Min­istry warns against dan­gers of sil­i­cone in­jec­tions

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ABU DHABI: 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 Conirm­ing 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 Conirmed 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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