Microfocused ultrasound: more safety with FDA certification

Author: Dr. Borriello Carlo

Date: 25/02/2019

Increasingly often we hear about FDA certification; not everyone knows, however, that the FDA (Food and Drug Administration), as Dr. Borriello explain, is the US government agency that supervises drugs and foodstuffs. Founded in 1906, the FDA brings together doctors, scientists, engineers, chemists and all other types of person who can analyse and evaluate the production processes and health impact of any product intended for human consumption. Undoubtedly, continues Dr. Borriello, the broadest field in which this agency operates is the pharmaceutical and electromedical sector.

In fact, a new drug or a new device is tested for many years before being put on the market. Through a rather structured path, which passes first from the laboratory (in vitro) and only subsequently in vivo, the biological effectiveness of this or that substance and its toxicity are evaluated. Only and exclusively if this first phase has produced results worthy of interest does the procedure move on to a clinical trial which, in turn, can take years before the product in question is placed on the market.

However, underlines Dr. Borriello, the activity of control practically never ends because marketing is followed by very careful and rigid vigilance that enables periodic updating of the product information leaflet and which, in the event that risk is found, can decree the withdrawal from the market of that product or that procedure at any time.

That is why FDA has been synonymous worldwide with health authoritativeness and safety for over a hundred years.

As Dr. Borriello illustrates, this premise allows us to explain sufficiently why an approved FDA method is safer than a copy of the method itself. In fact, when we talk about health, it is not enough to copy an already approved technology to guarantee its effectiveness. To use a trivial simplification: buying a bag by a renowned Parisian fashion house in a boutique is not the same as buying one of its imitations. The scenic effect for the wearer will probably be similar, but in practice it takes just wait a few weeks to understand that buying a copy was only a waste of money.

Likewise, let us now try to imagine what important repercussions a copied drug or imitated electromedical device might have on health. To date, microfocused ultrasound is a revolutionary technology in the world of aesthetic medicine.

As Dr. Borriello explains, the ability of microfocused ultrasound to cause real non-surgical lifting has made this technology unique.

FDA approval for microfocused ultrasound in the field of aesthetic medicine came in 2009; subsequently, the American government agency endorsed its effectiveness and made it one of the most imitated technologies.

Since there is no "transitive property" in medicine, it is important for the patient to ask his/her doctor for information on the certification of devices, especially for microfocused ultrasound treatments lacking FDA certification.

In this specific case, Dr. Borriello continues, the US government agency has formulated four different approvals for the same microfocused ultrasound technology. In 2009 it was inaugurated for eyebrow lifting, then for neck and chin lifting; approval for ultrasound tracing to visualise the skin during treatment came in 2013 and then, in 2014, for rejuvenation of the cleavage.

Especially in recent years, this has been followed by the arrival on the market of countless copies of the certified American progenitor: these are devices that release microfocused ultrasounds in the dark, that is, without any ultrasound visualisation, and/or at a frequency and depth not tested for human tissues, or at least not verified by authoritative international control bodies.

As Dr. Borriello points out, high-intensity microfocused ultrasound is currently also used in oncology to reduce the size of tumours. But who would place their trust in a medical technology like this if it was not certified? Or even, who would place their trust in a diagnosis made with the aid of an ultrasound device that mounts an imitated probe?

Application of a specific technology in the field of aesthetic medicine should necessarily follow the same rational flow; relying on a centre that offers a microfocused ultrasound device "like that of a doctor" but which is not certified can represent a real risk for the patient's health.

In short, concludes Dr. Borriello, the safest way to obtain a documented and reliable result with microfocused ultrasound is to rely on certified equipment, used only and exclusively by specialist doctors following an attentive and rigorous training programme.

All this always with the main purpose that characterises the medical profession: to safeguard the psychophysical health of all patients.

Borriello Carlo


Dr. Borriello Carlo

Medical Surgeon
Lucca (Italy)

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