Public Warning under s94A of the Health Care Complaints Act - Unsafe and Illegal Practices at Beauty and Cosmetic Clinics
28 Sep 2017
PUBLIC WARNING UNDER S94A OF THE HEALTH CARE COMPLAINTS ACT 1993: UNSAFE AND ILLEGAL PRACTICES AT BEAUTY AND COSMETIC CLINICS
The NSW Health Care Complaints Commission is concerned about complaints regarding cosmetic procedures undertaken in cosmetic clinics and the risks to the health and safety of people attending those clinics.
What should consumers do to protect themselves?
The Commission strongly urges those individuals seeking cosmetic procedures or cosmetic surgery to be vigilant in their research prior to proceeding. In all cases the following factors should be considered before committing to the procedure or surgery:
1. Is the procedure supported by a practitioner who is appropriately qualified, experienced and accredited?
Cosmetic procedures typically involve the use of Schedule 4 drugs which include, but are not limited to, Botulinum toxin type A (Botox) and hyaluronic acid injection preparations (Dermal fillers)and medications designed to numb tissue such as Lidocaine in injectable and cream form. For these medications, the consumer is required to have a consultation with a registered medical practitioner (in person or by video), for a management plan to be created and for that medical practitioner to prescribe the restricted substance. The consumer is required to be under the direct care or supervision of the medical practitioner.
2. Is the facility appropriately registered, infection controlled and equipped?
Cosmetic procedures are wide ranging and there are a number of relevant requirements in legislation regarding the licensing and registration requirements of these facilities.
Consumers considering skin penetration procedures should be mindful that if there is no registered practitioner working at premises where skin penetration procedures are performed, the facility must be notified to the relevant local council. This enables random inspections to be conducted to monitor compliance with the Regulations. Consumers should also satisfy themselves of the following:
The premises needs to be clean and hygienic, have a waste disposal bin, have a hand basin that has a clean supply of water and have liquid soap and single use towels or a hand dryer for drying hands;
Protective equipment needs to be worn by the person carrying out the procedure, including the use of gloves that have never been worn and a clean gown or apron;
Needles used must not have been previously used and need to be disposed of using an appropriate sharps container.
Medication ampoules must only be used once and the consumer is entitled to ask that the single use ampules are shown to them before and / or during the procedure.
3. Are you having cosmetic surgery?
There are extra protections in place for consumers who are undergoing cosmetic surgery (which includes procedures such as significant liposuction, fat transfer, facial implants that are on the bone or involve deep tissue surgery, breast augmentation or reduction, and “tummy tuck”).
These procedures are the subject of new legislative requirements that came into operation in March 2017. The full list of cosmetic surgical procedures which need to be conducted at licensed premises is at http://www.legislation.nsw.gov.au/regulations/2016-288.pdf.Consumers should assure themselves that any facility that involves the administration of anesthetic (including a general, epidural or major regional anesthetic to achieve more than conscious sedation) or that involves cosmetic surgery of the kind listed in the regulation is in fact licensed.
Cosmetic surgical procedures are also required to be performed by a medical practitioner and the consumer should be assessed by that medical practitioner before scheduling the procedure. Consumers are encouraged to ask a medical practitioner about their qualifications, training and experience. They can also check to see if a practitioner is registered in Australia through the Australian Health Practitioner Regulation Agency (AHPRA) website on www.ahpra.gov.au. If the practitioner is not registered in Australia, you should not proceed.
4. Are you appropriately informed?
The practitioner performing the procedure should provide the consumer with enough information to make an informed decision about whether to have the procedure. Consumers should be provided with at least the following information:
What does the procedure involve?
Is the procedure new or experimental?
What products are being used in the procedure and are these products registered?
What are the range of possible outcomes of the procedure?
What are the risks and possible complications associated with the procedure?
Why is this warning being issued?
In NSW consumers are increasingly spending money on a range of cosmetic services. These services include a range of skin penetration procedures including micro-needling and Platelet Rich Plasma treatment, non-surgical breast and hip enhancements, nose bridge lifts, double eyelid suturing and anti-ageing facial treatments. The procedures often include the administration of Schedule 4 prescription-only medication including Botulinum toxin type A (Botox) and hyaluronic acid injection preparations (Dermal fillers), in addition to medications designed to numb tissue such as Lidocaine in injectable and cream form.
The issues raised in the complaints received include:
- Whether the products being used in these treatments are registered or unregistered products. Use of unregistered products which may be of inferior quality and untested pose a health risk. The import and supply of medication that is not on the Australian Register of Therapeutic Goods (ARTG) is unlawful and dangerous since there is no way of determining the efficacy and safety of the medicines.
- Whether the person prescribing the medication is registered under the Health Practitioner Regulation National Law. The Schedule 4 medications typically used in cosmetic treatments must be prescribed to the individual by a registered medical practitioner. The administration of medications by non-registered and unqualified persons without a prescription is dangerous because there is no informed assessment of the clinical risks associated with the treatment and no validation of their qualifications and experience. Consumers who receive treatment in these circumstances are taking unnecessary risks that could ultimately lead to life changing injuries or indeed death.
In response to these complaints the Commission has completed and is conducting a range of investigations. One key element of this work is the active investigation of complaints concerning the care and treatment of a woman who died following a cosmetic procedure at the Medi Beauty Laser and Contour Clinic in Chippendale, NSW.
The Commission is also involved in joint operations with the NSW Department of Health’s Pharmaceutical Regulatory Unit to inspect beauty/cosmetic clinics in a number of areas across Sydney to examine their operations and identify and address any areas of non-compliance.
The Commission has serious concerns that persons are carrying out medical-related procedures to ‘improve’ aesthetic appearance whilst not appropriately registered as a medical practitioner. No registered medical practitioners were present during the inspections of any of these clinics. The inspections also provided evidence that medicines that are not on the ARTG continue to be unlawfully imported into Australia and used in beauty/cosmetic clinics.
A number of non ARTG medications were seized during the joint operation. These included Lidocaine cream with significant strength (ranging from 10.5 to 19.8 %), Erythromycin Ointment, (an antibiotic) and Schedule 4 medication unlawfully imported in bulk from China, and non ARTG Botulinum toxin type A imported from South Korea. In addition, Hyaluronidase, A (an injectable enzyme solution that speeds the natural breakdown of hyaluronic acid) was seized. This medication is used to counteract the effects of hyaluronic acid based fillers for patients whose original dermal filler treatments did not turn out as they expected. Non ARTG approved Iodine and Vitamin B and C injections were also seized together with anesthetic lip and eyebrow paste.
A significant amount of non- ARTG medical devices imported from China were also found. These included Cannulas, needles, sutures, gauze, masks and gloves. These devices must be sterile and such imported devices cannot be guaranteed to have been sterilized to Australian standards therefore potentially increasing the risk of infection to consumers.
Please find attached translation to Mandarin
For further information, contact the Executive Officer of the Health Care Complaints Commission, on 9219 7444 or send an email to email@example.com.
The information in this media release is correct at the time of publication. Orders may change; for example, conditions may no longer apply. For current information regarding the status of a registered health practitioner, including any conditions that currently apply, please check the National Register at www.ahpra.gov.au.