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What is FDA approval and why does it matter for aesthetic treatments?

What is FDA approval and why does it matter for aesthetic treatments?

POSTED ON: 27th October 2018

When you’re considering an aesthetic treatment – whether it’s a laser treatment, injectable or any other face, skin or body treatment – do you ask your clinic whether all the equipment they use is FDA approved?

At Health & Aesthetics, whatever the treatment we are carrying out, we only use medical-grade, FDA approved equipment.

But we’ve found that many of our patients, when they first come to us, don’t necessarily understand what that means, or why it should be important to them. When we explain, it gives them even more confidence that they are in safe hands.

So we decided to share this information with you.

WHAT IS THE FDA?


The FDA is a US organisation responsible for evaluating data to determine whether a new drug, or piece of equipment, is safe and effective enough to be offered to patients. It ensures that equipment works properly and delivers the benefits that the manufacturers claim.

The FDA’s regulations and controls ensure that companies marketing new medical devices can’t make claims about their safety and effectiveness without proper data to back up their claims, as well as making sure that doctors and patients have the information they need to use equipment – or, in the case of drugs, prescribe and take them – safely.

HOW DOES MEDICAL EQUIPMENT GET FDA APPROVAL?


To get FDA approval, a company must prove, through rigorous research and clinical testing, that it is safe and effective. Clinical testing is often overseen by medical professionals with specific expertise in the area, and the manufacturer must work with them, and the FDA, to ensure the tests meet stringent scientific standards and that the test patients are protected. The FDA’s own scientists, statisticians and other experts analyse the data from the trials alongside other research, and, based on its findings, decide whether or not to approve the equipment for use.

What’s the difference between FDA approval and the European CE mark?
A great deal, as the table below shows:

FDA VS CE APPROVAL
Source: https://www.ttopstart.com/news/the-appropriate-strategy-will-overcome-the-limited-safety-value-of-ce-marki

Essentially, the CE mark only requires proof of safety (a vital thing in itself) and technical performance – but it doesn’t demand proof that the machine delivers effective results, and can leave the responsibility for that in the hands of an individual doctor.

FDA approval assures that, used correctly, the equipment will not only be safe, but will deliver the results claimed by the marketing material.

DOES EVERY CLINIC USE FDA APPROVED, MEDICAL-GRADE EQUIPMENT?


Sadly, no. There is a slew of alternative equipment on the market, and many clinics choose to use cheaper (often Chinese-made) copies of the market-leading, FDA approved machines we insist on here at Health & Aesthetics.

The manufacturers of these machines don’t have to prove their efficacy, so you may find yourself paying for treatments which don’t deliver the results promised.

But that’s not the worst case scenario. Because these cheaper machines haven’t been so rigorously tested, they are not guaranteed to be as safe as the FDA approved equipment. So there’s a real risk that certain types of treatment – like laser treatments, for example – can result in burns, painful treatments and complications.

WHY IS HEALTH & AESTHETICS DIFFERENT?


Put simply, not every aesthetics clinic pays the same attention to patient safety as we do.

Dr Rekha Tailor

I’m Rekha Tailor, Director of the multi-award-winning Health & Aesthetics clinic, and I’m an experienced, fully-qualified medical doctor and one of the UK’s leading non-surgical cosmetic specialists. I understand the concerns and needs of our patients, and I’m passionate about providing only the safest, best and evidence-based treatments for natural-looking results.

So I insist on using the highest quality, FDA approved equipment for any of the treatments we offer, and administer many of the treatments myself. I have had specialist training in every treatment, which I regularly update, and also ensure that all of our skilled aestheticians are fully trained in every procedure they carry out.

Every patient has an in-depth consultation, so that we, and you, can be sure that your personal treatment plan is right for you – maximising the results and minimising the risk of complications. Patient safety is at the heart of everything we do, and I see investing in the very best equipment, products and training as fundamental to that.

Find out more about Health & Aesthetics.

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