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Complications and Effectiveness of FDA-Approved Liposuction and Noninvasive Fat Reduction Devices: An Analysis of
Andrea Lin1, Jocelynne Dorotan2, Sameer Patel2
1Department of General Surgery, Temple University Hospital, Philadelphia, PA.
Background:
Liposuction is the fourth most performed cosmetic procedure in the United States, increasing from 211,067 procedures in 2020 to 347,782 in 2023. While the estimated complication rate is 2.4%, long-term outcomes remain understudied.
Objectives:
Although FDA-approved devices are advertised to consumers with caution of short-term complications, the known long-term sequelae and overall effectiveness are limited. This study quantifies the frequency and types of complications for the most commonly utilized devices.
Methods:
Complaints for 14 FDA-approved liposuction devices-including 5 radiofrequency, 4 laser, 2 ultrasound-assisted, 1 power-assisted, 1 cryosuction, and 1 deoxycholic acid device-from 2020 to 2025 were recorded from the Manufacturer and User Facility Device Experience (MAUDE).The total liposuction procedures documented by the American Society of Plastic Surgeons were obtained from the annual reports 2020-2023 for 6 of these devices.
Results:
Among 1.8 million procedures, 642 complications were reported (0.04% rate) over the last 5 years. Cryoliposuction accounted for the majority, 72.7% (n = 467/642), with 99% of these complaints linked to paradoxical adipose hyperplasia. Ultrasound-assisted liposuction comprised 13% (n = 84/642), with 54% attributed to machine malfunctions, often due to the liposuction cannula tip breaking off the device (25.5%). Paradoxical rebound (71%) and burns (8.1%) were common.
Conclusions:
With less than a 1% estimated complication rate, liposuction devices, regardless of mechanism, is relatively safe. Cryoliposuction and ultrasound devices disproportionately contributed to complaints, suggesting technical error or user challenges. Although ineffectiveness and contour deformity are known long-term complications, paradoxical rebound was the most frequent complaint, potentially influenced by patient expectations of effectiveness.1 These findings highlight the need to examine the use of these devices, assess potential complications, and counsel patients' expectations.
