FDA warns about facial treatments

Want to have a baby face again? Planning a visit to a beauty clinic to have those wrinkles lifted? Make sure the treatments you are offered are not called "stem cell roller" or "derma roller", two techniques that the Food and Drug Administration (FDA) has not yet approved due to safety reasons.

The FDA yesterday called a hurried press conference after it found on Friday that some branches of two popular beauty clinics - Nitiphon Clinic and Vuthi-Sak Clinic - have offered their customers such treatments. Dr Niphon Phopat-tanachai, deputy secretary of the FDA, yesterday said the treatments required specific medical devices that the FDA had not yet allowed to be imported as their qualifications are still doubtful.

While the two beauty clinics advertised the techniques as wrinkle removals that boost collagen to create clear, "baby faces", Niphon said the stem cell roller and derma roller techniques could cause dermatitis and infection on facial skin. As the main devices used in such treatments are rollers equipped with needles that clinicians roll around a customer's face, the clinics require a high level of hygiene in both use of the rollers and subsequent cleaning. Niphon was afraid that if clinicians were not aware and hygienic enough, the treatments could spread infectious diseases.

The FDA together with the Department of Health Service Support, which oversees private hospitals and clinics, on Friday raided Nitiphon clinics at Victory Monument and Big C Lat Phrao as well as Vuthi-Sak Clinic's Siam Square and Seacon Square branches after learning that the clinics had posted advertisements about the two treatments on the Internet.

Dr Noppadol Noppakhun, president of the Dermatological Society of Thailand, said there had been no research on the effectiveness and adverse impacts of the two treatments. Even the United States FDA has not yet certified the safety of the treatments, said Noppadol. He said he was informed that the Medical Council of Thailand had received several complaints from customers who received adverse effects from the two treatments.

Noppadol said he had alerted dermatologists who are members of the association across country not to use these medical devices on patients. He said the association would ask the medical council to consider whether or not the use of these devices was in violation of professional medical standards. If found in violation, users would be punished according to the 2007 medical device control laws.

Niphon said the clinic owners and the importers of these devices had violated the Public Health Ministry's ministerial regulations of 2006. Under the law, importers could be fined a maximum of Bt250,000 or five-years' imprisonment or both, and clinic owners could be fined a maximum of Bt20,000 and jailed for six months for falsely advertising the benefits of the medical devices.

The owners of the two beauty clinics could not be reached for comment yesterday. A staff member at Nitiphon Clinic said he was not informed by the FDA about the case. "Our operation always abides by the law and FDA regulations," he said.

Pongphon Sarnsamak

The Nation