Unsafe use of silicone injections can lead to deformities
Individuals who go for silicone injections should be aware of the risks associated with these injections.
Dubai - The FDA has made it clear that the only approved use for silicone injections is the silicone oil used in the intraocular injection
The Ministry of Health and Prevention (MOHP) has warned healthcare 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.
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 silicone injections is the silicone oil used in the intraocular injection for some limited indications.
Dr Amin Hussein Al Amiri, assistant undersecretary for public health policy and licensing at the MOHP, said that since 2008 the UAE has been one of the leading countries in the region and the world in enacting legislation and imposing strict controls for the registration of medical devices such as silicone injections. This is part of its strategy to provide a vital legislative framework, good governance and quality regulatory services for the health sector.
"The process is not limited to the marketing authorisation in terms of ensuring necessary validation from the internationally approved assessment centres, 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 said.
Risk of injectionsIndividuals 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. 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 anaesthesia and hypersensitivity to anaesthetics. 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 silicone 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 silicone injections.
Warning from FDA authorities Dr Al Amiri pointed out that the FDA has issued a warning to consumers and healthcare workers about the 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 unauthorised 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 include permanent deformities and even death.
The MOHP official added that the FDA recognises 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 different adverse effects.
Cosmetic operations need to be supervised by medical staff, not beauty salon employeesDr Al Amiri called on the public not to pay attention to misleading advertisements which promote cosmetic injections at homes. He also asked residents to ignore advertisements claiming special cosmetic injections unless the advertisement is licensed by the health ministry.
He emphasised that most promises made by ads published on social networking sites are unrealistic and not based on medical facts. He explained that cosmetic operations need to be supervised by doctors, specialists and surgeons and not by beauty centre staff, and must be conducted only under the supervision of medical professionals.
Health facilities have received emergency cases from unlicensed cosmetic injectionsHospitals 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, according to Dr Al Amiri.
He pointed out the need to report illegal practices to the ministry, 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 www.cpd-pharma.ae or contact the following: Telephone 04 2301448; Fax 04-301947; email email@example.com.
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