Friday, July 10, 2009

Feds: 41 patients got fake Botox

Federal authorities accuse a Gastonia plastic surgery company with ordering 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.

Click here to read the federal complaint.

“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.

Read the full story here.

- Kirsten Valle


Anonymous said...

This event occured in 2004. No doctors were charged. No charges of fraud were leveled against any doctors or the practice. There is only a misdemeanor charge for a mislabeling of a product. Patients were contacted in 2004 who received the product with no ill effects reported. It is highly probable that this practice ordered a product that was marketed to them by a US company and stopped using it as soon as they realized that there was a FDA labeling problem. Not all products must be FDA approved. We take vitamins everyday and they are not FDA approved. Be careful of the spin.

Anonymous said...

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