CATEGORY 78 AUSTRALASIAN DENTIST LINICAL There are some new kids on the block when it comes to the cosmetic injectables, and there has been a lot of internet buzz around them. In a moment we will take a look at what is new, what is coming and what has been around for a while but gone a little under the radar. But first, let us take a brief look at how products are registered here in Australia. Therapeutic Goods administration (TGA) is the government body responsible for evaluating, assessing and monitoring products that create therapeutic change to a person. This might be as seemingly simple as a sunscreen, all the way through to a Carbon dioxide ablative laser, and everything in between. We are extremely fortunate to have a body like this as it creates protection for the public and practitioners. Only products that are proven to be effective and safe will be included on the TGA register, known as the Australian register of Therapeutic goods (ARTG). In the medical, dental and cosmetic practice, all equipment should be assigned an ARTG number, such that we can use it legally and safely on our patients. It is also important that we do not take it upon ourselves to import goods into Australia, under the guise that the product is already available here and listed on the ARTG register. To import a good from overseas, you must be a registered sponsor, and then apply for your own ARTG number for that product. There are huge penalties for a breach of the TGA rules. If we look at the overseas markets, there are literally hundreds of brands of cosmetic Game-changers in cosmetic injectables By Dr Giulia D’Anna through all the layers of the skin over the next 12-24 hours, within a circumference of three to four centimetres. The technique and treatment is unique, and the practitioner will need to attend hands-on training tomaster this new pharmaceutical. How does Profhilo work? Profhilo has 32mg/ml of high molecular weight, and 32mg/ml of low molecular weight – thus the name “hilo”. The highly dense gel (having a total of 64mg/ml of HA in the product) is formed under intense pressure and temperature, and has no cross-linking at all. This means that is looks like very runny gel compared to the globular appearance of regular hyaluronic acid, despite its very high density. Profhilo is delivered in a 2ml syringe. Profhilo will not fill and it will not restore contour to the skin or lips. Instead it targets fine lines, dullness, skin laxity and lack of elasticity. Results will not be immediate, instead seen over time. It acts as a bio-remodelling agent by reactivating skin turnover, fibroblast activity and even having some effects on the deep fat and bone. Adipocytes will being forming deep fat, which is essential for a youthful appearance, as the loss of these fat pads over time are a large contributing factor to the ageing process. Once injected, the product will sit in a “raised bubble” until it dissipates through the layers of the skin, meaning that the downtime is based on the disappearance of the injected product only. There is no local anaesthetic included, so some areas of the face can be quite uncomfortable to treat, but it is a swift treatment. Is Profhilo safe? Profhilo gained an ARTG listing around may 2022 here in Australia, but it has been used in New Zealand for over two years. It has been available in the UK and Europe for over 7 years. There have been well over 5 million treatments performed globally, and only 12 adverse reactions reported. All of these were minor, requiring minimal or no intervention from the treating practitioner. Dr Giulia D’Anna injectables on the market. It is quite literally out of control. The situation is so much better and safer because of the checks and balances we have here in Australia. Although it takes sometimes a very long time for products to gain an ARTG listing here, we can sleep soundly knowing that stringent testing and scrutiny has taken place before the products are unleashed into our hands. What’s new? Profhilo There is a new class of injectable called Profhilo, manufactured by the company IBSA in Italy. Profhilo is an injectable bioremodelling agent in a class of its own. Profhilo contains bio-identical hyaluronic acid, meaning that when injected, it looks and acts exactly like your own innate hyaluronic acid. However unlike other traditional fillers, Profhilo is not a volumizing filler. Instead it is injected in the upper dermis of the skin, in what are called Bio-aesthetic points (BAP). There are five sites on each side of the mid and lower face. Once injected, the injected HA will spread
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