Ultherapy Adverse Events: What a Systematic Review Could and Could Not Establish

A systematic review of microfocused ultrasound with visualization (MFU-V) found that temporary swelling and redness were the most commonly recorded treatment-related reactions. The authors said most reactions in published studies were at most moderate and resolved without sequelae. They also identified a serious five-person case series, including one case of subcutaneous atrophy. A separate US device-reporting database contained reports of lipoatrophy, neurologic problems, scarring, and ocular symptoms including vision loss. No published study had directly examined whether MFU-V complicates a later facelift. In an anonymous survey at least four months after treatment, 53.1% reported satisfaction and 55% said expectations were met; the authors said nonsurgical tightening does not replace surgical lifting.

• In published clinical studies, temporary swelling and redness (edema and erythema) appeared most often; three trials reported no treatment-related adverse events.
• The review called one patient’s subcutaneous atrophy “permanent,” but the original case paper recorded spontaneous improvement at six weeks and did not establish permanence.
• No published facelift-compromise report was found, and no primary study directly tested that later-surgery question.
• The US MAUDE database yielded 106 selected records with 170 reported adverse-event entries. Its percentages describe shares of those entries, not incidence among treated patients.
• One report of a problem during facelift followed two MFU-V and two RF microneedling treatments; a single-cause inference is not possible.
• An anonymous survey found 53.1% satisfied and 55% saying expectations were met at least four months later. The authors set a modest expectation for nonsurgical tightening.

The review associates the name Ultherapy with the MFU-V device it examined. Its safety observations come from the reviewed evidence and do not apply automatically to every focused-ultrasound device. Published studies mostly recorded temporary reactions, but serious cases and less-verifiable postmarketing reports also appeared. The absence of a published later-facelift case has limited meaning because that outcome had not been directly studied.

These published findings are not the clinic’s treatment outcomes. Nor do they assess one person’s suitability, expected change, or risk.

Introduced in 2009, MFU-V focuses ultrasound into thermal coagulation points of about 1 mm³ at approximately 65 °C and depths of 1.5, 3.0, and 4.5 mm, the paper says. The proposed path bypasses the epidermis and reaches the mid-to-deep reticular dermis and superficial musculoaponeurotic system (SMAS). The authors describe collagen contraction followed by new collagen formation over months. This describes a device mechanism, not settings or a result for one person.

Key findings

• The review’s published studies most often recorded temporary edema and erythema. The authors described the great majority of reported treatment-related events as no worse than moderate and resolving without sequelae; three trials reported none.
• In a 2018 five-person case series, Patient 1 developed subcutaneous atrophy. The review called Patient 1’s subcutaneous atrophy ‘permanent,’ but the primary case paper recorded improvement at six weeks and follow-up through nine weeks; it did not establish whether the atrophy was permanent or fully resolved.
• No published study reported a compromised later facelift, but none directly investigated later facelift outcomes. An absence of reports cannot be turned into zero risk.
• MAUDE’s 106 selected records contained 170 adverse-event entries; these are passive reports without a treated-patient denominator.
• The single reported facelift problem followed four prior treatments, two MFU-V and two RF microneedling, so it cannot be assigned to MFU-V alone.
• In one abdominal tissue comparison, superficial and deep fat-compartment adipocytes did not differ between treated and control sides. One person’s abdomen at one time point cannot settle long-term facial risk.
• At least four months after treatment, the cited anonymous survey found 53.1% satisfaction and 55% saying expectations were met. The authors distinguished modest nonsurgical tightening from a surgical lift.

Reactions most often recorded in published studies

Three included trials reported no treatment-related adverse events. In studies that recorded reactions, temporary edema and erythema appeared most often. The review used a background total of 506 participants for many percentages, although the studies differed in body area, follow-up, and how they recorded adverse events.

• Edema and erythema: Ten studies reported these reactions in 120 people, shown by the review as 23.7% of 506. The recorded cases resolved without treatment or sequelae within 90 days; 78.3% resolved within 14 days. Three other trials mentioned the reactions without giving a patient count.
• Postprocedural pain: Three trials reported pain in 21 people, shown as 4.2% of 506. In an abdominal-treatment group, 17 recovered without treatment within four days. One person with throbbing pain recovered within 21 days after anti-inflammatory medication. The remaining three people, treated on the face or neck, had no reported resolution time.
• Wheals, welts, and linear marks: Six studies reported them in 14 people, shown as 2.8% of 506. Some resolved within a few days to 14 days; other resolution times were not reported.
• Localized numbness or dysesthesia: Four trials reported these in nine people, shown as 1.8% of 506. One lower-neck numbness report resolved on day five after anti-inflammatory treatment. Four jawline numbness reports, three involving a deep supraorbital nerve branch, and one perioral numbness report resolved within 14–21, seven, and 30 days respectively, without recorded sequelae. Those nine were not eyelid-ptosis cases. A separate case report described supraorbital sensation loss on day four, unilateral brow droop by day 14, and recovery by day 30.
• Bruising: Two studies reported three people, without treatment or resolution times. The review prints 0.06% for those three and 0.02% for one white dermal papule; neither figure matches simple division by 506. The counts are retained without a new rate.
• Forehead post-inflammatory hyperpigmentation: Two people developed this by day 30 after forehead treatment. The authors suggested darker skin tones and use of a deeper-reaching transducer, where underlying bone may reflect ultrasound, as possible factors. This does not establish causation or frequency.

The review used 506 people as a background denominator across heterogeneous reports, so its percentages are neither fixed rates for all MFU-V procedures nor predictions for one person. Resolution was not documented for every recorded symptom.

Serious reactions reported, with uncertain long-term course

The reviewers found few serious treatment-related events in published studies, but the events were substantial. A 2018 case series described five people who developed combinations of blisters, erosions or ulcers, skin and subcutaneous swelling, atrophy, or skin necrosis after a single MFU-V session. The review called Patient 1’s subcutaneous atrophy permanent. The primary case paper recorded atrophy at three weeks, spontaneous improvement at the six-week visit, and resolution of induration and tenderness by nine weeks. Patient 1 also reported a prior episode of facial fat atrophy after monopolar radiofrequency treatment six years earlier; the original case authors said the long interval made its relationship to the later event difficult to assess. The case paper did not document permanence or the later course. Improvement at six weeks does not prove full resolution.

The series also left some outcomes unknown. One poorly healing ulcer was excised after three weeks, and another person’s residual linear atrophy was corrected with hyaluronic acid filler. Two people were lost to follow-up. This small series cannot give a general incidence estimate. The later course of some serious events remains unknown.

In a separate study of 29 people who received both MFU-V and ablative CO₂ laser resurfacing, researchers reported one case of pseudofacial lipoatrophy and one of scarring. The reviewers suggested that hyaluronidase-containing local anesthetic might have dissolved an existing HA filler, creating apparent fat loss. They also noted the laser’s known scarring risk. These cases cannot establish what MFU-V alone caused.

A tissue observation from one abdomen

One person underwent MFU-V on one side of the abdomen, then a planned abdominoplasty six weeks later. Compared with the opposite side, the treated area had greater fascial thickness, fibrous-band density, and collagen in dermis and subcutaneous tissue. The study found no difference in adipocytes in the superficial or deep fat compartments.

This tissue observation covers one abdomen at one follow-up point. It cannot rule out facial lipoatrophy or establish long-term safety for other people.

What is known about a later facelift

The review found no peer-reviewed study reporting a later facelift compromised by MFU-V at the search date. This may be reassuring, but no primary study had directly examined that outcome. Surgeons had raised anecdotal concerns in professional and social-media discussions about facial fat and surgical planes; those accounts had not been robustly tested. Neither the published record nor the anecdotes can establish one person’s surgical risk.

The authors also searched the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database. It includes required reports from manufacturers, importers, and device-user facilities and voluntary reports from clinicians, patients, and consumers. Among the selected reports was one account of difficulty during a facelift: a 58-year-old woman reportedly had deep scarring noted during lower-face and neck surgery.

She reported four earlier procedures more than 24 months before the operation: two MFU-V sessions and two radiofrequency microneedling sessions. That history cannot establish MFU-V as the sole cause. The authors said the cumulative effect of repeated MFU-V was still unknown.

The largest included primary study had 93 participants; the longest follow-up was 360 days. Small studies, short observation, clinical-trial conditions, and publication bias could leave later surgical problems underrepresented. Examining this question would require larger, multicenter studies with longer follow-up.

MAUDE reports describe entries, not patient incidence

The search left 106 selected records containing 170 adverse-event entries; one record could contain more than one event. The figures below show shares of those 170 reported entries. They are not the chance that a treated person will experience an event.

Neurologic reports included nerve damage, localized numbness, dysesthesia, and ptosis. These 29 reports are a different evidence stream from the nine sensory cases in clinical studies. The 12 ocular reports ranged from ectropion and dry-eye keratitis to vision loss.

The remaining 70 of 170 entries included blisters or burns, 11 (6.5%); increased laxity, eight (4.7%); hyperpigmentation, four (2.4%); and 24 reports classified as other (14.1%). Entries describing milder reactions included edema or erythema, three (1.8%); postprocedural pain, eight (4.7%); wheals, welts, or linear marks, seven (4.1%); bruising, two (1.2%); and headache, three (1.8%). Most headache reports were described as mild, but one had a sudden “thunderclap” quality. The “other” reports included tooth movement, loss or pain, tinnitus, hairline recession, lack of facial sweating, fatigue, recurrence of Lyme disease, vocal-cord swelling or paralysis, nasal-valve collapse, temporomandibular-joint dysfunction, chronic radiation syndrome, and brain injury, among other reported problems. Listing an entry does not prove device causation.

Individual MAUDE reports are often unverified and may be biased. They do not give a complete device-safety picture. Searches return only reports matching the wording used within the preceding 10 years, and some information may be withheld.

The total number of treated people or procedures is unavailable. Thus 18.8% is not lipoatrophy incidence, 0.6% is not the probability of surgical difficulty, and causation cannot be established from the entries alone.

Satisfaction and the expected scope of change

Reviewers cited an anonymous survey collected at least four months after MFU-V: 53.1% reported satisfaction and 55% said treatment met expectations. The available full text gives no survey sample size, exact questions, or respondent characteristics. These figures are not a success rate for the review’s 506 participants or a forecast for an individual.

The authors used these figures to argue for explaining the limits of nonsurgical tightening beforehand. They described mild tightening as the best possible outcome without surgery and discussed MFU-V for mild-to-moderate skin and soft-tissue laxity. For severe laxity or prominent platysmal bands, they suggested considering surgical options. They called surgical lifting the reference treatment for skin laxity and said nonsurgical results do not replace it. These are the review authors’ scope statements, not a treatment choice for one person.

Where this evidence came from

Humphrey and colleagues published this systematic review in Dermatologic Surgery in 2025. They searched PubMed/MEDLINE on March 19, 2024 for English-language human primary studies, centering on noncombined MFU-V for face and upper-neck laxity rather than sessions combined with botulinum toxin or fillers. Of 37 unique records, 19 papers published from 2010 to 2023 and involving 506 participants were included: 15 clinical trials, one retrospective study, two case series, and one case report. They also examined references for supporting data, including the single-person abdominal histology report. The review did not perform a pooled meta-analysis. Searching one database and English-language studies could miss other evidence. The patient-level course of the 2018 series comes from the original Friedmann paper.

Separately, the authors searched MAUDE on April 16, 2024 using the device name. They screened 144 records dated January 30, 2014 through February 16, 2024 and excluded duplicates, combination treatments, primarily non-face or non-neck treatment, and reports without a specified patient adverse event, among other exclusions. This yielded 106 records and 170 event entries. The clinical literature’s background 506 people and the database’s 170 entries are different denominators and cannot be combined or compared as rates.

The available full-text rendering has no separate conflicts-of-interest or funding disclosure section. That absence does not show that no conflicts or funding existed. The paper’s maximum primary-study sample was 93 and maximum follow-up 360 days; no primary study directly tested later facelift outcomes. Unexpected numbness, drooping, blisters or skin injury, or visual changes after treatment warrant medical assessment.

References

1. Humphrey VS, Rambhia PH, Gmyrek R, Chapas A. “Microfocused Ultrasound With Visualization: A Systematic Review of Adverse Events and Risk of Subsequent Facelift Compromise.” Dermatologic Surgery. 2025;51(4):424–429. PubMed · DOI.
2. Friedmann DP, Bourgeois GP, Chan HHL, Zedlitz AC, Butterwick KJ. “Complications from microfocused transcutaneous ultrasound: Case series and review of the literature.” Lasers in Surgery and Medicine. 2018;50(1):13–19. doi:10.1002/lsm.22768. https://pubmed.ncbi.nlm.nih.gov/29154457/

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