政府’t警告有以下危险‘permanent makeup’

美国食品药品监督管理局(FDA)正在提醒公众注意,有许多与个人经历过的不良事件有关的不良事件,这些人曾经历过某些微色素沉着程序(一种纹身的形式)”permanent makeup”用于唇线笔,眼线笔或眉毛颜色。迄今为止,FDA已意识到50多种不良事件,并正在调查发送给制造商的其他报告。已报道的反应包括在眼睛和嘴唇区域出现肿胀,开裂,脱皮,起泡和疤痕,以及肉芽肿(与感染有关的慢性炎症组织肿块)形成。在某些情况下,所报告的影响导致严重毁容,导致进食和说话困难。

美国FDA:
FDA警告消费者有关不良事件”Permanent Makeup”

美国食品药品监督管理局(FDA)提醒公众,许多与个人经历过的不良事件有关的不良事件已经历了某些微色素沉着程序(一种纹身形式)的应用”permanent makeup” for lip liner, eyeliner, or eyebrow color. The adverse events are associated with certain ink shades of the Premier Pigment brand of 永久化妆 inks, which are manufactured by the American Institute of Intradermal Cosmetics, doing business as Premier Products, in Arlington, TX. FDA is currently investigating this matter.

迄今为止,FDA已意识到50多种不良事件,并正在调查发送给制造商的其他报告。已报道的反应包括在眼睛和嘴唇区域出现肿胀,开裂,脱皮,起泡和疤痕,以及肉芽肿(与感染有关的慢性炎症组织肿块)形成。在某些情况下,所报告的影响导致严重毁容,导致进食和说话困难。

In July 2003, the manufacturer reported to FDA its intent to remove five of its ink shades from the market, based on six adverse events that had been reported. However, FDA has obtained additional reports of adverse events involving ink shades that were not included in the firm’s removal effort. While the investigation continues, FDA is alerting consumers about associated adverse event reports received about Premier Products ink shades identified on the FDA website at http://www.cfsan.fda.gov/~dms/cos-tat2.html.

FDA considers intradermal tattoos (including 永久化妆) cosmetics and considers the pigments used in the inks to be color additives requiring premarket approval under the Federal Food, Drug, and Cosmetic Act. However, FDA has not traditionally regulated tattoo inks or the pigments used in them. The actual practice of tattooing is regulated by local jurisdictions.

As FDA continues its investigation, the agency urges consumers and healthcare providers to continue to report adverse reactions from tattoos, including 永久化妆, to FDA as well as to state and local health authorities. Contact information for your nearest FDA district office is available online at http://www.fda.gov/ora/fed_state/Small_business/sb_guide/regions.htm and in the blue pages of your local phone directory. Reports of adverse reactions may be reported also to FDA’s Emergency Operations Center at 301-443-1240 or Center for Food Safety and Applied Nutrition (CFSAN) Adverse Events Reporting System (CAERS) at (301) 436-2405 or email at [email protected]

For related information, see Tattoos and 永久化妆 http://www.cfsan.fda.gov/~dms/cos-204.html.



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