Adverse Events of Non-Invasive Body Contouring: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Abstract

BACKGROUNDMultiple non-invasive modalities have become popular alternatives to surgical procedures for body contouring.OBJECTIVETo analyze adverse events (AEs) associated with non-invasive body contouring devices reported through the Manufacturer and User Facility Device Experience (MAUDE) database.METHODS AND MATERIALSThe MAUDE database were queried for AEs associated with non-invasive body contouring devices between January 2011 and June 2021. An extensive list of keywords and brand and manufacturer names was used.RESULTSA total of 1,325 reports with 1,590 AEs were identified among 6 modalities. More than 70% were reported in the past 5 years. Cryolipolysis made up 38.3% reports, which mostly pertained to paradoxical hyperplasia and hernias. Radiofrequency had the most reports (41.9%). Like laser devices, most of their reports described burns. Focused ultrasound was commonly associated with unintentional fat loss and surface irregularities. Focused electromagnetic field resulted in only 7 reports.CONCLUSIONThe analysis of present study supports previous studies concerning common local symptoms caused by these devices, but it also reveals complications not reported in previous device studies. This study highlights the importance of proper technique and adherence to device guidelines. Practitioners should be knowledgeable of potential complications from each device to both prevent and manage them accordingly.

Literature review of adverse events associated with cryolipolysis

“…More research is needed to determine if there are major differences in AEs based on specific CoolSculpting device or region (abdomen, submental, etc.) MDRs can be reported from outside the United States, so adverse event data in the MAUDE database for cryolipolysis includes a mix of US and non‐US devices, which may not all meet the same safety standards 5 . Other limitations of the MAUDE database include under‐reporting of AEs to the FDA, the fact that reports are not subject to review to determine a true link between a device and an AE; and that sources are not prescreened, with one study showing that 17.8% of submissions between 1997 and 2018 were from physicians, and only 0.5% of these reports were submitted directly to the FDA, while the manufacturer submitted 99% of the physician reports 16,24 …”

“…Hernias were the second most commonly reported AE, a total of 55 or 10.8% of all AEs reported. This included new hernias (55.2%) and exacerbation of preexisting hernia (44.8%), with over 25% of patients requiring surgery to repair 5 …”

“…In recent years, it has become increasingly evident that PAH may not be as rare as once believed 17 . PAH is believed to be underreported, and because the manufacturers' reported risks may be based on number of cycles instead of number of patients (with patients typically undergoing multiple cycles), the perceived risk of developing PAH was low 5,9,10 . As the New York Times wrote to simplify how the risk of developing PAH can be represented in dramatically different ways: if 2 patients received 10 treatments of CoolSculpting, and 1 developed PAH, the manufacturer would report 1 in 20 (5%) treatments as the risk of developing PAH, whereas physicians would report 1 in 2 patients, so 50% 10 .…”

“…MDRs can be reported from outside the United States, so adverse event data in the MAUDE database for cryolipolysis includes a mix of US and non-US devices, which may not all meet the same safety standards. 5 Other limitations of the MAUDE database include under-reporting of AEs to the FDA, the fact that reports are not subject to review to determine a true link between a device and an AE; and that sources are not prescreened, with one study showing that 17.8% of submissions between 1997 and 2018 were from physicians, and only 0.5% of these reports were submitted directly to the FDA, while the manufacturer submitted 99% of the physician reports. 16,24 Additionally, machine users may have different levels of experience, licensure, and up-to-date knowledge of optimal machine settings for effectiveness and safety.…”

“…16 As mentioned earlier, due to the nature of the MAUDE database having MDRs reported from both US and non-US users, the exact device not always known or reported, and the underreporting of AEs to the FDA in general, it is not quite clear what percentage of PAH incidences are due to CoolSculpting in the United States, CoolSculpting outside the United States, cryolipolysis with non-FDA-approved devices, and even cryolipolysis with counterfeit machines. 5 This further complicates our understanding of the true risk of developing PAH post-procedure.…”