In this day and age we are lucky to have such a vast number of non-surgical aesthetic solutions, which are often used in adjunct to surgery, and in some cases replacing it.
At Inject Skin, we are proud to offer only clinically proven solutions to maintain a youthful appearance, and reverse the signs of ages. Our devices and products are heavily researched and distributed in Australia by globally reputable companies (think Galderma and Syneron Candela).
Unfortunately, the rapid industry growth has surpassed the ability for governing bodies to keep up, and this has left the door open to dodgy practices, products and devices which shouldn’t be allowed or used in Australia. Many of you may be familiar with the following case, which has happened recently, right here on the Sunshine Coast.
A recent story appearing in the Sunshine Coast Daily (making both national and international news) is that of a botched “plasma” eyelift treatment a Sunshine Coast local received at someone’s house during a training session.
Although I don’t know all of the particulars, I do know the following:
- This device is not TGA approved, but by definition is a medical device and legally should be
- The trainer/distributor of this device is not a medical professional
- The device does not have any clinical papers to support its efficacy
- This device is available to people with no medical or anatomical training for use around the eye
The treatment has left the client with scarring of her upper eyelids which may be permanent. How does this happen?
I reached out to the company supplying this device months ago when I found out it was being used in Australia. I was told that it did not require TGA approval as it is “not classed as a medical device”, and therefore is made available to “dermal therapists and experienced beauty therapists.” When asked about clinical research behind the device, I received the response “I do not have any scientific data specific to the xxxx machine, we are a small company, however the plasma technology is the same.” The “technology is the same” is in reference to the TGA approved Plexr device.
At this point I was completely floored. A high powered device, used around the eye to alter skin and the anatomy to produce a “non-surgical blepharoplasty” is available to anyone? And there are no clinical papers which show its efficacy or adverse reaction/complication profile?
By definition, the device used in this case is a medical device. In accordance with the Therapeutic Goods Act of 1989, a device/product/drug is defined as medical if it is “to be used for human beings for the purpose of … modification of the anatomy”. Considering this knock-off device is marketed for non-surgical blepharoplasty (reduction or removal of excess fat and skin around the eyes), it certainly meets the criteria.
What is the role of the TGA in this, and other cases?
The TGA looks at devices imported into the country and ensures that there is clinical evidence of efficacy and risk minimisation. It is a very comprehensive review which is both time consuming and expensive. By directly circumventing the TGA, the device used on the scarred client is cheap to own, and can be purchased by just about anyone.
There are a few takeaway lessons from this unfortunate case:
- Always ascertain the qualifications of the person performing your treatment.
- Ask about the device (where it came from, is it TGA approved, are there clinical papers showing its efficacy, what are the risks).
- Get a second opinion. Most clinics (including ours) offer complimentary consults, so gathering more information is often free.
- If something sounds too good to be true, it probably is.
I implore everyone not to jump into procedures, and ensure that the people performing the treatments are qualified, and the devices (if used) are of the highest quality.