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The US Food and Drug Administration recently urged plastic surgeons and other physicians to make sure the BOTOX® Cosmetic they are treating their patients with is purchased from the USA. This past December, the FDA issued a warning to 350 medical practices that they may have received BOTOX® Cosmetic from foreign countries, which would mean the BOTOX® Cosmetic was unapproved by the FDA.

In the US, drugs and medical devices are regulated by the FDA. When the FDA approves something like BOTOX® Cosmetic, it means:

  • The product has been tested for safety and effectiveness.
  • Product packaging must contain labeling indicating risks and side effects.
  • Product labeling must contain directions for proper use.

BOTOX® Cosmetic and other injectables purchased from a different country may not be FDA approved. Such a product may not be effective in reducing fine lines, and it may not tell you and your doctor what the potential side effects are.

If your plastic surgeon is using unapproved BOTOX® Cosmetic or a non-cosmetic version of BOTOX® Cosmetic, there is no way to know whether the product has been properly manufactured and stored, and whether it is uncontaminated and effective.

When you go to a BOTOX® Cosmetic consultation or appointment, ask your surgeon about the product: from what country was it purchased and is it BOTOX® Cosmetic?

For BOTOX® Cosmetic in Beverly Hills, please contact Pasadena Cosmetic Surgery to schedule a free consultation with board-certified plastic surgeon Dr. Martin O’Toole.