2017-03-20 08:01:15
The demand for aesthetic procedures is growing strongly, stimulated by the development of new devices using lasers, intense pulsed light, ultrasound, cold or even radiofrequencies. Acts of so-called “permanent” hair removal and “lipolysis” are now performed using devices intended for professionals, in medical practices or beauty salons. Moreover, the practice of hair removal using appliances for domestic use, essentially by means of intense pulsed light, is growing rapidly. All the methods used can cause side effects, which can range from mild inflammatory reactions to skin burns.
This increase in the demand for aesthetic procedures and the variety of devices and technologies currently deployed on the market therefore deserve particular attention to be paid to the risks associated with these practices. However, except for certain laser devices reserved for professional use, the placing on the market of devices for aesthetic purposes is not regulated with regard to their potential effects on health.
In addition, various operators are required to implement devices for professional use whose status and level of training are disparate. Some devices are notably available over the counter to individuals, which raises the question of the risks associated with their use by users, who are by definition untrained.
Faced with these findings, the Directorate-General for Health, the Directorate-General for Labour, the Directorate-General for Risk Prevention and the Directorate-General for Competition, Consumer Affairs and Fraud Prevention contacted ANSES to the realization of an expertise relating to the evaluation of the health risks related to the use of the devices intended for the practice of the acts for aesthetic purposes.
Adverse effects ranging from mild inflammatory reactions to skin burns
The Agency emphasizes that mild adverse effects are systematically reported by the studies on the use of hair removal and lipolysis devices analyzed within the framework of this expert appraisal.
In the case of hair removal devices, the most frequently reported adverse effects are immediate, localized, low-intensity and short-lasting inflammatory reactions. Pigmentation disorders, later, are observed less frequently. Burning sensations and moderate pain during the sessions, qualified by the experts as mild adverse effects, are also reported. More significant effects are observed following improper use of the devices: deep skin burns and eye burns.
With regard to lipolysis, the most frequently reported adverse effects are significant inflammation and pain. Cases of transient hyper- or hypo-pigmentation, acne or scabs may also occur, more rarely, when using a laser diode, cryolipolysis or mechanical massage. Cryolipolysis causes immediate side effects: erythema, inflammation with edema and pain; these effects regress spontaneously within a few hours. The Agency also notes that the principles of operation and efficiency of some of these devices have not been demonstrated.
The Agency’s recommendations
In view of the results of the expert appraisal, ANSES emphasizes the need to take measures aimed at limiting the occurrence of the adverse effects observed. It recommends reviewing the entire regulatory framework associated with aesthetic devices and their use, with the aim of improving the protection of the health and safety of users, both in a professional and domestic setting.
The Agency recommends subjecting devices for aesthetic purposes, including for domestic use, to the same requirements as those applicable to medical devices in order to guarantee satisfactory levels of efficacy and safety. The devices concerned include in particular those using optical radiation (lasers and IPL), unfocused ultrasound, cold or radiofrequency. This adaptation of the regulations might involve a modification of the definition of medical devices. This recommendation is consistent with current European work aimed at revising the regulation on medical devices.
In addition, ANSES recommends the establishment of mandatory prior information for people who are exposed to cosmetic procedures concerning the risk of occurrence of adverse effects. ANSES also recommends studying the relevance of a measure of non-use of such devices, in a professional context, on minors or before an age to be defined.
Finally, the possible long-term effects on the health of the professionals performing these acts and on the environment have not been the subject of published assessments. ANSES therefore draws the attention of the public authorities to the issue of the safety of professionals performing aesthetic procedures who may be exposed to physical agents, as well as to smoke and other fumes.
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