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FDA Issues Warning Against Unapproved Fat-Melting Treatments at Medspas

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The FDA recently issued a warning regarding the safety of various aesthetic treatments, particularly unapproved fat-dissolving injections. These injections, marketed under brand names like Aqualyx, Lipodissolve, Lipo Lab and Kabelline, lack approval the organization says, posing big safety risks due to the absence of evaluation for safety and effectiveness. Add this to prior FDA warnings regarding medspas and about the risks associated with wellness IVs, inappropriate mixing of products and the lack of proper sterilization, and it signals a growing problem.  

Risky Procedures and Lack of Oversight at Medspas

Beyond the dangers associated with unapproved injections, concerns arise over the improper or unsafe injection practices by unlicensed personnel. According to the FDA, some practices could lead to increased risks of scarring, skin infections and serious complications. “Medspas as a category currently have a very broad definition, staffing can range from nurse practitioners or RN providers to estheticians based on the various state laws, often performing the same procedures with vastly different levels of education, experience and training,” says Santa Monica, CA dermatologist Ava Shamban, MD. “Ideally, all staff should be well-trained and receiving ongoing continuing education. They should never attempt procedures with inadequate training or proper supervision.” 

Expert Opinions: A Growing Concern

New York dermatologist Paul Jarrod Frank, MD, expresses concern not only about fat-reduction treatments but also the proliferation of health and wellness centers offering various treatments without proper oversight. “These centers are opening up like crazy with everything from legitimate IV infusions like NADH and B12, to hangover solutions and treatments for overall well-being and beauty. Some of them have science behind them while some do not,” says Dr. Frank. “Most importantly, a lot of these places are performing these treatments without any oversight or healthcare professionals. They may seem like harmless wellness treatments, but anything that has the potential to be helpful also has risks of complications.”

Southfield, MI plastic surgeon Mariam Awada, MD shares her dismay at the growing prevalence of unqualified non-physicians providing medical treatments at medspas. “The FDA’s actions are past due and insufficient in protecting unknowing and innocent patients from non-physician injectors who have infiltrated the business for sole financial gains and left patient safety behind.”

Regulation Challenges 

The experts interviewed stress the importance of having board-certified aesthetic specialists overseeing the facilities. Grand Rapids, MI, plastic surgeon Bradley Bengtson, MD acknowledges the difficulty in regulating standalone medspas. He notes that spas should be led by a core aesthetic physician, such as a board-certified plastic surgeon, dermatologist, oculoplastic surgeon or facial plastic surgeon. “It would be very difficult to regulate and would probably wipe out 90 percent of standalone medspas if you required a core aesthetic physician to be present. Most are ER, internal medicine and family practice doctors that know little about aesthetic surgery or nonsurgical procedures. As one of our long-term aesthetic experts always used to say, ‘it’s more important who’s behind the syringe than what’s in the syringe.’”

Prioritizing Qualified Practitioners

Dr. Shamban underscores the importance of supervising physicians participating in the ongoing care. “Supervising physicians need to be well-trained, accessible and participatory in the ongoing care of skin and body,” says Dr. Shamban.

Dr. Frank says the best way to protect yourself is by asking critical questions about the providers and the procedures being performed. “Who is performing these treatments? Is it a nurse? It is nurse practitioner? Is it a physician assistant? Is it a physician or is it a tech? If they’re using the words ‘tech’ or ‘medical esthetician,’ then it’s probably not someone licensed to perform these procedures,” he says. “Is there a physician on site who’s experienced in managing complications? What could happen in this procedure? Anyone that tells you it’s 100% safe is selling you a beachfront property in Iowa; nothing is 100% safe. These are basic things. If they can answer these questions appropriately, then you’re probably in a legitimate place.”

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