Posted: 11/15/2012 By: Jackie Callaway
TAMPA – Liquid facelifts rank as the top non-surgical cosmetic procedure in the nation. The demand for Botox and fillers has triggered a rise in illegal injectables.
The FDA has issued an ongoing alert for unlicensed Botox that is shipped in from other countries. Captain Domenic Veneziano, the FDA’s Director of Import Operations said. “We don’t want potentially dangerous products to get in the hands and be used by the American people.”
But the I-team found doctors on both sides of the bay inundated with offers for cheap offshore unlicensed Botox and fillers not approved for sale in the United States.
According to the American Society for Aesthetic Plastic Surgery, doctors pay about $530 for a box of two syringes of Juvederm Ultra. We discovered off shore sellers from Europe and Japan pitching a box of Ultra 2 for half the price. But there’s a catch. According to the FDA, Ultra 2 can not be legallysold or used in the USA.
The I-team combed thru dozens of doctor’s websites, Groupons and Facebook offers. We discovered both Clearwater Aesthetic Medicine, also known as the Creative Health Center, and Adora Body Sculpting Clinic in Brandon, Palm Harbor and Wesley Chapel advertising the use of Juvederm Ultra 2.
With an undercover camera, we went for a consultation. At Clearwater Aesthetic, Medicine Dr. Jayam Iyer offered our producer a pamphlet on Juvederm Ultra 2. At Adora Body Sculpting’s Brandon Office, no mention of Ultra 2 during the consult, but we did notice something about the Botox box sitting in the exam room.
The word cosmetic is missing from this box. Legitimate Botox containers always contain the word ‘cosmetic,’ according to Allergan the manufacturer.
In an email, Allergan pointed out, “… only Allergan’s product is called Botox Cosmetic … ” Boxes and vials missing the ‘cosmetic’ label may be real Botox, but its not approved for cosmetic use in the United States.
Dr. Iyer’s office never returned our calls or emails and when we attempted to get answers in person we were quickly asked to leave.
Adora Body Sculpting Clinic responded through their attorney ,who wrote in an email. “Juvederm Ultra 2 and Ultra 3 are FDA approved formulations of Juvederm, and are manufactured in FDA inspected facilities by Allergan.”
Yet the FDA says “… only Allergan’s Juvederm Ultra and Ultra Plus XC with lidocaine are approved for use in the United States.”
FDA documents obtained by the I-team reveal that agents began looking into Adora Body Sculpting Clinic’s use of fillers, specifically Botox and Juvederm Ultra 2 and 3 back in March.
According to the American Society for Aesthetic Plastic Surgery, risks associated with unlicensed filler range from dangerous reactions to outdated or ineffective products.
The I-Team combed thru 900 cases in which Florida’s Department of Health disciplined medical professionals in the last five years. We could only find three cases involving offshore bought or illegal filler. Several doctors we spoke with say the numbers are proof not enough is being done to punish those who buy and inject unwitting patients with illegal filler.
There are steps you can take to protect yourself. The FDA’s website contains a list of approved fillers. Botox manufacturer Allergan posts pictures and a list of legitimate providers on its site.
Allergan the makers of Botox Cosmetic and Juvederm lists those physicians that buy directly from them in their physician locator sites that can be found on www.BOTOXCosmetic.com
Here is a link to the FDA’s approved list of wrinkle fillers. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CosmeticDevices/WrinkleFillers/ucm227749.htm