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Federal authorities have charged a Gastonia plastic surgery company for giving patients a cheap Botox substitute without telling them it had not been proven safe for use on humans.
Southeastern Plastic Surgery, which is based in Gastonia and has offices in Shelby and Lake Wylie, bought the product in 2004 from an Arizona company, which said in advertising materials the product had not been approved by the federal Food & Drug Administration, charges filed in federal court today allege.
Southeastern then used the product as an alternative to Botox Cosmetic, which is used to treat wrinkles, the charges say.
“Southeastern decided to purchase (the product) for use on human patients because, among other things, the product was substantially cheaper than Botox Cosmetic and had a longer shelf life,” court documents allege.
A Southeastern employee declined to comment today, and the company's attorney did not immediately return phone calls.
According to the federal charges, which accuse the company of misbranding a drug, Southeastern ordered 10 vials of the substitute product and, despite labels reading, “for research purposes only – not for human use,” administered it to 41 patients starting in 2004. It's not clear from court documents how long the practice continued.
The company asked the patients to sign a consent form that falsely said the product was shown to be safe in clinical trials, and then charged them prices comparable to treatments with the more expensive Botox Cosmetic, the charges allege. Botox injections can cost several hundred dollars each.
The U.S. Attorney's office is asking the company to forfeit any property involved in administering the drug, plus about $15,190 in proceeds from the alleged violations. Staff researcher Maria David contributed.
