture (1 in 60000 for siltex Mentor). The risk was calculated only for companies that complied with a request for provision of sales data. We did see ALCL arising from other implant manufacturers, but were not able to calculate risk due to their refusal to supply data for analysis.

The study also identified clusters of multiple cases arising from the same practice. These clusters are currently under investigation, with the consent of the center and/or surgeon, and there is insufficient evidence presently to comment as to likely causative factors.

Causation

Recent news articles suggested that there is a link with cut-price providers. There is no such link that has been established to date by analysis of evidence.

A unifying theory was proposed by the ANZ epidemiology paper and has become widely accepted worldwide as the best explanation for factors that cause BIA-ALCL.

The unifying theory cites four inter-related factors:
1. Textured implants (with a higher risk for high surface area textures)
2. Bacterial contamination at the time of surgery to reach a threshold to cause inflammation
3. Patient genetic predisposition
4. Time – for the process to develop

Bacteria have been identified in association with these tumours, similar to the association between gastric lymphoma and Helicobacter pylori.

Breast implant surgery in Australia

The exact numbers of breast implants in women is hard to define however last year about 1.5 million were inserted worldwide (International Society of Aesthetic Plastic Surgery, ISAPS) and about 150,000 had implants removed.
Implants are not life devices and all will need revision in due course. The commonest reasons for revision are capsular contracture, implant migration, poor aesthetic result, size change and rupture. Different types of implants perform differently, give different outcomes and have different relative risks of these complications.

Conservatively there are 30 million women (60 million implants) in the world with textured implants. There are 388 independent confirmed case of BIA-ALCL. 55 confirmed cases in Australia. There are 12 deaths worldwide with many of these occurring before treatment principles were better understood. 3 of these deaths were in Australia.

The risk for Australian women of breast cancer is about 1:8. These are separate diseases.

We support the maturing of the Australian Breast Device Registry as the best way to prospectively collect outcome data following breast implant surgery.

Recommendations

All patients undergoing breast implant surgery must provide informed consent that includes a discussion of risks of BIA-ALCL

Implant selection should take into account what the patient already has, what the goals are, the patients lifestyle and the risks relative to various implant options.

Implant specific risk should be discussed in the context of overall benefits of a particular implant type and/or texture.

Routine implant removal is not indicated for asymptomatic women with breast implants including textured implants.

All women with implants who note changes in their breasts should seek advice. The overwhelming majority will not have BIA-ALCL.

To read the full TGA update: www.tga.gov.au
For more information on BIA‐ALCL: www.asaps.org.au

Media enquiries: Sandra Renowden 0403823218 or email sandra@mohrpr@com.au

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The TGA has been posting updated information about this condition since 2011 and this updated alert was been generated following a recent expert advisory panel in view of additional generated from research performed by a joint BIA-ALCL task force with representatives from the Australian Society of Plastic Surgeons, Australasian Society of Aesthetic Plastic Surgeons, New Zealand Association of Plastic Surgeons the Australian Breast Device Registry and the Peter MacCallum Cancer Centre.

#1 what is breast implant associated-anaplastic large cell lymphoma (BIA-ALCL)?

• A rare type of lymphoma that develops adjacent to breast implants
• It usually develops as a swelling of the breast 3 to 14 years after the insertion of breast implants which is due to fluid collecting around the implant or it can present as a lump in the breast or armpit

#2 BIA-ALCL is not same as breast cancer

• BIA-ALCL develops in the fluid around breast implant and is usually contained by the fibrous capsule around implants
• It does not develop in the breast tissue

#3 what are the symptoms of BIA-ALCL?

• The most common symptom is a persistent swelling of the breast but can include other symptoms such as a lump in the breast or armpit
• These symptoms develop between three and 14 years following the insertion of breast implants and most commonly around eight years
• The swelling of the breast is due to fluid accumulating around the implant
• The lymphoma develops around the breast implant in the fluid and in most cases is contained within the fibrous capsule the body makes around the implant and is not in the breast tissue itself

#4 what is the risk of developing BIA-ALCL?

• This is a rare disease and only about 50 patients have been identified in Australia and about 10 in New Zealand
• Because this is a rare disease it is difficult to be certain about the absolute risk of developing this disease
• The risk may be around one in 5000 for women with breast implants (for each woman who develops this disease there are 4999 women who don’t)
• The risk of breast cancer is about one in eight women

#5 are some women more at risk than others?

• To date: no Australian or New Zealand cases have been reported in women who have only had smooth implants Based on current available data: it is uncertain whether textured implants of different types carry different risks It is not possible to predict who will develop BIA-ALCL
• It has occurred in women who have breast implants for cosmetic reasons and also for breast reconstruction
• It has occurred in women with both saline implants and silicone implants

#6 how is BIA-ALCL diagnosed?

• If a woman develops swelling of the breast which has an implant they are sent for an ultrasound scan and if fluid is detected this will be removed and tested for BIA-ALCL
• Specific tests are asked for to exclude or diagnose BIA-ALCL
• Most fluid collections around breast implants are not BIA-ALCL but proper testing will be able to tell them apart
• Mammograms are not useful in diagnosing BIA-ALCL
• In confirmed cases MRI and PET/CT scans may be performed to help stage the disease

#7 should women with breast implants be screened for BIA-ALCL?

• At this point expert opinion is that women without symptoms or changes in their breasts do not need regular ultrasound scans
• Breast implants are not life long devices
• If there are changes in your breasts associated with breast implants and especially if there is general swelling or a lump you should have a breast examination and this may need to be investigated further

#8 what is the treatment of BIA-ALCL?

• The majority of cases are cured with the removal of implants and the fibrous capsule around them from both breasts.
• The majority of patients require no additional treatment.
• Less commonly additional treatment such as chemotherapy and radiotherapy may be required

#9 should breast implants be removed just in case?

• Breast implants are not lifelong devices and in general all will need to be removed or replaced at some point The commonest reasons for implant removal or replacement are capsular contracture, implant migration, implant rupture
• Without symptoms or signs of BIA-ALCL routine implant removal is not required unless there are other concerns

#10 do we know what causes BIA-ALCL?

• Australian and New Zealand Plastic Surgeons in partnership with local and international research organisations are at the forefront of investigating this disease and we are working proactively with the government to keep them informed (Therapeutic Goods Administration -TGA and Medsafe in New Zealand)
• Bacteria have been identified within the lymphoma and around implants in affected breasts
• There is accumulating evidence that a long-term inflammatory response to the presence of these bacteria is one of the factors that may cause of BIA-ALCL
• There may also be genetic factors involved for individual women
• We are continuing to investigate this disease to improve our understanding

#11 are there ways to make breast implant surgery safer?

• There is accumulating evidence that bacteria are associated with other complications of breast implant surgery as well such as the risk for capsular contracture which does not lead to cancer
• Infection control standards are extremely important in breast surgery to ensure best outcomes and Specialist Plastic Surgeons are expertly trained to ensure the highest standards of patient safety and lowest risk of infection

#12 what should you do if you are concerned about your breast implants?

• Firstly you should contact your surgeon and if you are unable to do this you should see your GP for a referral to a Specialist Plastic Surgeon
• If you have swelling of the breast associated with a breast implant you may need a referral for an ultrasound to remove some fluid for testing and this will be able to determine if BIA-ALCL is present Immunohistochemistry is performed to identify a T-cell lymphoma that is positive for the CD30 receptor protein (CD30+) and negative for the anaplastic lymphoma kinase gene translocation (ALK-)
• Most breast swelling that occurs after breast implants is not due to BIA-ALCL however it does needs to be excluded

#13 can new breast implants be inserted when BIA-ALCL is treated?

• Current treatment protocols indicate that the removal of both breast implants with the capsule around them is required because a small number of cases that have been diagnosed on both sides at the same time
• Implants are not replaced at the same operation
• Smooth implants have been re-inserted 12 months following the adequate treatment of BIAALCL without disease progression however the safety of this strategy is still being investigated

#14 where can I get more information?

• The Therapeutic Goods Administration (TGA) is the government body responsible for the approval of the use of all medical devices including breast implants
• The TGA has recently updated its public information about BIA-ALCL.
• https://www.tga.gov.au/alerts

#15 what should I do if I am considering breast implants?

• Women who are considering breast implant surgery should discuss the risks and benefits of the procedure with their Plastic Surgeon including the risks of BIA-ALCL
• There are different implant types available and implant selection needs to take into account the risks and benefits of specific choices.
• Implant selection will be different from one person to the next.
• Breast implants are not lifetime devices and women with breast implants should all consider that they will require revision or replacement of the breast implants at some time 

Media enquiries: Sandra Renowden 0403 823 218 or email sandra@mohrpr.com.au

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Female Genital Cosmetic Surgery (FGCS) refers to non-medically indicated cosmetic surgical procedures which change the structure and appearance of the healthy external or internal genitalia of women.

According to figures from Medicare, the number of women undergoing FCGS in Australia has increased dramatically in recent years. It appears that in response to changing cultural norms this surgery is increasingly being sought by women who want to either feel ‘normal’ or look ‘desirable’. As a result, GPs are increasingly managing patients who present seeking surgery due to the concerns about the appearance of the genitalia.

Female genital cosmetic surgery – A resource for general practitioners and other health professionals provides information on what FGCS is, the factors driving demand, and a set of practical recommendations on how to manage women requesting a referral for FGCS or expressing concern regarding their genitalia.

Download brochure

Media enquiries: Sandra Renowden 0403 823 218 or email sandra@mohrpr.com.au

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