Washington - The US Food and Drug Administration is cracking down on fat melting injections used in spas across the country, saying the drugs have not been proved safe or effective.
Lipodissolve injections, a popular non surgical alternative to liposuction, are used to dissolve small fat deposits around the legs, arms and belly. The FDA said on Wednesday the drugs have not been cleared by federal scientists, as required by law.
The agency issued warning letters to a half-dozen spas that offer the injections, citing them for making unsubstantiated claims about lipodissolve therapy.
"The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience," states a letter to All About You Medspa in Madison, Indiana.
Other spas cited by the FDA included: Pure Med Spa of Boca Raton, Florida, Monarch Med Spa of King of Prussia, Pennsylvania and three others.
The website for Monarch Med Spa claims that, "Rather than go through the pain and discomfort associated with liposuction, patients now have the option of a series of injections with very minimal discomfort."
FDA regulators demanded that the spas stop using such claims and notify the agency within 15 working days of what they are taking to correct the violations.
Spas that offer the injections say they are safe and effective. Safety advocates have demanded proof and urge patients to think twice before paying thousands of dollars for an unproven procedure.
Some patients have complained of swelling, hard lumps and dark spots on their skin after receiving the therapy.
Lipodissolve and similar treatments use two chemicals, phosphatidylcholine, or PC, and sodium dioxycholate, or DC. Injections with the PC/DC mix are not a treatment for obesity but a way to dissolve deposits of fat in certain areas.
- SAPA
