UAE one of the first countries in the region to put strict controls on registration of medical devices, says Dr. Amin Al Amiri
The Ministry of Health and Prevention (MOHAP) has warned health care practitioners and community members via a Circular No. 216 of 2017 about the risks involved in using silicone injections, which are falsely promoted as approved by the US Food and Drug Administration (FDA). Injections used to enhance the size of buttocks, breasts and other parts of the body can lead to serious injuries and irreversible deformities. In the circular sent to the directors of the medical districts, public and private hospitals, doctors, pharmacists and assistant pharmacists, and directors of public and private pharmacies, the Ministry recommends ensuring the safety of these products before using them. The FDA has made it clear that the only approved use for silicon injections is the silicon oil used in intraocular injection for some limited indications.
UAE a world leader in enforcing strict regulations on the registration of medical devices
H.E. Dr. Amin Hussein Al Amiri, MOHAP’s Assistant Undersecretary for Public Health Policy and Licensing, said that since 2008 the UAE has been one of the leading countries in the region and the world in enacting legislations and imposing strict controls for the registration of medical devices such as silicone injections, as part of its strategy to provide a vital legislative framework, good governance and quality regulatory services for the health sector. He mentioned that the process is not limited to the marketing authorization in terms of ensuring necessary validation from the internationally approved assessment centers, including the FDA, and ensuring necessary trials have been done and confirming standards of quality, the Ministry also obligates manufacturers and suppliers to submit periodic reports on the safety and post marketing surveillance reports, in accordance with the requirements of the Ministry, which are in line with the best international standards.
Medical products marketing guide to ensure compliance with safety standards
H.E. Dr. Al Amiri pointed out that the Ministry has issued a guide on practices for marketing and distribution of medical products under Ministerial Decree No. 1412 of 2017 from H.E. AbdulRahman bin Mohammed Al Owais, Minister of Health and Prevention. He explained that the guide aims to regulate the marketing of medical products in line with ethical medical and pharmaceutical standards, thereby promoting an environment in which drug choices are based on the merits of each product and the health needs of patients.
He reviewed the terms of good marketing practices in the country covering major topics including marketing licensing, product card approval, information provided in marketing materials in accordance with the approved medical leaflet, and marketing and supporting information. He said that marketing materials should be accurate, balanced and objective and must be based on a recent assessment of all relevant evidence. He added that the materials should promote the proper use of medical products and must be consistent with the policies adopted for health care facilities.
Risks associated with silicone injections
Individuals who go for Silicone injections should be aware of the risks associated with these injections. If the needles are not sterile, they can be the source of infections. Individuals must be careful in selecting the clinic for these kinds of procedures. Injecting close to the eyes leads to the fall of the eyelid on the eye, and local bleeding may occur in the tissues and the injections can also cause nerve damage outside the area of the facial muscles; silicone may also reach areas other than the muscles of the face, causing temporary muscle paralysis. The procedure also involves risks related to anesthesia and hypersensitivity to anesthetics. In some cases, a serious reaction can lead to a dangerous drop in blood pressure.
Medical reports have cited a variability in response to silicone between the skin and muscles. A resistance to silicon develops over time, or the amount of injected material may become less effective or lose its effectiveness altogether. The patient may experience a leakage of the eyebrows and the fall of the eyelid due to overdose or error in choosing the location of the injection. In addition to the chance of his or her smile becoming asymmetrical, the patient may also suffer from leakage of some saliva if silicone is improperly injected in the mouth. Respiratory problems arising from large quantities of the substance injected into the neck are also common. Consequently, patients may suffer depression and isolation for months before correcting the defects caused by incorrect administration of silicon injections.
FDA warning
H.E. Dr. Al Amiri pointed out that the FDA has issued a warning to consumers and healthcare workers about serious injuries and deformities that could result from the use of injectable silicone or products marketed to fill the skin to enhance the size of the buttocks, breasts and other parts of the body.
The FDA has confirmed that it has significant concerns about unsafe silicone injections that are marketed for body sculpting by unauthorized persons, with serious effects sometimes caused by silicon. The FDA has intervened to take action against perpetrators who promote these products and has also informed the public of the risks, which can include permanent deformities and even death.
The MOHAP official added that the FDA recognizes proven medical observations – such as the increased risk of cancerous white blood cells forming in women who have undergone injection – and acknowledges that there are other medical doubts about the effects of different adverse effects.
Cosmetic operations need to be supervised by medical staff and not by beauty salon employees
The official called on the public not to pay attention to misleading advertisements which promote cosmetic injections in the houses and to ignore advertisements claiming special cosmetic injections, unless the advertisement is licensed by the Ministry of Health and Prevention in the UAE. The Assistant Undersecretary further emphasized that most promises made by ads published on social networking sites are unrealistic and are not based on medical facts. He explained that cosmetic operations need to be supervised by doctors, specialists and surgeons and not by beauty center staff, and must be conducted only under the supervision of medical professionals.
Ministry organizes inspection campaigns to monitor compliance of beauty centers
H.E. Dr. Al Amiri pointed out that Ministry inspectors carry out inspection campaigns even on weekends to monitor unhealthy practices in health facilities, especially beauty centers that provide silicone injections, Botox, Fillers and others. He stressed that the Ministry does not tolerate any violation of the licensing standards for professionals or quality of health services, because the ministry is entrusted with the health of society by the law.
He added that during inspections, the teams check for compliance with medical and pharmaceutical practices and organize appropriate control records for violators in order to take strict actions based on health regulations.
Health facilities receive emergency cases from unlicensed cosmetic injections
The Assistant Undersecretary confirmed that hospitals have been receiving emergency cases resulting from serious health complications caused by illegal medical practices using unknown cosmetic injections or containing substances harmful to patients with heart and blood pressure defects. He called on patients and cosmetics researchers to refer to licensed health facilities in the country to obtain reliable medical treatments that are worth their health and money, noting the availability of advanced medical facilities approved by prestigious international institutions. He pointed out the need to report illegal practices to the Ministry of Health and Prevention, health authorities, or police stations in the country. He advised those experiencing side effects to fill out the Adverse Drug Reaction (ADR) form available at http://www.cpd-pharma.ae or contact the following: telephone 04 2301448 / fax 04-301947 / email pv@moh.gov.ae.
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