10/09/07
The Physicians Coalition for Injectable Safety has issued a warning that fat dissolving, fat melting, injection lipolysis, or other injectable treatments touted to reduce localized body fat are unproven medical treatments and should not be mistaken as an accepted medical or aesthetic treatment of localized fat reduction.
"Injections to unwanted fat, using compounded pharmaceuticals, or herbal agents, claim a medical result—the degradation (breakdown) of adipose (body fat) and it’s excretion from the body," says Julius Few, MD, associate professor of plastic surgery at Northwestern University Feinberg School of Medicine, in Chicago, and a member of the Coalition. "To date, the substances in these injections have not gone through FDA sanctioned clinical trials or the research necessary to document the medical results claimed or clearly identify the potential underlying complications."
The Coalition stresses the importance of FDA approval for any pharmaceutical injected into the body. An injected substance that is not FDA approved should only be used as part of a formal clinical trial.
"Clinical trials cannot be marketed, they can only be offered to patients who are already seeking some form of medical intervention for a condition, in this case, the reduction of localized fat," says coalition leader Roger A. Dailey, MD, FACS, of Portland, Oregon and professor at Oregon Health & Sciences University. "In addition, anyone who agrees to participate in a clinical trial is essentially agreeing to be a test subject."
The Coalition says that physicians should make sure that injectables are approved by the FDA for aesthetic indications and that they are appropriately labeled and packaged to reflect their authenticity. Physicians should also talk to their patients about alternatives and about complications that may arise from the injectables.
[www.medicalnewstoday.com, October 9, 2007]
