Thursday 17 January 2019

UAE ministry warns against dangers of silicone injection

DUBAI, January 13, 2018

The UAE Ministry of Health and Prevention (Mohap) has warned health care practitioners and community members 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, cautioned the ministry. 
In the Circular No. 216 of 2017 sent to the directors of the medical districts, public and private hospitals, doctors, pharmacists and assistant pharmacists, and directors of public and private pharmacies, Mohap 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 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 pointed out 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, he added.
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.
Dr Al Amiri said 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.
He called upon the public not to pay attention to misleading advertisements which promote cosmetic injections in the houses and ignore advertisements claiming special cosmetic injections, unless the advertisement is licensed by the Ministry of Health and Prevention in the UAE. 
According to him, most promises made by ads published on social networking sites are unrealistic and are not based on medical facts. 
"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," he added.-TradeArabia News Service 

Tags: UAE ministry | dangers |

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