Energy-based Devices Research Articles

A review of combined treatments for melasma involving energy-based devices and proposed pathogenesis-oriented combinations.

Melasma is an acquired disorder of hyperpigmentation, affecting a million individuals worldwide. Energy-based devices (EBDs) employed to treat melasma include various types of lasers, intense pulsed light (IPL), and radiofrequency (RF). Recent studies have attempted to address recalcitrant and recurring melasma by combining energy-based devices with topical or oral medications. This article reviews EBDs-based augmented treatment for melasma and suggests practical pathogenesis-oriented treatment regimens. Treatment algorithms are proposed to address various components of melasma. A systematic PubMed search was conducted acquiring information from various studies on combination treatments of melasma involving EBDs. The 286 retrieved articles were filtered by title to contain at least one type of energy-based modality such as laser, IPL, or RF along with at least one other treatment method. Based on their subject matter, combinations were further categorized into the subheadings: laser plus medication, laser plus laser, and IPL- and RF-containing treatment methods. There are many energy-based combination treatments that have been explored for mitigation of melasma including laser therapy with medication, multi-laser therapies, IPL, RF, and microneedling devices. Melasma is an exceedingly difficult condition to treat, however, choosing the appropriate tailor-made treatment combination can improve the final outcome.

The efficacy of erbium-doped yttrium aluminum garnet (Er:YAG) laser in the treatment of decreased sexual sensation: a randomized, placebo-controlled trial.

Vaginal laxity, a common cause of decreased sexual sensation, is a common problem affecting the quality of life of women worldwide. Recently, lasers and energy-based devices (EBDs) have been applied in the treatment of this condition. The aim of this study was to compare the efficacy and safety of Er:YAG laser and placebo in treating decreased sexual sensation in Asians. Forty-two patients with decreased sexual sensation were randomized into 2 groups: intervention (laser treatment) and control (placebo treatment). Both groups received two treatments, at 1-month interval. Subjective and objective evaluations were done at baseline, 1-, 3-, and 6-month follow-ups. Pain score and adverse effects were also recorded. In the laser group, there was significant improvement in the patients' vaginal tightness satisfaction at 1- and 3-month follow-ups (P = 0.002 and 0.004) and also in the patients' overall satisfaction at 1- and 3-month follow-ups (P = 0.003 and 0.001). Pelvic floor muscle contraction was significantly better in the laser group after the first treatment (P = 0.043). No serious adverse effects were noted. Er:YAG laser provides improvement of sexual sensation for an average of 3 months following treatment. Mild and transient adverse effects such as leukorrhea, dryness, dysuria, vaginal itching, and spot bleeding were noted in the laser group, and these were not significantly different from the control group.

Histological and immunohistochemical changes in facial skin treated with combined ablative and non-ablative laser therapy.

BackgroundFacial skin rejuvenation is a highly sought after procedure. Different materials, energy‐based devices and techniques have been shown to offer good results in facial rejuvenation.AimsThe aim of this study was to evaluate the macroscopic and histological and immunohistochemical changes in facial skin treated with a combined laser therapy.Patients/MethodsFourteen patients aged from 38 to 59 years were included in the study. Two different wavelengths (2940 and 1064 nm) were used in this four‐step procedure.ResultsSignificant improvement according to classification for age‐related changes in all areas of the face was achieved. There were also significant structural changes in the epidermis and dermis, confirmed with histology and immunohistochemistry.ConclusionThe dual‐wavelength protocol has been found to provide excellent results for facial rejuvenation.

Dissection Methods in Abdominoplasty: A Systematic Review and Meta-Analysis

Abdominoplasty is one of the most common cosmetic procedures performed worldwide. Despite recent advances in surgical technique, the risk of complications remains high. The advantages of using various dissection devices as a method of flap elevation in abdominoplasty remains unclear. A systematic search was undertaken to identify studies comparing electrocautery dissection with scalpel dissection and plasma-kinetic energy-based dissection methods in abdominoplasty. A meta-analysis was performed using the selected studies. Seven studies were analyzed. These studies included a total of 1143 patients who underwent abdominoplasty using electrocautery (n = 617), steel scalpel (n = 457), or plasma dissection (n = 69). A meta-analysis was conducted, which showed an overall reduction in incidences of seroma, operative time, and length of hospital stay in the scalpel dissection group compared with the electrocautery group. The plasma dissection group showed a reduction in rate of postoperative wound infection and hematoma, as well as a reduction in drain output and length of hospital stay, compared with the electrocautery group. There are few studies comparing outcomes using different dissection techniques in abdominoplasty. These studies are small and heterogeneous in design. However, using plasma-kinetic energy-based devices or scalpel dissection appears to be associated with reduced complication rates, shorter operative time, lower drain volumes, and a reduction in the length of hospital stay.

Management of skin thinning and aging: review of therapies for neocollagenesis; hormones and energy devices.

Hormone replacement therapy and various devices exist to treat signs of aging, such as skin thinning, yet there are no reviews summarizing or evaluating their role in neocollagenesis and the associated increase in skin thickness. To review the literature regarding stimulation and generation of new collagen in the dermis in two parts. Part 2 reviews oral and topical hormone replacement therapy as well as energy-based devices. The PubMed database was searched for related literature. Studies involving the use of hormone supplements and energy devices with a resultant change in collagen production or skin thickness were obtained and reviewed for evidence. Hormones, including estrogen, testosterone, and dehydroepiandrosterone, and human growth hormone have been reported with substantiating evidence for neocollagenesis and dermal thickening. Energy devices, including radiofrequency, ultrasound, and laser therapy, have also been reported to stimulate neocollagenesis. The results presented in certain literature are not based on randomized controlled trials. Hormone deficient individuals can regain skin thickness with hormone replacement therapy. Dermal heating can provide a substantial amount of neocollagenesis; however, laser technology, specifically CO2 , appears to be the most effective at increasing skin collagen and tightening.

A comparison of the Thunderbeat and standard electrocautery devices in head and neck surgery: a prospective randomized controlled trial

PurposeNew energy-based sutureless vessel ligation devices, such as the Thunderbeat (Olympus Medical Systems Corp., Tokyo, Japan), could reduce operative time and limit blood loss in head and neck surgery; however, efficacy and safety in major head and neck surgery have not been investigated in a prospective, randomized study.MethodsThis prospective, double-arm, randomized controlled trial consisted of two parts: total laryngectomy (TL) and neck dissection (ND). Thirty patients planned for TL were randomized in two groups. For the ND part, forty-two operative sides were likewise randomized. In both parts, Thunderbeat was used in addition to the standard instrumentation in the intervention groups, while only standard instrumentation was used in the control groups. Primary outcome values were blood loss, operative time and complication rate.ResultsFor the TL part there was no difference in mean blood loss (p = 0.062), operative time (p = 0.512) and complications (p = 0.662) between both hemostatic techniques. For the neck dissection part, there was a reduction in blood loss (mean 210 mL versus 431 mL, p = 0.046) and in operative time (median 101 (IQR 85–130) minutes versus 150 (IQR 130–199) minutes, p = 0.014) when Thunderbeat was used. There was no difference in complication rate between both hemostatic systems (p = 0.261).ConclusionThe Thunderbeat hemostatic device significantly reduces operative blood loss and operative time for neck dissections, without increase in complications. In TL, blood loss using Thunderbeat was comparable with the standard technique, but the operative time tended to be shorter.Trial registrationUMCG Research Register, Reg. no. 201700041, date of registration: 18/1/2017

The efficacy of energy-based devices combination therapy for melasma.

Melasma is a recalcitrant pigmentary disease with a complex pathogenesis. Monotherapy often results in unsatisfactory results with high recurrence rate. In this review article, we evaluate efficacy of energy-based devices combination therapy for melasma. We reviewed published literature since 2010 up to November 2020 regarding adjuvant therapy of energy-based devices with other treatment modalities in the treatment of melasma. After final selection, we assessed 49 articles. Energy-based devices include lasers, non-coherent lights, radiofrequency, iontophoresis, sonophoresis, microneedling, and microdermabrasion. Adjuvant therapies other than energy-based devices were lightening agents, chemical peels, platelet rich plasma (PRP) and mesotherapy. Combination of Q-switched neodymium-doped: yttrium, aluminum, and garnet (QSNY) with either intense pulsed light therapy (IPL) or pulsed-dye laser (PDL) are recommended in recalcitrant melasma in patients with light skin photo types and with dilated skin vessels (especially with PDL). Combination of fractional microneedling radiofrequency or microneedling with QSNY leads to promising results and is a safe treatment modality, especially in darker skin types. Application of topical lightening agents in combination with laser therapy leads to higher efficacy with less adverse effects (post-inflammatory hyperpigmentation) and rebound of melasma. Combination of ablative techniques with QSNY is not recommended, due to the high risk of permanent adverse effects such as guttate hypopigmentation and exacerbation of melasma.

Effect of energy-based devices on post-operative parathyroid function and blood calcium levels after total thyroidectomy

ABSTRACT Introduction: Energy-based devices are widely used in thyroid surgery in order to achieve optimal hemostasis, while their role in the incidence of hypocalcemia and hypoparathyroidism comprises a topic evaluated in numerous studies. Areas covered: The aim of this systematic review is to investigate the potential benefit of Ultrasonic Shears and Electrothermal Bipolar (Radiofrequency) System in thyroid surgery regarding the incidence of post-operative hypocalcemia and hypoparathyroidism. A systematic review of the literature in PubMed/Medline and Scopus databases was conducted. Forty-nine studies met the inclusion criteria and were analyzed. A statistically decreased rate of transient hypocalcemia and hypoparathyroidism was reported in 15 studies and 4 studies, respectively, when using energy-based devices. However, 18 and 13 surveys examined transient hypocalcemia and hypoparathyroidism, respectively, and demonstrated no statistical difference between energy-based devices and conventional hemostasis. No difference was observed between the groups concerning permanent hypocalcemia. Out of 13 studies, only 2 showed a significant reduction in the occurrence of permanent hypoparathyroidism in the energy-based device group. Expert opinion: Energy-based devices reduced the rate of transient hypocalcemia and hypoparathyroidism after thyroid surgeries in 42.8% and 23.5% of the included studies, respectively. Further studies are needed to evaluate their impact on permanent post-operative hypocalcemia and hypoparathyroidism.

Modern management of genitourinary syndrome of menopause.

The genitourinary syndrome of menopause (GSM) is the accepted term used to describe the broad spectrum of genitourinary tract symptoms and signs caused by the loss of endogenous sex steroids that occurs at the time of and after the menopause. Global improvements in healthcare have resulted in an ageing population. Today, women are spending 40% of their lives in the postmenopausal state, and with 50–70% of postmenopausal women reporting symptomatic GSM, safe and efficacious treatments are needed for this troublesome condition. This article reviews current evidence for non-pharmacological and pharmacological treatments with a focus on novel and minimally invasive procedures such as energy-based devices (CO2 laser, YAG laser), hyaluronic acid, dehydroepiandrosterone, and selective oestrogen receptor modulators.

Carboxytherapy Mask as Post Nanofractional Radiofrequency Treatment for Improvement of Facial Skin Quality and Photoaging

Background: Skin rejuvenation can be achieved with minimally invasive treatments using energy-based devices that feature reduced side effects and downtime. Post-treatment care is key to minimize any potential side effects and skin reactions such as erythema, dryness, or dyschromia. Objective: The objective of this study was to evaluate the efficacy and patient satisfaction of a novel carboxytherapy gel mask compared with petroleum-based lanolin-containing ointment to accelerate wound healing facial post-nanofractional radiofrequency treatment. Methods and Materials: Ten subjects were enrolled in this pilot, prospective, randomized, single-blind study and randomized into two arms. One arm received one nanofractional radiofrequency treatment with ointment right after and four consecutive days of ointment applications twice a day, while the second arm followed this regimen with a carboxytherapy gel mask application right after and four consecutive days after treatment. Investigator, safety, and patient assessments were conducted at 24 hours and one-week post treatment. Safety was monitored throughout. The primary endpoint was defined as the degree of investigator global assessment (IGA) in photodamage, pigmentation, and wrinkles using standardized photographs. Secondary endpoints included investigator-rated degree of erythema, edema, crusting, exudation, percentage healing, improvement of skin quality, and patient satisfaction. Results: Nine patients completed the study. There was improvement of one degree in IGA for photodamage, pigmentation and wrinkles in all patients using the carboxytherapy gel mask at the one-week follow up. Blinded investigator ratings showed significant improvement of dryness, erythema, edema, crusting, and percentage healing at the 24-hour follow up, with all patients remaining the same a week post treatment. All patients in the carboxytherapy group were satisfied with the treatment and had no adverse effects. Three patients in the petroleum-based lanolin-containing group experienced mild edema and acne breakout that resolved two weeks after treatment. Conclusion: Carboxytherapy delivered via a gel mask after skin rejuvenation procedures is a safe and effective strategy to improve clinical outcomes and reduce post-treatment side effects. J Drugs Dermatol. 20(4):461-465. doi:10.36849/JDD.5856

Radiofrequency Microneedling: A Comprehensive and Critical Review.

Many studies have evaluated radiofrequency microneedling (RFMN) in various dermatologic conditions. However, the efficacy and safety of RFMN, and how it compares with other energy-based devices in a clinician's armamentarium, remains unclear. To review higher-quality evidence supporting RFMN and the dermatologic conditions which it can be used in. A search was conducted in MEDLINE and EMBASE from inception to May 13, 2020, using the terms: "radiofrequency microneedling" OR "fractional radiofrequency" OR "radiofrequency needling" OR "radiofrequency percutaneous collagen induction." Only randomized, split body or blinded studies with original data on humans were included. Non-English or non-dermatology-related studies were excluded. Forty-two higher-quality studies were included after applying the inclusion and exclusion criteria. There were 14 studies for skin rejuvenation, 7 for acne scars, 6 for acne vulgaris, 5 each for striae and axillary hyperhidrosis, 2 for melasma, and 1 each for rosacea, cellulite, and androgenetic alopecia. Radiofrequency microneedling is an effective intervention that can be used repeatedly and safely in combination with other treatment modalities and in individuals with darker skin phototypes. Radiofrequency microneedling-induced dermal remodeling and neocollagenesis are slow and progressive but continue to improve even 6 months after treatment.

Updates on Therapeutic Alternatives for Genitourinary Syndrome of Menopause: Hormonal and Non-Hormonal Managements.

Postmenopausal atrophic vaginitis, along with vasomotor symptoms and sleep disorders, is one of the most troublesome symptoms of menopause. However, many women do not manage this symptom properly due to insufficient knowledge of the symptoms or sexual embarrassment. With appropriate treatment, many postmenopausal women can experience relief from discomforts, including burning sensation or dryness of the vagina and dyspareunia. Topical lubricants and moisturizers, systemic and local estrogens, testosterones, intravaginal dehydroepiandrosterones (DHEAs), selective estrogen receptor modulators, and energy-based therapies are possible treatment modalities. Systemic and local estrogen therapies effectively treat genitourinary syndrome of menopause (GSM), but they are contraindicated in patients with breast cancer, for whom lubricants and moisturizers must be considered as the primary treatment. Intravaginal DHEA and ospemifene can be recommended for moderate to severe GSM; however, there is insufficient data on the use of intravaginal DHEA or ospemifene in patients with breast cancer, and further studies are needed. Energy-based devices such as vaginal laser therapy reportedly alleviate GSM symptoms; however, the U.S. Food and Drug Administration warning has recently been issued because of complications such as chronic pain and burning sensations of the vagina. To summarize, clinicians should provide appropriate individualized treatment options depending on women's past history, symptom severity, and chief complaints.

Lasers and energy-based devices for treating Pre-cancerous and Non-Melanoma Skin Cancers: A review of literature

Skin cancer has been the most common type of malignancies overall with an increasing incidence. The standard of treatment is surgical excision or Mohs Microscopic surgery for high-risk cancer or sensitive areas. Lasers have been used with promising results for treating non-melanoma skin cancers. This paper provides an overall review of the available lasers and energy-based devices utilized for treating NMSK; Squamous Cell Carcinoma In Situ, Invasive Squamous Cell Carcinoma, Basal Cell Carcinoma, Keratoacanthoma, Verrucous carcinoma, and the pre-cancerous Actinic keratosis, and Porokeratosis

Efficacy of focused radiofrequency with ultrasound in body contouring: A study of 64 patients.

Energy-based devices are increasingly used for noninvasive body contouring. Our aim was to investigate the clinical efficacy of combined radiofrequency and ultrasound device for reduction in body circumference in various body parts. The aim of our study was to investigate the clinical efficacy of combined focused radiofrequency and ultrasound device for reduction in body circumference in various body parts. We aimed to report objective measurements in terms of circumference reduction and patient satisfaction scores. We retrospectively analyzed data of 64 patients who were treated with focused radiofrequency and ultrasound device during August 2017-December 2019. All patients had received 4 sessions at one-week interval. Body circumference measurements were done before treatment and one month after the last session. Patients were also asked to score their satisfaction with the result of treatment on a scale of 1 to 5. Abdomen was treated in 40 patients, thighs in 18 patients, and arms in 7 patients. One patient had received treatments to both abdomen and thighs. Circumference measurements in all body parts differed significantly between baseline and one month after the 4th session. Patients were satisfied with the result of treatment (score: 4.48±0.66). No adverse events were noted. Focused radiofrequency and ultrasound combination is a safe and effective treatment modality for body contouring. Patients should be informed about moderate degrees of improvement.

Body contouring using a combination of non-invasive energy-based devices

In this article, the author will be reviewing fat anatomy and physiology, as well as outlining how fat is distributed. Only after this baseline knowledge is established, can a comprehensive discussion on how to body contour by reducing fat be discussed thoroughly. The way cellulite develops and why females are predisposed to it is also detailed, followed by emphasis on the chronology in a holistic slimming approach (first is fat loss, then toning, followed by firming, anti-cellulite, figure shaping and spot reduction), the proper sequence of treating from the inside going out or from the inner visceral fat to the outer subcutaneous fat, from the deep reserve fat of the subcutaneous fat towards the superficial fat of the subcutaneous fat, and what ‘specific’ parameters should be used for each ‘separate’ energy (for example, infrared, radiofrequency and skin curving) after discussing the vast myriad technologies involved in different non-invasive energy based devices, including those employing lasers, primarily for aesthetic purposes, but consequently with health benefits.

The Efficacy and Safety of a Variable Square Pulse (VSP) Erbium:YAG Laser for Treatment of Enlarged Pores in Asians.

Enlarged pores are one of the most common causes of skin surface irregularities. Existing studies supporting the benefit of lasers and energy-based devices (EBD) for this condition are limited, with a short duration of follow-up period. We aimed to evaluate the efficacy and adverse effects of Er:YAG laser for treatment of enlarged pores in dark-skinned patients. Nineteen subjects (aged 26-47 years) with skin phototypes III (21.1%) and IV (78.9%) and enlarged pores were treated with 4 monthly sessions of Erbium:YAG laser. Objective (ultraviolet light A video camera) and subjective (clinical evaluation by two blinded dermatologists) assessments were obtained at baseline, 1-month after each treatment and at 1, 3, and 6 months after the final treatment. The weighted mean score of quartile grading scales showed significant improvement in pore size from baseline starting at 1-month after the third treatment and continued until 3 months after the fourth (final) treatment (P < 0.001). However, the improvement dropped significantly at 6 months after the final treatment. Objective measurements of the improvements in skin surface smoothness and wrinkles corresponded with the physician raters' clinical evaluation. Erbium:YAG laser is a safe and effective treatment for enlarged pores in dark-skinned individuals. Maintenance treatments are recommended to achieve a longer-lasting outcome. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Safety Profile of Combined Same-Day Treatment for Botulinum Toxin With Full Face Nonablative Fractionated Laser Resurfacing.

Spread of botulinum toxin outside the treated muscle is a concern, when energy-based device treatment is performed on the same day as toxin injection. We assessed the frequency of eyelid ptosis after the glabella/periorbital botulinum toxin injection and nonablative fractionated laser performed at the same session. This single-center, retrospective study identified treatments consisting of glabella and/or periorbital botulinum toxin injection and nonablative fractionated laser treatment to full face from 2017 to 2019 and eyelid ptosis determined by documentation of the complication at a follow-up encounter, or prescription of apraclonidine. Six hundred sixteen treatments of glabella/periorbital botulinum toxin injection and full-face nonablative fractionated laser on the same day on 393 individuals were identified. Five hundred eighty treatments (94%) included botulinum toxin injected in the glabella, 541 (88%) in the periorbital areas, and 508 (82%) in the forehead. Nonablative fractionated lasers used to treat the cohort were a 1,927-nm thulium and a 1,550-nm er:glass laser. Eyelid ptosis complication was documented in one case (0.2%) following the combined laser and toxin treatment. The risk of spread of glabella/periorbital botulinum toxin to an unintended muscle was minimal in the setting of the concomitant full-face nonablative fractionated laser.

Topical Delivery of Nivolumab, a Therapeutic Antibody, by Fractional Laser and Pneumatic Injection.

PD-L1 is a tumor ligand that binds to the PD-1 receptor on immune cells, thereby inhibiting the antitumor immune response. The antibody nivolumab is a PD-1 inhibitor, Food and Drug Administration approved for systemic treatment of several aggressive cancer types. Topically applied nivolumab may hold potential as a future strategy to treat keratinocyte cancer, but its molecular properties preclude unassisted topical uptake. The aim of this study was to investigate uptake and biodistribution of topically delivered nivolumab, assisted by two physical enhancement techniques with different delivery kinetics; ablative fractional laser (AFL) and electronically controlled pneumatic injection (EPI). In vitro porcine skin was exposed to CO2 AFL (20 mJ/mb, 5% density), followed by passive diffusion of nivolumab in a Franz cell (1 mg/ml, 18 hours, n = 6) or treated with EPI (4 bar) for immediate delivery of nivolumab (1 mg/ml, 10 minutes, n = 6). The resulting nivolumab skin concentrations were quantified by enzyme-linked immunosorbent assay (ELISA) at three skin depths (100, 500, and 1500 µm), comparing the uptake from assisted delivery with intact skin. Biodistribution of nivolumab in the skin for all interventions was visualized by laser ablation-inductively coupled plasma-mass spectrometry (LA-ICP-MS) and fluorescence microscopy. Delivery of nivolumab by AFL-assisted passive diffusion and immediate EPI both resulted in significantly enhanced uptake of nivolumab in all skin depths compared with intact skin (P < 0.05). WithAFL, nivolumab concentrations reached 86.3 µg/cm3 (100 µm), 105.8 µg/cm3 (500 µm), and 19.3 µg/cm3 (1500 µm), corresponding to 2-10% of the applied concentration, with the highest deposition in the mid dermis. Immediate EPI delivered 429.4 µg/cm3 (100 µm), 584.9 µg/cm3 (500 µm), and 295.9 µg/cm3 (1500 µm) into the skin, corresponding to 29-58% of the applied nivolumab concentration. From qualitative visualization of the biodistribution, it appeared that nivolumab distributed in a horizontal and continuous homogenous band in the upper and mid dermis through AFL-exposed skin, whereas EPI-delivery showed a deep focal deposition extending into the deep dermis. AFL-assisted passive diffusion and immediate EPI-assisted delivery show the potential to deliver therapeutic antibodies locally. Future in vivo and pharmacokinetic studies would reveal the full potential for topical antibody delivery by energy-based devices. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports.

Energy-based devices have gained momentum as minimally invasive procedures to treat both medical and cosmetic pelvic floor disorders including genitourinary syndrome of menopause, vaginal laxity, stress urinary incontinence, dyspareunia, and vulvar disorders such as lichen diseases and vestibulitis. However, the FDA recently issued a statement cautioning patients and providers that the safety and efficacy of energy-based devices for the treatment of vaginal symptoms has not been well established. Additionally, the FDA sent letters to the manufactures of energy-based devices with notifications that they could be violating the marketing standards of the FDA. The existing data on side effects is insufficient and limited to observational studies. We sought to characterize the safety events of vaginal energy-based devices by analysis of surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database and specifically look at those events that occurred prior to the July 30, 2018 warning. The MAUDE database was queried between September 30, 2013 and October 31, 2019 for all vaginal energy-based devices. The incidence of safety events was reported for these devices and the most common complaints were described and characterized. Event reporting was analyzed before and after July 30, 2018. Forty-two unique and relevant medical device reports (MDRs) were retrieved. The Mona Lisa Touch had the highest number of MDRs (40.5%) followed by ThermiVa (16.7%) and Viveve (14.2%). Each medical device report was associated with a single patient experience and within the 42 medical device reports, there were 85 complaints. A majority of the MDR complaints (52.9%) were also indications for energy-based devices procedures, which include vaginal pain, dyspareunia, lichen sclerosis, and urinary frequency. Two-thirds of the complaints (68.2%) were related to pain, but serious adverse events such as third-degree burns (3.5%) were rare. Most of the reportable events occurred before July 30, 2018 (83.3%), but most were reported after July 30, 2018 (78.6%). MAUDE-reported data suggests that the majority of patient complaints after vaginal energy-based device treatment include vaginal pain, bladder pain, and urinary symptoms. This study suggests that the majority of complaints are not severe, and some may be related to progression of the disease. The few severe adverse events reported in the MAUDE database may have contributed to the FDA warning regarding energy-based devices. Recall bias after the FDA warning, as well as the potential for litigation, may have prompted an increase in adverse event reporting after July 30, 2018.

Prophylaxis of Post-Inflammatory Hyperpigmentation From Energy-Based Device Treatments: A Review

Post-inflammatory hyperpigmentation (PIH) is an acquired hypermelanosis that can result from inflammatory dermatologic disease, trauma, or iatrogenesis from procedures. This condition disproportionately affects individuals with skin of color, and it can place a significant psychosocial burden on affected patients. The management of PIH is, therefore, of great interest to clinicians, especially dermatologists. The treatment of established PIH has long been a principal focus within the literature, with publications on the topic outnumbering publications on prophylaxis of PIH. Prophylaxis strategies to prevent PIH vary greatly in clinical practice, likely due to the absence of an evidence-based consensus. Published approaches to PIH prophylaxis include pretreatment (topical alpha hydroxy acids, retinoids, hydroquinone, and brimonidine) and post-treatment strategies (photoprotection, corticosteroids, and tranexamic acid). This review will examine the current literature on prophylaxis of PIH from energy-based device treatments.