Conference Coverage

Few physicians report adverse events related to body contouring devices

 

Key clinical point: Most physicians do not report adverse events related to noninvasive body contouring devices to the FDA .

Major finding: Of 83 medical device reports, 26 were related to cryolipolysis.

Study details: An analysis of 83 complications of noninvasive fat reduction and cellulite reduction devices reported to the FDA.

Disclosures: Dr. Wulkan reported having no financial disclosures. One study coauthor holds positions on advisory boards of, is a consultant for, and has intellectual property and/or stock options with various industry companies, such as Soliton and Allergan.

Source: Wulkan et al. ASLMS 2018.
 


 

REPORTING FROM ASLMS 2018

– Most physicians do not report adverse events related to noninvasive body contouring devices to the Food and Drug Administration, a database review showed.

“The FDA mandates that manufacturers and device operators disclose medical device reports to monitor suspected injuries and device malfunctions to the Manufacturer and User Facility Device Experience [MAUDE] database,” study author Adam J. Wulkan, MD, said at the annual conference of the American Society for Laser Medicine and Surgery. “Given the rapid growth in the noninvasive fat reduction market, it is essential physicians be aware of associated adverse events.”

Dr. Adam J. Wulkan

Dr. Adam J. Wulkan

In what is believed to be the first study of its kind, Dr. Wulkan, a dermatologist at Massachusetts General Hospital, Boston, and his associates performed a search of complications of noninvasive fat reduction and cellulite reduction devices reported to the MAUDE database from January 2014 to October 2017. The search yielded 98 medical device reports (MDRs), most of which were submitted by patients.

“Given that this is the largest database for adverse events, I was surprised how few reports were done by physicians,” Dr. Wulkan said in an interview.

He reported results from 83 of the 98 MDRs. A total of 26 MDRs reported on cryolipolysis and included newly diagnosed or exacerbation of prior umbilical hernias (10), neuropathies (5), paradoxical fat hyperplasias (4), blisters (3), rashes (1), flu-like symptoms (1), gastroenteritis (1), and prolapsed bladder/uterus/rectum (1). Of the 11 MDRs for radio-frequency devices, 10 were burns/blisters and 1 fire.

Dr. Wulkan went on to note that 17 MDRs were reported for 1060-nm laser lipolysis, including burns/blisters (5), nodules (4), pain (3), cellulitis/abscesses (2), excessive swelling (1), neuropathy (1), and vomiting (1). There were four cases of burns on MDRs from focused/pulsed ultrasound procedures. One was on a non–FDA approved body site and another after combination radio-frequency/infrared treatment for cellulite reduction.

There were eight MDRs reported with 1440-nm laser cellulite reduction, including burn (5), unacceptable cosmesis (2), and faulty power supply (1). In addition, there were 12 MDRs reported on high-frequency ultrasound, including burns/blisters (9), subcutaneous nodules (2), and excoriation (1). Finally, vacuum-assisted submission was associated with five MDRs, including festooning/unacceptable cosmesis (2), seroma/hematoma (1), laceration (1), and nodules (1).

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