Silicone injections MOHAP warns against dangers.
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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.
Dr. Amin Hussein Al Amiri, MOHAP’s Assistant Under-Secretary for Public Health Policy and Licencing, 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 explained that the process is not limited to the marketing authorisation 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.
Dr. Al Amiri noted that the Ministry has issued a guide on practices for marketing and distribution of medical products under Ministerial Decree No. 1412 of 2017 from Dr. Abdul Rahman bin Mohammad bin Nasser 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.
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.
The Assistant Under-Secretary 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.
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.
Dr. Amin Hussein Al Amiri, MOHAP’s Assistant Under-Secretary for Public Health Policy and Licencing, 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 explained that the process is not limited to the marketing authorisation 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.
Dr. Al Amiri noted that the Ministry has issued a guide on practices for marketing and distribution of medical products under Ministerial Decree No. 1412 of 2017 from Dr. Abdul Rahman bin Mohammad bin Nasser 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.
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.
The Assistant Under-Secretary 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.
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