The FDA has issued a warning for the use of lipodissolve, a treatment which is supposed to dissolve fat in localized areas. On April 7th, the FDA sent warnings to 6 known medical spas, and their parent Brazilian company, which it claims are using “false and misleading statements” to market their fat dissolving treatments.
“We are concerned that these companies are misleading consumers. It is important for anyone who is considering this voluntary procedure to understand that the products used to perform lipodissolve procedures are not approved by the FDA for fat removal.” says Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
The FDA says that it wants consumers to be aware of the following facts about lipodissolve treatments:
- Lipodissolve has not been approved or even evaluated by the FDA for use in dissolving fat
- FDA is not aware of any evidence which supports the claims of effectiveness of the substances used in lipodissolve
- The safety of the lipodissolve when used alone or in combination with other substances is unknown
- The FDA is not aware of any clinical studies to support medical uses of lipodissolve
The FDA has also issued a strong warning about unexpected negative side effects reported by patients who have undergone lipodissolve treatments including:
- Permanent scarring
- Skin deformation
- Deep, painful knots under the skin in areas where lipodissolve was injected
“Finally the FDA has acted to stop not only this false and deceptive advertising by these companies but also to stop this human experimentation by the use of these non-approved drugs for lipodissolve. I have seen numerous patients over the past several years with pain, skin breakdown and skin unevenness from this technique,” says Dr. Rohrich.
“The bottom line is that it simply does not work. If you want to remove fat nonsurgically there are some treatments coming to the market soon in the USA which will not only work but be safe as well.”
See the FDA’s warning here: