Federal regulators warn of an uptick in severe infections and other adverse health outcomes related to IV treatments and aesthetic procedures performed at unregulated med spas.
Medical spas, AKA med spas, are day spa/aesthetic medical facilities offering various services, including botulinum toxin injections (Botox), injectable dermal fillers, nonsurgical fat reduction, laser hair removal, microdermabrasion, and tattoo removal.
In addition, these facilities may offer IV drip infusions that claim to replenish vitamins, boost hydration, and promote wellness.
The popularity of med spas has resulted in significant revenue growth, as recent estimates indicate it has become a $15 billion industry.
However, as medical spa popularity soars, health officials are seeing an uptick in adverse health events, including severe infections related to med spa procedures.
For example, in 2021, the FDA warned consumers about med spas preparing compounded drug products for IV and other injections in unsanitary conditions. Moreover, drugs delivered in IV hydration clinics, medical spas, and mobile IV infusion services may not comply with state regulations or meet the conditions of section 503A of the FD&C Act.
The agency says the drug products can become contaminated when compounded in unsanitary conditions and cause severe illness or death.
One case of severe illness occurred in 2021. The FDA says a 50-year-old female was treated for suspected septic shock and multi-organ failure after receiving an at-home IV vitamin infusion compounded by a medical clinic providing IV therapies and vitamin injectables. The woman’s blood cultures showed Pseudomonas fluorescens, a gram-negative bacterium found in soil and water.
More recently, the agency warned consumers about the dangers of unapproved fat-dissolving injections delivered at med spas and other facilities.
The agency's warning letter points to reports about individuals who experienced permanent scars, serious infections, skin deformities, cysts, and other adverse events after receiving unapproved fat-dissolving injections. Moreover, some cases involved unlicensed medical spa employees.
Additionally, NBC News reports that med spas are not federally regulated and have no standard operating procedures. Instead, they fall under state authority. In the report, Alex Thiersch, the chief executive of the American Med Spa Association, said that while all states require a doctor or other medical provider on staff, states may not have the resources to enforce these requirements.
To help mitigate the issue, the American Med Spa Association provides legal guides and training to assist facility owners with industry and state regulations and ensure they prioritize safety.
Med spa safety tips
With numerous reports of infections and other poor outcomes, individuals who want to receive treatment at a med spa should thoroughly investigate the facility and its staff before receiving injections or IV infusion therapy.
For example, an individual can check the board certification status of the provider performing the procedure by searching the American Board of Medical Specialties website, Certification Matters. To check the licensing status of a healthcare provider, a person can visit their state's license verification website.
The cleanliness of the med spa is critical. Consumers should carefully inspect the facility, note any unsanitary conditions, and observe whether staff uses sound hygienic practices such as hand washing and wearing medical gloves.
In addition, med spa personnel should inform patients about the procedure's risks and benefits. Moreover, before undergoing treatment, the prospective patient should ask the provider what to do in the event of an adverse reaction and where to seek help.
Finally, consumers may want to avoid procedures advertised at an extreme discount or make health claims not backed by science.
- American Society of Plastic Surgeons. What to look for in a quality med spa.
- American Med Spa Association. The 2022 Medical Spa State of the Industry Executive Summary in Context.
- FDA. FDA highlights concerns with compounding of drug products by medical offices and clinics under insanitary conditions.
- FDA. Using Fat-Dissolving Injections That Are Not FDA Approved Can Be Harmful.
- Medical Board of California. Medical Spas - What You Need to Know.