Medical Centre Estetic has been ordered to stop providing healthcare services after Finnish authorities identified a series of patient safety, medicine, medical device and data protection deficiencies at the Helsinki clinic.
The Licensing and Supervisory Agency conducted an unannounced inspection of Medical Centre Estetic Oy, also known as Laakariklinikka Estetic Oy, on 26 August. The inspection was carried out with the Finnish Medicines Agency Fimea and the Finnish Safety and Chemicals Agency Tukes.
The action followed reports received by authorities in May and June concerning procedures at the clinic that were considered to pose risks to patients.
Inspectors found several medicines that did not have marketing authorisation in Finland, including botulinum toxin, hyaluronidase, topical anaesthetics and antibiotic creams.
Senior inspector Toni Honkakorpi said medicines without Finnish marketing authorisation should not be stored at healthcare facilities because their contents and safety have not been assessed through the country’s approval system.
The inspection also raised concerns about intravenous NAD+ treatments advertised by the clinic. According to the authorities, the product does not have marketing authorisation in Finland and has not been approved for intravenous administration.
Medicine storage was another concern. Inspectors found that some medicines were being kept in locations that could be accessed by people who were not healthcare professionals.
Authorities also found that the clinic was carrying out class 4 laser treatments without the required authorisation to provide the service.
Patient records were found to have shortcomings as well. Some documents required by law were missing, while the way other records were stored created risks to patient confidentiality and privacy.
The clinic was also unable to show during the inspection that botulinum toxin injections were consistently performed under a doctor’s direction and supervision. It could not demonstrate that a doctor was always available to attend the clinic when necessary.
The authorities said medical supervision is required for botulinum toxin injections because the treatments can involve risks that need to be assessed and managed by a doctor.
The inspection identified further problems involving medical devices. Some devices had missing or incomplete CE markings, while maintenance and operating instructions were incomplete for most of the equipment examined. The clinic also did not have a medical device register.
Honkakorpi said the findings indicated that the company did not have a sufficiently systematic process or the necessary expertise to ensure that medical devices were being used safely.
Taken together, the deficiencies led the Licensing and Supervisory Agency to conclude that the provider had not adequately recognised the seriousness of the problems identified during the inspection. The agency therefore ordered an immediate suspension of the clinic’s healthcare operations.
The decision involving Medical Centre Estetic comes after similar regulatory action against Nordicshape, another aesthetic healthcare operator in the Helsinki region.
Authorities suspended healthcare services at Nordicshape’s Espoo clinic in April after an inspection identified concerns including medicines without Finnish marketing authorisation, inadequate medicine storage, insufficient medical supervision and shortcomings involving medical devices.
Nordicshape’s Helsinki clinic was subsequently ordered to stop providing healthcare services in July following another inspection. Authorities again identified patient safety concerns, including the use of medicines without Finnish marketing authorisation and issues related to botulinum toxin treatments.
Nordicshape’s Espoo company filed for bankruptcy in July. The Helsinki suspension subsequently left the company without an operating clinic in Finland.
The cases place renewed attention on the regulatory requirements governing aesthetic healthcare services in Finland, particularly where prescription medicines, injectable treatments, medical devices and procedures carrying significant medical risks are involved. For providers, the inspections also demonstrate that compliance extends beyond the treatments themselves to medicine storage, medical supervision, patient records, equipment management and the protection of patient information.
