Energy-Based Medical Devices in Plastic Surgery: A Comparison of FDA-Approved Indications to Advertised Claims.

Abstract

Background: Lasers and energy-based devices are commonly employed in aesthetic medicine. In the United States, the FDA regulates lasers as medical devices, restricting marketing to approved indications and making off-label claims illegal. Despite this, no comprehensive analysis of off-label marketing prevalence exists.

Objectives: The authors of this study aim to compare the FDA-approved indications for 2 popular aesthetic lasers to their online advertising claims. Additionally, they seek to educate aesthetic providers on the current regulatory restrictions surrounding off-label advertising.

Methods: FDA-approved indications for 2 lasers-helium plasma dermal resurfacing and 2940 nm fractional erbium-doped yttrium aluminum garnet-were obtained from the publicly available Establishment Registration & Device Listings Database. Online advertisements regarding the capabilities of each laser were collected from practice websites in the United States.

Results: Our analysis of 100 online claims for each laser revealed that more than half of the websites advertising helium plasma (n = 59) and 44 websites advertising fractional lasers made at least 1 off-label claim. Both plastic surgeons and nonplastic surgeons made at least 1 off-label claim, with no statistically significant difference between the groups.

Conclusions: Despite FDA regulation of medical devices, online advertising regarding the indications and capabilities of popular medical lasers varies widely. Patients who seek information regarding aesthetic laser treatments may encounter inaccurate and differing claims for these treatments, potentially leading to false expectations and poor patient outcomes.

Level of evidence 4 risk: