A Systematic Review of Helium Plasma Radiofrequency (Renuvion)

Abstract

Background

Helium plasma radiofrequency (Renuvion, previously J-Plasma) is a new energy-based device that causes coagulation of the subcutaneous fat. The device has recently received 501(k) clearance by the Food and Drug Administration (FDA) for soft tissue contraction after liposuction. A systematic review has not been previously published.

Methods

An electronic search was undertaken to identify publications describing clinical experience with this technique. The US government clinical trials website and the FDA website were queried. The CMS Open Payments database was accessed to evaluate financial bias.

Results

Twenty-five publications contained patient data with sufficient information for tabulation. Treatment areas included the face, neck, female and male breasts, trunk, and extremities, usually in combination with liposuction. Studies typically reported subjective surgeon evaluations of photographs and surveys. None of the studies provided standardized photographs with measurements comparing Renuvion to traditional methods. Measurements on matched photographs of breasts treated with Renuvion did not substantiate the authors' claims. The findings of an ultrasound study of the abdominal fat layer were undermined by incorrect labeling of the tissue planes. Most studies were funded by the manufacturer and most investigators had financial conflicts. Few studies mentioned subcutaneous emphysema. Four case reports described patients who suffered helium-induced pneumothorax, pneumomediastinum, pneumoperitoneum, and pneumomastia. Adverse events reported to the FDA included 15 life-threatening events and 3 fatalities. Full-thickness burns were frequently reported. The number and severity of the adverse events greatly exceeded those reported for radiofrequency and ultrasound devices.

Discussion

No evidence supports a claim of skin tightening beyond that which may be achieved using traditional or ultrasonic liposuction. Helium gas may permeate body cavities, with serious repercussions.

Conclusions

Marketing has taken precedence over science and safety considerations. This technology introduces serious safety risks to patients, including death, with no proven compensatory benefit.

Energy-based devices have been promoted over the last 3 decades to provide skin tightening either as a standalone treatment or in combination with liposuction. In the 1990s, ultrasound assistance was introduced to selectively dissolve fat cells while preserving connective tissue and improving skin tightening.^1,2 The Vibration Amplification of Sound Energy at Resonance (VASER) system (Solta Medical, Bothell, WA) is 1 such treatment that is in common use today. However, any benefit from ultrasound energy in skin tightening has not been rigorously demonstrated.^3,4

Other energy-based devices include laser liposuction (eg, Smartlipo, Cynosure, Westford, MA), cryolipolysis (eg, Coolsculpting, AbbVie, North Chicago, IL), radiofrequency (InMode, Lake Forest, CA), electromagnetic treatments (EmSculpt, BTL, Boston, MA.), and a combination of electromagnetic treatments and radiofrequency (EmSculpt Neo). However, claims of advantages over traditional liposuction frequently do not hold up to scrutiny.^{3,4,5,6,7,8,9,10,11,12,13} Marketing concerns often take precedence over sound scientific evaluation of devices.^6,7,8 Recent systematic reviews have called into question treatment efficacy and safety.^10,12,13 Radiofrequency treatments are not superior to traditional methods, such as submental lipectomy, liposuction, or abdominoplasty.¹⁰ Thermal treatments, by heating the subcutaneous tissue and producing coagulation necrosis, introduce additional complications, such as burns, prolonged induration, seromas, numbness, and neuropathies.¹⁰ Electromagnetic treatments do not have a sound physical basis for fat reduction (or muscle hypertrophy); rigorous measurements fail to confirm a significant benefit.^12,13

Recently, helium plasma radiofrequency treatments have been promoted to produce skin tightening, either on its own or, more commonly, following liposuction.¹⁴ Only 1 helium plasma radiofrequency device is available in the US, manufactured by Apyx Medical (Clearwater, FL), labeled Renuvion, previously called J-Plasma. The device produces coagulation of the subcutaneous tissue following liposuction. However, a systematic review of studies using this method has not been published. In addition to thermal effects, this device introduces a new, and potentially serious, complication—subcutaneous emphysema from helium gas.^{15,16,17,18,19}

Helium plasma radiofrequency treatments are a hot topic at meetings today.^20,21 Many plastic surgeons have either purchased the Renuvion device or are considering adding this device to their practices.

Caution is needed when reviewing the literature because investigators of energy-based devices typically receive payments from the manufacturer.^10,12,13 Authors may also be members or chairpersons of the company medical advisory board, own stock, or hold stock options.^10,12 The influence of such financial relationships in positively affecting product evaluation is well-known.^22,23,24 Investigators who are not only passive investors but company officers and shareholders have a financial obligation to the company. A fiduciary responsibility makes it impossible for them to remain objective.²⁴ Surgeons must look beyond marketing considerations alone and do their due diligence before introducing a new technology to their practice.⁸

METHODS

An electronic literature review was conducted to identify publications that evaluated the helium plasma radiofrequency device in cosmetic surgery. The search terms “helium plasma,” “J-Plasma,” and “Renuvion” were entered into the PubMed search engine. The search included all articles published in English starting in 2018, the year this method was first published for cosmetic application.²⁵ The US government clinical trials website was examined for registered studies of the Renuvion device.²⁶ The Manufacturer and User Facility Device Experience (MAUDE) database²⁷ was queried to identify problems reported to the US Food and Drug Administration (FDA). The Centers for Medicare & Medicaid Services (CMS) Open Payments database²⁸ was accessed to evaluate manufacturer payments to investigators.

RESULTS

The electronic literature review identified 36 publications describing helium plasma radiofrequency treatments for cosmetic applications.^{16,17,18,19,25,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59} Twenty-five articles contained case reports or series of treated patients with sufficient information for tabulation (Table 1).^{29,30,31,32,33,34,35,36,37,38,39,40,42,43,45,47,48,49,50,51,53,54,55,56,57,58,59}

TABLE 1.

Publications Evaluating Renuvion (Apyx Medical) Helium Plasma Radiofrequency Treatments

#	Study (Year)	No. Patients	Evaluation	Control Group	Other Devices	Area	Follow-up	Complications	Financial Conflict
1	Gentile (2019)29	4	Case reports	No	None	Face, nose, submental area	3 mos	None	Funding for animal studies by Apyx. No disclosure for RG, although a conflict is reported in other publications
2	Doolabh (2019)30	32	Chart review	No	VASER	Neck, arms, female breasts, abdomen, hips, scapular rolls, buttocks, thighs, legs	6 (3–8) mos	None	Study funded by Apyx. No disclosure for VD although this author received funds according to the Open Payments database
3	Gentile (2020)33	2	Case reports	No	VASER	Face (with facelift)	12 mos and 6 mos	None	RG is a consultant for Apyx and InMode
4	Ruff et al (2020)34*	37, 148	Chart review, evaluation of photographs, patient surveys	No	VASER or SmartLipo	Thighs, arms, buttocks, female and male breasts, hips, lower face, abdomen, scapular rolls	3.5 (1 day-11 mos)	7.8%	Study sponsored by Apyx. Writing assistance provided. All authors are paid consultants, speakers, and recipients of clinical research grants for Apxy. PR, EZ, and RG are stock option recipients and Apyx medical advisory board members.
									RG also owns Apyx stock
5	Ibrahiem (2022)35	66	Surgeon evaluation, surveys	Yes	VASER	Arms	13 (7–31 mos)	13.6%, burn 1.5%, emphysema 4.5%	None disclosed
6	De Souza et al (2022)36*	49	Surveys	No	Liposuction	Abdomen, flanks, submental area, arms, buttock fat injection	N.A.	None	Apyx funded the study. No disclosures for authors
7	Ruff et al (2022)37*	84	Chart review	No	VASER	Male breasts (69 patients also treated in other areas)	1.5 mos. (1 day–37.5 mos)	7%	Study funded by Apyx. All authors received payments for participation. EZ and PR are medical advisory board members, consultants, and clinical research investigators for Apyx and receive stock options and hourly compensation. AM and JL are consultants and clinical research investigators for Apyx. RP received study funding
8	Ruff et al38* (2022)	192	Chart review	No	VASER	Lower face, neck, scapular rolls, arms, male and female breasts, lower body	3 mos (1 day–15 mos)	24%, seromas 6.8%	Study funded by Apyx. Authors received payments for participation. PR is a medical advisory board member, consultant, and clinical research investigator for Apyx and receives compensation in Apyx stock and hourly compensation. PV is a consultant for Apyx. MN received study funding.
9	Shridharani and Kennedy (2022)39*	47	Chart review	No	Liposuction	Arms, neck, flanks, abdomen, upper back, thighs, buttocks, male breasts		Numbness 100%, nausea 43%, motor nerve injury 2%, induration 2%	Apyx funded the study. Authors reported no conflicts. However, SMS is a key opinion leader for Apyx, a consultant, and research funding recipient.41
10	Ruff et al (2023)40	65	Evaluation of photographs	No	None	Submental area and neck	6 mos	Nerve weakness 6.2%, pruritus 6.2%, hematomas 4.6%, induration 3.1%	All physician investigators are consultants for Apyx. PR is a member of the medical advisory board and RG was a member during the trial. PR and RG own stock options
11	Cala Uribe et al (2024)42	95	Chart review	No	VASER, BodyTite, power-assisted liposuction, diode laser	Arms	N.A.	14.6%, edema 8.5%, cording 4.4%	LCU serves as a consultant and receives royalties as a speaker for InMode
12	Driscoll et al (2024)43	180	Chart review	No	VASER	Abdomen, thighs, arms, submental area, hips, back	N.A.	13.3%, edema 5%, persistent skin laxity 3.3%, seromas 2.2% hematomas 1.6%, burn 0.5%, neuralgia 0.5%	GB and BK are paid consultants for Apyx
13	Núñez Villar and Monroy (2024)45	220	Chart review	No	Pretreatment of buttocks before fat transfer	Buttocks	Up to 1 yr	Hyperthermia 4.5%, retraction in lower buttock 0.5%	Administrative support from Apyx for drafting and publication
14	Kluska et al (2024)47	229	Chart review	Yes	Ultrasound	Arms, thighs, back, breast, buttocks, face, hips, leg, neck	312 d (1–1570 d)	14.8%, seromas 7.0%, burns 0.9%	Authors are consultants for Apyx and receive hourly compensation for consulting. Previously, CD was a paid presenter and trainer for InMode
15	Ouf et al (2024)48	15	Subareola disk size, skin redundancy, surveys	Yes	VASER	Male breasts	6 mos	33%, seromas 13.3%, hematomas 6.7%, burns 6.7%	None reported
16	Nichols and Albershardt (2024)49	4	Ultrasound	No	Power-assisted liposuction	Abdomen	Intraoperative only	None “during intraoperative period”	Study funding was provided by Apyx. CN and DA are consultants and clinical trial investigators for Apyx and consultants for GE Healthcare (Chicago, IL)
17	Tambasco et al (2025)50	639	Chart review, evaluation of photographs	No	VASER	Abdomen, flanks, thighs, knees, arms, back	25 mos (12–39 mos)	8.6%, seromas 5.6%, hyperpigmentation 1.3%, subcutaneous emphysema 0.3%	DT is a consultant for Solta Medical and Apyx
18	Barone et al (2025)51	38	Patient photographs, BODY-Q, ultrasound	Yes	Liposuction	Abdomen, flanks, with abdominoplasty	2 yrs	10.5%, seromas 5.2%, dehiscence 5.2%	None disclosed
19	Vanek et al (2025)53	40	Clinical evaluation of adverse events	Yes	VASER	Abdomen, with abdominoplasty	N.A.	32.5%, seromas 15%, wound dehiscence 10%	PV is a consultant and clinical trial investigator for Apyx. Funding for study and publication support provided by Apyx, including funding for medical writing assistance
20	Sterodimas et al (2025)54	15	Photographic evaluation, surveys, tape measurements	No	None	Female breasts	6 mos	None	Funding provided by Apyx. AS is a medical advisory board member and consultant for Apyx, and has received stock options, research grants, and hourly compensation for consulting services. Outside medical writing assistance was funded by Apyx. Kari Larson, Senior Director of Clinical Affairs at Apyx, assisted with manuscript drafting
21	Sterodimas et al (2025)55	30	Photographic evaluation, surveys	No	None	Forehead	24 mos (1–57 mos)	Bruising 20.0%, edema 16.7%	Apyx sponsored the retrospective data collection. AS is a medical advisory board member and consultant for Apyx and received stock options for his participation in the medical advisory board, research grants, and hourly compensation for consulting activities. BN is a consultant for Apyx. Outside medical writing assistance was provided. Kari Larson at Apyx assisted with manuscript drafting
22	Tambasco et al (2025)56	100	Patient surveys, Likert scale	No	Liposuction	Abdomen, with lipoabdominoplasty	19.7 mos	Hyperpigmentation 8%, seromas 6%, subcutaneous emphysema 2%	DT is a consultant for Solta Medical and Apyx
23	Tambasco et al (2025)57	21	Chart review	No	Liposuction	Inner thighs, with inner thigh lifts	16.8 mos (12.0–36.5 mos)	Seroma 2%	DT is a consultant for Solta Medical and Apyx
24	Hoyos et al (2025)58	174	Chart review, patient surveys	No	High-definition liposuction	Arms, legs, back, neck, abdomen, pectorals, buttocks, waist, axillae, knees, trunk	7.5 mos (2–24 mos)	Pneumoperitoneum 0.6%, pneumoretroperitoneum 0.6%, duck voice 0.6%	AEH was an unpaid consultant and speaker for Sound Surgical Technologies (VASER). ED is a consultant for InMode
25	Kimbrell59	26	Chart review, photographic evaluations, forehead measurements, patient surveys	No	None	Forehead	7 mos (3–10 mos)	2 neurapraxias, 1 seroma	LK is a consultant, principal investigator, and speaker for Apyx. The study was funded by Apyx. Medical writing assistance was provided. Technical assistance was provided by Apyx.

*Studies included in review used to obtain FDA 510(k) clearance for contraction of subcutaneous tissue following liposuction for aesthetic body contouring.⁴¹

N.A., not available.

Treatment areas included the face and neck, female and male breasts, abdomen, flanks, back, thighs, arms, and legs. One study reported using this device to treat the lower eyelids.²⁶ Two recent studies reported using this device in the forehead.^55,59 Although the results are not yet published, 1 clinical trial was registered for evaluation of labia treatment.⁶⁰ Another publication investigated fat transfer recipient site preparation in mice.⁴⁴ A recent study from Peru reported using helium pneumodissection prior to gluteal fat injection.⁴⁵ In some cases, the device was used as a standalone treatment. However, in most cases, Renuvion was used after tumescent infusion and liposuction. Liposuction methods included traditional liposuction, power-assisted liposuction (MicroAire, Charlottesville, VA), VASER, or, in 1 study, Smartlipo (Cynosure Lutronic, Westford, MA) laser-assisted liposuction (Table 1).³⁴

Most studies reported case reports, chart reviews, subjective evaluation of patient photographs, and surveys (Table 1). Most publications did not report consecutive patients or inclusion rates. Many studies did not report institutional review board approval.^{25,29,30,31,32,33,34,35,39,57,58}

Ruff et al³⁴ found that most patients (77%) “reported aesthetic improvement and were happy with their results, would recommend to a friend, and would consider having their procedure repeated (68%). Overall satisfaction was achieved by 74%.” Hoyos et al⁵⁸ reported that 44% of patients were “very satisfied” and 41% were “partially satisfied” after helium plasma treatment.

Photographic Comparisons

Ruff et al³⁴ calculated a 68.6% reduction in the submental angle. This figure was determined by comparing percentages in highly cropped nonstandardized photographs (Fig. 1). The authors did not report the absolute difference in angle measurements (23.3°), but rather the percentage difference in the angle measurements (68.6%). In their review article used to obtain FDA clearance for soft-tissue contraction following liposuction, Shridharani et al⁴¹ showed a single set of facial photographs depicting Renuvion treatment of the submental area. Although the authors did not provide measurements, comparison of matched photographs reveals a 2-mm reduction in submental fullness (Fig. 2).

FIGURE 1.

A, B, This patient underwent treatment of the submental area using liposuction and helium plasma. The age and posttreatment time are not provided. The authors indicate “submental angles” of 33.96° before treatment and 10.65° after treatment. Rather than a 23.31° change (33.96–10.65), the authors compare percentages and calculate a difference of 100 – (10.65/33.96 × 100%) = 68.6%. The photographs are highly cropped and do not allow a comparison of chin tilt. Adapted from Ruff et al.³⁴

FIGURE 2.

A, B, This 31-year-old woman is seen before and 9 months after helium plasma radiofrequency liposuction. The images have been matched for size and orientation. The submental fullness is reduced 0.20 cm. A facial vertical height of 10 cm is used for calibration. Adapted from Shriharani et al.⁴¹

In their 2020 invited review article, Ruff et al³⁴ reported that “the mean reduction in abdominal width was 82.1% (range, 52%–100%) and mean area reduction was 96.0% (range, 29.7%–66.2%).” A correction was published, clarifying that the mean area reduction was 65.3%, not 96.0%.⁶¹ No correction was made for the 82.1% reduction in abdominal width, with a range of 52%–100%. Ruff et al³⁴ provided before and after lateral photographs of an abdomen, with superimposed horizontal lines. The authors claimed a 29.7% reduction in abdominal area, although there are no measurements on the photographs. When the images are matched for size and orientation (Fig. 3), there is no evidence of a reduced abdominal width.

FIGURE 3.

A, B, This patient underwent treatment of the abdomen using helium plasma radiofrequency and ultrasound-assisted liposuction. The age and posttreatment interval are not reported. The authors report a 29.7% reduction in the abdominal area. The images have been matched for size and orientation using existing skin markings (scars from previous surgery), correcting a slight difference in magnification and tilt. The lower white line is the reference line used for matching. There is essentially no difference in the linear dimension of the abdomen (the upper white line) on this lateral view. The images are calibrated using a 25-cm abdominal width. Adapted from Ruff et al.³⁴

Sterodimas et al⁵⁴ recently published a “minimally invasive breast lift scarless mastopexy” using Renuvion. The authors reported an improvement in sternal notch-nipple distances. However, the before-and-after photographs were affected by differing magnification and orientation (tilt). The authors' photographs may be compared using a published method that facilitates matching and provides computer-assisted measurements (Figs. 4, 5).⁶² Three of the 4 sets of photographs were suitable for analysis. One set could not be evaluated because the lateral photographs were rotated, with a different camera angle, and the pretreatment and posttreatment frontal photographs appeared to be the same photograph. Breast measurements showed slight differences in breast projection, upper pole projection, lower pole level, and sternal notch-nipple distances. The greatest mean difference was a loss of 0.26 cm in upper pole projection. Mean changes in the other values measured only 1 mm or less (Table 2). These differences were not significant (P > 0.05) when compared with a paired t test.

FIGURE 4.

A, B, Frontal photographs of a 49-year-old woman before and 180 days after a helium plasma radiofrequency treatment of her breasts. The authors reported that the posttreatment photographs were correctly identified by 100% of reviewers and that the appearance scores were “much improved.” The patient survey noted that she was “very satisfied,” with “less sagging breasts,” “breasts look higher on chest,” “nipple placement is improved,” and “breasts appear more youthful.” The images are matched for size and orientation using the Canfield 7.4.1 Mirror Imaging software (Canfield Scientific, Parsippany, NJ). Although it is not noted, the patient appears to have had an abdominoplasty, evidenced by downward movement of her abdominal tattoos and small skin lesions. The sternal notch-nipple distances are slightly greater after treatment. The lower pole level has dropped 0.88 cm on the right breast and 0.60 cm on the left breast. The photographs have been calibrated using a 32.5-cm mean upper arm length. MPost, plane of maximum postoperative breast projection. Adapted from Sterodimas et al.⁵⁴

FIGURE 5.

A, B, Lateral photographs of the patient depicted in Figure 4 have been matched for size and orientation, correcting a 2.0° tilt. The breast projection is unchanged. Upper pole projection is slightly decreased. MPost, plane of maximum postoperative breast projection. Adapted from Sterodimas et al.⁵⁴

TABLE 2.

Breast Measurements Before and 6 Months After Renuvion Helium Plasma Radiofrequency Treatment

Patient	Breast	Magnification (%)	Tilt (°)	Breast Projection	Upper Pole Projection, cm	Lower Pole Level, cm	Right SN-N Distance, cm	Left SN-N Distance, cm
1 before	Right			6.94	3.01	3.43	26.94	27.66
1 after		2.5	−2.0	6.92	2.79	3.58	27.97	28.31
Change				−0.02	−0.22	+0.15	+1.03	+0.65
3 before	Right	6.7	11.0	9.66	4.53	5.53	23.51	23.27
3 after				10.28	4.06	5.64	23.35	23.07
Change				+0.62	−0.47	+0.11	−0.16	−0.20
4 before	Right	0	6.3	9.22	5.16	4.32	22.97	23.54
4 after				8.76	5.07	3.86	22.14	22.79
Change				−0.46	−0.09	−0.46	−0.83	−0.75
Mean				+0.05	−0.26	−0.07	+0.01	−0.10
P*				NS	NS	NS	NS	NS

*Paired t test. Negative value indicates elevation of the lower pole level.

NS, not significant; SN-N, sternal notch-nipple distance.

Ibrahiem³⁵ published photographs of a patient after Renuvion treatment of her arms (Fig. 6). Ruff et al³⁷ provided photographs of a gynecomastia patient treated with breast tissue excision, ultrasound-assisted liposuction, and helium plasma radiofrequency, attributing the skin contraction to the Renuvion treatment (Fig. 7).

FIGURE 6.

A, B, This 38-year-old woman is shown before and 21 months after VASER liposuction followed by Renuvion treatment. A 32.5-cm arm length is used for calibration.

FIGURE 7.

A–D, This 26-year-old male is seen before and 6 months after an excisional gynecomastia procedure with ultrasound-assisted liposuction and “helium plasma device skin contraction of the chest.” The original images are slightly out of focus. Reprinted from Ruff et al.³⁷

Ultrasound Measurements

Only 2 studies provided imaging of the fat layer with measurements, both using ultrasound.^49,51 Nichols and Albershardt⁴⁹ determined that power-assisted liposuction produced an average 36.7% reduction in the thickness of the fat layer between the skin and Scarpa's fascia. Subsequent treatments with helium plasma radiofrequency caused additional reductions in the depth of the fat layer as more passes were made. The authors did not calculate the additional reductions as a percentage of the original fat layer thickness, but rather as a percent difference of the already-reduced fat layer after liposuction (44%). This reduction is evident in the ultrasound images (Fig. 8).

FIGURE 8.

Ultrasound images of the abdomen. A, Before treatment, B, after liposuction, and C, after Renuvion treatment. The authors have labeled the tissue layers. The original scale for the preoperative measurement was 6 cm versus 3.5 cm for the subsequent images (71% enlarged). This discrepancy was corrected to allow an accurate visual comparison of the tissue thickness. Measurements were made with the assistance of the Canfield 7.4.1 Mirror Imaging software. The original thickness of the fat layer was 4.34 cm. After liposuction, this layer decreased to 1.80 cm (a 58% reduction). After 4 passes with the Renuvion device, this layer was thinned to 0.73 cm (25% additional reduction), for a total reduction of 83%. The mislabeled Scarpa's fascia (SF) layer (misnamed “Scamper's fascia in the original figure legend) borders the rectus abdominis (RA) muscle. This tissue layer is actually the muscle fascia. CF, Camper's fascia. In the last image, the tissue layer appears to be thinning medially (to the right). It is likely that this location was closer to the midline of the abdomen. Adapted from Nichols and Albershardt.⁴⁹

The total decrease in thickness of the fat layer was 3.61 cm (83.2%). Ultrasound images show a 2.54-cm reduction (70.4% of the total reduction) from liposuction before Renuvion treatment, which produced an additional 1.07 cm (29.6% of the total reduction) decrease in abdominal fat thickness. Most of the reduction (70.4%) was provided by liposuction. The authors confused the Scarpa's fascia (mislabeled “Scamper's fascia”) with the rectus abdominis muscle fascia. In the final image, the rectus abdominis muscle is coursing obliquely toward the skin, which suggests a more medial location of the ultrasound transducer.

The Methods section indicates that 5 patients were enrolled, and data for 5 patients are included on the Clinical Trials website.⁶³ However, data for only 4 of the 5 patients are published. The authors explain that in 1 patient, the helium was not adequately removed, compromising the measurements. The authors also report that “no adverse events were observed during the intraoperative period.”⁴⁹ However, the Clinical Trials website reveals that all 5 patients experienced adverse events, including 3 with subcutaneous nodules, 1 with hypoesthesia, and 3 seromas, detected by ultrasound.⁶³

One clinical study from Italy was both prospective and randomized. Barone et al⁵¹ compared ultrasound measurements of the abdominal fat thickness in lipoabdominoplasty patients treated without Renuvion (n = 38) and with Renuvion (n = 38). The mean pretreatment thicknesses were very similar (22 mm and 23 mm). The mean 6-month postoperative measurements were 42 mm and 31 mm, respectively. At 1 year, the mean values were 26 mm and 24 mm. Both control and treatment groups showed a paradoxical increase in thickness at 6-month and 1-year time intervals. The reason for the increase is unclear. Actual ultrasound images are not provided. The authors cautioned that “the most important thing is communication and creating realistic expectations that inelastic skin, being a personal characteristic, is something that cannot be changed.”⁵¹

Complications

Six studies reported no complications (Table 1).^{29,30,33,36,49,54} Doolabh³⁰ reported 100% acceptable final outcomes and no adverse events or complications. Although the risk of subcutaneous emphysema is well-known, many publications did not mention this risk,^{25,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,46,47,48,49,52,53,54,55,57,59} which is unique to helium plasma treatment. Only 5 studies mentioned this problem.^{35,45,50,51,56} None of these 5 studies received manufacturer funding.

A review article that summarized data from 5 manufacturer-funded publications (Table 3) concluded that “there appears to be no new or elevated risks associated with the use of helium plasma radiofrequency following liposuction compared to liposuction alone.”⁴¹ Neither the review article nor the 5 publications mention subcutaneous emphysema. According to the disclosure statement, Apyx “executed this real world data (RWD) review and provided funding for the writing and publication of this manuscript.” This review supported the FDA decision to issue a 510(k) clearance for contraction of subcutaneous tissue following liposuction for aesthetic body contouring.⁴¹

TABLE 3.

Studies Evaluating Renuvion (Apyx Medical) Helium Plasma Radiofrequency Treatments Supporting FDA 510(k) Clearance*

#	Authors (yr)	Journal	Control Group	Impact Factor	Indexed on PubMed	Financial Conflict
1	Ruff et al (2020)34	Dermatological Reviews	No	0.40	No	Study funded by Apyx. Authors have conflicts
2	De Souza and de Souza (2022)36	J Aesthet Reconstr Surg	No	0.30	No	Study funded by Apyx
3	Ruff et al (2022)37	J Aesthet Reconstr Surg	No	0.30	No	Study funded by Apyx. Authors have conflicts
4	Ruff et al (2022)38	Aesthet Surg J Open Forum	No	1.6	Yes	Study funded by Apyx. Authors have conflicts
5	Shridharani and Kennedy (2022)39	Aesthet Surg J Open Forum	No	1.6	Yes	Study funded by Apyx. Authors have conflicts

*For contraction of subcutaneous tissue following liposuction for aesthetic body contouring.⁴¹

Ruff et al³⁴ reported crepitus in 40% of patients. Shridharani and Kennedy³⁹ documented temporary numbness in 100% of patients and nausea in 43% of patients.³⁹ Ruff et al³⁸ reported a 24% complication rate, including a 6.8% rate of seromas. Kluska et al⁴⁷ reported a 14.8% complication rate, including a 7.0% incidence of seromas and 2 burns (0.9%). Sterodimas et al⁵⁵ reported bruising (20.0%) and edema (16.7%) after forehead treatment. Ruff et al⁴⁰ reported nerve weakness in 6.2% of patients treated in the submental area and neck. An unusual complication was reported by Núñez Villar and Monroy⁴⁵ after pneumodissection of the recipient site in preparation for buttock fat transfer; 4.5% of patients experienced hyperthermia (Table 1).

Vanek et al,⁵³ in a retrospective study of Renuvion treatment at the time of abdominoplasty and liposuction, reported a 32.5% complication rate, including a 15% rate of seromas and a 10% incidence of wound dehiscence.

In 2018, a case report of helium causing severe subcutaneous emphysema and pneumomediastinum after J-Plasma facial skin rejuvenation was reported at a thoracic surgery meeting in Spain.¹⁵ Four case reports of extensive subcutaneous emphysema have been published subsequently.^16,17,18,19 Lim et al¹⁶ reported a 48-year-old woman who developed extensive subcutaneous emphysema along with a pneumomediastinum and retroperitoneal gas after VASER liposuction and J-Plasma treatment of the thighs. Ten hours after the procedure, she started to feel hot and noticed swelling and tightness of her neck, upper chest, and abdomen, along with “crackles” under her skin.

Another case report, published in a hyperbaric medicine journal,¹⁷ described a 54-year-old woman who was referred to a hyperbaric clinic with severe subcutaneous emphysema of the head and neck, pneumomediastinum, and pneumopericardium (Figs. 9, 10). A third case report described a 34-year-old woman who underwent VASER liposuction and Renuvion “skin tightening” of her abdomen, flanks, and lateral thighs. On the second day after surgery, she developed subcutaneous emphysema, pneumoperitoneum, and pneumomediastinum.¹⁸ A 73-year-old woman was discovered to have extensive pneumomastia on a screening mammogram 2 weeks after Renuvion treatment of her upper arms.¹⁹ Fortunately, all 4 patients recovered, although 1 patient suffered a middle ear injury from her hyperbaric oxygen treatment.¹⁷ None of these case reports are referenced in the studies identified in this review. No MAUDE reports were filed for these published adverse events.

FIGURE 9.

A, B, This 54-year-old woman underwent upper arm skin tightening using the Reunvion/J-Plasma device at a dermatology clinic. She is seen immediately after the procedure and 2 hours after the procedure. Within minutes of having the procedure, she reported chest tightness and shortness of breath. Widespread facial and neck edema was noted. The patient was discharged home. Within an hour of discharge, she experienced progressively worsening facial, eyelid, and neck edema, with severe dyspnea on deep inspiration. In addition to pain, the patient had crepitus throughout the right upper extremity, upper chest, neck, and face. The patient was treated with 100% oxygen and a hyperbaric oxygen treatment. During compression, she had difficulty with middle ear equalization and suffered right otic barotrauma. Her symptoms improved and resolved in 6 days. Reprinted from Winstead-Derlaga and Allen.¹⁸

FIGURE 10.

A–C, Sagittal, frontal, and axial images from a noncontrast computed tomography scan of the 54-year-old woman in Figure 9 before hyperbaric oxygen treatment revealed extensive subcutaneous emphysema, pneumomediastinum, and pneumopericardium. D, A chest radiograph showed diffuse subcutaneous emphysema.

A recent publication from Colombia reported 2 patients with severe abdominal pain immediately after surgery. Computed tomography revealed pneumoperitoneum in 1 case and a pneumoperitoneum, pneumomediastinum, and retropneumoperitoneum (dissecting the suprarenal fascia) in the other patient. Both patients underwent emergency exploratory laparoscopies, which found no evidence of a visceral injury. The cause was determined to be helium diffusion. Another patient developed “duck-like speech” 24 hours after surgery, resolving the next day.⁵⁸

Conflict of Interest

Most studies received funding from the manufacturer.^{29,30,34,36,37,38,39,45,49,53,54,55,59} Frequently, the authors were also consultants (Table 1). Some investigators were medical advisory board members and stock owners. Only 3 studies^35,48,51 reported no corporate funding for the study and no financial conflicts among the authors. None of the studies disclosed whether the authors received their Renuvion devices or disposable handpieces at no charge or at a discount.

Table 4 provides payment information obtained from the CMS Open Payments database. The list includes Jack Zamora, a surgeon who has trademarked a “J-Plazty” “cold plasma skin tightening” technique using Renuvion.⁶⁴ No payments from Apyx are reported on the CMS Open Payments website for Shridharani, and no disclosure is made in a publication by Shridharani and Kennedy.³⁹ However, this investigator has disclosed that he is a key opinion leader for Apyx, a consultant for this manufacturer, and a research funding recipient.⁴¹

TABLE 4.

CMS Open Payments From Apyx Medical to Investigators, 2017–2023

Author	Total Payments (USD)
Jack Zamora61	641,275
Paul Ruff 34,37,38,40,41,44	237,786
Diane Duncan	193,001
Brian Kinney	158,378
Vaishali Doolabh30,34,41	151,160
Richard Gentile25,29,31,32,33,34,40	111,916
Craig McCoy31	97,953
Adrian Mowlavi37	81,069
Jason Emer	66,813
Melinda Kimbrell59	55,633
Edward Zimmerman34,37,41	54,940
Michael Kluska47	53,848
Rikesh Parikh37	23,310
Matthew Nykiel38	20,914
Barry DiBernardo40	19,512
Paul Vanek38,53	17,008
Jonathan Lebowitz37	7,402
Total	1,991,918
Mean	117,172

CMS, Centers for Medicare & Medicaid Services.

Table 3 lists the studies that were reviewed by Shridharani et al⁴¹ and used to obtain FDA approval for contraction of the subcutaneous tissue.⁴¹ None of the studies featured a control group. Two of the studies^36,37 were published in a little-known journal that is not indexed on PubMed and has an impact factor of 0.30.⁶⁵ Another study was published in Dermatological Reviews,³⁴ which has an impact factor of 0.40⁶⁶ and is also not indexed. This article included 2 patient cohorts whose charts were reviewed and was considered to represent 2 studies (for a total of 6 studies).⁴¹ The other 2 studies were published in the recently indexed open access journal, Aesthetic Surgery Journal Open Forum,^38,39 which has an impact factor of 1.6.⁶⁷ All 5 publications were sponsored by Apyx.^{34,36,37,38,39}

FDA Manufacturer and User Facility Experience (MAUDE) Reports

The FDA has 102 adverse event reports listed for Renuvion.²⁷ The first report was filed in June 2021 and the most recent report was filed in May 2025. There are 33 adverse event records for J-Plasma, filed between April 2020 and November 2023,²⁷ for a total of 135 adverse event reports for this device. These reports are summarized in Tables 5 and 6. An effort was made to delete duplicate reports. Most adverse events were burns. Fifteen adverse events were considered life-threatening, including 5 cases of pneumothorax, 3 cases of pneumoperitoneum, and 2 cases of pneumomediastinum. Adverse events were rarely reported by the attending physician. Most reports were made by the manufacturer.²⁷

TABLE 5.

Manufacturer and User Facility Device Experience Reports for Renuvion and J-Plasma (Apyx Medical), April 2020 to June 2025

No.	Report Date	Age	Sex	Body Area	Other Device	Adverse Event	Treatment
	Renuvion
1	5/12/25	40	F	Medial thighs	PAL	Burns	Debridement, Silvadene
2	4/25/25	59	F	Medial thighs	None	Third-degree burn, broken tip	Attempts to retrieve tip were unsuccessful
3	4/25/25	28	M	Axilla	VASER	Third-degree burn	Debridement, Silvadene
4	2/18/25	N.A.	F	Lower face, neck	None	Burn, contracture, scarring, discoloration	Steroid injections with mild improvement
5	12/20/24	48	F	Jawline, neck	PAL	Burn, 2-cm area of skin necrosis	Silvadene
6	11/26/24	69	F	Jawline, neck	PAL	Thermal injury left neck, burn, scar tissue	Silvadene
7	11/4/24	57	F	Lower face, neck	VASER, CO2 resurfacing	Neck swelling, hematoma	Evacuated in ER
8	11/4/24	39	F	Lower face, neck	VASER	Neck swelling, large hematoma, scarring	Evacuated in ER
9	8/6/24	44	F	Neck, submental area	PAL	Burn	Hyperbaric oxygen, topical antibiotics, exosomes
10	7/2/24	53	F	Thighs, knees	PAL	Third-degree burn of right medial thigh	Bacitracin
11	5/20/24	55	F	Arms	Liposuction	Burn, scar	Flammazine cream
12	5/10/24	64	F	Neck	None	Third-degree burn with necrotic tissue	Ointment
13	3/29/24	N.A.	F	Inner thighs	PAL	Third-degree burn	Full-thickness skin graft
14	3/22/24	N.A.	F	Jawline, submental area	PAL	Neck hyper- and hypopigmentation	None
15	2/27/24	48	F	Arm	None	Cannula broke, foreign body in patient	Retrieval with X-ray assistance
16	2/9/24	19	F	Abdomen	PAL	Burn	Antibiotic cream
17	1/12/24	48	F	Abdomen	None	Severe scarring, discoloration, disfiguration of 16 × 9-cm area	Will require reconstructive surgery for deformity
18	12/4/23	67	F	Jaw	Liposuction	Third-degree burn	Debridement
19	10/24/23	N.A.	F	Neck	None	Third-degree burn	EMLA, wound gel, foam
20	10/24/23	N.A.	F	Arms	VASER, Morpheus	Long-term nerve damage. Bilateral numbness and tingling from wrists to armpits	N.A.
21*	8/8/23	43	F	Abdomen, neck	Liposuction	Helium embolism, cardiac arrest, death	ECMO
22	6/23/23	N.A.	F	N.A.	N.A.	Full-thickness burn, discoloration	N.A.
23	6/23/23	38	F	N.A.	N.A.	Necrosis, discoloration, infection, full-thickness burn	N.A.
24	5/18/23	63	F	Face	Facelift	Erythema, inflammation	N.A.
25	5/10/23	55	F	Face, neck	None	Nerve damage in the neck below chin	Eyedrops
26	5/10/23	67	F	N.A.	N.A.	Severe burns and permanent scarring	Atorvastatin, Climara Pro
27	4/17/23	57	F	N.A.	N.A.	Pneumothorax	N.A.
28	4/10/23	73	F	Face	N.A.	Impaired healing, stripes on face	N.A.
29	3/31/23	39	F	N.A.	N.A.	Full-thickness burn	N.A.
30	3/23/23	48	F	N.A.	VASER	Full-thickness burns	N.A.
31	3/23/23	N.A.	F	N.A.	N.A.	Full-thickness burn	N.A.
32	2/24/23	49	F	Abdomen, flanks, back	Liposuction	Pain, erythema, discoloration, numbness, impaired healing	None
33	1/4/23	55	F	Abdomen, arms, knees, face, neck	N.A.	Numbness, deformity, scarring, wrinkling	None
34*	12/22/22	46	F	Abdomen, flanks	High-definition liposculpture, mini-abdominoplasty	Dyspnea, hypoxia, pneumoperitoneum	2-Day hospitalization, diagnostic laparoscopy that ruled out perforation
35	12/22/22	66	F	N.A.	N.A.	Full-thickness burns	N.A.
36	12/6/22	63	F	Face, neck	N.A.	Burns of face and neck, erythema, nerve pain, hypersensitivity, impaired speech. Impaired quality of life	Percocet, gabapentin, Tylenol, calcium, chondroitin
37	11/29/22	53	F	N.A.	N.A.	Hardening under skin	None
38	11/23/22	42	F	N.A.	N.A.	Fibrosis	Will require surgery
39	11/11/22	N.A.	F	Submental area, neck	Liposuction	Full-thickness burn	Aloe, antibiotic ointment, dressings
40	11/4/22	39	F	Back, bra rolls	Liposuction	Persistent pain and loss of movement, insomnia	Neurology referral
41	10/11/22	61	F	Abdomen, flanks, arms	Liposuction and abdominoplasty	Skin of chest, neck, and face “crackling.” Pain	Lasted 48–72 hrs
42	9/24/22	N.A.	F	Submental area	VASER	Burn	Steroid injections, microneedling
43	8/26/22	N.A.	F	N.A.	N.A.	Extreme chest pain and could not breathe after gas was injected. Swelling and gas under skin and in lungs. “Felt I was going to die”	Almost 2 wks for the gas to clear and to breathe without coughing or pain
44*	7/26/22	41	F	Back, waist	Liposuction	Tachycardia (pulse 145), dsypnea, high fever	Hospitalized
45	7/15/22	55	M	Neck	Liposuction	Numbness	N.A.
46	7/15/22	60	F	Submental area	PAL	Full-thickness burn	None
47	7/13/22	N.A.	N.A.	Abdomen	Liposuction	Second-degree burns of right and left abdomen	N.A.
48	7/6/22	48	F	Abdomen, flanks	Liposuction	Necrosis, second-degree burns	Hyperbaric oxygen
49	6/28/22	40	F	Abdomen, buttocks	VASER	Persistent pain and numbness	None
50	6/24/22	N.A.	F	Submental area	SmartLipo	Full-thickness burn. Right eye swelling from residual helium.	Silvadene cream, antibiotics. Burn excised.
51	5/12/22	N.A.	F	Abdomen, flanks	Liposuction	Third-degree burn of flank	N.A.
52*	5/11/22	48	F	N.A.	N.A.	Extensive subcutaneous emphysema (face, neck, arms, back, abdomen, thighs). Respiratory distress. Bilateral pneumothoraces	ICU admission, chest tube
53	4/21/22	N.A.	F	Face	N.A.	Third-degree burns, pain, permanent scars of nearly entire face	Will require additional procedures and surgery
54	4/13/22	58	F	Arms	N.A.	Dyspnea. “Excess gas that blew my body up.” Arms appear worse.	Ambulance to ER. Hospitalized overnight. 3-Week recovery
55	4/13/22	52	F	Neck	Upper neck lift	Internal scars and skin tethering	Additional procedures to alleviate damage
56	4/5/22	56	F	Arms	Liposuction	Neuropathy—odd shivering type of pain	Gabapentin
57	3/31/22	N.A.	F	Abdomen	VASER, BodyTite	Burns	N.A.
58	3/20/22	N.A.	F	Abdomen, buttocks	Liposuction	Subdermal damage. Irregular contour	Abdominoplasty recommended
59	3/9/22	N.A.	F	Face, forehead, jawline, chin	N.A.	Burn, discoloration	Hydrocortisone, Retin-A, hydroquinone
60	3/8/22	31	F	Abdomen, thighs, back, arms, buttocks	Liposuction	Violent chest and back pain. Trapped gas. Pneumomediastinum	N.A.
61	2/16/22	34	F	Submental area	Liposuction	Marginal mandibular nerve injury	Oral steroid
62	2/3/22	46	F	Abdomen, thighs	Liposuction	Second- and third-degree burns, largest 10 cm × 4 cm	Hyperbaric oxygen, Trental, ointment
63	1/26/22	N.A.	F	Submental area	N.A.	Fibrous bands	Massage, steroid injections
64	1/19/22	N.A.	F	Abdomen	PAL	Pain, seroma, inflammation, uneven contour	Steroid injections, release of scar tissue anticipated
65	1/12/22	N.A.	F	Abdomen	Liposuction	Adhesions	Release of adhesions anticipated
66*	1/7/22	35	F	Abdomen, thighs, back, arms	Liposuction, body lift, breast lift, implants	Pain, dyspnea, full pneumothorax	Hospitalized 3 nights, chest tube
67	1/4/22	N.A.	F	Upper neck	Mini-lift	Tethering, loose skin	Skin resection, Bellafill, microneedling
68*	12/15/21	N.A.	F	Abdomen, medial thighs, lateral chest	Liposuction, breast augmentation	Severe hypotension, bradycardia, pneumothorax, gas buildup	N.A.
69	11/29/21	N.A.	F	Neck, jowl	N.A.	Inflammation, fever	Keflex
70	11/19/21	33	F	Abdomen, inner thighs	Liposuction	Edema of lower extremities, abdomen	Lasix, NSAID
71*	11/19/21	N.A.	F	Inner thighs	PAL	Vital signs dropped, air embolism suspected. Inadequate gas egress	Vital signs normalized after resuscitation
72	11/17/21	N.A.	F	Lower face, neck	VASER	Infection, abscess	Drainage, antibiotics, Medrol dose pack
73	11/16/21	70	N.A.	Submental area and neck	N.A.	Fibrosis, protruding bands, skin damage	N.A.
74	11/7/21	32	F	Abdomen, flanks, upper back, arms	VASER	Full-thickness burns of arm, discoloration	Hyperbaric oxygen, Silvaderma
75	11/7/21	23	F	Abdomen, flanks, upper back	VASER, mastopexy, lipotransfer	3 × 5-cm blisters, full-thickness burns of abdomen	Hyperbaric oxygen, Silvaderma
76	11/6/21	38	F	Abdomen, flanks, back	Liposuction	2 × 3-cm blisters, full-thickness burns	Hyperbaric oxygen, Silvaderma
77	11/4/21	28	N.A.	Flanks, back, arms, hips, inner thighs	Abdominoplasty, VASER	Full-thickness burns	Debridement, hyperbaric oxygen, Silvaderma, Aquacel
78*	10/26/21	53	M	Submental area	PAL	Hypopharyngeal edema, hematoma, airway compression	Emergency intubation, hospitalized 10 d
79*	10/22/21	N.A.	N.A.	Abdomen, flanks, back, bra rolls	Lipoabdominoplasty	Left pneumothorax and pneumoperitoneum, retroperitoneal bleed, infection	Hospitalized, transfused 2 units of packed red blood cells, percutaneous drainage, IV antibiotics
80	10/22/21	N.A.	N.A.	Abdomen, flanks, lower back	PAL	Steel blade from handpiece lodged in patient's right flank	Foreign body left in patient
81	10/22/21	28	N.A.	Abdomen	VASER	Full-thickness burns with sloughing	N.A.
82	9/22/21	N.A.	N.A.	N.A.	N.A.	Fragment of blade broke off in left scapular area	C-arm used to locate fragment. Attempts to remove it were unsuccessful
83	9/20/21	N.A.	N.A.	Abdomen	Liposuction	Tip of handpiece broke off in left upper abdomen	Not seen on x-ray. Remains in patient
84	9/20/21	N.A.	N.A.	Thighs, buttocks	N.A.	Gas in chest, lip swelling, numbness. Indentations of thighs, discoloration	Laser treatment of discoloration
85	9/20/21	N.A.	N.A.	Abdomen	Liposuction	Scars	N.A.
86*	8/27/21	N.A.	N.A.	Abdomen, back, inner thighs	PAL. Breast reduction, gluteal lipograft	Severe pain, extensive burns, helium subcutaneous emphysema, renal failure, death	Hospitalization, intubation, ventilator, dialysis. No autopsy
87	8/26/21	N.A.	N.A.	Abdomen, flanks	N.A.	Burns, scars	N.A.
88	8/23/21	N.A.	N.A.	Submental area	N.A.	Neck scarring	N.A.
89	8/11/21	51	N.A.	Upper abdomen	N.A.	Adhesions, wrinkling	N.A.
90	7/27/21	55	N.A.	Torso and thighs	VASER	Excruciating pain, disfigurement. Loss of range of motion. Back is “hard as a rock”	Pain management doctor, lymphatic massage, shock wave therapy, told to contact an attorney
91	6/3/21	N.A.	N.A.	N.A.	Liposuction	Blister, burn	Skin graft
92	3/5/21	N.A.	N.A.	Jawline	None	3 × 5-cm burn, scar	Steroid injections
93	1/28/21	N.A.	N.A.	Flanks	VASER, MicroAire	Full-thickness burns	N.A.
94	12/4/20	33	N.A.	Thighs	N.A.	Part of steel blade broke off	Foreign body removed with small incision
95	12/4/20	25	N.A.	N.A.	N.A.	Fragmentation of handpiece	Intervention to remove foreign body
96	11/20/20	42	N.A.	N.A.	Liposuction	Third-degree burn	N.A.
97	7/31/20	N.A.	N.A.	N.A.	N.A.	Fragmentation of handpiece	Intervention to remove fragment
98	6/24/20	N.A.	N.A.	N.A.	N.A.	Fragmentation	N.A.
	J-Plasma
1	11/29/23	50	F	Arms, thighs, chin	Liposuction, buttock fat transfer	Subcutaneous emphysema, dehydration, cellulitis, abscess	Hospitalized 11 d, removal of arm abscess
2	8/28/23	29	F	Abdomen, flanks	Liposuction, buttock fat transfer	Hyperhidrosis	Glycopyrrolate
3*	7/20/23	42	F	Neck, abdomen	Liposuction	Cardiac arrest and death after “skin tightening” after liposuction	ECMO
4	1/31/23	47	F	Face	N.A.	Facial nerve injury	Resolved in 3 months
5	11/17/22	32	F	N.A.	VASER	Unspecified injury	N.A.
6	9/27/22	43	F	Torso	Liposuction	Torso “hot to the touch for 2 mos,” weakness, discoloration, incessant pruritis, numbness	Home nurse for 7 wks, Trazodone, Cymbalta, Wellbutrin, Advil, Xanax
7*	5/16/22	38	F	Abdomen	VASER	Hypotension, discoloration, skin wrinkling, hematoma, internal scars, burn marks	Hospitalization, abdominoplasty for skin wrinkles, laser treatments for discoloration
8	4/4/22	43	F	Abdomen, arms	Liposuction, buttock fat transfer	Bruising, discoloration	N.A.
9*	3/21/22	20	F	Abdomen, flanks	Liposuction, buttock fat transfer	Hemorrhage	Hospitalization, in ICU for 6 d, blood transfusion
10*	3/21/22	38	F	Abdomen	Liposuction	Hemorrhage, skin feels like it is “burning off,” excessive pain, insomnia, “trapped gas under my skin”	Hospitalization, surgical treatment of contour irregularities
11	3/21/22	57	F	N.A.	N.A.	Severe burns, oozing pus for 4 mos	Hospitalization
12*	6/1/21	N.A.	N.A.	N.A.	N.A.	Dyspnea, headache, vertigo, residual helium, pneumomediastinum, pneumoperitoneum, pneumothorax	Hospitalization
13	5/14/21	N.A.	N.A.	N.A.	N.A.	Handpiece tip broke off inside patient	N.A.
14	5/7/21	N.A.	N.A.	Neck	N.A.	Permanent hypopigmentation	N.A.
15	4/20/21	N.A.	N.A.	N.A.	N.A.	Hyperpigmentation	Hyperbaric oxygen, unsuccessful
16	11/11/20	47	N.A.	N.A.	N.A.	Erythema, nodules, skin discoloration, subcutaneous nodule, hypersensitivity	N.A.
17	10/8/20	N.A.	N.A.	Thighs	N.A.	Full-thickness burns	N.A.
18	7/10/20	N.A.	N.A.	N.A.	N.A.	Inadequate helium interface between handpiece and generator	Urgent recall
19	5/8/20	62	N.A.	N.A.	None	Skin discoloration, erythema, pain, prolonged recovery	N.A.
20	4/28/20	N.A.	N.A.	N.A.	N.A.	Inflammation, swelling, firm bands, helium retention, prolonged healing	Hyperbaric oxygen, massages, compression methods, steroids
21	4/24/20	25	N.A.	Face	None	Pain, redness, skin discoloration	N.A.
22	4/23/20	33	N.A.	N.A.	N.A.	Handpiece fragmentation. No patient injury	None required
23	4/23/20	N.A.	N.A.	N.A.	N.A.	Handpiece fragmentation with foreign body	Intervention to remove fragment
24	4/23/20	29	N.A.	N.A.	N.A.	Handpiece fragmentation. No patient injury	None required
25	4/23/20	N.A.	N.A.	N.A.	N.A.	Handpiece fragmentation with foreign body	Intervention to remove fragment
26	4/10/20	68	N.A.	Lower face and neck	VASER	Subdermal adhesions	N.A.
27	4/3/20	N.A.	N.A.	Thighs	N.A.	Third-degree burn	N.A.
28	4/3/20	51	N.A.	Thighs	VASER	Second-degree burn	N.A.

*Listed as life-threatening.

ECMO, extracorporeal membrane oxygenation; N.A., not available; PAL, power-assisted liposuction; VASER, Vibration Amplification of Sound Energy at Resonance system.

TABLE 6.

Summary of FDA MAUDE Adverse Event Reports for Renuvion and J-Plasma (Apyx Medical), 2020–2025

Complication	Number
Burn or scar	66
Pain	18
Discoloration	16
Hospitalization	16
“Life threatening”	15
Foreign body from device	10
Contour deformity, adhesions, tethering	9
Hyperbaric oxygen treatment	9
Numbness	7
Dyspnea, airway compression	6
Fibrosis, hardening	5
Wrinkling, loose skin	5
Pneumothorax	5
Hematoma	4
Nerve injury	4
Neuropathy	3
Death*	3
Subcutaneous emphysema	3
Pneumoperitoneum	3
Pneumomediastinum	2
Hypotension	2
Blood transfusion	2
Skin graft	2
ECMO	2
Helium embolism	1
Tachycardia	1
Bradycardia	1

*1. Suspected helium embolism. 2. Cause of death not determined, subcutaneous emphysema was detected but not believed to be the source of the problem. 3. Patient had liposuction of neck and abdomen. Patient arrested after doctor “had gone back to reform (sic) skin-tightening with J-plasma,” as reported to the FDA by the patient's mother.

Three deaths after Renuvion treatment were reported to the FDA. One death was believed to be caused by a helium embolism and was reported by the anesthesia provider. In another patient, the cause of death was undetermined. Subcutaneous emphysema was recorded but not believed to be the cause of death. A third death occurred in a 42-year-old woman. Her mother, who reported the event to the FDA, wrote that her daughter suffered a cardiac arrest after the doctor “had gone back to reform (sic) skin tightening with J-plasma,” after doing liposuction.

There were 10 cases of the Renuvion handpiece fragmenting, leaving a foreign body in the patient, which was usually retrieved, but sometimes, this was not possible and the fragment stayed in the patient (Table 5).

DISCUSSION

This new method has received a great deal of favorable press recently. NewBeauty awarded Renuvion the 15^th Annual Beauty Award for Best Minimally Invasive Skin Tightener. Calobrace comments, “Renuvion skin tightening has been a game changer. The tightening is seen immediately during surgery because the device shortens the fibrous septae between muscles and skin, not by heating the skin. We use it with almost every liposuction case and have seen great results in the bra line, hips, arms, and neck.”⁶⁸

However, measurement data to support claims of skin tightening are lacking. A cervicomental angle⁶⁹ (ideally 110°) was described by Ellenbogen and Karline as the angle between the anterior border of the neck and the mandibular border with the head and neck in a neutral position. The “submental angle” (Fig. 1) reported by Ruff et al³⁴ is a different ad hoc measurement. Standardized photographs are mandatory when making any comparisons of measurements.⁸ Otherwise, any difference may be fictitious. For example, a similar change in this angle may be made simply by having the patient look up in the pretreatment photograph (Fig. 11). When the images are severely cropped (Fig. 1), the reader cannot assess whether the facial profile is the same in the before-and-after photographs.

FIGURE 11.

A, B, These photographs depict a 29-year-old woman with her chin up and in a neutral forward gaze. The angle of the submental border compared with the horizontal plane with her chin up measures 36.8°. With her chin down, the angle drops to 13.3°, a difference of 23.5° (36.8°–13.3°). The photographs were taken less than a minute apart. Any difference is purely related to chin tilt. Expressed as a percentage, the difference is 100–(13.3/36.8 × 100%) = 63.9%.

Plastic surgeons know that skin tightening frequently occurs after traditional or ultrasonic-assisted liposuction. Figures 12 and 13 show the results of traditional liposuction and a medial platysmaplasty. These results appear superior to those obtained with Renuvion, with reductions of submental fullness approaching 1.00 cm (0.89 cm and 0.94 cm), compared with 0.20 cm for Renuvion (Fig. 2).⁴¹

FIGURE 12.

A, B, This 22-year-old woman is seen before and 1 year after a submental lipectomy, consisting of liposuction (without energy assistance), direct fat excision, and a medial platysmaplasty. The submental fullness is reduced by 0.89 cm.

FIGURE 13.

A, B, This 45-year-old woman is seen before and 3 months after a submental lipectomy, consisting of liposuction (without energy assistance), direct fat excision, and a medial platysmaplasty. The submental fullness is reduced by 0.94 cm.

Only 1 study offers data regarding skin tightening of the abdomen.³⁴ However, the data are unrealistic. A reduction in width of 52%–100% (mean reduction 82.1%) is difficult to comprehend. A 100% reduction would make the abdomen disappear. Even much smaller reductions would be difficult to reconcile with the limits imposed by the skeleton, muscle, and abdominal contents. When the authors' abdominal photographs are compared, there is no evidence of a reduction (Fig. 3).

By comparison, Figures 14 and 15 demonstrate results that can be achieved with ultrasound-assisted liposuction alone. Measurements on standardized photographs reveal an 11.3% skin tightening on linear measurement, equating to a 21.3% contraction of skin area (Fig. 14). Figure 16 illustrates the degree of skin contraction possible in gynecomastia treatment without Renuvion.⁷⁰

FIGURE 14.

A, B, This 22-year-old woman is also depicted in Figure 12. She underwent liposuction of the lower body and arms, along with a submental lipectomy. Ultrasonic assistance was used (Lysonix 3000, Mentor Corp., Santa Barbara, CA). Measurements on the skin reveal a 1.20-cm reduction (11.3%). This linear change equates to a skin area contraction of 21.3% (100 – (0.887 × 0.887 × 100%)).

FIGURE 15.

A, B, This 42-year-old woman is seen before and 3 months after ultrasound-assisted liposuction of her arms and axillae. The right arm demonstrates a reduction of 1.05 cm (7.5%), equating to an area reduction of 14.4%.

FIGURE 16.

A–D, This 37-year-old male patient is seen before and 11 months after liposuction (225 cc per breast) in combination with direct breast tissue excision using periareolar incisions. He had previous gynecomastia surgery elsewhere. He has scoliosis, accounting for the elevated position of the right shoulder. His skin contraction was excellent, so that he did not require subsequent skin-excisional surgery. He also had liposuction of his abdomen and flanks. Reprinted from Swanson.⁷⁰

Evaluation of measurements on matched breast photographs (Figs. 4, 5) reveals essentially no difference after Renuvion treatment (Table 2).⁵⁴ The fact that photographic evaluations and surveys showed treatment benefits,⁵⁴ despite essentially no change in breast measurements, is a testament to the limits of subjective methods to evaluate results. Objective data are essential when evaluating a new technology.⁸

One study provides objective data in the form of ultrasound images of the fat layer. However, there are problems with the data presentation and interpretation. Nichols and Albershardt⁴⁹ do not alert the reader to the 71% increase in scale (ie, the fat layer is magnified) between the preoperative measurement and the first posttreatment image, minimizing the benefit of liposuction alone, before Renuvion treatment. The authors do not report whether the same site on the abdomen was used for repeated measurements. A small difference in site selection can produce a fictitious difference in fat thickness.¹² The inclination of the rectus abdominis muscle suggests that the final measurement was made closer to the midline, where the fat layer is thinner.

Another problem with this ultrasound study is the mislabeling of the Scarpa fascia layer. Scarpa's fascia is normally located about one third of the distance from the muscle fascia to the skin (Figs. 17, 18).⁷¹ Figure 19 shows the difference in thickness of the adipose layer as the transducer is moved a few centimeters toward the midline, illustrating the importance of consistent siting when making ultrasound measurements. Figure 20 demonstrates the degree of reduction of the fat layer (approximately 50%) provided by ultrasonic liposuction alone,⁷² as demonstrated on magnetic resonance images.

FIGURE 17.

Schematic diagram of the abdominal wall showing the fascial layers and lymphatic system. Reprinted from Friedman et al.⁶⁴

FIGURE 18.

Ultrasound image of the right abdominal wall in a 29-year-old woman who has not undergone any abdominal surgery or treatments. The muscle fascia borders the rectus abdominis muscle. Scarpa's fascia and Camper's fascia are identified.

FIGURE 19.

A–D, Ultrasound images of the same 29-year-old woman depicted in Figure 18, showing the change in thickness of the subcutaneous fat as the transducer is moved medially toward the midline.

FIGURE 20.

A–D, This 24-year-old woman's photographs and magnetic resonance imaging scans were taken before and 6 months after liposuction of her lower body, arms, and axillae and breast augmentation. The total aspirate volume was 3250 mL. The subcutaneous fat appears white in these coronal, T1-weighted images. Measurements are indicated at the level of the left flank and outer thigh. Reprinted from Swanson.⁴

Treatment of the labia⁶⁰ is a concern because there is almost no subcutaneous fat layer in this unique appendage and therefore no rationale for efficacy. The tight tissue space and high temperature would increase the risk of a burn. Local numbness and dysesthesias would not be well tolerated.¹⁰

Ethical Reporting of Results

Only 1 study provided images that support a reduction in the abdominal fat layer after treatment.⁴⁹ Although the trial description indicates that the study is complete and that there were 5 participants,⁶³ the publication contains data for only 4 patients.⁴⁹ All 5 patients experienced adverse events, yet none are reported in the publication. The trial description includes a notation that an agreement exists between the investigators and the sponsor (Apyx) that there IS (capitalized in the description) an agreement that “restricts the principal investigators' rights to discuss or publish trial results after the trial is completed.” Furthermore, “the data produced by this sponsored study is the sole property of Sponsor. Sponsor must be provided with the opportunity to review all Investigator-prepared abstracts, publications, or presentations for a period of thirty (30) days for presentational materials and abstracts and forty-five (45) days for manuscripts.”⁶³

According to ethical guidelines,^73,74 researchers must retain control over study design, data analysis, and publication decisions. Sponsors should not be able to prevent or delay publication based on study results.

Manufacturers commonly provide discounted devices and products to investigators.¹⁰ The authors may not be charged for use of the device or may even be allowed to keep the device at no charge after completion of the study. This form of indirect payment to physicians is unlikely to be disclosed, but creates bias in the form of a quid pro quo to report favorable results and downplay complications.^22,23,24

FDA Clearance

On March 14, 2022, the FDA issued a warning against using the Renuvion/J-Plasma device for skin improvement.⁷⁵ According to the FDA, use of the device for procedures intended to improve the appearance of the skin, including dermal resurfacing or skin contraction, alone or in combination with liposuction, was associated with significant adverse events, some of which required treatment in an intensive care unit. These adverse events included second- and third-degree burns, infection, skin color changes, scars, nerve damage, bleeding, and air or gas accumulation under the skin, in body cavities, and in blood vessels. The FDA recommended that health care providers cease using Renuvion/J-Plasma for these types of procedures, as the device (at that time) was not cleared or approved for use in this setting.⁷⁵ A link to this advisory is no longer available. The reason for the FDA's dramatic change from a warning to an endorsement in the form of additional clearance is unclear, especially in view of the rapidly accumulating MAUDE reports (Table 5).²⁷

The FDA's decision to expand indications was based on a 2023 review published by Shridharani et al.⁴¹ All 4 authors are key opinion leaders and consultants for Apyx and recipients of research funding from this manufacturer. Three authors are members of the Apyx medical advisory board. Two authors own stock options. According to the disclosure, Apyx “executed this real world data (RWD) review and provided funding for the writing and publication of the manuscript.” It is unclear why funding would be necessary for a review article.

The Renuvion device has a 510(k) clearance.¹⁴ This type of clearance is reserved for devices that have safety profiles that are similar to an existing FDA-cleared device and, therefore, do not need to obtain premarket approval. The helium plasma radiofrequency device was originally cleared as a tool for tissue ablation.¹⁴ Its adaptation as a cosmetic instrument for skin tightening, with injection of helium gas, is a substantially different application. Insufflating elective cosmetic patients with helium does seem to be a risky innovation (Tables 5, 6).

In making its determination, the FDA relied on 5 publications that were published in low-impact journals (Table 3). Table 7 summarizes the characteristics of low-quality publications. Remarkably, the 5 studies^{34,36,37,38,39} feature every one of these traits. Most concerning is the complete avoidance of recognition of subcutaneous emphysema as an issue.

TABLE 7.

Characteristics of Low-Quality Publications

Number	Characteristic
1	Low-impact (<1.0) or nonindexed journal
2	Nonconsecutive cases
3	No description of eligibility criteria or inclusion rate
4	Reliance on subjective ratings (eg, Likert scales, surveys, surgeon evaluations)
5	Inadequate sample size
6	No control or comparison group
7	Authors receive reimbursement from manufacturer
8	Nonstandardized, poor quality photographs
9	Black backgrounds
10	Figures lack basic information (eg, age, follow-up time)
11	Underreporting of complications
12	Lack of objective measurements
13	Reporting percentages without actual data
14	Data that are not possible
15	Improper terminology (eg, “stomach” instead of “abdomen”; “leg” instead of “thigh”)
16	External medical writing assistance or manuscript preparation
17	Manufacturer maintains control and decision making regarding publication
18	No IRB approval or waiver
19	No discussion of regulatory status
20	Omission of discussion and references to studies with contradictory data or conclusions

Recognizing the Problem

An analogy is to be found in the case of textured breast implants. The FDA held an advisory committee meeting in March 2019 to consider their safety.⁷⁶ After hearing testimony from surgeons (who defended the devices) and patients (who called for a ban on them),⁷⁷ the FDA initially decided, on May 2, 2019, to keep macrotextured implants available.⁷⁸ In June 2019, the author's “Call for Action” editorial to abandon textured devices was published in Annals of Plastic Surgery,⁷⁹ accompanied by an editorial by the Journal editor making the same recommendation.⁸⁰ On July 24, 2019, the FDA reconsidered its original decision and requested that Allergan (an AbbVie Company, North Chicago, IL) withdraw its macrotextured devices from the market.⁸¹

Many of the adverse events reported in the MAUDE database place blame for the complication on the operator's lack of experience or poor judgment.²⁷ The device itself is seldom held responsible. However, this explanation is not reassuring. There will always be inexperienced operators. Any device must be safe enough to be used even by inexperienced operators. This has been the case for ultrasound devices. These units may malfunction, but patient injury is unlikely. Ultrasound devices have not been causally linked to life-threatening events or deaths. Similar to macrotextured breast implants, a marginal aesthetic benefit, even if it were real, cannot justify adding a potentially lethal complication for a cosmetic procedure.⁷⁷

Adverse Events

The adverse event reports for Renuvion and J-Plasma (Tables 5, 6) may be compared with the MAUDE records for InMode's BodyTite and FaceTite, which use internal radiofrequency, but no helium (Table 8). Only 17 adverse events have been reported over the same time period (2020–2025), 4 events for FaceTite and 13 records for BodyTite.²⁷ These include 11 burns and 4 cases of neurapraxia. There were no reported life-threatening complications or deaths. The number of adverse event reports for Renuvion (n = 135) is much greater and includes 15 life-threatening events.

TABLE 8.

Summary of FDA MAUDE Adverse Event Reports for InMode BodyTite and FaceTite, 2020–2025

Complication	Number
Burn or scar	11
Neurapraxia	4
Life-threatening	0
Deaths	0

Table 9 summarizes adverse event reports for VASER,²⁷ which has been available since 2001.⁸² There were 140 adverse event reports between the first report in February 2016 and 2025.²⁷ Forty-eight of these reports were burns. In 15 cases, Renuvion was used during the same procedure. Many adverse events (n = 51) were device malfunctions, which usually caused no patient harm, although in 3 cases a defective ultrasound board was deemed responsible for burns. Three adverse events were labeled life-threatening and 3 deaths were reported. None of the deaths (sepsis, pulmonary edema, and a suspected cannula penetration or pulmonary embolism) was linked to the VASER device.

TABLE 9.

Summary of FDA MAUDE Adverse Event Reports for VASER, 2016–2025

Complication	Number
Device malfunction	51
Burn or scar (15 with Renuvion)	48
Pain (2 with Renuvion)	6
Hardening, fibrosis, tightening (2 with Renuvion)	6
Hospitalization	6
Seroma (3 with Renuvion)	5
Neuropathy	4
Discoloration (3 with Renuvion)	4
Life-threatening	3
Death*	3
Skin grafts (1 with Renuvion)	2
Contour irregularity	1
Hyperbaric oxygen (2 with Renuvion)	2
Pulmonary edema	1
Sepsis	1
Anemia	1
Blood transfusion	1
Loose skin	1
Lymphedema (with Renuvion)	1
Skin port broke, in patient, required removal	1

*Deaths: 1. Septic shock. 2. Pulmonary edema. 3. Suspected cannula penetration or pulmonary embolism.

Although a case of traumatic subcutaneous emphysema following traditional liposuction has been reported,⁸³ this complication is exceedingly rare in the absence of helium plasma.

In documenting a fatality in a 43-year-old woman (report date August 8, 2023), caused by suspected helium embolism, the attending anesthetist who submitted the adverse event report wrote, “The Renuvion handpiece was then inserted into the submandibular space by the surgeon. During this portion of the procedure, I noted a sudden but very transient insufflation of the right neck which extended just superior to the mandibular margin of the right cheek. The insufflation that was noted, dissipated very quickly. Moments later a sudden drop was noted in the end-tidal CO₂ tracing on the anesthesia monitors… Epinephrine 1 mg IV push was given with chest compressions being initiated. Multiple rounds of epinephrine were given, but the patient could not be stabilized.”

One patient reported her experience (report date August 26, 2022) to the FDA, “As soon as they injected the gas, I had extreme chest pain and couldn't breathe. The doctor had to stop the procedure. I had issues with swelling and gas under my skin and in my lungs and thought I was going to die. It took over a week, almost 2, for the gas to clear and for me to breathe without coughing or pain.”

Clark Schierle, in his panel presentation at the 2024 American Society of Plastic Surgeons annual meeting,²⁰ shared a remarkable personal experience. He reported that his patient was struck by a car 1 or 2 weeks after Renuvion treatment of her submental area and neck. Coincidentally, the accident occurred as she was walking to her postoperative appointment to see him. Schierle observed that “she had helium everywhere.”²⁰ A consulting thoracic surgeon almost inserted a chest tube in the emergency department. Fortunately, Schierle was in the same building and was able to inform the emergency department staff that her extensive subcutaneous emphysema was related to her Renuvion treatment and not to vehicular trauma.

Underreporting of adverse events is well-known. It is estimated that only 1%–10% of adverse events are reported to the FDA.⁸⁴ Moreover, more serious complications are less likely to be reported than less serious ones.⁸⁵

2025 Panel Presentation

Energy devices are a perennial subject of panel discussions at plastic surgery meetings. This subject was recently discussed at the 2025 American Society of Plastic Surgeons Spring meeting.²¹ The panel moderator was Paul Ruff, who has authored many of the publications on Renuvion and is the second-highest recipient of compensation from Apyx (Table 4). Three of the 4 panelists disclosed conflicts with Apyx. Subcutaneous emphysema, and complications from helium penetration of spaces (eg, pneumothorax, pneumomediastinum, pneumoperitoneum), were not mentioned by any of the panelists during the 90-minute presentation. There was an audience question about excessive tightness and fibrosis after Renuvion treatment. Vanek, one of the panelists, commented that he has observed tightness and fibrosis in the neck and that fat grafting may be needed. Schierle²⁰ concurs that Renuvion damages the fibroseptal network, which is noticeable if the patient returns for surgery.

Vanek cautions that the equipment cost may be prohibitive for surgeons. The treatment adds 10–20 minutes of time per zone treated. When using Renuvion, he leaves the drains in for 1–2 weeks.²¹

Proposed Mechanism

The first principles basis for this treatment merits consideration. Liposuction is already known to produce skin contraction on its own (Figs. 12,13,14,15,16).⁴ Any additional contraction from ultrasound energy has long been postulated, although never conclusively proven.⁴ The concept is selective destruction of fat cells with preservation of connective tissue,⁴ called the fibroseptal network.

Thermal devices are not selective.^10,13 These devices produce an internal burn, causing protein denaturation and coagulation. Because the treatment is not selective for adipocytes, all tissues are affected. Not surprisingly, numbness is common because the nerves in the treated areas are susceptible to injury. The marginal mandibular branch of the facial nerve is at risk when the submental area is treated.¹⁰

Numbness also occurs after traditional liposuction. However, this numbness tends to disappear after a few months.⁴ Numbness after thermal treatment may persist indefinitely.¹⁰ Neuropathic pain can be a problem. This kind of persistent pain is resistant to treatment (Table 5). The cause of hyperthermia⁴⁵ is unclear.

This treatment was originally called “cool atmospheric plasma,”²⁵ despite the fact that the atmosphere contains almost no helium. The helium gas was compared to an air conditioner.²⁹ The tissue temperature briefly spikes to over 85° C, causing instantaneous tissue coagulation.²⁹ Radiofrequency devices include temperature probes.¹⁰ Renuvion does not have a temperature monitor.²⁰ Schierle²⁰ comments, if the operator turns up the energy, there is greater risk of burns and hyperpigmentation; if they turn it down, there is more dissatisfaction.

The need for additional treatment using helium plasma radiofrequency after liposuction has been completed is open to question. At this point, much of the injected fluid has been suctioned, along with the excess adipocytes. The tissue is less expanded by this fluid medium. The tissue has already been thinned out by liposuction. These changes narrow the safety margin. Saline solution is replaced as a buffer by the helium gas. However, this gas is unlike saline in that it is not readily absorbed by the body. Large volumes of gas are injected, typically at a rate of 1.5 or 2.0 L/min, but sometimes as high as 4 L/min.²¹ The gas must be released by the surgeon, necessitating additional incisions and more time to milk the tissues to remove the gas. Despite these maneuvers, crepitus is common (40%).³⁴ Shridharani²⁰ calls this sensation “rice crispy crackles.” However, trapped gas may not be a trivial matter. The gas may extend along tissue planes and fill cavities in the chest, around the heart, and within the peritoneal cavity.^16,17,18,19

Marketing Concerns

When considering a new technology, surgeons are often attracted by the marketing prospects.^6,8 Plastic surgeons wish to stay up to date and offer the latest technology. In a recent Apyx-sponsored webinar,⁸² Paul Kim cautions that if surgeons do not embrace this technology, they will lose patients. Kluska⁸² comments that Renuvion “brings patients in.” The devices are in the 6-figure range.²⁰ The handpieces are single-use products that cost about $500 each.⁵¹

Clinics now offer “AirSculpt® Patented Fat Removal and Transfer Technology.”⁸⁶ The fee for awake small-caliber liposuction of the “upper and lower stomach, waist, and flanks” is $10,000 plus $4500 for “tightening add on,” called AirSculpt+, which includes Renuvion. Treatment of the upper arms costs $5000, plus $2500 for tightening add-on. Patients are informed that this technology is like plucking grapes off of a grape vine instead of taking cheese to a cheese grater. According to the website, the results are instant and the recovery time is 48 hours.⁸⁴

Speakers emphasize the need to temper patient expectations.^20,82 Schierle²⁰ advises patients that about a third of them will have a good response. He comments that these patients are the ones on the website and “get people through the door.” By comparison, patients after surgical treatments, such as a facelift will report much higher satisfaction rates, above 90%.²⁰ The lower satisfaction rate associated with Renuvion treatments may lead to more negative reviews.

CONCLUSIONS

None of the published studies provide reliable evidence of additional skin contraction beyond what is produced by liposuction. The treatment entails additional cost, time, and introduces new, life-threatening risks.

Helium plasma radiofrequency treatments for skin tightening represent a case study in the problems created by placing marketing concerns ahead of science.

This device differs from existing energy-based devices in that it calls for insufflation of the tissues with helium gas, which may cause life-threatening subcutaneous emphysema. Helium gas may extend into the chest, peritoneum, and mediastinum. Deaths have been reported. The MAUDE database reveals a distressing high rate of reported complications.

The evidence strongly indicates that this device is dangerous for patients. These serious health risks need to be recognized by plastic surgeons, our patients, our journals, and the FDA. We have a shared responsibility to protect our patients from expensive treatments that provide no additional benefit but are likely to increase the risk of complications, including death. Such risks are unacceptable for a cosmetic treatment. The device should be reconsidered for clinical use pending further independent evaluation.