News that Australian company ESCHOICE Pty Ltd has been fined over $25,000 by the Therapeutic Goods Administration (TGA) for the alleged importation of counterfeit products and medical devices for use in cosmetic procedures has been welcomed by the Australasian Society of Aesthetic Plastic Surgeons (ASAPS).
Dr Naveen Somia, President of ASAPS, said counterfeit cosmetic injectables like anti-wrinkle injections and dermal fillers are dangerous and risks death or disfigurement. Cosmetic anti-wrinkle injections and dermal fillers have to be transported in a temperature controlled environment for them to be safe and effective. When there is no quality control involved, how can you be sure that the package was not sitting on the tarmac in Dubai in the sweltering heat of 50 degrees?
“In Australia, patients have a right to safety when they elect to have an injectable cosmetic treatment. However, in recent times, we have had a spate of events where patient safety has been compromised.
“There was the death of Jean Huang in August 2017 at the hands of a foreign national who was not registered to practice medicine in Australia. This year we have seen the first case in Australia of a dermal filler causing blindness in a patient and the ABC’s Four Corners program that aired in August highlighted several instances of catastrophic outcomes for patients from cosmetic medicine providers who demonstrated an inability to play by the rules,” Dr Somia said.
Australia’s therapeutic goods legislation prohibits the import, export, manufacture and supply of therapeutic goods for human use that is not included in the Australian Register of Therapeutic Goods (ARTG) or otherwise the subject of an exemption, approval or authority. Non-compliance with the legislation may result in court action, including the seizure and forfeiture of goods, hefty fines and/or terms of imprisonment.
During the year, raids on beauty salons in Victoria and NSW found many breaches where counterfeit products were being used, and laws that govern who and how injectable cosmetic treatments should be performed were not being adhered to.
Dr Somia said in response to these incidents, we congratulate the Victorian the NSW Governments who have stepped up efforts to protect patient safety.
“However, what we now see is a patchwork effect across the country of complicated laws regulating the cosmetic medicine industry. We would implore every jurisdiction to come together and show a united front under national legislation to come down mercilessly on providers who show no regard for the rules or patient safety.
“Counterfeit products pose a risk to patient safety as they contain harmful toxins that have not been approved by the TGA. They do not respond in the same way to the antidote products should they be administered incorrectly. And, if injected into one of the five high-risk areas in the face, a patient can suffer blindness, stroke and skin death (skin necrosis) almost instantly,” Dr Somia said.
Other complications include infection and complications related to infection. Patients can experience a foreign body granuloma, hypersensitivity, painful lumps and bio fill formation resulting in chronic (long-term) infection and irritation. Skin discolouration and pigmentation, numbness and hypersensitivity due to nerve irritation.
Dr Somia said in untrained hands, counterfeit injectables can turn deadly.
“It is ironic that you cannot buy codeine without a doctor’s consultation and a prescription, but you can get Schedule 4 drugs such as dermal fillers injected into high-risk areas without a consultation with a doctor.
“We strongly encourage people to do their research to ensure the product they are having administered is what it says it is, the person performing the procedure is appropriately qualified and trained, and the procedure is done in a safe and licensed setting,” Dr Somia said.
For more information: The TGA has warned of the risks of ‘home based’ cosmetic injections and published a factsheet on ‘things to consider before undergoing a procedure involving dermal fillers.
Media contact: Julia Power, National PR and Marketing Manager 0414 276 990