Recent cases of botulism-like illness following neurotoxin injections in nonmedical settings have prompted the American Society for Dermatologic Surgery Association (ASDSA) to call on states to increase oversight of medical care in all settings, including medical spas.
In a press release issued on April 12, the ASDSA referenced investigations in Illinois and Tennessee in which suspected counterfeit neurotoxins were associated with individuals' symptoms resembling botulism, including several that required hospitalization. These cases "emphasize the patient safety risks associated with receiving medical procedures in unlicensed, unapproved settings without proper oversight of medical care," the release adds.
The cases also "highlight the need for increased public protection measures, like the recommendations in the ASDSA's "Medical Spa Safety Act" to ensure patients' safety," according to the press release, which notes the increasing demand for facial fillers and neuromodulators in the United States.
Enforcement is needed to ensure that all patients receive Food and Drug Administration (FDA)-approved products "and not counterfeit products or unsafe treatments," ASDSA president Seth Matarasso, MD, who practices dermatology in San Francisco, said in the press release. "Lack of regulation and enforcement has enabled many to offer medical procedures for cosmetic purposes outside of their training and expertise," he said.
Key Takeaways
All clinicians need to understand that aesthetic procedures are medical procedures and require a level of due diligence in patient evaluation and care before, during, and after the procedure, said Pooja Sodha, MD, director of the Center for Laser and Cosmetic Dermatology, at George Washington University, Washington, DC, in an interview.
"FDA-approved medications should only be offered, and these should be obtained through well-defined sources to ensure their safety and purity," she said.
However, some challenges to the enforcement of safety in medical spa settings persist, Sodha told Medscape Medical News. "To my knowledge, state and federal policies providing clear and up-to-date safety and legal guidelines for aesthetic procedures performed at medical spas by registered nurses, nurse practitioners, physician assistants, and physicians are limited, and in our current medical care structure, national oversight is challenging," she said.
A pretreatment checklist assessment, she suggested, could be helpful "to ensure patient safety and help to standardize clinical practice in nonmedical settings."
Other challenges include a lack of clear guidelines for aesthetic providers regarding initial assessment examinations, post-procedure follow-up, and evaluation for any future medical treatment, as well as "continued ambiguity on the exact meaning of physician oversight for those sites that delegate aesthetic services and appropriate and clear guidelines on what procedures require a licensed provider to perform versus oversee the treatment," she said.
Additional Guidance, Actions Needed
As for additional guidance or actions, "we may be migrating towards a system that designates and assigns clearer licenses and authorizations to perform these services and care for patients," said Sodha. A licensing process would entail academic understanding of anatomy, pharmacology, and tissue interactions, as well as practical hands-on training that emphasizes the importance of the pre-procedure consultation and post-procedure follow-up and care, she said. "Experience in caring for the unintended outcomes is vital to delivering the best care we can," she added.
Sodha had no financial conflicts to disclose.