A review of the Manufacturer and User Facility Device Experience (MAUDE) database highlights the most common adverse event associated with medical devices.
Adam Wulkan, M.D., a fellow at Massachusetts General Hospital in Boston who spoke at the American Society for Laser Medicine and Surgery annual conference last month in Dallas, presented findings from an analysis he conducted on adverse events associated with cosmetic medical devices.
The analysis is based on a review of MAUDE records from Jan. 1, 2014 to Oct. 1, 2017 for adverse events associated with seven noninvasive body contouring devices: cryolipolysis, 1060 nm diode hyperthermic laser lipolysis, high intensity focused ultrasound, 1440-nm pulsed laser, high frequency ultrasound, vacuum-assisted subcision and radiofrequency.
“Overall, these are all relatively safe devices when used properly. It is a highly competitive market for device manufactures, filled with devices that are revolutionizing the field of noninvasive body contouring,” he said.
Even though it is the most prominent database of its kind in the U.S., few physicians, manufacturers and patients use it, which may explain why so few adverse events have been recorded on MAUDE.
The analysis was associated with a number of limitations, including the tendency of adverse events reported by patients to be vague. While patient participation can be insightful, it’s not necessarily informative since many patients treat MAUDE like an online product review website, instead of a mechanism by which to report adverse events directly to the U.S. Food and Drug Administration, which manages MAUDE. More physician users would be beneficial, Dr. Wulkan said.
“Physician education about the existence of this database hopefully will initiate further interest in contributing to that growth. The more information manufacturers and clinicians have about these devices and their safety, the higher quality of care we can provide to our patients,” he said.
While not statistically significant, the findings were insightful. “It is critical to correlate the number of adverse events with the popularity of the device. One should anticipate that the more a device is used in practice, the greater the number of adverse events that may occur,” Dr. Wulk said.
Adverse events by treatment type
- Cryolipolysis, a non-invasive body contouring treatment that freezes fat cells, is the most commonly used device recorded in MAUDE, but then — the procedure has been conducted over six million times worldwide. “It is remarkable how infrequently adverse events occur — given its immense popularity,” Dr. Wulkan said.
- There were 10 reported cases of hernia, both new onset and exacerbation of a previously diagnosed hernia. “Generally speaking, we have been educated that this modality is only capable of exacerbation of a previously diagnosed hernia. Given that some of the reports claim to be a new onset hernia suggests either that these are undiagnosed hernias or that this treatment is capable of hernia formation,” he said.
- The procedure was also associated with four cases of paradoxical adipose hyperplasia, which Dr. Wulkan says is a well-known adverse event. “We are still learning why this happens, how often it occurs, and if there is any patient demographic that might be predisposed to it,” he said.
- Three patients reported blisters, whereas one patient each reported a rash, flu-like symptoms, gastroenteritis and prolapsed bladder. “However, just because a patient may have experienced certain illnesses after treatment does not imply causation. It seems obvious, but it is important to carefully assess all of the information reported and for individuals to make their own judgments regarding the association between the treatment and the claimed adverse event,” Dr. Wulkan said.
1060 NM DIODE HYPERTHERMIC LASER LIPOLYSIS
- For 1060 nm diode hyperthermic laser lipolysis — which is used for non-invasive body contouring —adverse events included five cases of burn or blister, four cases of nodules, three cases of pain, two cases of cellulitis or an abscess, and one patient each reported excessive swelling, neuropathy and vomiting.
HIGH INTENSITY FOCUSED ULTRASOUND (HIFU)
- HIFU is a procedure used for skin lifting and tightening. Four cases of burn or blister were recorded in this report.
1440-NM PULSED LASER
- 1440-nm pulsed laser for cellulite reduction was associated with five cases of burn and one incidence of a faulty power supply.
HIGH FREQUENCY ULTRASOUND
- There were nine cases of a burn or blister, two cases of subcutaneous nodules and one reported excoriations (scratches).
- Two patients reported festoons associated with this minimally invasive procedure for cellulite. One patient reported a case each of seroma, laceration and nodule.
- There were 10 cases of a blister or burn and one incidence of a device fire.