Counterfeits and Medical Spas in Dermatology: A Call for Patient Safety
Jordan V. Wang, MD, MBE, MBA, Thomas Jefferson University, Philadelphia, Pennsylvania
Counterfeit medical devices and injectables have recently garnered interest. These unregulated products are typically imported into the United States, marketed to practitioners, and then purchased at significantly reduced prices, either knowingly or unknowingly. The savings are generally passed on to patients as bargain prices. However, unlike their original counterparts, these counterfeits have neither been tested nor verified using certified quality control measures. Without clearance by the US Food and Drug Administration (FDA) for patient use, there can be no assurances of safety, efficacy, and reliability. Penalties by the FDA’s Office of Criminal Investigations can be steep. Shedding more light on the current state of counterfeit medical devices in dermatology can help to increase awareness and lead to improved patient safety. Our recent survey of aesthetic practitioners demonstrated that counterfeit medical devices and injectables are frequently encountered in dermatology, especially in the United States. For example, 37.4% and 41.1% of respondents have encountered counterfeit medical devices and injectables, respectively. About half of respondents were solicited to purchase them, and they were also witnessed for sale at conferences in both the United States and abroad. Some respondents admitted to purchasing them, both knowingly and unknowingly. The vast majority believed them to be endangering patient safety, have experienced related adverse events, and wanted stricter rules and regulations.
Medical spas have experienced a recent rise in popularity by consumers. They can offer various aesthetic procedures, including neurotoxins, fillers, and lasers and light devices. Oftentimes their prices are marketed as lower than those directly from physician-based practices. Rules and regulations, especially concerning their oversight and credentialing processes, vary from state to state. Unfortunately, many patients have experienced various complications from medical spas. Shedding more light on the current state of medical spas and their complications in dermatology can help to increase awareness and lead to improved patient safety. Our recent survey of aesthetic practitioners demonstrated that patients who have experienced complications from medical spas are frequently encountered. For example, of all cosmetic complications encountered in the past 2 years, the majority reported that the percentage of complications seen in their practice attributable to medical spas ranged from 61% to 100%. The most commonly cited complications from medical spas were burns, discoloration, and misuse of product, while the most commonly cited treatments resulting in complications were fillers, intense pulsed light, and laser hair removal. For safety and outcomes, medical spas were rated as inferior to physician-based practices. Practitioners believed medical spas to be endangering patients, desired stricter rules and regulations, and requested more support from medical societies.