A review of the FDA's 510(k) approvals process for electromagnetic devices used in body contouring
acne vulgaris; cellulite; cutaneous lesions; Electromagnetic devices; facial wrinkles; Google Trends; hair reduction; laser skin resurfacing; pigmented lesions; premarket approval; RF energy; vascular lesions
Introduction: Greater demand for noninvasive techniques to reduce cellulite and contour the body has led to the growth of electromagnetic and radiofrequency devices. In this study, we aimed to characterize the evolution and safety of electromagnetic devices marketed in the U.S. over the last two decades. Methods: We examined records from a U.S. FDA database documenting premarket approval of electromagnetic devices between January 1, 2000 and October 31, 2018. Additionally, we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports of adverse events. Results: Thirty-one devices were approved from 2012-2018. Initially marketed to temporarily reduce muscle pain and cellulite, indications for these devices have expanded. The MAUDE database revealed 61 reports of adverse events including acute skin damage, dyspigmentation, infection, hair growth, scarring, and others. Discussion: Although electromagnetic devices are gaining increasing public attention and marketed to be safe, the frequency and types of adverse events are not well-documented. Importantly, the MAUDE database has limitations including submission of incomplete, inaccurate, untimely, or unverified data make determining the true number of adverse events difficult. Further investigation is greatly needed to define appropriate parameters and outcomes for the use of electromagnetic devices in body contouring and skin enhancement.
Wang Sophie; Manudhane Albert; Ezaldein Harib H; Scott Jeffrey F
The Journal of Dermatological Treatment
2019
2019-06
<a href="http://doi.org/10.1080/09546634.2019.1566589" target="_blank" rel="noreferrer noopener">10.1080/09546634.2019.1566589</a>
Powered muscle stimulators: an investigation into newly FDA 510(k) approved devices marketed for muscle toning and esthetic benefit.
premarket approval; 510(k); abdominal muscles; MAUDE; muscle blood flow; Muscle conditioning; muscle toning; pain relief; slendertone; transcutaneous electrical muscle stimulation
INTRODUCTION: Powered muscle stimulators have been popularized in recent years due to their muscle toning effects. This study aims to describe marketing trends and reporting of adverse effects of powered muscle stimulators. METHODS: We performed a cross-sectional retrospective analysis of records from the United States FDA database for 510(k) premarket approval of powered muscle stimulators between January 1, 2000 and December 31, 2018. The FDA MAUDE database was reviewed for adverse events reported with device usage. RESULTS: One hundred and seventeen devices received 510(k) premarket approval between 2000 and 2018, with the first approval occurring in 2001. Initially, devices were marketed to assist with muscle toning and strengthening, but more recent indications include the treatment of pain, increased local muscle blood circulation, and prevention of post-surgical venous thrombosis. Thirty-six adverse event reports have been submitted and published in the MAUDE database over the past 10 years by 11% of manufacturers. DISCUSSION: Powered muscle stimulators are growing increasingly popular amongst consumers and healthcare providers due to their ease of use and perceived esthetic, muscle strength, and pain relief benefits. Additional investigation to determine optimal treatment parameters and potential adverse effects is necessary due to the growing popularity of these devices.
Manudhane Albert P; Wang Sophie; Ezaldein Harib H; Scott Jeffrey F
The Journal of dermatological treatment
2019
2019-02
<a href="http://doi.org/10.1080/09546634.2019.1587148" target="_blank" rel="noreferrer noopener">10.1080/09546634.2019.1587148</a>
YouTube as a Source of Dermatologic Information on Isotretinoin
Accutane; comments; dermatology; information; isotretinoin; mobile app; patient education; Social Media; video-sharing; YouTube
Xiang Laura; Ravichandran Sairekha; Tamashunas Nina; Wan Angie; Mazmudar Rishabh S; Scott Jeffrey F
Journal of the American Academy of Dermatology
2019
2019-12-13
Journal Article
<a href="http://doi.org/10.1016/j.jaad.2019.12.014" target="_blank" rel="noreferrer noopener">10.1016/j.jaad.2019.12.014</a>
PMID: 31843656