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FDA ISSUES A WARNING…”LIPODISSOLVE.”

FDA ISSUES A WARNING TO MEDICAL SPAS, RAISING THE ISSUES OF SAFETY AND EFFECTIVENESS OF “LIPODISSOLVE.”

Medical Spas around the country were recently issued a warning from the FDA for making misleading and/or false statements about the safety and effectiveness of LIPODISSOVE.  At Cosmetic Plastic Surgery Clinic in Savoy (Champaign-Urbana) and Bloomington, we encourage consumers to think twice about signing up for an elective procedure like Lipodissolve that could be putting them at risk.   While many people believe that lipodissolve is a brand new procedure brought about by “leading edge medical spas,” in reality it is simply the use of multiple injection s of a combination of drugs that is said to create possible partial destruction of fat cells.  Consumers need to be aware that these substances have not been evaluated by peer review and have not been approved by the FDA. The safety of the drugs being used in Lipodissolve is unknown.

The use of these drugs began many years ago in the 1970’s in Europe and South America when drugs were used to try to modify the structure of fat in a technique called mesotherapy.  Mesotherapy was not able to provide safe, consistently effective results. More recently, Mesotherapy was “re-invented” in the United States through the term of Lipodissolve.  Spas inject deoxycholate or phosphatidylcholine into the fat to destroy and/or modify the structure of fat.  The effects of the medication cannot be properly controlled, since the diffusion rate; that is, the rate in which the substance moves through the tissue cannot be predicted. Therefore, the reach of these substances vary from individual to individual and from injection to injection.  If one looks at the results of mesotherapy throughout the years in Europe and South America, they have been haphazard.  The procedure has never been able to gain a foothold as a venue for treatment of fat deposits anywhere in the world.  The resurrection of this technique in the United States is at the present time, an unproven technique without validation by peer review and is outside the limits of approval by the FDA.  Frankly, practitioners that use these drugs, whether in a medical spa or outside a medical spa, do it at their own risk.  In my opinion, they also put the safety and well being of their patients and/or subjects at risk.  Specifically, the FDA sent letters in April to the following spas:

  • Monarch Medspa, King of Prussia, PA
  • Spa 35, Boise Idaho
  • Medical Cosmetic Enhancements, Chevy Chase, MD
  • Innovative Directions in Health, Edina, MN
  • PURE Med Spa, Boca Raton, FL
  • All About You Med Spa, Madison, IN

Stating that the drugs utilized have not proven to be safe and/or effective, also noting that these substances have not been approved and that the involved companies have made claims that lipodissolve has an outstanding safety record and is superior to other fat removal techniques including liposuction.  FDA regulators have called on the spas to stop making such misleading claims of safety and effectiveness, and to notify the agency within 15 days of what steps they are taking to correct the violation.

The FDA, as a regulatory agency, has received reports of adverse effects such as scarring, skin irregularity, painful nodules in the subcutaneous tissue where the material was injected, etc.  As consumers, we need to remember that tumescent liposuction as a procedure has proven to be safe and effective by peer review. It is practiced worldwide.  Tumescent Liposuction has an unmatched safety record and when done by experienced cosmetic or plastic surgeons, has revolutionized the treatment of bulges, fat pockets and localized unsightly fat deposits.  Buyers beware – gimmicks cannot replace proven procedures.    The FDA seems to corroborate what surgeons have known for many years.  While tumescent liposuction has been proven safe and effective, no such approval exists for lipodissolve.

Dr. Castillo, Past-President of American Society for Liposuction Surgery

G. D. Castillo, M.D.
COSMETIC PLASTIC SURGERY
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