A total of 12 women have sought medical help at the University Multi-profile Hospital for Active Treatment and Emergency Medicine (UMBALSM) “N. I. Pirogov“ after botulinum toxin injections, said in a television interview the head of the Clinic for Nervous Diseases at the UMBALSM “N. I. Pirogov” Assoc. Prof. Dr. Maria Dimitrova, quoted by BTA.
The Minister of Health Assoc. Prof. Silvi Kirilov ordered a comprehensive review and analysis of the regulations affecting aesthetic medicine, and the Ministry of Interior and the Sofia District Prosecutor's Office took the case into their own hands.
One woman is in serious condition
Four women have been hospitalized in “Pirogov“, one of them is in serious condition, Assoc. Prof. Dr. Maria Dimitrova announced. According to her, the patient in serious condition has pronounced muscle weakness, impaired swallowing function and cardiological complications after the procedure, Dr. Dimitrova explained. The other three hospitalized women in “Pirogov“ have moderately severe symptoms, she added. Women with milder symptoms will recover completely. The reason for this is that botulinum toxin is a preparation that exhausts its effect within 3 to 6 months. In more severe cases, it will take time and medication to control the condition, Dr. Dimitrova added. She explained that the antitoxin is expected to arrive for the patient, who is in serious condition.
The identity of the beautician has been established
The identity of the beautician who applied botulinum toxin has been established, and explanations have been taken from her, the director of the Executive Agency “Medical Supervision“ Ivanka Dineva announced in a television interview. She also said that the General Directorate “National Police“, together with “Medical Supervision“, managed to voluntarily seize the medicinal product from the woman. It has already been established what it is and where it came from, Dineva explained. The lady is not a doctor, she does not have the legal right to perform such manipulations, Dineva was categorical. Tomorrow we have a meeting with the director of the Executive Agency for Medicines to continue these actions, Dineva added. She indicated that they have information about who manufactured the product and that it was not purchased from the territory of Bulgaria. The director of the “Medicine Supervision“ also said that the medicinal product was not imported legally.
The Ministry of Health begins an inspection
The Minister of Health, Assoc. Prof. Silvi Kirilov, ordered a comprehensive review and analysis of the regulations affecting aesthetic medicine, with a view to making the necessary changes, the press center of the Ministry of Health announced. In parallel, regional health inspectorates are launching extraordinary inspections throughout the country for the performance of unregulated medical activities and services in the field of aesthetic medicine.
Joint teams of the General Directorate of the National Police, the Ministry of Health and the Executive Agency for Medical Supervision are working to clarify all facts and circumstances in the cases of patients admitted to the hospital "N.I. Pirogov" due to complications after Botox injections.
The Ministry of Interior is taking action on the cases of women injured after Botox injections, the Ministry of Interior announced.
The Sofia District Prosecutor's Office also announced that it is taking action on the cases of women injured after botulinum toxin injections.
Over the past 10 years, 16 cases of botulism have been registered in Bulgaria, with only some of the patients requiring the use of botulinum antitoxin. In the period 2017-2021, as well as in the past 2024, there was not a single registered patient.
Botox (botulinum toxin) is a medicinal product that is used only by prescription for the appropriate therapeutic indications and dosage. Six medicinal products with the international non-proprietary name Botulinum toxin have been registered on the Bulgarian market. Five of them are intended for temporary improvement of the appearance of wrinkles in the upper part of the face, and one - for symptomatic treatment of certain medical conditions. This product is reimbursed with public funds.
The Ministry of Health has called on all citizens to make an informed and responsible decision in advance when carrying out aesthetic procedures.
Organizations have called for stricter control
The state must control who performs medical procedures, the press service of the Bulgarian Medical Association (BLS) announced. Botulinum toxin is a medicinal product that is used on prescription and is administered by a doctor in a registered medical facility, the professional organization added. The lack of strict control multiplies the practice of non-medical specialists massively performing medical activities, the BMA added. The state, represented by the Executive Agency “Medical Supervision“, must monitor and control who performs medical procedures. Regional health inspectorates carry out control over beauty salons, which are public facilities and are not allowed to perform such medical activities.
Why is there a lack of botulinum antitoxin in Bulgaria and why are unqualified people allowed to perform medical procedures, asked the Patient Organizations “Together with You“ in position.
Later, the head of the Clinic for Nervous Diseases at the University Hospital "N. I. Pirogov" Assoc. Prof. Dr. Maria Dimitrova pointed out that it turned out to be a very difficult logistical task for the antitoxin to come to Bulgaria. According to her, the delivery times are significantly longer, but thanks to the work of the institutions, it will arrive tomorrow. When asked why it is not in Bulgaria, Dimitrova replied that it is not registered for use in our country.