The US Food & Drug Administration has warned about the potential for serious injuries with radiofrequency (RF) microneedling for skin procedures, after a series of reports of burns, scarring, disfigurement and nerve damage.
The agency said it was working with manufacturers of the class II medical devices with the hopes of identifying mitigation strategies, adding that while its evaluation was ongoing, patients, caregivers, and healthcare providers should be aware of the chances of complications during dermatologic or aesthetic skin procedures.
RF microneedling uses an array of small electrodes – microneedles – to treat wrinkles or to achieve certain skin effects, sometimes referred to as resurfacing, tightening, or rejuvenation.
Medpage Today reports that each microneedle produces a small area of intense heat at its tip, which leads to changes of the tissue, and that some serious complications have required surgical repair or medical intervention to treat the injuries.
The agency is also advising patients and caregivers that RF microneedling is a medical procedure and that the devices should not be used at home, and to seek care from a registered healthcare provider with training and experience on the use of these devices if such procedures are being considered, or if problems arise after treatment.
See more from MedicalBrief archives:
HIV diagnosis after dodgy ‘vampire facials’
Botched botox and the UK’s legislative crackdown on ‘cosmetic cowboysʼ
UK crackdown on beauty clinics: ‘one in five put clients at risk’