Cryolipolysis accounted for a majority of noninvasive cosmetic procedures associated with adverse events, according to an analysis of data from the Manufacturer and User Facility Device Experience (MAUDE).
The number of noninvasive body-contouring procedures performed in the United States increased by fivefold from 2011 to 2019, attributed in part to a combination of improved technology and new medical devices, as well as a “cosmetically savvy consumer base heavily influenced by social media, ” wrote Young Lim, MD, PhD, of the department of dermatology, Massachusetts General Hospital, Boston, and coauthors.
However, premarket evaluations of many new medical devices fail to capture rare or delayed onset complications, and consumers and providers may not be fully aware of potential adverse events, they said. The MAUDE database was created by the Food and Drug Administration in 1991 to collect information on device-related deaths, serious injuries, or malfunctions based on reports from manufacturers, patients, and health care providers.
The researchers used the MAUDE database to identify and highlight adverse events associated with noninvasive body contouring technology in order to improve patient safety and satisfaction.
In their report, published in Lasers in Surgery and Medicine, they analyzed 723 medical device reports (MDRs) reported between 2015 and 2021: 660 for noninvasive body contouring, 55 for cellulite treatments, and 8 for muscle stimulation.
“Notably, of the 723 total MDRs between 2015 and 2021, 515 (71.2%) were reported in 2021, with the next highest reported being 64 in 2019 (8.8%),” the researchers wrote.
Overall, paradoxical hyperplasia (PAH) accounted for the majority of adverse reactions in the noninvasive body-contouring category (73.2%). In PAH, patients develop additional adipose tissue in areas treated with cryolipolysis. In this study, all reports of PAH as well as all 47 reported cases of abdominal hernias were attributed to the CoolSculpting device.
For cellulite treatments, the most common MDRs — 11 of 55 — were scars and keloids (20%). The Cellfina subcision technique accounted for 47% (26 of 55) of the MDRs in this category, including 9 of the scar and keloid cases .
Only eight of the MDRs analyzed were in the muscle stimulation category; of these, burns were the most common adverse event and accounted for three of the reports. The other reported AEs were two cases of pain and one report each of electrical shock, urticaria, and arrhythmia.
Patients are increasingly opting for noninvasive cosmetic procedures, but adverse events may be underreported despite the existence of databases such as MAUDE, the researchers wrote in their discussion.
“PAH, first reported in 2014 as an adverse sequelae of cryolipolysis, remains without known pathophysiology, though it proportionately affects men more than women,” they noted. The incidence of PAH varies widely, and the current treatment of choice is power-assisted liposuction , they said, although surgical abdominoplasty may be needed in severe cases.
The findings were limited by several factors including the reliance of the quality of submissions, the selection biases of the MAUDE database, and the potential for underreporting, the researchers noted.
However, “by cataloging the AEs of the growing noninvasive cosmetics market, the MAUDE can educate providers and inform patients to maximize safety and efficacy,” they said.
The size of the database and volume of reports provides a picture that likely reflects overall trends occurring in clinical practice, but in order to be effective, such databases require diligence on the part of manufacturers and clinicians to provide accurate, up-to-date information , the researchers concluded.
More Procedures Mean More Complications
“As the market for minimally and noninvasive cosmetic procedures continues to expand, clinicians will likely encounter a greater number of patients with complications from these procedures,” said Jacqueline Watchmaker, MD, a general and cosmetic dermatologist in Scottsdale, Ariz., in an interview .
“Now more than ever, it is important for providers to understand potential side effects of procedures so that they can adequately counsel patients and optimize patient safety,” and therefore the current study is important at this time, she commented.
Watchmaker, who was not involved in the study, said that, overall, she was not surprised by the findings. “The adverse events analyzed from the Manufacturer and User Facility Device Experience parallel what is seen in clinical practice,” she said. “I did find it slightly surprising that an overwhelming majority of the medical device reports (515 of 723) were from 2021.” As the authors discuss, the reasons for this increase may include such factors as more flexible pandemic work schedules, pandemic weight gain, and the rise in MedSpas in recent years, she added.
“Some patients mistakenly think that ‘noninvasive’ or ‘minimally invasive’ procedures are risk free,” said Watchmaker. “However, as this review clearly demonstrates, complications can and do occur with these procedures. It is our job as clinicians to educate our patients on potential adverse events prior to treatment,” she emphasized. Also, she added, it is important for clinicians to report all adverse events to the MAUDE database so the true risks of noninvasive procedures can be more accurately assessed.
As for additional research, “It would be interesting to repeat the same study but to look at other minimally and noninvasive cosmetic devices such as radiofrequency and ultrasound devices,” Watchmaker noted.
The study received no outside funding. Lim and his coauthors, Adam Wulkan, MD, of the Lahey Clinic, Burlington, Mass., and Mathew Avram, MD, JD, of Massachusetts General Hospital, had no financial conflicts to disclose. Watchmaker had no financial conflicts to disclose.
Medical device-related adverse events can be reported to the FDA’s MAUDE database here.
This story originally appeared on MDedge.com, part of the Medscape Professional Network.